Selective inhibition of estrogen production and activity in human

FIELD: medicine.

SUBSTANCE: bioactive food additive contains the products of Morinda citrifolia processing, which is used to inhibit the aromatase or aromatase enzymes transforming the androgens to estrogens, to inhibit the receptor binding to estrogens and to decrease and/or regulate the estrogen production. The invention reduces and regulates the estrogen production.

EFFECT: efficient in treatment of estrogen-dependent cancer and conversion of estrogen-dependent malignant tumors.

60 cl, 1 tbl, 1 ex

 

The SCOPE TO WHICH the INVENTION RELATES.

The present invention relates to estrogenic action in the human body. More specifically, the present invention relates to the use of biologically active composition or the additive for selective inhibition of estrogen production and provision of estrogenic action in the human body, where the composition includes one or more food processing plants Indian mulberry, whose scientific name is Morinda citrifolia L.

The LEVEL of TECHNOLOGY

Estrogens are steroid hormones mainly produced by the ovaries and is responsible for promoting estrus and the development and maintenance of female secondary sex characteristics. In humans, estrogen is produced in the ovary, probably in the cortical substance of adrenal glands in the testes and complex fetus-placenta. Estrogens have different functions. For example, they are responsible for the development of female secondary sexual characteristics, and during the menstrual cycle and their effect on the female genitals is to provide an environment suitable for fertilization, implantation and nutrition of the embryo in the early stages of development.

For the production of estrogen is responsible enzyme called aromatase, which is part of the enzyme complex known as cytochrome P450, to the which is present in various organs and tissues of the body and, in particular, in some vital organs. The enzyme aromatase in the body is expressed in the placenta, adipose tissue, hair follicles, muscles, bones, liver and brain. Brain aromatase is in the front and mediobasal the hypothalamus.

Aromatase effect on the conversion of C19 androgens to aromatic C18 estrogenic steroids. However, aromatase is also able to metabolize xenobiotics. The ability or function aromatase to convert adrenergic androgenic substrates in estrogen is considered as the only source of estrogen in women in postmenopausal period. Therefore, inhibitors of the enzyme aromatase is used for treatment of postmenopausal breast cancer and other estrogen-dependent diseases.

Only recently, aromatase inhibitors have been found to be effective in the treatment of breast and other estrogen-dependent diseases. The use of such inhibitors continues to grow. Aromatase inhibitors belong to the family of the hormonal drugs which in laboratory testing and in some clinical trials have demonstrated significant anticancer activity against breast cancer diagnosed in women in postmenopausal period. Aromatase inhibitors are particularly preferred, and eff is active in cases when women have a high sensitivity to estrogen.

It was found, and believe that more than two thirds of breast cancers are estrogen-sensitive, because they are able to grow and proliferate in the field of breast cancer and to go beyond it. To prevent such excessive growth introduced the use of aromatase inhibitors, which reduce the amount of circulating estrogen in the body of women in the postmenopausal period and, thus, cause the cessation of growth or even a decline in estrogen-sensitive or estrogen-dependent tumors. Estrogen-sensitive malignant tumor is also called ER+(estrogen receptor positive), or, in other words, progesterone-receptor positive (PR+).

Any cancer or tumor cells have receptors (binding sites)that are located on their cell membrane. When the production and secretion of estrogen in the body is its binding to these cell receptors. Thus, to determine the effectiveness of the inhibitor therapy can be estimated at each receptor and the effectiveness of its binding to estrogen. The efficiency of binding is usually called "status of the receptor". Along with this, the status of the receptor is responsible for the invasiveness of breast cancer.

Many aromatase inhibitors inhib the shape of the binding with estrogen receptors, while others inhibit aromatase enzymes, whose function is the conversion of androgens into estrogens. In addition, aromatase inhibitors reduce the amount of estrogen more efficiently after menopause, because during menopause both ovaries cease to produce estrogen. However, this does not mean that the body does not produce estrogen. Low levels of estrogen, which occurs after menopause is the result of work aromatase enzymes that turn other natural hormones into estrogen. Essentially, aromatase inhibitors have been developed for efficiently blocking the production of estrogen by the enzyme aromatase. As a result, the levels of estrogen in the body decreases, and estrogen-dependent tumors begin to shrink and disappear. On the contrary, pre-menopausal oestrogen is mainly produced in the ovaries and only a small amount is produced in the conversion process under the action of aromatase. Numerous studies have shown that women premenopausal aromatase inhibitors is not sufficient to reduce the levels of estrogen to affect tumor growth.

Currently a very limited number of aromatase inhibitors has been approved by Management under the control over products and medicines and is in use. Most the iroko used inhibitors are arimidex® Aromasin® and femara® and all of them have been few clinical trials. Despite the fact that they effectively inhibit aromatase enzymes, these inhibitors cause numerous unwanted side effects in patients, making their use in the treatment less popular and allogenically. Interestingly, approved the treatment of women in the postmenopausal period include the use of drugs that are both reversible and irreversible blocking estrogen receptors on cell surfaces. Their side effects include, but are not limited to, sweating, hot flashes, fatigue, change in appetite, headache, bone pain, chest pain, coughing, difficulty breathing and, in some patients, the thrombus formation.

Also, there are techniques to obtain estrogen to increase the level of estrogen in the body. Such techniques include receiving estrogen from the urine of pregnant horses. Despite the method, it has some side effects that are similar to side effects that occur with hormone-replacement therapy, such as sweating, hot flashes, fatigue, change in appetite, headache, bone pain, chest pain, cough, shortness of breath, and the like. In this regard, attempts were made which create better methods of obtaining and/or improved compositions for safe estrogen, which can be used in the body.

Thus, although currently there are technologies that are used for inhibiting estrogen production and for obtaining research and development team of estrogen for use in the body, there are still shortcomings, including such unwanted side effects like sweating, hot flashes, fatigue, change in appetite, headache, bone pain, chest pain, cough, shortness of breath, and the like. Accordingly, in this area requires additional techniques or even techniques that could replace the existing ones.

SUMMARY of the INVENTION

The present invention relates to estrogenic action in the human body. More specifically, the present invention relates to the use of biologically active composition or the additive for selective inhibition of estrogen production and provision of estrogenic action in the human body, where the composition includes one or more products derived from plants of the Indian mulberry, whose scientific name is Morinda citrifolia L.

The implementation of the present invention is associated with a biologically active composition or additive, obtained from plants of the Indian mulberry, whose scientific name is Morinda citrifolia L. ("Morida citrifolia"). The Morinda citrifolia product may be obtained from fruits, leaves, seeds, roots or any other part of Morinda citrifolia. In one embodiment, the implementation of the dietary Supplement includes fruit juice, Morinda citrifolia, restored from pure puree the fruit is grown in French Polynesia. The additive may also include other natural juices, such as concentrate, natural grape juice concentrate, blueberry juice and/or concentrate other natural juice. In one of the embodiments of the liquid fraction obtained from the fruit Morinda citrifolia and used for the production of biologically active additives for use. In at least one embodiment, the implementation of a dietary Supplement called "Tahitian Noni"® and can be purchased from Morinda, Inc., principal place of business which is located at 5152 N. Edgewood Dr. #100, Provo, UT, 84604.

In another embodiment, a biologically active additive obtained from the leaves of Morinda citrifolia from getting dry or powdered biologically active additives that may be added, for example in tablet form for use. Even in one of the embodiments the composition is in the form of a dermal cream, which is applied to the surface of the skin of the individual.

At least, and W is gcih variants of implementation of the present invention are biologically active additive or composition provides estrogenic effect in the body, the effect of biologically active additives or compositions softer than the effects of estrogen and, therefore, does not cause related side effects. For example, hormone replacement therapy can cause cancer of estrogen-dependent cells in organs such as mammary gland, uterus and/or ovaries, the use of biologically active additives is preferred because of its slower excretion.

Biologically active additive or composition can be used as a replacement of estrogen in hormone replacement therapy, thus its action is weaker. In the case of high concentrations of natural estrogens, dietary Supplement will reduce the effect of natural estrogen, and at very low concentrations of natural estrogen it will provide estrogenic activity.

In some embodiments, the implementation of women get leaf extract, juice or other Morinda citrifolia product in liquid form, in dry form in a capsule or in the form of a cream. In one of the embodiments, the patient receives at least one gram per day. Thus, in accordance with at least some of the options for implementation of the present invention the use or application by other biologically active additives individual provides estrogenic effect in the body of the patient DL the prevention or termination of such symptoms as hot flashes, night sweats, bleeding, depression, which is characterized at the beginning of menopause. In addition, biologically active additive prevents osteoporosis or improves the condition of osteoporosis.

There are two types of cells called osteoblasts and osteoclasts, which are responsible for maintaining the normal state of the bone tissue. Osteoblasts are responsible for the rebuilding of bone, and osteoclasts are responsible for the destruction of bone matrix. The level of calcium in the blasts must be constant and bone is a buffer to maintain calcium levels. If the level of calcium in the blood decreases, the bone matrix will be destroyed by osteoclasts, increasing the level of calcium. During pregnancy calcium from the mother's blood is actively absorbed by the embryo, as is the formation of his skeleton. Therefore, the metabolism of bone matrix of the skeleton of the mother increases. During pregnancy, estrogen levels are high, since estrogen is very important for processes in osteoblasts responsible for bone reconstruction, and during menopause estrogen levels drop. The process of bone realignment of weakening, the woman loses bone matrix and occurs osteoporosis. Thus, the use of biologically active additives of the present invention can provide an oestrogenic effect and to compensate for the sweat and bone matrix in the body. Thus, in accordance with at least some of the options for implementation of the present invention the product of the processed Morinda citrifolia, for example leaves, juice or other part of the Morinda citrifolia, can be used for the selective provision of estrogenic action in the body.

At least in some embodiments, the implementation of the dietary Supplement, in addition, inhibits aromatase or aromatase enzymes, the function of which is the conversion of androgens into estrogen, thereby inhibiting the binding with estrogen receptors and reducing and/or regulating the production of estrogen, while also reducing the amount produced estrogen in the body and regulating such products by inhibiting aromatase in the treatment of cancer and, in particular, in the treatment of estrogen-dependent malignant tumors by introducing into the organism (e.g., by ingestion) safe, predetermined dose of the composition of biologically active additives, which includes one or more processing products Morinda citrifolia for a predetermined safe period of time.

In one embodiment, the implementation of product processing Morinda citrifolia received in the form of fruit juice, leaves, puree juice or juice puree, pulp fruit, seed oils and/or dietary fiber, using the technique(s)is written(s) here. Then the quantity of any product or combination of products included together with other ingredients in the composition of dietary supplements that have beneficial effects on the body and contributing to the treatment of cancer and providing preventive effects by inhibiting aromatase enzymes.

One of the embodiments of the present invention relates to compositions of biologically active additives including at least one product processing Morinda citrifolia, for inhibition of aromatase or aromatase enzymes in mammals; and the way of its introduction.

One of the embodiments of the present invention also relates to compositions of biologically active additives, which includes at least one product derived from one of several forms of Morinda citrifolia (preferably fruit juice or powder of the leaves), together with other ingredients, either natural or synthetic, if necessary. The preferred composition of biologically active additive is a liquid composition that can be administered orally or via intravenous injection, where the active ingredients, namely Morinda citrifolia, is able to be absorbed in the tissues and to inhibit aromatase and reduce/regulate the production of estrogen.

One is C of embodiments of the present invention relates to a method of inhibiting aromatase and treating, the inhibition, prevention and reversibility of the growth of cancer cells, through prophylactic use of the composition of biologically active additives, comprising as an active ingredient includes at least one product processing Morinda citrifolia.

Although the ways and methods of the present invention have been proved for specific applications in the field of selective inhibition of the production of estrogen and/or estrogen actions in the body, the person skilled in the art will understand that these methods and techniques can have a large number of different practical applications, and in many different forms with obtaining a composition which is the product of the processed Morinda citrifolia to provide selective control estrogen levels by inhibiting the production of estrogen and/or provide moderate estrogenic action.

These and other features and advantages of the present invention will be described or will become fully apparent from the following description and the accompanying claims. The characteristics and advantages may be realized and obtained by means of the instruments and combinations, listed in detail in the attached claims. In addition, characteristics and advantages of the present invention can be explored through practical what about the application of the invention or will be apparent from the description, below.

DETAILED description of the INVENTION

The present invention relates to estrogenic action in the human body. More specifically, the present invention relates to the use of biologically active composition or the additive for selective inhibition of estrogen production and provision of estrogenic action in the human body, where the composition includes one or more food processing plants Indian mulberry, whose scientific name is Morinda citrifolia L.

The present invention relates to a method and the method of obtaining drugs for the selective inhibition of estrogen production and provision of estrogenic activity and for the treatment and prevention of the growth of cancer cells in mammals, as well as to reduce the production of estrogen, stimulates growth of estrogen-dependent cancers, in mammals, by prophylactic use of the composition of biologically active additives containing at least one product Morinda citrifolia in processed form.

Presents preferred embodiments of the invention will be better understood, and its effects and advantages more clearly indicated by separation of the following detailed description. The first part refers to a General description of the plant Morinda citrifolia, including the Isla to the description of its origin, methods of processing and rendering the beneficial effects on the body, as well as the methods used to obtain products processing Morinda citrifolia, is used as the main active ingredients of the compositions of biologically active additives described here; the second part in more detail and specifically discusses the structure and composition of which is the product of processing Morinda citrifolia used to provide estrogenic actions; and in the third part in more detail and specifically described compositions of biologically active additives and compositions, which include product processing Morinda citrifolia used for inhibition of aromatase and reduce/control the production of estrogen in the body, as well as to various methods of application of these biologically active additives for inhibiting the growth, proliferation, metastasis and viability of estrogen-dependent cancer cells. There are also examples of experimental studies and the results obtained.

Accordingly, the following description of the present invention is divided into three subheadings: "dietary Supplement", "Providing estrogenic action and Inhibition of estrogen production". The subheadings used solely for the convenience of the reader and should not be considered as the constraints.

Dietary Supplement

Embodiments of the present invention relates to biologically active additive, which is obtained from recycled plant Indian mulberry, whose scientific name is Morinda citrifolia L. ("Morinda citrifolia"), which is a shrub or small tree up to 10 m oval Leaves are at the same height against each other. Small white flowers form a fleshy, globose, umbrella-shaped inflorescence. The fruits are large, fleshy and oval. Mature fruits have a creamy-white color and edible, but have an unpleasant taste and smell. This plant is native of Southeast Asia, but in ancient times it spread over a vast area from India to Eastern Polynesia. Wild plant grows randomly, and cultural grows on plantations and small private plots. Flowers Morinda citrifolia small, white, three -, five-petalled, cylindrical, fragrant, a length of about 1.25, see Flowers bloom complex fruit consisting of many small fruits, in the United ovoid, ellipsoid or globose, rough body, with waxy, white or greenish-white or yellowish, translucent skin. On the surface of the fruit has "eyes", similar to potato. Juicy, unpleasant taste, dull yellow or yellowish-white fruit will gain numerous red-brown, solid, oblong-triangular, winged 2-cell bone, each of which contains four seeds.

Fully ripe fruit has a pronounced smell like procureme cheese. Although the fruit has been used as food by some nationalities, most often of the plant Morinda citrifolia used as a source of red and yellow paint. Recently, the plant Morinda citrifolia was interest from the point of view of nutritional and health effects, discussed below.

Since, for all practical applications the fruit of the Morinda citrifolia is inedible, the fruit must be processed in such a way as to make it appetizing to humans, and include it in biologically active additive used to provide estrogenic actions of aromatase inhibition and effects on various cancer cells. Processed fruit juice of Morinda citrifolia can be obtained by separating the seeds and peel from the juice and pulp of the ripe fruit of Morinda citrifolia; the separation of juice from the pulp by filtration; and packaging the juice. Alternatively, instead of packing juice, the juice can be immediately included as an ingredient in another food product, frozen or pasteurized. In some embodiments, the implementation of the juice and pulp can be processed into a homogeneous mixture for mixing with d the natives ingredients. Another method includes drying the frozen fruit and juice. The fruit and juice can be restored when the final product-juice. Other methods include air drying fruit and juices before chafing.

Embodiments of the present invention provide for the extraction of Morinda citrifolia product from the leaves of Morinda citrifolia and use of this product in the composition of capsules or tablets for inhibiting estrogen production and ensure estrogenic actions in the body.

Embodiments of the present invention also include the use of fruit juice and/or fruit purees obtained from the plant Morinda Citrifolia. In this preferred method of obtaining fruit juice of Morinda citrifolia fruits are harvested by hand or with mechanical equipment. The fruits can be harvested when their size reaches at least 1 inch (2-3 cm) to 12 inches (24-36 cm) in diameter. Preferably, the color of the fruit can be dark green, yellow-green, white, and intermediate shades. After collecting the fruit thoroughly washed before any further processing.

The fruit is left to ripen or endure from 0 to 14 days, usually 2-3 days. The fruit Matures or it is kept in the fixture so that he had no contact with the ground. The fruit during ripening preferably bracelet cloth or mesh material, but the fruit can ripen without it. The fruit is ready for further processing, if the color is bright, light green, light yellow, white, or translucent. The fruit is carefully inspected for damage or excessive green color and hardness. Broken or solid green fruit is separated from the suitable fruit.

Preferably, ripe fruit, and fruit that stand for further processing and transport, are placed in airtight plastic containers. Containers with ripe fruit can be stored from 0 to 30 days. Often before processing containers with fruit stored 7-14 days. If desired, before further processing the containers can be stored in cold conditions. After removing from the container the fruit is subjected to manual or mechanical sorting. Skin and seeds are separated from the juice and pulp.

The juice and pulp can be Packed into containers for storage and transportation. Alternatively, the juice and pulp can be immediately processed into the final product-juice. The containers can be stored in cold conditions, can be frozen or kept at room temperature.

The juice and pulp of Morinda citrifolia preferably mixed until a homogeneous mixture, which can then be mixed with other ingredients, such as flavorings, sweeteners, nutritional components, rastitelnymi components and dyes. The final product-the juice is preferably heated and pasteurized at a minimum temperature of 181°F (83°C) or at a maximum temperature of 212°F (100°C).

Other product derived from Morinda citrifolia is a puree and juice puree, either as a concentrate or diluted form. Essentially, puree represents the fruit pulp is separated from the seeds, and differs from the fruit juice is another product that is described here.

Each product is placed and sealed in a final container of plastic, glass or other suitable material that can withstand the treatment temperature. The containers leave when the temperature at which occurred the content, or they can be cooled down quickly and placed in a shipping container. Preferably, the transport containers wrapped in the material in order to maintain or control the temperature of the product in the final container.

The juice and pulp can then be separated through the filter unit. Preferably, the filter unit consists of, but is not limited to, the centrifuge Cup, strainer size from 1 micron to 2000 microns, more preferably less than 500 microns, filter press, reverse osmosis or any other standard commercial filtration devices. PR is doctitle, working pressure filtration is in the range from 0.1 psi to about 1000 psi. The preferred flow rate is between 0.1 g/min to 1000 g/min and, more preferably, between 5 and 50 g/min Juicy, fresh pulp is washed and filtered at least once and up to 10 times to remove all the juice from the pulp. Fresh pulp usually contains 10-40% by weight of fiber. Preferably, fresh pulp pasteurized at a minimum temperature of 181°F (83°C), then a is Packed in a cylindrical box for further processing or cooking of the product, which is rich in fiber.

The product of the processed Morinda citrifolia can also be dietary fiber. In addition, the product processing Morinda citrifolia may be in the form of an extract (for example, powdered extract), extracted from the leaves of Morinda citrifolia. The product processing Morinda citrifolia may be in the form of oil. The Morinda citrifolia oil usually contains a mixture of several different fatty acids, such as triglycerides, such as palmitic, stearic, oleic and linolenic fatty acid, and other fatty acids, which are present in smaller quantities. In addition, the oil preferably contains an antioxidant, inhibiting the degradation of the oil. Preferably, use normal dietary antioxidants.

Morinda citrifolia rich nature of the implementing components. For example, natural ingredients include: (leaves) alanine, anthraquinones, arginine, ascorbic acid, aspartic acid, calcium, beta-carotene, cysteine, cystine, glycine, glutamic acid, glycosides, histidine, iron, leucine, isoleucine, methionine, nicotinic acid, phenylalanine, phosphorus, Proline, resin, Riboflavin, serine, beta-sitosterol, thiamine, threonine, tryptophan, tyrosine, ursolic acid and valine; (colours): acacetin-7-o-beta-d(+)-glucopyranosid, 5,7-dimethyl-apigenin-4'-o-beta-d(+)galactopyranoside, and 6,8-dimethoxy-3-methylanthracene-1-o-beta rhamnosyl-glucopyranoside; (in fruits) acetic acid, asperuloside, butyric acid, benzoic acid, benzyl alcohol, 1-butanol, Caprylic acid, dekanovu acid, (E)-6-dodecene-gamma-lactone, (Z,Z,Z)-8,11,14-eicosatrienoic acid, elaidic acid, ethyl decanoate, ethyl hexanoate, ethyl octanoate, ethyl palmitate, (Z)-6-(ethylthiomethyl) benzene, eugenol, glucose, heptane acid, 2-heptanon, hexanal, hexanamide, hexandiol acid, Caproic acid (hexanoic acid), 1-hexanol, 3-hydroxy-2-butanone, lauric acid, lemon, linoleic acid, 2-methylbutanoyl acid, 3-methyl-2-butene-1-ol, 3-methyl-3-butene-1-ol, methyl decanoate, methyl elaidate, methylhexanoate, methyl 3-methylthio-propanoate, methyloctanoic, methyl oleate, metrpolitan, 2-m is typomania acid, 3-multiproperty acid, myristic acid, novanova acid, octanoic acid (Caprylic acid), butyric acid, palmitic acid, potassium, scopoletin, undecanoate acid, (Z,Z)-2,5-undecadien-1-ol and woeful; (roots) anthraquinones, asperuloside (rubyhornet acid), damnacanthal, glycosides, Morondava, morindin, morindin, slimy substance, nonunital, rubiadin, onomatology ether rubiadin, resin, carnival, sterols, and trihydroxysilyl anthraquinone-onomatology ether; (root bark) alizarin, horrobin, glycosides (pentose, hexose), Morondava, marinangel, morindin, morindin, resinous substance onomatology ether rubidium, and carnival; (wood) astragalo-2,3-dimethylether; (from tissue culture) damnacanthal, lucigen, lucigen-3-primaverii, and Merendon-6-beta-premieroil; and (from plants) alizarin, alizarin-alpha-methyl ether, anthraquinones, asperuloside, Caproic acid, Morondava, morindin, morindland, octanoic acid, and ursolic acid.

As indicated, most recently, it was found that the use of products containing Morinda citrifolia, is good for health. It was found that Morinda citrifolia able to select and produce xeronine, which is relatively small alkaloid that is physiologically active in the body. Xeronine meets practical and in all healthy cells of plants, animals and microorganisms. Despite the fact that the plant Morinda citrifolia has a negligible amount of free xeronine, it contains a significant number of predecessor xeronine called proxeronine. Moreover, Morinda citrifolia contains an inactive form of the enzyme proxeronine, which converts proxeronine in xeronine. In the publication R.M.Heinicke University of Hawaii "The Pharmacologically Active Ingredient of Noni indicates that Morinda citrifolia is the best raw material for making xeronine", due to the presence of building blocks proxeronine and proxeronine. These building blocks contribute to the selection and production of xeronine in the body. Essential nutrient, xeronine has four functions.

First, xeronine serves as an activator of enzymes of the small intestine. These enzymes are essential for effective digestion, have a sedative effect on the nerves and is essential for overall physical and emotional state. Secondly, xeronine protects and maintains the shape and flexibility of protein molecules so that they could pass through the cell wall and used for the formation of healthy tissue. Without these nutrients coming into the cell, the cell is unable to effectively do their jobs. Without proxeronine that produces xeronine, affected cells, and posledstviya the body. Thirdly, xeronine increases since cell membranes. This increase allows you to enter the cage of a larger polypeptide chains (amino acids or proteins). If these circuits are not used, they are disposed of. Fourthly, xeronine derived from proxeronine, increases pore, thereby contributing to a better absorption of nutrients.

In each tissue has cells that contain proteins with receptor sites for absorption of xeronine. Some of these proteins are inert forms of the enzymes for the activation of which requires the absorption of xeronine. Thus, xeronine safely and quickly removes dead tissue from the skin by transforming the system procollagenase organism-specific protease. Other proteins, after interaction with xeronine acquire potential receptor sites for hormones. Thus, the property of Morinda citrifolia to improve the human condition, probably due to the ability of xeronine to convert some receptor proteins brain in active areas for absorption of endorphins, the feel-good hormones. Other proteins form pores in the membranes of the intestines, blood vessels and other organs. The absorbance of xeronine these proteins changes the shape of the pores and, thus, affects the passage of molecules through membranes is.

It is known that as a result of its favourable effects of Morinda citrifolia provides many incredible effects in cancer patients suffering from arthritis, headaches, digestive disorders with malignant tumors, broken bones, high blood pressure, diabetes, pain, infection, asthma, toothache, spots on the skin, immune deficiency, and the like.

Compositions containing Morinda citrifolia can be. in a form suitable for oral administration, systemic administration, injection and the like. As for the oral composition, such a composition may be, for example, in the form of tablets or lozenges, aqueous or oily suspensions, dispersible powders or granules, emulsions, syrups or elixirs. Compositions intended for oral use can be obtained by any method known in this field for more Morinda citrifolia compositions, and such compositions may contain one or more agents selected from the group comprising sweeteners, flavouring substances, dyes and preservatives. Tablets contain Morinda citrifolia in a mixture with non-toxic pharmaceutically acceptable inert fillers that can be used to obtain tablets. These inert fillers can be, for example, inert diluents, granularly and and dezinfeciruyuhimi substances, binding agents and lubricants. Tablets may be uncoated or can be coated using known technologies, in order to avoid destruction and absorption in the gastrointestinal tract that provides deferred action for an extended period of time. For example, you can use materials that provide deferred action, such as glycerylmonostearate or glycerylmonostearate.

Water suspension containing Morinda citrifolia in a mixture with inert fillers that can be used to obtain aqueous suspensions. Such inert fillers are suspendresume substances, such as sodium carboxymethyl cellulose, methylcellulose, hypromellose, natriolienate, polyvinylpyrrolidone, tragacanth gum and Arabic gum; dispersing or wetting agents may be natural phosphatides, for example lecithin, or condensation products of oxide alkylene with fatty acids, for example polyoxyethylene, condensation products of ethylene oxide with long chain aliphatic alcohols, for example heptadecadiene-axiatonal, or condensation products of ethylene oxide with partial esters derived from fatty acids and exit, as, for example, polyoxyethylene sorbitol monooleate, or condensation products of ethylene oxide with partial EF is Rami, originating from fatty acids, and anhydrides of exit, for example polyethylene, sorbitan monooleate.

Thus, embodiments of the invention selectively inhibit the production of estrogen and provide estrogenic action. In some embodiments, the implementation of liquid or dry extract includes product processing Morinda citrifolia. In other embodiments, implementation, to facilitate the admission of the product provided in the form of capsules. In some embodiments, the implementation of at least one gram is applied daily until symptoms disappear.

Providing estrogenic actions

As described above, the present invention relates to the control of oestrogen action in the human body. More specifically, the present invention relates to the use of biologically active composition or the additive for selective inhibition of estrogen production and provision of estrogenic action in the human body, where the composition includes one or more products derived from plants of the Indian mulberry, whose scientific name is Morinda citrifolia L.

Phytoestrogens are certain compounds found in plants that have a similar effect with natural estrogens. Plants rich in phytoestrogens are claparon racemose (Cimicifuga racemosa), soybean (Glycine max.), rainy clover (Trifolium pratense) and hops (humulus lupulus). Studies conducted by the inventors show that Morinda citrifolia (fruits and leaves) also exhibits estrogenic activity. This is confirmed by the fact that women who consume foods rich in phytoestrogens, less health problems during menopause.

Estrogenic activity of alcoholic extract of leaves of Morinda citrifolia was studied in two In vitro methods. (1.) Replacement of estrogen on the selected receptor alpha and beta (ER-alpha, ER-beta); and (2.) Introduction alkaline phosphatase in cells Ishikawa (carcinoma of the endometrium person). Used alcohol extract of crushed dry leaves of Morinda citrifolia (grown in Tahiti). One milliliter of the extract contains 100 ál of leaves.

In the case of replacement of estrogen were used recombinant ER-alpha and ER-beta. Receptors were saturated by estradiol, labeled with tritium. After adding the test substance was measured by the free unbound radioactivity. The method used was based on the publication Kuiper et al., 1998. Kuiper GG, Lemmen J G, Carlsson B, Corton J C, Safe S H, van der Saag P T, van der In In and Gustafsson J A (1998) Interaction of Estrogenic Chemicals and Phytoestrogens with Estrogen Receptor Beta. Endocrinology 139: pp 4252-4263.

The results showed that both receptors has been a steady replacement of estradiol. Replacement of estrogen reached the 100% level, which is characteristic of phytoestrogens. The affinity of the extract of the leaves to ER-alpha was p is almost 5 times more than to ER-beta (see figure 1).

Induction of the enzyme alkaline phosphatase is under control of the estrogen receptor. It is known that estradiol has a regulatory function in bone reconstruction. Alkaline phosphatase is a key enzyme in this process. Cells Ishikawa used as a model for studies of agonistic action of compounds with estrogenic activity (Wober J, Weisswange I and Vollmer G (2002) Stimulation of Alkaline Phosphatase Activity in Ishikawa Cells Induced by Various Phytoestrogens and Synthetic Estrogens. J Steroid Biochem Mol Biol 83: pp 227-233).

The leaf extract of Morinda citrifolia has a secondary, but significant induction of alkaline phosphatase in cells Ishikawa. The maximum effect was obtained at a concentration of 0.3 ml/ml (corresponding to 30 mg of dry leaves/ml). Higher concentrations inhibited the induction of the enzyme (see figure 2).

Accordingly, the estrogenic activity of alcoholic extract of leaves of Morinda citrifolia, has been shown in two in vitro assays commonly used to study estrogenic activity. Both studies showed positive effects. The results suggest the possible use of the leaves of the Noni to treat symptoms caused by lack of estrogen (for example, the menopause and oophorectomy).

Phytoestrogens and estrogen-like molecules capable of binding estrogen receptors, which in turn can cause an action under the service action of estrogen in cells and tissues. Recently, soybean isoflavones was demonstrated selectivity for selective estrogen receptor modulators (SERM), which has a beneficial effect on the body, without causing unwanted actions. Beneficial effects may include prevention of breast cancer and can cause stunted growth and, in some cases, the cause apoptosis of prostate cancer cells in vitro and in vivo, and can also prevent osteoporosis.

As reported, some phytoestrogens have anti-androgenic effects and antioxidant properties. Mechanisms include inhibition of 5α-reductase, 17β-hydroxysteroid-dehydrogenase, aromatase, tyrosine-specific protein kinases and DNA topoisomerase II. One of the best explanations of the biological activity of the estrogen-like molecules is that phytoestrogens have a weak estrogenic action, but stimulate a specific activity of ER agonists and antagonists of ER, which depend on the cellular environment and promoter, and suggest that such compounds with weak estrogenic activity will stimulate tissue-specific activity of agonists or antagonists of ER.

Some studies have shown that some phytoestrogens can inhibit the enzymes that convert androgens into estrogens, namely aromatase and 17² -hydroxysteroid dehydrogenase type 1&5 and not others. As presented below, the dietary Supplement containing the product of the processed Morinda citrifolia, inhibits the enzyme aromatase. This dietary Supplement also provides estrogenic actions.

Tahitian Noni® has high antioxidant properties, compared with Pycnogenol®. It was found that compounds with the effect of estrogen prevent disease brittle bones in mice, but do not cause side effects. This discovery can be used to assist and facilitate that older women, who have ceased to use hormone replacement therapy (GST) because of the risk of cancer and heart disease that are associated with GST.

Before hormone replacement therapy (GST) estrogen and derivatives of estrogen used to prevent osteoporosis, but now it is no longer used in some countries because of side effects. Thus, the use of hormone replacement therapy is limited in severe symptoms, but the women are recommended to carry out treatment when symptoms are moderate because they are an inconvenience.

Estimated possible estrogen-agonistic effect of the dry form of concentrate juice puree Tahitian Noni® (TNPJC) immature females is ISA of the ICR in the maximum tolerated dose of 4000 mg/kg, introduced orally once daily for three consecutive days. The dry form TNPJC received using Rotor Vap under pressure and at low temperature.

Found that the dose of 4000 mg/kg is the cause of the increase of the total mass of the uterus (not the mass of dry matter) by approximately 50% relative to the comparison group (0.03 mg/kg β-estradiol 3-benzoate increases the full weight of the uterus on 83%), which shows the possible estrogen-agonistic activity. It might also suggest a dependence on dose.

A huge dose of the dry form TNPJC causes a 50% increase, while a small dose (0.03 mg/kg) of estradiol-3-benzoate is a cause of significant weight gain observed above.

Briefly, concentrate, juice, puree Tahitian Noni has protivokomarinye effects, anti-cancer, antioxidant and other beneficial effects, Tahitian Noni prevents the side effects of estrogen-like compounds, as well as in selected dose has estrogen-like effects that can explain the benefits for women in premenopausal and postmenopausal women, such as prevention of osteoarthritis, osteoporosis, and other useful effects mentioned above.

In accordance with the variants of implementation of the present invention, a dietary Supplement containing product processing Morinda citrifolia, ensure which ensures a mild estrogenic effect. Natural hormones have a very fast cycle, as are secreted under the influence desolations processes and, therefore, in order to guarantee the fast control system, you need to get control of the controller, which is the hormone, and the only way such control is to remove it for the new release of the hormone system. Thus, if we consider the natural estrogen, the half-life of this component is very short. Thus, to ensure a constant level of hormone necessary to use a compound which has the effect similar to the natural hormone, but not removed from the system as quickly due to some chemical changes in the molecule.

For example, the steroid compound contains estrogenic 1 group in this system, and natural enzymes that eliminate estrogen from the blood stream cannot convert derived, thus it remains active for a long time in the body. For a continuous treatment for several days or weeks, you cannot use the natural hormone, it is necessary to use derivatives, which are more slowly eliminated from the body. Accordingly, there may be used a dietary Supplement product processing Morinda citrifolia. This biologically active add is and works in the same way with natural hormone and has a strong action. The action is very strong and sometimes stronger than the natural hormone, so the side effects of the hormone are compounded under the action of these compounds. Phytoestrogens are estrogen from a chemical point of view, but from a biological point of view, they are estrogens. Because they have estrogenic effects, they interact with the system and have similar, but not identical, responses or effects with estrogen. Their effect is weaker and has no peaks.

In the presence of estrogen, their effects may be antagonistic action of estrogen. Thus, there are many opinions about whether the use of natural estrogens. Women taking foods rich in phytoestrogens, rarely get breast cancer and have fewer problems during menopause. Phytoestrogens are found in various natural food products, especially in soy and other plants. Soy is rich in phytoestrogens and women in Japan and China consume a lot of soy products.

According to at least some variants of implementation of the present invention, a dietary Supplement containing product processing Morinda citrifolia may be represented in the form of capsules or cream such as cream, penetrating through the skin or through mucous membranes.

The absorption rate of the leaves of Morinda citrifolia is ri ingestion is high. In order to find a connection with estrogenic effects, you need a certain limit value. The function of estrogen in the body or cells is detected in the cell receptor, and then the binding to this receptor, then this complex estrogen-receptor attached to DNA and stimulates the induction of specific proteins, which are then produced by the cells and, thus, it is the mechanism of their action. Thus, to detect estrogenic action, you can follow this mechanism of action.

First, it was shown that the compound binds to the receptor to receptor saturation of natural estrogen in radioactive form, after adding other compounds to the receptor, this connection will be to displace estrogen from the receptor, due to competition for the site of the receptor between natural estrogen and other estrogen. If the connection is associated, the estrogen is released. You can say, linking - this is the first stage and the second stage is the connection of complex estrogen - receptor with DNA and stimulation induction of some proteins.

The connection can bind the estrogen receptor, but do not show estrogenic action, if it manifests this action, it acts as an antagonist. After that there is inhibition of estrogen, since the receptor is Zan is tym, estrogen cannot find the free receptor and, consequently, cannot act. Thus, the authors conducted a search for compounds which bind the receptor and then act like estrogen. This leads to the functioning of several proteins. Therefore conducted both studies. First, we examined the binding with the receptor and, secondly, determine the endpoint.

The leaf extract of Morinda citrifolia acts like estrogen and provides estrogenic actions. However, the effect of the extract is weaker than the effect of natural estrogen, so it does not cause any side effects.

Adverse effect of hormone replacement therapy is that it can cause cancer of estrogen-dependent cells, such as breast cancer, uterine, ovarian, when treatment with high doses of estrogen or synthetic estrogens obtained from natural estrogen, but has a longer effect due to lower excretion. If you treat women with high doses of estrogen in a certain period of time, maybe years, it can cause breast cancer, or uterine cancer, or ovarian cancer, especially breast cancer and endometrial cancer.

So often women refuse to hormone replacement therapy, but need the other weaker substitute for hormone replacement therapy. For these the compounds interestingly, when high concentrations of natural estrogen, they act as antagonists, which means that they weaken the action of natural estrogen, and at very low concentrations of natural estrogen, they act as estrogen, thereby maintaining the estrogenic action or have estrogenic actions. This means that these compounds will contribute to the alignment of the concentrations of estrogen, thereby helping women avoid emergency situations.

Symptoms, which usually occur in women during the onset of menopause and sometimes to the cessation of menstruation forever, include hot flashes, night sweats and/or depression. Bleeding and depression can be very strong. Another effect of long-term administration is osteoporosis, resulting in permanent changes in bone matrix. Bone matrix is degraded and reconstructed again. There are two types of cells responsible for this process, called osteoblasts and osteoclasts. Osteoblasts necessary to rebuild bone, and cells-osteoclasts responsible for bone degradation, which is very important, as the level of calcium in the blasts must be constant and bone is the buffer level of calcium. While reducing the level of calcium in the blood degradation of bone and calcium levels. While b is of pregnancy, the calcium from the mother's blood is actively absorbed by the embryo to build the skeleton. Thus, the flow rate of the bone matrix of the skeleton of the mother during pregnancy should increase. This increases the level of estrogen during pregnancy, since estrogen is important for the process occurring in cells-osteoblasts, which rebuilds the bone, and during menopause, the estrogen level decreases, and the adjustment process becomes weaker bone matrix is gradually destroyed and osteoporosis occurs.

For determining the activity of compounds of MDA-6 (RT # 1026431) was performed enzymatic analysis and analysis of radioligand binding. The methods used in this study to achieve the maximum reliability and reproducibility have been adapted based on the scientific literature. In each study to ensure the reliability of the obtained results used reference standards. Studies were performed in the conditions described in the accompanying section "Methods" of this description. Literary reference(CI) for each study are given in the section "references".

A value determined by the IC50nonlinear regression method of least squares using Data Analysis Toolbox™ (MDL Information Systems, San Leonardo, CA, USA), where the K iis the inhibition constant, and the value of Kiwas calculated using the equation of Cheng and Prusoff (Cheng, Y., Prusoff, W.H., Biochem. Pharmacol. 22: 3099-3108, 1973), using the experimental value IC50the test compound, the concentration of radioligand used in the study, and the initial value of Kdligand (obtained experimentally in MDS Pharma Services). Presents the hill coefficient, which determines the slope of the competitive binding curve, was calculated using Data Analysis Toolbox™. The hill coefficients significantly different from 1.0, assume that the bias binding does not follow the laws of the effective mass with a single binding site. Where data IC50, Kiand/or nHpresented without standard average error (SEM), data are insufficient to be quantitative, and the values presented (IC50, KinH) should be interpreted with caution.

The generalization of the results shown in the following table in order of ranking efficiency calculated values IC50and/or Ki. The results of biochemical studies are presented as percent inhibition of specific binding or activity. All other results are expressed in terms of quantification, respectively, research pok is explained in the table. For primary studies only low concentrations with significant response met the research criteria. Also shown are either the results of repeated trials of low dose/concentration, satisfy the criterion of significance, or in the case of inactivation, when the highest dose/concentration not satisfy the criterion of validity, if such tests were conducted. If those tests are not required, there is shown a primary screening repeat with the quantitative indicators (e.g., IC50±SEM, Ki±SEM and nH). If the screening shows primary screening repeat with semi-quantitative data (for example, calculated values IC50, Kiand nHwhere possible (concentration range of 4 logarithmic units); secondary functional analyses, if any, were performed at 30 μm, and MONTHS or MIC was determined only when the activity in the primary tests>50% at a concentration of 1 logarithmic unit lower than the original test. Significant responses (≥50% inhibition or stimulation for biochemical research), noted in the primary studies listed below.

136010 Lipogenesis 5-LO

Source: PBMN cells of a person

Substrate: endogenous arachidonic acid from PBMNC

Diluent: 100% N 20

Time inactivated/temp: 15 minutes/37°

Incubation time/temp: 15 minutes/37°

Incubation buffer: HBSS (balanced salt solution Hanks)

Method of quantitative determination: EIA determination of the number of LTB4

Criterion validity: ≥50% of maximum stimulation or inhibition

226010 Estrogen ER

Source: recombinant Sf9 cells of human and insect

Ligand: 0,5 nm3H estradiol

Diluent: 100% H2About

Incubation time/temperature: 2 hours/25°

Incubation buffer: 10 mm Tris-HCl, pH 7.5, 10% glycerol, 1 mm DTT, 1 mg/ml BSA

Non-specific ligand: 1 μm diethylstilbestrol

Kd: 0,2 nm*

Bmax: 1400 pmol/mg protein*

Specific binding: 85% *

Method of quantitative determination: radioligand binding

Criterion validity: ≥50% of maximum stimulation or inhibition

250600 Leukotriene D 4

Source: lung of the Guinea pig Hartley

Ligand: 0.2 nm3H leukotriene D4(LTD4)

Diluent: 100% H2O

Incubation time/temperature: 60 minutes/25°

Incubation buffer: 50 mm Tris-HCl, 0.01% of BSA, 5 mm CaCl2, 5 mm MgCl2, bacitracin 100 μg/ml, 1 mm phenylmethylsulfonyl fluoride.

Non-specific ligand: 0,1 μm leukotriene D4(LTD4)

Kd: 0,2 nm*

Bmax0.24 pmol/mg protein*

Specific binding: 85%*

Method of quantitative determination: radioligand binding

Criterion validity: ≥50% of maximum stimulation or inhibition

226050 Estrogen ERβ

Source: recombinant Sf9 cells of human and insect

Ligand: 0,5 nm3H estradiol

Diluent: 100% H2O

Incubation time/temperature: 2 hours/25°

Incubation buffer: 10 mm Tris-HCl, pH 7.5, 10% glycerol, 1 mm DTT, 1 mg/ml BSA

Non-specific ligand: 1 μm diethylstilbestrol

Kd: 0,13 nm*

Bmax: 3000 pmol/mg protein*

Specific binding: 90% *

Method of quantitative determination: radioligand binding

Criterion validity: ≥50% of maximum stimulation or inhibition

271200 Serotonin 5-HT1B

Source: the cerebral cortex of the rat Wistar

Ligand: 10 PMl25I CYP

Diluent: 100% H2O

Incubation time/temperature: 90 minutes/37°

Incubation buffer: 50 mm Tris-HCl, 154 mm NaCl, 10 μm pargyline, 30 μm izoprenalin, pH 7, 7

Non-specific ligand: 10 μm serotonin (5-HT)

Kd: 0,19 nm*

Bmax: 0,14 2 pmol/mg protein*

Specific binding: 70% *

Method of quantitative determination: radioligand binding

Criterion validity: ≥50% of maximum stimulation or inhibition

Accordingly, b is lo shows the estrogen receptors have a higher ability to bind NSAID ligands with higher affinity. Most of these ligands, a mixture of agonists and antagonists have been developed and used in the treatment of women in the postmenopausal period. Moreover, steroid estrogens play an important role in the development of the organism, but also in the differentiation of certain cells, functioning male and female reproductive systems have a positive effect on osteoblasts and their functions, cardiovascular and Central nervous system.

The effects described above, mediated by two nuclear proteins, such as ERα ERβ. Binding of estrogen or estrogen-like molecules with these intranuclear proteins leads to structural-conformational changes that, in turn, will dimerize the ligand-receptor complex leads to activation of genes under the control DNA.

The documentary was confirmed that xenoestrogens, phytoestrogens and synthetic estrogens are able to bind with the receptors of estrogen, which in turn mimic the actions of estrogen person in a specific cell and tissue specific manner, as, for example, those that are well known in the reproductive systems. However, estrogen and estrogen-like molecule and its receptor can activate in various areas throughout the body and, in particular, in the brain. Estrogen and estrogen-like molecules act as a strong neuroprotective antioxidant, which can activate the transcription of genes for direct or indirect neuroprotective actions.

Any connections that through these receptors are nuclear proteins can have either a stimulating effect (agonist) in certain tissues (e.g. bone and the antagonist in other tissues) and block (antagonist) in other tissues (e.g. breast and uterine cancer). Some recent scientific studies suggest that the regulation of heart rhythm and heart rate ERα the form is more important than ERR. Thus, it was made a few assumptions about selective antagonist ERα for effective control of cardiac activity.

To evaluate the activity of concentrate juice puree Tahitian Noni® conducted experimental study of radioligand binding to establish the effects of concentrate juice puree Tahitian Noni® ונוח and Tahitian Noni® on the estrogen receptors ERα ERβand the results were as follows:

1% concentrate juice-Tahitian Noni puree = 99% inhibition of ERα with IC500,31%

1% concentrate juice-Tahitian Noni puree = 99% inhibition of ERβ the IC 500,28%

2% Tahitian Noni® = 20% inhibition of ERα

2% Tahitian Noni® = 40% inhibition of ERβ

Based on these results it can be assumed that there is a dose-dependent effect of Tahitian Noni® inhibition of estrogen receptors ERα Erβ, respectively, compared with concentrate juice-Tahitian Noni puree in these in vitro studies. Moreover, these results show that the Tahitian Noni® and concentrate juice puree Tahitian Noni have a beneficial cardioprotective effect, is effective in the treatment of postmenopausal symptoms, osteoarthritis, breast cancer, uterine cancer and colon cancer.

The following describes agonistic activity against estrogen products processing Morinda citrifolia. This means that estrogen is a hormone with many properties, and this hormone is needed to maintain the internal equilibrium of the system. Thus, estrogen is required to connect the nervous system and the endocrine and especially important for the reproductive system that makes possible the birth of a child, while it participates not only in the stages of pregnancy, but also in the stages of forming the attractiveness of women to men, i.e. estrogens form secondary sexual characteristics, make smooth the skin and so on. In the body estrogen regulates various cells, performing ineach authority special role. This role is to proliferation, such as the uterus, for example, at the moment of fertilization should be sensitive to egg collection, and then to feed her, and then, with the growth of the embryo new blood vessels must germinate from the uterus and enter the embryo for its power, therefore, estrogen can induce the growth of cells, and during pregnancy increases the mass of the entire uterus, therefore, the body increases cell division.

And the same applies to the mammary gland. Mammary gland must grow in order to produce milk after giving birth, therefore, estrogen induces the growth of these cells as well. Cancer begins with cell growth, but usually the cells at the right time stop growing, but sometimes they mutate and cell growth does not stop, and compounds that induce cell growth, can promote the formation of tumor cancer cells, and this is why estrogen increases the frequency of cancer in these organs, because estrogen induces the growth of cells of the uterus and breast. Another effect of estrogen is, for example, induction of the synthesis of specific protein angiotensin in the liver, which regulates blood pressure and much more. It also regulates the processes in the brain that control mood. Estrogen promotes good mood is the mood of women, when the bearing and child birth, and in case of its absence is often depression. In men, estrogen also has some activity (not estrogen is a female hormone, men also have estrogen). In small concentrations, and after menopause in women, the level of concentration of estrogen is reduced to the concentration of estrogen in men.

Usually men do not receive treatment with synthetic estrogens, except in those cases when they have prostate cancer as men testosterone has the same effect on the cells of the prostate gland, thus, and sexual function, what estrogen has on female sexual function, and especially testosterone promotes the growth of prostate cells, and in the presence of a single malignant cells and high levels of testosterone they can grow into a tumor to form prostate cancer and testosterone and estrogen are antagonists, in the treatment of men with estrogen it has on testosterone antagonistic effect and reduces the growth of prostate cells. This is the basis for the treatment of men suffering from prostate cancer by estrogen. If they begin to show feminine characteristics, they begin to grow Breasts, ceases to grow a beard, and is like the, but the vital estrogens do not cause such symptoms because they are reacting. Thus, when receiving the vital estrogen men do not lose their sexual functions, or have not observed any changes in their phenotype. When this vital estrogen does not reduce the growth of prostate cells and do not reduce the risk of prostate cancer that could be another useful property of the vital estrogen expressed in men.

Estimated possible estrogen-agonistic action of a test substance TNCONC immature female ICR mice, the maximum tolerated dose of 4000 mg/kg, administered orally once a day for three consecutive days. Significant estrogen-agonistic activity, which is manifested by a change in the wet weight of the uterus was observed for TNCONC (50% increase compared with the group receiving placebo). Each of the test animals was observed an increase of the intestine; however, in the test period changes in behavior were observed. It was concluded that TNCONC dose of 4000 mg/kg oral (PO) has a significant estrogen-agonistic activity in mice.

Below are the materials and equipment:

1. Test substance and the dosage - TNCONC provided by the company Morinda, Inc., was dissolved in 2% Tween 80/0,9% NaCl. For tester is of the maximum tolerated dose of 4000 mg/kg was injected intraperitoneally daily for three consecutive days and used a dose of 10 ml/kg

2. Animals - used female mice ICR provided by the firm MDS Pharma Services - Taiwan Ltd. Allocate space for 5 animals was 29×18×13 see Animals were placed in cages ARES11and contained in an environment with controlled temperature (22°-24°C) and humidity (60%-80%) with 12-hour cycles of day and night, at least one week before the experiment in the laboratory MDS Pharma Services-Taiwan Laboratory. They were given free access to commonly used laboratory diet to rats (Lab Diet, Rodent Diet, PMI Nutrition International, USA) and tap water. All aspects of this work, including placement, experimental and handling of animals were performed mainly in accordance with International fundamental principles for biomedical research involving animals (International Guiding Principles for Biomedical Research Involving Animals (CIOMS Publication No. ISBN 92 90360194, 1985).

3. Reagents - β-estradiol 3-benzoate (Sigma, USA), pyrogen-free saline (Sinton, Taiwan) and Tween 80 (Wako, Japan).

4. Equipment - cells of animals (ShinTeh, R. O. C.), electronic weighing 0.0001 g - 9,9999 g (R160P, Sarturius, Germany), glass syringe (1 ml, 0.5 ml Mistuba, Japan), a needle for subcutaneous injection (26 G × 1", TOP Corporation, Japan), needle for oral administration to mice, scissors stainless steel (Klappencker, Germany).

The test substance was administered at the maximum tolerated dose of 4000 mg/kg nutribase is but (IP) for three consecutive days to a group of five immature female mice ICR mass 13± 1, Animals were scarificial 24 hours after the final dose and measured the wet weight of the uterus of each animal. The increase in wet weight of the uterus on 50 percent or more (≥50%) compared with the control group of animals indicates a possible estrogen-agonistic activity. The following table presents the results of the study:

Table 1
The Protocol 9531000 estrogen-agonistic activity in mice
ProcessingProcessing pathDoseNo.The weight of the uterus (mg)% reduction
IndividualAverage
MediaIP10 ml/kg114,9
(2% Tween 80/216,1
0.9% NaCl)314,7
418,0
514,615,7-
PT# 1026431-IP4000 mg/kg123,4
ADD (MDA-6)223,5
(TNCONC)327,5
419,6
523,523,5(50)
β-estradiolPO0.03 mg/kg128,7
3-benzoate220,7
331,3
435,6
534,930,2(83)

Placebo or the test substance was administered IP for three consecutive days immature female mice weighing 13±1, Animals were scarificial 24 hours after the final dose and determine the wet weight of the uterus of each animal. The increase in wet weight of the uterus on 50 percent or more (≥50%) compared with the group of animals receiving placebo, shown in brackets, indicates a possible estrogen-agonistic activity. Note: the value in the group receiving estradiol was compared with the initial control placebo oral 2% Tween 80 (wet weight of the uterus was 16.5 mg).

Thus, as shown above, received diet composition or Supplement which includes one or more processed products derived from plants of the Indian mulberry, whose scientific name is Morinda citrifolia L., and used to provide estrogenic actions in the human body.

Inhibition of estrogen production

The following describes the method and its characteristics and composition of inhibiting aromatase and treating and preventing the growth of cancer cells of the mammal, as well as to reduce in the body of a mammal the production of estrogen, which promotes the growth of estrogen-dependent placecast is the R tumors, each through preventive administration of a composition of biologically active additives comprising at least one form of product processing Morinda citrifolia.

Embodiments of the present invention relate to an aromatase inhibitor to the composition of biologically active additives, or the aromatase inhibitor, or composition affecting the estrogen-dependent cancer cells, which comprises Morinda citrifolia plant Indian mulberry. Morinda citrifolia is included in the compositions of biologically active additives together with various native or suitable for in vivo treatment of a patient. For example, the inhibitor can be taken orally, injected, injected, or absorbed in any other suitable way in accordance with a prescription.

In one of the typical embodiments, the composition of biologically active additives of the present invention, includes one or more processing products Morinda citrifolia, in amounts of between 0.01 and 100 percent by weight, preferably between 0.01 and 95 percent by weight. Several embodiments of the compositions presented below. However, they are presented only as examples, and the person skilled in the art it is clear that can be obtained from other compounds or compositions comprising the product of the processed Morinda citrifolia.

The product is pererabotki Morinda citrifolia includes, at least one of the active ingredients in biologically active additive or contains one or more active ingredients, such as quercetin and rutin, and others, for the implementation of inhibiting aromatase and reduce and control the production of estrogen by inhibiting the binding of estrogen receptor by estrogen, as well as to effect the destruction of estrogen-dependent cancer cells, in particular, estrogen-dependent cancer cells at an early stage.

The active ingredients in the product processing Morinda citrifolia can be extracted using various alcohols or alcohol mixtures, such as methanol, ethanol and ethyl acetate, or other derivatives of alcohol, while using any known in the field processes. In the final composition or compositions of the active ingredients of quercetin and rutin are presented in quantities from 0.01 to 10 percent by weight. These quantities can also be concentrated in higher concentrations in which they are present in quantities ranging from 10 to 100 percent.

Product processing Morinda citrifolia can be mixed with various other ingredients to produce different compositions, for example compositions of biologically active additives, local skin composition or other. In the composition of biologically active additives used in the tsya any ingredients, which is safe for ingestion by a mammal, in particular humans, and can exist in various forms, for example in the form of liquids, tablets, lozenges, aqueous or oil solutions, dispersible powders or granules, emulsions, syrups, Alexiou and the like. Moreover, since the composition of biologically active additives preferably used orally, it may contain one or more substances selected from the group comprising sweeteners, flavourings, colourings, preservatives and other medicinal substances, in accordance with a prescription.

In compositions for topical application of the composition also use ingredients that are safe for absorption by the body of a mammal and may exist in various forms, such as gels, lotions, creams, ointments and the like, each contains one or more carriers. Ingredients for systemically injected compounds (e.g., intravenously) may also include any known in the field.

The present invention also describes a method of administration of the composition of biologically active additives in the body of a mammal to inhibit aromatase, as well as to reduce and/or regulate the production of estrogen. In one typical embodiment, the method includes the following stages (the) formulation of the compositions of biologically active additives, includes partly the product of processing Morinda citrifolia, present in an amount between 0.01 and 95 percent by weight, where the composition also includes a carrier, for example, water or distilled water, and may also include other natural or artificial ingredients; (b) introducing a composition of biologically active additives in the body of a mammal, the way that the product of the processed Morinda citrifolia adequately digested; (C) repeating the above phases as often as necessary to ensure the effective number of product processing for inhibiting aromatase enzymes, whose function is the conversion of androgens into estrogens, inhibition of binding with estrogen receptors and/or reducing and/or regulating the production of estrogen.

Stage of introduction of the composition of biologically active additives in the body of a mammal preferably includes oral administration of the composition. In particular, the composition of biologically active additive may be a liquid, gel, solid or other form, which will allow the composition to be quickly absorbed and concentrated in the large intestine. It is important to note that the stage of introduction of the composition of biologically active additives should be carried out in an efficient manner, so that the greatest concentration is a function of the composition of biologically active additives was absorbed in tissues and cells. In order for the composition of biologically active additives showed an effect, it must be adequately digested. After adequate absorption, the composition can then begin to act by inhibiting aromatase, preventing the binding of estrogen receptors and reducing the number of produced estrogen.

In another embodiment, the phase of introduction of the composition of biologically active additives may include injection of the composition with intravenous pump. This technology is advantageous because it will allow the composition to be localized in the region where the composition will have the greatest efficiency, or in the area where will be the greatest concentration of the composition of biologically active additives, for example, in the field of breast cancer in patients with breast cancer. In one typical embodiment, the composition of biologically active additives is introduced by the use of 1 teaspoon to 2 ounces, preferably 2 ounces of the composition of biologically active supplements every two hours daily or at least twice a day for a long period of time. Also the composition of biologically active supplements should be taken on an empty stomach, which means the period of time at least two hours before meal or liquid. As a result, the composition of biologically active additives can act the VNO to inhibit aromatase, thus, have a positive impact on estrogen-dependent cancer cells and inhibiting their growth in the body. Of course, the person skilled in the art will understand that the number of the composition and frequency of application can vary in different individuals.

Subsequent tables illustrate or represent some preferred compositions or compositions considered in accordance with the present invention. As stated, they are intended only to illustrate embodiments of the invention and does not limit it.

Part One
IngredientsThe percentage by weight
Juice puree or juice Morinda citrifolia100%
Part Two
IngredientsThe percentage by weight
The juice of Morinda citrifolia85-99,9%
Water0.1 to 15%
Part Three
IngredientsThe percentage by weight
the juice of Morinda citrifolia85-99,9%
fruit juice, non-Morinda citrifolia0.1 to 15%
Part Four
Ingr dirty The percentage by weight
the juice of Morinda citrifolia50-90%
Water0.1 to 49.9 percent
fruit juice, non-Morinda citrifolia0.1 to 30%
Part Five
IngredientsThe percentage by weight
juice, Morinda citrifolia puree85-99,9%
Water0.1 to 15%
Part Six
IngredientsThe percentage by weight
juice, Morinda citrifolia puree85-99,9%
fruit juice, non-Morinda citrifolia0.1 to 15%
Part Seven
IngredientsThe percentage by weight
juice, Morinda citrifolia puree50-90%
Water0.1 to 49.9 percent
fruit juice, non-Morinda citrifolia

Part Eight
0.1 to 30%
IngredientsThe percentage by weight
dietary fiber Morinda citrifolia0.1 to 30%
Water1-98,9%
fruit juice, non-Morinda citrifolia1-99,9%
Part Nine
Ingredients

dietary fiber Morinda citrifolia
The percentage by weight of 0.1-30%
Water1-98,9%
juice or juice, Morinda citrifolia puree1-99,9%
Part Ten
Ingredients

oil Morinda citrifolia
The percentage by weight of 0.1-30%
the carrier medium70-98,9%
other ingredients1-95%
Part Eleven
IngredientsThe percentage by weight
product Morinda citrifolia10-80%
the carrier medium20-90%
Part Twelve
IngredientsThe percentage by weight
product Morinda citrifolia5-80%
the carrier medium20-95%
Part Thirteen
IngredientsThe percentage by weight
oil or oil extract of Morinda citrifoliaof 0.1-20%
the carrier medium20-90%
Part Fourteen
Ingredients juice puree or juice Morinda citrifolia The percentage by weight of 0.1-80%
oil Morinda citrifoliaof 0.1-20%
the carrier medium20-90%
Part Fifteen
IngredientsThe percentage by weight
Morinda citrifolia concentrate, juice, puree or concentrate juice100%
Part Sixteen
IngredientsThe percentage by weight
concentrate juice or juice concentrate, Morinda citrifolia puree85-99,9%
Water0.1 to 15%

As stated in one typical embodiment, the present invention describes a method of administration of the composition or composition for internal use for the inhibition of aromatase, reduce/regulate estrogen production, inhibiting the binding of estrogen to receptors, and treatment, prevention, inhibition, destruction and complete change in the effects of estrogen-dependent tumors and growth of malignant cells within the field of malignant tumors, such as breast cancer. Essentially, this method involves the introduction of a composition for use in the body of a mammal affected by cancer cells. Here we consider the use the use of several embodiments of the composition for internal use, including a variety of ingredients, each implementation includes one or more forms of product processing Morinda citrifolia, as explained and shown here, and carrying the agent or the environment.

In one preferred method inhibited aromatase or aromatase enzymes, made an impact on estrogen-dependent cancer, prevented, destroyed and/or completely changes the growth of cancer cells, by appointment in the morning on an empty stomach at least one ounce (1) one of the compounds with the composition of One Part of Sixteen, described above, and at least one (1) oz on an empty stomach in the evening, just before bedtime. In one example, which is not a limitation, medicinal Morinda citrifolia processed into juice Tahitian Noni®produced by the company Morinda, Inc., Orem, Utah.

In one typical embodiment, the composition for internal use includes the following ingredients: product processing Morinda citrifolia, present in an amount between 10 and 80 percent by weight; and a carrier medium present in an amount between 20 and 90 percent by mass.

In this embodiment, the product processing Morinda citrifolia may include the juice of one or more processed fruit Morinda citrifolia juice puree, processed Morinda citrifolia, recycled dietary fiber Morinda citrifolia, and/or oil extract of Morinda citrifolia.

In the other the typical embodiment, the composition for internal application contains the following ingredients: juice or juice puree from processed fruit Morinda citrifolia, present in an amount by weight between 0.1 and 80 percent; oil processed Morinda citrifolia, present in an amount by weight between 0.1 and 20 percent; and a carrier medium present in an amount by weight between 20 and 90 percent. Juice puree or fruit juice of Morinda citrifolia may also be formulated with dietary fiber processed Morinda citrifolia presented in similar concentrations.

In accordance with the present invention, private ways of introducing compositions for oral use may include any way of actual introduction of the composition for use in the body of a mammal, for the purposes described here. Although there are many private methods, the present invention determines that the composition for internal use can be injected, transdermal, oral or systemically. Regardless of which method is used, the main thing is that the composition is completely absorbed, so that the composition for internal use, in particular Morinda citrifolia and other active ingredients, can effectively inhibit aromatase and act on the estrogen-dependent cancer, thus contributing to the reduction and subsequent inhibition and prevention of this cancer, and estrogen-dependent cancer cells at any early stage can be the ruin the us.

The carrier medium, installed in the above Compositions may include any ingredient that can be introduced into the body of the mammal and which is also capable of providing a carrier medium for processing product Morinda citrifolia. Certain compounds bearing environments known in the field and is not described here in detail. As indicated, the purpose of the carrier medium is to ensure the delivery of product processing Morinda citrifolia in the composition for internal use, which can be introduced into the body.

The following examples explain and represent the preventive and therapeutic effects of products of processing of Morinda citrifolia on aromatase and estrogen-dependent cancer cells, as well as preventative and treatment effects of Morinda citrifolia against the proliferation or metastasis of these cancer cells. These examples are presented here not as a limitation, but as an illustration of the advantages and benefits, as well as therapeutic effects, Morinda citrifolia products.

Example 1

Modern treatments available to women with breast cancer in postmenopausal women include medical schemes either blocking or inhibition of oestrogen receptors or blocking the action of aromatase. However, these treatments are not able to combine both steps. Recent experimental what you've done, using in vitro assay to assess inhibition aromatase enzyme activity radioligand binding Morinda citrifolia in the form of juice-Tahitian Noni puree®.

In this experiment, we used recombinant human cells as a source of estrogen receptors ERα ERβ. Each of the enzymes of the positive control, diethylstilbestrol aromatase and SOUR 2C19, had a human origin.

First explored 1% juice-Tahitian Noni puree®. The results of this test showed that the active ingredient Morinda citrifolia caused or induced 89% inhibition of aromatase receptor enzyme CYP450 2C19, 99% inhibition of aromatase estrogen-alpha receptor enzyme, and 102% inhibition of aromatase estrogen beta receptors of the enzyme. These results clearly suggest that the juice of the Morinda citrifolia puree used in concentration had a significant effect on the inhibition of aromatase and estrogen receptors, which inhibits stands comparison with modern forms of treatment.

Moreover, it was found that Morinda citrifolia inhibited 81% 1A2, 89% 2C19, 81% 2S9, 93% 2D6, and 77% 3A4 SUR enzymes.

Thus, as discussed here, embodiments of the present invention encompass estrogenic effect in the body. More specifically, the present invention relates to note is the biologically active composition or the additive for selective inhibition of estrogen production and provision of estrogenic action in the human body, where the composition is formulated from one or more food processing plants Indian mulberry, whose scientific name is Morinda citrifolia L. the Present invention may be embodied in other private forms, not outside of his essence or essential characteristics. It is believed that describes the options for implementation are illustrating and not limiting.

Thus, the scope of the invention defined by the attached claims and not in accordance with the description presented above. All changes within the meanings and range of equivalents of the claims are covered by the invention.

1. Product application processing Morinda citrifolia as a dietary Supplement for the selective inhibition of the production of estrogen in the body of a mammal and ensure estrogenic actions in the body.

2. The use according to claim 1, where the product processing is one of:

(i) fruit juice of Morinda citrifolia:

(ii) an oil extract of Morinda citrifolia;

(iii) dietary fiber Morinda citrifolia;

(iv) juice, Morinda citrifolia puree;

(v) Morinda citrifolia puree;

(vi) concentrate fruit juice of Morinda citrifolia;

(vii) concentrate juice, Morinda citrifolia puree; and

(viii) extract from the leaves of Morinda citrifolia.

3. The use according to claim 2, additionally providing the e stage, providing recommended the use of biologically active additives, which recommended the use includes

use one oz. of biological additives in the day;

the use of more than one liquid ounce of biologically active additives in the day; and

the use of less than one fluid ounce of biologically active additives in the day.

4. The use according to claim 3, where the recommended application additionally provides for the use of dietary supplements before eating.

5. The use according to claim 1, where the application involves either (i) the use, or (ii) transdermal application.

6. The use according to claim 1, additionally providing for the use of dietary supplements as an aromatase inhibitor.

7. Application of the extract of the leaves of Morinda citrifolia in the form of dietary supplements as an aromatase inhibitor to control the production of estrogen in the body of a mammal for the selective inhibition of estrogen production and provision of estrogenic action.

8. The use according to claim 7, further providing for the use of recycled extract to provide estrogenic actions in the body.

9. The use according to claim 7, where the recycled extract is presented in the form of skin cream.

10. The use according to claim 7, where the recommendation is consistent application includes

use one oz. of biologically active additives in the day;

the use of more than one liquid ounce of biologically active additives in the day; and

the use of less than one fluid ounce of biologically active additives in the day.

11. The use of claim 10, where the recommended application additionally provides for the use of biologically active additives before eating.

12. Biologically active additive for inhibiting estrogen production and increased levels of estrogen in humans, where the additive contains product processing Morinda citrifolia.

13. Biologically active additive indicated in paragraph 12, where the product is selected from the

(i) the leaves of Morinda citrifolia; and

(ii) juice of Morinda citrifolia.

14. Method of inhibiting aromatase and aromatase enzymes, the function of which is the conversion of androgens into estrogens, where the method involves the administration to a mammal of a composition containing the product of the processed Morinda citrifolia in an amount of from about 0.01 to 100 wt.%, where specified product processing Morinda citrifolia contains the active ingredient quercetin.

15. The method according to 14, where the number of the specified quercetin is from about 0.1 to 100 wt.%.

16. The method according to 14, where the specified product processing Morinda citrifolia is at least one of:

(i) fruit juice of Morinda citrifolia;

(iii) dietary fiber Morinda citrifolia;

(iv) juice, Morinda citrifolia puree;

(v) Morinda citrifolia puree;

(vi) concentrate fruit juice of Morinda citrifolia; and (vii) concentrate juice, Morinda citrifolia puree.

17. The method according to 14, where the specified product processing Morinda citrifolia, also contains as an additional active ingredient rutin, which synergistically inhibits specified aromatase together with the specified quercetin.

18. The method according to 17, where the number of the specified routine is from about 0.1 to 10 wt.%.

19. The method according to 14, where this composition is introduced in one of the following ways:

(i) oral;

(ii) transdermal application specified on the affected area;

(iii) injection specified in the affected area;

(iv) intravenous; and

(v) system.

20. Method of inhibiting aromatase and prevention of the formation and growth of estrogen-dependent cancerous cells in a mammal, where the method includes the following stages:

stage added product processing Morinda citrifolia in alcohol solution;

phase separation and extraction of active ingredient specified product processing Morinda citrifolia from the specified mortar;

the introduction of this extracted active ingredient in the mammalian organism is the future, where indicated extracted active ingredient inhibits, prevents, will neutralize and reverses the effects of these estrogen-dependent cancer cells.

21. The method according to claim 20, where the specified product processing Morinda citrifolia includes at least one of (i) fruit juice, processed Morinda citrifolia, and (ii) the product of the processed Morinda citrifolia, including puree processed Morinda citrifolia.

22. The method according to claim 20, where the specified alcohol solution selected from the group comprising essentially methanol, ethanol, an ethyl acetate and other alcohol derivatives.

23. The method according to claim 20, where the specified active ingredient is of quercetin.

24. The method according to item 23, where the specified active ingredient is rutin, which synergistically inhibits the formation and growth of these estrogen-dependent cancer cells together with the specified quercetin.

25. The method according to claim 20, where the specified stage of entry into force of this extracted active ingredient provides for oral ingestion by a patient two ounces of food product twice a day on an empty stomach, where the specified food product contains the specified active ingredient derived from the processing product Morinda citrifolia.

26. The method according to claim 20, where the specified stage of entry into force of this extracted active ingredient involves applying the composition for double the th application in the specified area, where the specified composition for topical application contain the specified active ingredient derived from the processing product Morinda citrifolia.

27. Method of inhibiting aromatase and prevention of the formation and growth of estrogen-dependent cancer cells in a mammal, the method provides

stage oral administration in the morning on an empty stomach specified mammal at least one ounce of the composition of biologically active additives containing product processing Morinda citrifolia;

stage oral administration at bedtime on an empty stomach specified mammal at least one ounce of the composition of biologically active additives; and

the repetition of these stages of oral administration a daily basis, until such time as such estrogen-dependent cancerous cells will not be destroyed.

28. The method according to item 27, where the specified composition of biologically active supplements contain processed fruit juice of Morinda citrifolia in an amount of about 100 wt.%.

29. The method according to item 27, where the specified composition of biologically active additives contains;

the processed fruit juice of Morinda citrifolia in an amount of from about 85 to 99.9 wt.%; and

water in an amount from about 0.1 to 15 wt.%.

30. The method according to item 27, where the specified composition of biologically active additives contains

the processed fruit juice of Morinda citrifolia in to the a number of from about 85 to 99.9 wt.%; and

juices fruits, non-Morinda citrifolia, in the amount of from about 0.1 to 15 wt.%.

31. The method according to item 27, where the specified composition of biologically active additives contains

the processed fruit juice of Morinda citrifolia in an amount of from about 50 to 90 wt.%;

water in an amount from about 0.1 to 49.9 wt.%; and

juices fruits, non-Morinda citrifolia, in the amount of from about 0.1 to 30 wt.%.

32. The method according to item 27, where the specified composition of biologically active additives contains juice puree from processed fruit Morinda citrifolia in an amount of about 100 wt.%.

33. The method according to item 27, where the specified composition of biologically active additives contains

juice puree from processed fruit Morinda citrifolia in an amount of from about 85 to 99.9 wt.%; and

water in an amount from about 0.1 to 15 wt.%.

34. The method according to item 27, where the specified composition of biologically active additives contains

juice puree from processed fruit Morinda citrifolia in an amount of from about 85 to 99.9 wt.%; and

juices fruits, non-Morinda citrifolia in an amount of from about 0.1 to 15 wt.%.

35. The method according to item 27, where the specified composition of biologically active additives contains

juice puree from processed fruit Morinda citrifolia in an amount of from about 50 to 90 wt.%; and

water in an amount from about 0.1 to 49.9 wt.%; and

juices fruits, non-Morinda citrifolia, in the amount of from approximately the 0.1 to 30 wt.%.

36. The method according to item 27, where this stage of oral administration comprises oral administration of two ounces of the composition of biologically active additives.

37. The way the regulation of estrogen production and inhibiting the ability of estrogen receptor contact estrogen, where the method includes the following stages:

stage oral administration in the morning on an empty stomach at least one ounce of the composition of biologically active additives containing product processing Morinda citrifolia; and

stage oral administration in the evening before going to sleep at least one ounce of a specified composition of biologically active additives.

38. The method according to clause 37, where the specified composition of biologically active supplements contain processed fruit juice of Morinda citrifolia in an amount of about 100 wt.%.

39. The method according to clause 37, where the specified composition of biologically active additives contains

the processed fruit juice of Morinda citrifolia in an amount of from about 85 to 99.9 wt.%; and

water in an amount from about 0.1 to 15 wt.%.

40. The method according to clause 37, where the specified composition of biologically active additives contains

the processed fruit juice of Morinda citrifolia in an amount of from about 85 to 99.9 wt.%; and

juices fruits, non-Morinda citrifolia in an amount of from about 0.1 to 15 wt.%.

41. The method according to clause 37, where the HDMI is tion of biologically active additives contains

the processed fruit juice of Morinda citrifolia in an amount of from about 50 to 90 wt.%;

water in an amount from about 0.1 to 49.9 wt.%; and

juices fruits, non-Morinda citrifolia, in the amount of from about 0.1 to 30 wt.%.

42. The method according to clause 37, where the specified composition of biologically active additives contains juice puree processed fruit Morinda citrifolia in an amount of about 100 wt.%.

43. The method according to clause 37, where the specified composition of biologically active additives contains

juice puree processed fruit Morinda citrifolia in an amount of from about 85 to 99.9 wt.%; and

water in an amount from about 0.1 to 15 wt.%.

44. The method according to clause 37, where the specified composition of biologically active additives contains

juice puree processed fruit Morinda citrifolia in an amount of from about 85 to 99.9 wt.%; and

juices fruits, non-Morinda citrifolia in an amount of from about 0.1 to 15 wt.%.

45. The method according to clause 37, where the specified composition of biologically active additives contains

juice puree processed fruit Morinda citrifolia in an amount of from about 50 to 90 wt.%;

water in an amount of from about 0.1 to 49.9 wt.%; and

juices fruits, non-Morinda citrifolia, in the amount of from about 0.1 to 30 wt.%.

46. The method according to clause 37, where this stage of oral administration provides for oral administration of two ounces of the specified composition of biologically active additives, aged is evno twice a day.

47. Method of inhibiting aromatase and the ability of estrogen to communicate with oestrogen receptors for the treatment, prevention, inhibition, destruction and treatment of estrogen-dependent cancerous mammalian cells, where the method includes the following stages:

stage system the introduction of the composition for internal ingestion by a mammal, where the specified composition for internal injection contains

product processing Morinda citrifolia, in the amount of from about 10 to 80 wt.%; and

the carrier medium in an amount of from about 20 to 90 wt.%.

48. The method according to p, where the specified product processing Morinda citrifolia is at least one of:

(i) processed fruit juice of Morinda citrifolia;

(ii) juice puree processed fruit Morinda citrifolia; and

(iii) dietary fiber processed Morinda citrifolia.

49. The method according to p where the specified stage of the inner introduction of a composition selected from the group consisting of intravenous injection, oral administration and injection.

50. Method of inhibiting aromatase and the regulation of estrogen production, where the method includes the following stages:

the stage of introduction of the composition for use in the body of a mammal, where the specified composition for internal application contains

product added the TCI Morinda citrifolia, in the amount of from about 5 to 80 wt.%; and

the carrier medium in the amount from about 20 to 95 wt.%.

51. The method according to item 50, where the specified product processing Morinda citrifolia selected from the group consisting of processed fruit juice of Morinda citrifolia, juice puree fruits processed Morinda citrifolia, dietary fiber processed Morinda citrifolia oil processed Morinda citrifolia oil and extract, processed Morinda citrifolia.

52. The method according to item 50, where this stage of introduction of the composition for internal use, provides a means selected from the group consisting of intravenous injection, oral administration, transdermal application and injection.

53. The aromatase inhibitor for therapeutic effects on estrogen-dependent tumor mammalian cells containing composition of biologically active additives containing at least one product processing Morinda citrifolia.

54. The aromatase inhibitor according to item 53, where the specified product processing Morinda citrifolia is at least one of:

(i) fruit juice of Morinda citrifolia;

(ii) juice, Morinda citrifolia puree;

(iii) concentrate juice, Morinda citrifolia puree;

(iv) concentrate fruit juice of Morinda citrifolia; and

(v) dietary fiber Morinda citrifolia.

55. The aromatase inhibitor according to item 53, where the specified product processing Morinda citrifolia specified compositions of biologically active the additive further comprises an active ingredient quercetin, in the amount of from about 0.1 to 10 wt.%.

56. The aromatase inhibitor according to item 53, where the number of the specified product processing Morinda citrifolia is from about 0.01 to 100 wt.%.

57. The aromatase inhibitor according to § 55, where the specified product processing Morinda citrifolia also contains rutin as an additional active ingredient, which acts synergistically with quercetin in the treatment of migraine headaches and associated symptoms.

58. The aromatase inhibitor according to § 57, where the number of the specified routine is from about 0.1 to 10 wt.%.

59. The aromatase inhibitor according to item 53, where the specified composition of biologically active additives (i) is administered orally, (ii) is applied transdermal specified on the affected area, (iii) is administered intravenously or (iv) systematically.

60. Method of regulating the production of estrogen in the body of a mammal for therapeutic effects on estrogen-dependent tumors, where the method includes the following stages: stage systemic injections of the composition for use in the body of a mammal, where the specified composition for internal application contains product processing Morinda citrifolia, in the amount of from about 0.1 to 100 wt.%.



 

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20 cl, 15 sch, 14 tbl, 55 ex

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Compound // 2323940

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FIELD: CHEMISTRY.

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2 ex

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3 tbl

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3 tbl

FIELD: medicine; pharmacology.

SUBSTANCE: medicine for treatment of tuberculosis, contains the 30% alcoholic tincture of medicinal plants: knotgrass (Polygonum aviculare) herb, garden violet (Viola tricolor) herb, aspen (populus tremula) rind, agrimony (Agrimonia) herb, agrimony (Agrimonia) roots, rough-fruited cinquefoil (Potentilla recta) herb, golden thoroughwax (Bupleurum) herb, medic hop (Medicago lupulina) cone, Adonis vernalis herb, late red bartsia (Odontites vulgaris) herb, Betula leaf, bird cherry (Prunus padus) tree rind, common peony (Paeonia officinalis) root, common burdock (Arctium lappa) roots, foxtail clover (Trifolium rubens) bloom, cowberry (Comarum palustre) roots, Inula root, wheat grass (Agropyron) root, garden angelica (Angelica officinalis) root, coltsfoot herb, snowdrop anemone (Anemone sylvestris) herb, snowdrop anemone (Anemone sylvestris) root, locoweed semilunar (Astragalus) herb, arborescent aloe (Arborescence aloe) succus, swallowwort (Chelidonium majus) herb, black current (Ribes nigrum) leaf, garlic (Allium sativum) bulb, greater burnet (Sanguisorba officinalis) root, lady's finger (Lathyrus pratensis) herb, dandelion (Taraxacum officinale) root, stringing nettle (Urtica dioica) herb, common origanum (Origanum vulgare) herb, ginger plant (Tanacetum vulgare) herb, bottle brush (Equisetum arvense) herb, common wormwood (Artemisia absinthium) herb, crystal tea ledum (Ledum palustre) herb, common juniper (Juniperus communis) needle, parnassia herb, mother-of-thyme herb, flat-leaved snakeroot (Eryngium) herb, shinleaf (Ramischia secunda) herb, willow herb root and field pennycress (Thlaspi arvense) herb taken in specific proportion and added by 3 volume percent of 10% propolis tincture.

EFFECT: tincture shows efficiency in treating tuberculosis.

3 tbl

FIELD: medicine; pharmacology.

SUBSTANCE: medicine for treatment of tuberculosis, contains the 30% alcoholic tincture of medicinal plants: knotgrass (Polygonum aviculare) herb, garden violet (Viola tricolor) herb, aspen (populus tremula) rind, agrimony (Agrimonia) herb, agrimony (Agrimonia) roots, rough-fruited cinquefoil (Potentilla recta) herb, golden thoroughwax (Bupleurum) herb, medic hop (Medicago lupulina) cone, Adonis vernalis herb, late red bartsia (Odontites vulgaris) herb, Betula leaf, bird cherry (Prunus padus) tree rind, common peony (Paeonia officinalis) root, common burdock (Arctium lappa) roots, foxtail clover (Trifolium rubens) bloom, cowberry (Comarum palustre) roots, Inula root, wheat grass (Agropyron) root, garden angelica (Angelica officinalis) root, coltsfoot herb, snowdrop anemone (Anemone sylvestris) herb, snowdrop anemone (Anemone sylvestris) root, locoweed semilunar (Astragalus) herb, arborescent aloe (Arborescence aloe) succus, swallowwort (Chelidonium majus) herb, black current (Ribes nigrum) leaf, garlic (Allium sativum) bulb, greater burnet (Sanguisorba officinalis) root, lady's finger (Lathyrus pratensis) herb, dandelion (Taraxacum officinale) root, stringing nettle (Urtica dioica) herb, common origanum (Origanum vulgare) herb, ginger plant (Tanacetum vulgare) herb, bottle brush (Equisetum arvense) herb, common wormwood (Artemisia absinthium) herb, crystal tea ledum (Ledum palustre) herb, common juniper (Juniperus communis) needle, parnassia herb, mother-of-thyme herb, flat-leaved snakeroot (Eryngium) herb, shinleaf (Ramischia secunda) herb, willow herb root and field pennycress (Thlaspi arvense) herb taken in specific proportion and added by 3 volume percent of 10% propolis tincture.

EFFECT: tincture shows efficiency in treating tuberculosis.

3 tbl

FIELD: medicine; pharmacology.

SUBSTANCE: medicine for treatment of tuberculosis, contains the 30% alcoholic tincture of medicinal plants: knotgrass (Polygonum aviculare) herb, garden violet (Viola tricolor) herb, aspen (populus tremula) rind, agrimony (Agrimonia) herb, agrimony (Agrimonia) roots, rough-fruited cinquefoil (Potentilla recta) herb, golden thoroughwax (Bupleurum) herb, medic hop (Medicago lupulina) cone, Adonis vernalis herb, late red bartsia (Odontites vulgaris) herb, Betula leaf, bird cherry (Prunus padus) tree rind, common peony (Paeonia officinalis) root, common burdock (Arctium lappa) roots, foxtail clover (Trifolium rubens) bloom, cowberry (Comarum palustre) roots, Inula root, wheat grass (Agropyron) root, garden angelica (Angelica officinalis) root, coltsfoot herb, snowdrop anemone (Anemone sylvestris) herb, snowdrop anemone (Anemone sylvestris) root, locoweed semilunar (Astragalus) herb, arborescent aloe (Arborescence aloe) succus, swallowwort (Chelidonium majus) herb, black current (Ribes nigrum) leaf, garlic (Allium sativum) bulb, greater burnet (Sanguisorba officinalis) root, lady's finger (Lathyrus pratensis) herb, dandelion (Taraxacum officinale) root, stringing nettle (Urtica dioica) herb, common origanum (Origanum vulgare) herb, ginger plant (Tanacetum vulgare) herb, bottle brush (Equisetum arvense) herb, common wormwood (Artemisia absinthium) herb, crystal tea ledum (Ledum palustre) herb, common juniper (Juniperus communis) needle, parnassia herb, mother-of-thyme herb, flat-leaved snakeroot (Eryngium) herb, shinleaf (Ramischia secunda) herb, willow herb root and field pennycress (Thlaspi arvense) herb taken in specific proportion and added by 3 volume percent of 10% propolis tincture.

EFFECT: tincture shows efficiency in treating tuberculosis.

3 tbl

FIELD: medicine; pharmacology.

SUBSTANCE: medicine for treatment of tuberculosis, contains the 30% alcoholic tincture of medicinal plants: knotgrass (Polygonum aviculare) herb, garden violet (Viola tricolor) herb, aspen (populus tremula) rind, agrimony (Agrimonia) herb, agrimony (Agrimonia) roots, rough-fruited cinquefoil (Potentilla recta) herb, golden thoroughwax (Bupleurum) herb, medic hop (Medicago lupulina) cone, Adonis vernalis herb, late red bartsia (Odontites vulgaris) herb, Betula leaf, bird cherry (Prunus padus) tree rind, common peony (Paeonia officinalis) root, common burdock (Arctium lappa) roots, foxtail clover (Trifolium rubens) bloom, cowberry (Comarum palustre) roots, Inula root, wheat grass (Agropyron) root, garden angelica (Angelica officinalis) root, coltsfoot herb, snowdrop anemone (Anemone sylvestris) herb, snowdrop anemone (Anemone sylvestris) root, locoweed semilunar (Astragalus) herb, arborescent aloe (Arborescence aloe) succus, swallowwort (Chelidonium majus) herb, black current (Ribes nigrum) leaf, garlic (Allium sativum) bulb, greater burnet (Sanguisorba officinalis) root, lady's finger (Lathyrus pratensis) herb, dandelion (Taraxacum officinale) root, stringing nettle (Urtica dioica) herb, common origanum (Origanum vulgare) herb, ginger plant (Tanacetum vulgare) herb, bottle brush (Equisetum arvense) herb, common wormwood (Artemisia absinthium) herb, crystal tea ledum (Ledum palustre) herb, common juniper (Juniperus communis) needle, parnassia herb, mother-of-thyme herb, flat-leaved snakeroot (Eryngium) herb, shinleaf (Ramischia secunda) herb, willow herb root and field pennycress (Thlaspi arvense) herb taken in specific proportion and added by 3 volume percent of 10% propolis tincture.

EFFECT: tincture shows efficiency in treating tuberculosis.

3 tbl

FIELD: medicine; pharmacology.

SUBSTANCE: medicine for treatment of tuberculosis, contains the 30% alcoholic tincture of medicinal plants: knotgrass (Polygonum aviculare) herb, garden violet (Viola tricolor) herb, aspen (populus tremula) rind, agrimony (Agrimonia) herb, agrimony (Agrimonia) roots, rough-fruited cinquefoil (Potentilla recta) herb, golden thoroughwax (Bupleurum) herb, medic hop (Medicago lupulina) cone, Adonis vernalis herb, late red bartsia (Odontites vulgaris) herb, Betula leaf, bird cherry (Prunus padus) tree rind, common peony (Paeonia officinalis) root, common burdock (Arctium lappa) roots, foxtail clover (Trifolium rubens) bloom, cowberry (Comarum palustre) roots, Inula root, wheat grass (Agropyron) root, garden angelica (Angelica officinalis) root, coltsfoot herb, snowdrop anemone (Anemone sylvestris) herb, snowdrop anemone (Anemone sylvestris) root, locoweed semilunar (Astragalus) herb, arborescent aloe (Arborescence aloe) succus, swallowwort (Chelidonium majus) herb, black current (Ribes nigrum) leaf, garlic (Allium sativum) bulb, greater burnet (Sanguisorba officinalis) root, lady's finger (Lathyrus pratensis) herb, dandelion (Taraxacum officinale) root, stringing nettle (Urtica dioica) herb, common origanum (Origanum vulgare) herb, ginger plant (Tanacetum vulgare) herb, bottle brush (Equisetum arvense) herb, common wormwood (Artemisia absinthium) herb, crystal tea ledum (Ledum palustre) herb, common juniper (Juniperus communis) needle, parnassia herb, mother-of-thyme herb, flat-leaved snakeroot (Eryngium) herb, shinleaf (Ramischia secunda) herb, willow herb root and field pennycress (Thlaspi arvense) herb taken in specific proportion and added by 3 volume percent of 10% propolis tincture.

EFFECT: tincture shows efficiency in treating tuberculosis.

3 tbl

FIELD: production technology of food products.

SUBSTANCE: method supposes the medium making on the basis of milk whey and potato decoct and inoculation of symbiotic starter received from the cultivation of fungus culture and termophilic lactic acid bacillus (Bulgarian and acidophilous bacterium) at the temperature (30±2)°C during 2-3 days. Concentration of symbiotic biomass in conditions of batch fermentation with double medium neutralization and the received biomass separation. Fungus culture and termophilic lactic acid bacillus can be used in following correspondence 1:0.5:0.5 or 3:0.5:0.5.

EFFECT: this method increases acid-forming and spirit medium ability as well as increase the quantity of yeast.

4 cl, 4 tbl, 5 dwg, 8 ex

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