Contact-type purgative preparation, pharmaceutical composition upon its basis and method for preventing and treating constipations and affected biorhythm of defecation

FIELD: chemical and pharmaceutical industry.

SUBSTANCE: the present innovation deals with creating medicinal preparations of plant origin and could be applied for treating functional constipations and affected biorhythm of defecation. It is suggested to apply either dry aqueous or aqueous-alcoholic extract of horse chestnut seeds of Aesculus species to prepare curative-prophylactic preparation in case of constipation and affected biorhythm of defecation. The suggested preparation should be applied in the form of powder, tablets or suppositories. Pharmaceutical composition for preventing and treating constipation and affected biorhythm of defecation contains an active substance out of medicinal plant and a pharmaceutically acceptable filling agent, moreover, this preparation is designed as suppositories and contains either dry aqueous or aqueous-alcoholic extract of horse chestnut seeds of Aesculus species and suppository hydrophobic foundation at certain content of ingredients. Dry aqueous or aqueous-alcoholic extract contains 1-50% active substance as escin. As foundation it could contain either cacao oil or vitepsol. The method for preventing and treating constipations and affected biorhythm of defecation deals with introducing the suggested pharmaceutical composition into patient's anus 5-15 min before planned act of defecation. Application of "Rectum-activ" preparation provides positive result at treating functional psychogenic constipation: in 5-15 min after introducing a suppository into anus pronounced urgency for defecation. In case of course therapy for 4 wk one should observe restoration of natural urgency for intestinal evacuation. Moreover, purgative preparation causes no unfavorable pain feelings.

EFFECT: higher efficiency.

10 cl, 6 ex

 

The invention relates to chemical-pharmaceutical industry, namely the creation of herbal medicines, and can be used for the treatment of functional constipation and disorders of the rhythm of defecation.

Constipation - difficulty (violation) emptying of the bowel, accompanied by the absence of an independent chair for more than 2-3 days, which requires the use of laxatives or other AIDS. Today, this phenomenon is very common in the countries of Western Europe, North America and Russia. If earlier constipation was typical for the urban population, today it is often found and the rural population. The prevalence of constipation translates this problem into the category of social, requiring mass diagnostic, therapeutic and preventive measures. The importance of this problem is determined by the fact that many pathological conditions of the colon increase the risk of developing malignant neoplasms pathology or functionally related (dependent) digestive organs (gall bladder and bile ducts, stomach, duodenum, pancreas).

Currently therapy of constipation presents various methods of treatment, which include widespread use of laxatives and diet.

In the recent years abroad with this purpose have been increasingly used oral drugs containing extracts from medicinal plants. So, widely used for the Senado, Gloxina, Kapil, Regulax, castor Oil, Agiolax and Almost all other laxatives herbal remedies created on the basis of Senna leaf, buckthorn bark, fruit Zostera laxative and rhizome of rhubarb, containing antrahinonovye glycosides (RLS, 2002).

The disadvantage of oral laxatives is a long-term irritant effect on the entire intestine, large time period since acquisition to obtain the desired effect, and side effects: abdominal cramps, frequent loose stools, repeated urge to have a bowel movement.

In addition to oral means as laxatives use of rectal suppositories. Currently on the pharmaceutical market of Russia presents 9 items suppositories with laxative effects, including domestic - 3 (Bisacodyl-Nizhpharm, Glycolax, Glycerol), foreign - 6 (Bisacodyl, Dulcolax, Laxbene, fleet, Km-glycerolic, Km-sonofit) (RLS, 2002). Active ingredients all of these candles are 2 substances - Bisacodyl and glycerin. Both substances have significant disadvantages. Bisacodyl has a mild laxative effect, and glycerin causes inflammation of the rectum.

The objective of the invention is to develop a new l is educational-preventive means on the basis of the herbal extract high therapeutic activity aimed at the treatment of constipation of various etiologies: functional (the usual), psychogenic, senile, constipation in sedentary patients, and constipation associated with a decrease in the sensitivity of the receptor apparatus of the rectum.

This object is achieved by a group of inventions combined to form a single inventive concept.

The proposed use of dry water or water-alcohol extract of horse-chestnut seeds of the genus Aesculus for the preparation of therapeutic-prophylactic remedy for constipation and disorders of the rhythm of defecation.

The product is used in the treatment of functional constipation, psychogenic, senile, constipation in sedentary patients, constipation, associated with a decrease in the sensitivity of the receptor apparatus of the rectum.

The tool used in powder form, in the form of tablets or suppositories.

The proposed pharmaceutical composition for the prevention and treatment of constipation and disorders of the biorhythm of the bowel containing the active substance of the medicinal plants and pharmaceutical acceptable excipient, the tool is made in the form of a suppository and contains dry water or water-alcohol extract of horse-chestnut seeds of the genus Aesculus and suppozitornyj hydrophobic basis at the following content ingredient is for 1 candle mass of 1 g:

dry water or water-alcohol extract

horse-chestnut seeds 10-100 mg

suppozitornyj hydrophobic base the rest.

Dry water or water-alcohol extract of the seeds of horse chestnut contains 1-50% active ingredient of escin.

As a basis it can contain cocoa butter or witepsol.

Also we propose a method for the prevention and treatment of constipation and disorders of the rhythm of defecation, which consists in the fact that the pharmaceutical composition is injected into the anus for 5-15 minutes prior to the scheduled defecation.

To restore the natural biorhythm of defecation course of treatment up to 1 month.

The proposed tool called “Rectum-asset.

The chestnut is a large deciduous tree, leaves opposite, flowers white, gathered in upright pyramidal brush, fruit globular, covered with thorns pods, seeds, large 3-4 cm in diameter, shiny, brown. Less frequently used sheets that are to be procured in the first half of the summer. Used for medical purposes, the Mature seeds and flowers.

Bark of trunk and branches contains glycosides: esculin, hydrolysis of the disintegrating on esculetin (6-7-toxicomanie), fraxin and glucose; triterpene saponin escin, which gives the splitting of assignin; tannins and fatty oil.

In leaves of plants found quercitrin, isoquants the trine and quercetin related to flavonoid compounds, selected rutin and spiraeoside, astragalin; carotenoids lutein, violaxanthin.

The flowers contain quercitrin, rutin, isoquercitrin (Turova, Sapozhnikova, 1982).

Seeds contain coumarin glycosides (esculin, fraxin), flavonoids (quercetin, kaempferol), triterpene saponins (escin), fatty oil (5-7%), protein (10%), starch (50%), tannins (1%), vitamin E, b vitamins (Lcars roslini, 1989).

Preparations containing extracts of the seeds of horse chestnut, used in official medicine as Antihaemorrhoidal tools and varicose veins in pregnant women and mothers. In patients with varicose syndrome, decrease swelling and inflammation after administration of the drug. Positive results in patients with brain oedema in prescribing chestnut due to its anti-inflammatory effect and confirmed by normalization of EEG indices (Sokolov, zamotaev, 1989; Sokolov, 2000).

Drugs from the peel of ripe seeds of horse chestnut is used in the BPH (Gelencir N., 1982) and chronic prostatitis in combination with BPH (Mamchur FI, Kushniruk YU.N., 1992). An aqueous extract of the peel of the fruit slows adenomatous transformation and reparative effect on areas of the prostate gland, covered process is m The mechanism of action of this drug has not been studied, but the Polish scientists believe that smaller sizes and even resorption small adenomatous nodes contributes to the glycoside esculin in combination with vitamin E, which is rich chestnut seeds (Krylov A.A. and others, 1991; Mamchur FI, Kushniruk YU.N., 1992).

Fresh peeled seeds are prepared homeopathic medicine Aesculus hippocastanum. The tool is used in cultivation from DJ to D2 and is given 2-3 times a day, several drops: when dry catarrh of the nasopharynx, when hemorrhoid and trophic leg ulcers.

Consider that the bark of horse chestnut improves digestion and suppresses the accompanying inflammatory process is the secretion of the intestine. Therefore, it is recommended to apply a decoction from the bark of the chestnut with diarrhea. In febrile conditions we recommend to use it instead of Cinchona bark and willow. A decoction of the bark of the chestnut tree is used for ligation of suppurating wounds. Fruits recommended for cough with thick sputum. Externally the extract from the fruit of the chestnut tree is recommended for neuralgia, myalgia, rheumatism, inflammation of the skin and other (Modern herbal medicine, 1988).

Tincture of the flowers, bark or leaves, from time to time used in folk medicine is based on wheat vodka. It is used against diseases of veins and rheumatic complaints. Try to take her and also the bridges : and intestinal pain. In some cases, the chestnuts are roasted, then ground, mixed with flour and vinegar and this pasty mixture is placed on the hardened breast feeding mothers to soften. However, a serious need for this, because in pharmacies there are many preparations of horse chestnut, which can be used mainly in diseases of the veins (Burns, 1998).

Herbal medicines from horse chestnut (Aesculus hippocastanum L): infusions and decoctions of the bark, leaves, fruits, has long been used in folk medicine as an astringent, diuretic, styptic (with uterine and hemorrhoidal bleeding) funds. Different parts of the plant contain different amounts of saponins, flavonoids (rutin, quercetin) and other organic compounds. Particularly important is pharmacologically active substance is escin. Escin (Escin, Aescin, Ascin) - triterpene glycoside with a complex chemical structure; when the hydrolysis is split into assignin and three residue sugars. Escin has expressed cardio activity and provides antiexudative (anti-inflammatory) effect. The pharmacological activity of the total number of drugs derived from horse chestnut (aescusan, splashid and others), largely associated with the presence of escin.

Currently, Ro is these are registered with the following medications with chestnut.

RAVENOL (Anavenol)*

Combined drug in the form of pellets, containing esculin (close to the action on escin) 0.0015 g (1.5 mg), dihydroergocristine (nelfinavir) 0.0005 g (0.5 mg) and routine 0.03 g (30 mg), or in the form of drops containing 1 ml (20 drops) of esculin 0.0015 g (1.5 mg), dihydroergocristine (nelfinavir) 0.0005 g (0.5 mg) and rutin sodium sulfonate 0.04 g (40 mg).

Is Genotropin drug, used in chronic diseases of veins, phlebitis, varicose, ulcer, post-traumatic lesions of the veins and other

The effect of the drug is associated with cardio-properties of esculin and routine and special effects on peripheral vessels dihydroergocristine (see), which, being α-blocker, causes expansion of arterioles and, in addition, the tone of smooth muscles of the veins. The consequence of this is the improvement of blood flow in peripheral vessels.

ONEPLANT (Venoplant)*

Standardized dry extract of horse-chestnut seeds. Contains triterpene glycosides group of escin.

Has wendonside and anti-inflammatory (antiexudative action. Decreases observed in chronic venous disease increased activity of lysosomal enzymes in the wall of the capillaries, resulting in decreased vascular permeability, warned filtering nizkomolekularnah the x protein, water and electrolytes in the extracellular space.

Used for disorders of the venous circulation (varicose veins, chronic venous insufficiency with pain and feeling of heaviness in the legs, swelling of the legs.

REPARIL(Reparil)*

Cardio-and anti-inflammatory medication, the active ingredient of which is a triterpene glycoside (saponin) escin contained in the fruit (seeds), horse chestnut.

Reparil issued in the form of pellets, coated, resistant to gastric juice (reparil-40), and in the form of a gel (reparil-gel).

In the preparation of cardio-and anti-inflammatory properties of escin is used primarily to speed up the recovery options (reparatio) of organs and tissues (decrease swelling, pain) after injuries (including sports), operations, phlebitis, varicose veins, hemorrhoids, and some other pathological conditions.

Reparil-gel n Combined preparation for cutaneous application. Contained in 100 g of gel, 1 g of escin and 5 g of salicylate diethylamine.

Anti-inflammatory and analgesic action.

The local application of absorbed through the skin and relatively quickly detected in subcutaneous adipose tissue and muscle tissue.

Apply with injuries from bruises, restiani the m ligaments, when the hematoma, tendovaginitis, sciatica, lumbago and other pain syndromes, as well as the superficial phlebitis, varicose veins.

AESCUSAN (AESCUSAN®) Queisser Pharma GmbH & Co. (Germany)

The composition and release form. 100 g of the solution for oral administration contains dry extract of horse-chestnut seeds in terms of escin 6.25 g and thiamine chloride hydrochloride i g; in the bottle dropper to 20 ml, 1 pack of 1 vial.

Pharmacological action. Wendonside, antiexudative. Reduces the concentration of lysosomal enzymes and inhibits the degradation of mucopolysaccharides in the capillary walls. Reduces the permeability of blood vessels, preventing filtering of low molecular weight proteins, electrolytes and water in the lung space.

AESCUSAN 20 (AESCUSAN® 20) Sobering AG (Germany)

The composition and release form. 1 tablet coated liner contains dry extract of the fruit of the horse chestnut, the relevant content of escin 20 mg; blistere in 20 pieces, in a box of 2 blisters.

Pharmacological action. Wendonside. Lowers the activity of lysosomal enzymes, inhibits the breakdown of mucopolysaccharides in the wall space of the capillaries. Reduces vascular permeability, filtration of low molecular weight proteins, electrolytes and water in the extracellular space.

ESCIN (ESCIN)/DCF/

Triterpen the new glycoside (saponin) of the fruits (seeds), horse chestnut (in the form of sodium salt).

Drugs, anti-edematous, anti-inflammatory, wendonside, angioprotective. Prevents activation of lysosomal enzymes that break down proteoglycan, increases tone of venous walls, eliminates venous congestion; reduces the permeability and fragility of capillaries. The increased venous blood flow has a beneficial effect in diseases involving venous congestion (especially in the lower extremities), edema, trophic damage the walls of blood vessels, inflammation and thrombosis of the veins, helps repair tissues and organs.

ASSAWAN-GEL (Essaven)*

A gel containing 100 g: escin 1 g of heparin sodium salt of 10,000 IU, phospholipids, unsaturated fatty acids (linoleic, linolenic, oleic acid), ethyl alcohol.

Used for disorders of the venous circulation: varicose veins, inflammation of the superficial veins, swelling, bruises, sprains, sports injuries.

SPLASHID (Aesflazidum)

Combined product (from horse chestnut) in the form of tablets containing escin (from the fruit) 0,005 grams (5 mg) and total flavonoids (from leaves) - flavida 0,025 g (25 mg).

The content of active substances and medicinal effects similar to accutane.

Apply with phlebitis, thrombophlebitis, hemorrhoids. The proposed product contains dry water is or aqueous alcoholic extract of the seeds of the chestnut genus Aesculus.

Dry water or dry hydroalcoholic extract of the seeds of the chestnut prepared in accordance with the requirements of the existing Pharmacopoeia.

Pharmaceutical composition in the form of candles are distinguished by the content of EXTRACTA horse-chestnut seeds in 1 candle (baby -15 mg, 25 mg; adults : 50 mg, 100 mg).

The tool was prepared as follows.

Example 1. To 985 grams of melted fat (cocoa butter, witepsol and others), heated to temperature 40-45°add 15 grams of dry extract of horse-chestnut seeds and mix thoroughly in a mixer until a uniform distribution of the extract in basis. Received candlestick mass is poured into a cooled mould 1000 candles with a mass of 1 gram each.

Example 2. To 975 grams of melted fat (cocoa butter, witepsol and others), heated to a temperature of 40-45°add 25 grams of dry extract of horse-chestnut seeds and mix thoroughly in a mixer until a uniform distribution of the extract in basis. Received candlestick mass is poured into a cooled mould 1000 candles with a mass of 1 gram each.

Example 3. To 950 grams of melted fat (cocoa butter, witepsol and others), heated to a temperature of 40-45°add 50 grams of dry extract of horse-chestnut seeds and mix thoroughly in a mixer until a uniform distribution of the extract in the basis of the E. Received candlestick mass is poured into a cooled mould 1000 candles with a mass of 1 gram each.

Example 4. To 900 grams of melted fat (cocoa butter, witepsol and others), heated to a temperature of 40-45°add 100 grams of dry extract of horse-chestnut seeds and mix thoroughly in a mixer until a uniform distribution of the extract in basis. Received candlestick mass is poured into a cooled mould 1000 candles with a mass of 1 gram each.

Suppositories “Rectum-asset have a light brown color. The active ingredients of the drug are triterpene saponins group β-amirin, of which the main escin, derived asthenia. The absence of receiving the drug, thermal effects and heat-mass transfer processes, resulting in the loss of some components of the extract, ensures the preservation of the whole complex of biologically active substances in their native state.

Way of application and dose.

After releasing the candle from the blister, put it into the anus for 5-15 minutes before the scheduled time of defecation. To restore the lost natural biorhythm defecation carry out a course of treatment within 1 month.

The drug was tested on human volunteers suffering from constipation, namely:

Functional constipation - 7 che who ovec,

Psychogenic constipation - 5 people,

Senile constipation - 3 person

Clinical observations, we can note the high effect of this drug.

Very high effect of the drug was demonstrated in the treatment of patients with functional and psychogenic constipation.

The invention is illustrated by the following examples.

Example 1. Patient M., 35 years old, diagnosed with chronic functional constipation. To do this unsuccessfully in the past few years were treated with various laxatives, mainly tea containing Senna and cleansing enemas. Candles “Rectum-asset was administered 1 time per day, in the morning, immediately after waking up. A strong desire to bowel movements arose every time after 5-7 minutes after insertion of the suppository into the rectum. After a month's course using suppositories showed complete recovery of the natural urge to have a bowel movement. The patient stated that after the abolition of suppositories her daily in the morning after waking up after 15-30 minutes there is a natural urge to defecate, and disappeared irritability and headaches.

Example 2. Patient K., 25 years, the diagnosis - dyschezia. Disease psychogenic nature occurred 7 years ago, during the term service in the army. On his return from the army tried to be treated independently candles with bisacodylum the glycerin, but a positive result is not received. Candles with bisacodylum did not cause a laxative effect, and candles with glycerol caused a persistent inflammation of the rectum. To relieve the inflammation in the rectum did microclysters with vegetable oil. Completed the treatment candles “Rectum-asset scheme: 1 candle in the morning immediately after waking up. A strong desire to bowel movements arose every time after 5-15 minutes after insertion of the suppository into the rectum. After 30 days of treatment, after preparation, without the introduction of candles in the morning there is a natural urge for defecation, disappeared acne and abdominal pain.

These observations suggest that the drug “Rectum-asset gives a positive result in the treatment of functional and psychogenic constipation, i.e. through 5-15 min after the application of a suppository into the anus, there are strongly expressed the urge to have a bowel movement. During the course of treatment for 4 weeks showed restoration of the natural urge for bowel movements. In addition, laxative does not cause unpleasant pain.

1. The use of dry water or water-alcohol extract of horse-chestnut seeds of the genus Aesculus for the preparation of therapeutic-prophylactic remedy for constipation and disorders of the rhythm of defecation.

2. The use according to claim 1, characterized who eat what tool is used in the treatment of functional constipation, psychogenic, senile, constipation in sedentary patients, constipation, associated with a decrease in the sensitivity of the receptor apparatus of the rectum.

3. The use according to claim 1, characterized in that the product is used in powder form.

4. The use according to claim 1, characterized in that the product is used in tablet form.

5. The use according to claim 1, characterized in that the product is used in the form of suppositories.

6. Pharmaceutical composition for the prevention and treatment of constipation and disorders of the biorhythm of the bowel containing the active substance of the medicinal plants and pharmaceutical acceptable excipient, characterized in that it is made in the form of a suppository and contains dry water or water-alcohol extract of horse-chestnut seeds of the genus Aesculus and suppozitornyj hydrophobic basis in the following ingredients in 1 candle mass of 1 g:

Dry water or water-alcohol extract

horse-chestnut seeds 10-100 mg

Suppozitornyj hydrophobic base the Rest

7. The pharmaceutical composition according to claim 6, characterized in that the dry water or water-alcohol extract of the seeds of horse chestnut contains 1-50% active ingredient of escin.

8. The pharmaceutical composition according to claim 6, characterized in that as the basis she is holding a cocoa butter or witepsol.

9. Method for the prevention and treatment of constipation and disorders of the rhythm of defecation, characterized in that the candle according to claim 6 is introduced into the anus for 5-15 minutes before the scheduled time of defecation.

10. The method according to claim 9, to restore the natural biorhythm of defecation course of treatment up to 1 month.



 

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