Diarrhoea risk reduction

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to pharmaceutical industry, particularly to using probiotics in the manufacture of a drug or a therapeutic nutritional composition for long-term prevention of diarrhea in infants. Using the probiotic Lactobacillus rhamnosus ATCC 53103 or Lactobacillus rhamnosus CGMCC 1.3724, and the probiotic Bifidobacterium longum ATCC BAA-999 in the manufacture of a drug or a therapeutic nutritional composition to be introduced into an infant for at least three months for the purpose of long-term prevention of diarrhoea, wherein the probiotic is introduced into a breastfeeding infant from a nursing mother.

EFFECT: using the above probiotic strains from the nursing mother is effective for the purpose of long-term prevention of diarrhoea in infants.

6 cl, 2 ex

 

The technical field to which the invention relates.

This invention relates to the use of probiotic bacteria to reduce the risk of diarrhea in infants and young children.

The level of technology

Assume that just before birth the gastrointestinal tract of the child is sterile. During the normal birthing process he meets with bacteria from the digestive tract, skin and environment of the mother, and they begin to colonize. In the fecal microflora of healthy children, breastfed, which can be taken as the optimal microflora for this age group, dominated by Bifidobacteria species with some species of Lactobacillus and smaller amounts of Bacteroides, such as species, Bacteriodes fragilis, to exclude potential pathogens such as Clostridia. After weaning at approximately 2 years of age is established, the system of the intestinal microflora, similar to the adult system.

It should be noted that in healthy children, breastfeeding, Bifidobacteria form the basis of microflora, accounting for 60-90% of the total bacteria in the intestines of the child. Breastfeeding also encourages the development of putting barrier, which, together with the predominance of bifidobacteria, leading to increased absorption and thus, by utilization of the absorbed food.

Mate the Ukrainian milk is recommended for all children. However, in some cases, breastfeeding is inadequate or unfavorable for medical reasons, or mother abandon breastfeeding. In these situations, choose baby formula.

In the recent past to some bacterial strains were attracted considerable attention for the reason that they showed the valuable properties for humans when used inside. In particular, it was found that the specific strains of the genera Lactobacilli and Bifidobacteria are able to colonize the mucosa of the small intestine and reduce the ability of pathogenic bacteria to the adhesion to the intestinal epithelium, have immunomodulatory effects and help maintain health. These bacteria are sometimes referred to as probiotics, and has already proposed to add a suitable probiotic bacteria to baby formula.

Were conducted intensive research to identify new probiotic strains. For example, EP 0199535, EP 0768375, WO 97/00078, EP 0577903 and WO 00/53200 reveal specific strains of Lactobacilli and Bifidobacteria and their beneficial effects.

As stated above, due to its ability to colonize the mucosa of the small intestine and reduced ability of pathogenic bacteria to the adhesion to the epithelium of the small intestine, certain probiotic strains have already been suggested for the prevention and treatment on area infants. For example, WO 01/53201 offers the use of such strains of Lactobacillus, Lactobacillus paracasei CNCM I-2116, for the prevention or treatment of diarrhea, especially diarrhea caused by rotavirus. Describes a study in which the strain was applied to young children during the period of 29 days, and it was found that in the group treated with the strain, the occurrence of episodes of diarrhoea during the study period was 30% lower.

However, the frequency of episodes of infectious diarrhea during the first five years remains a significant problem for parents, nurses and medical staff.

The invention

During the study, originally designed to study the effect of 3 infant formula containing various combinations of probiotic bacteria on growth, tolerance and morbidity, the authors of the present invention unexpectedly found that feeding a specific combination of probiotic bacteria during the first three to four months of life reduces the incidence of diarrhea, not only during the period during which the applied bacteria, but also for at least 8 months after the termination of the use of probiotic bacteria.

Thus, the present invention provides the use of the probiotic Lactobacillus rhamnosus and probiotic Bifidobacterium longum in the production of medicines among the STV or therapeutic nutritional composition for use in infants for at least the first three months of life for long-term prevention of diarrhea.

The invention extends to the way long-term prevention of diarrhea in infants and young children by applying the in need of it newborn therapeutic amount of the probiotic Lactobacillus rhamnosus and probiotic Bifidobacterium longum for at least the first three months of life.

You must understand that the long-term prevention of diarrhoea during this period, important for the development of infants and young children, can have long-term beneficial effect on the health of individuals against the discomfort and inconvenience associated with episodes of diarrhea among them.

Disclosure of inventions

In this specification the following terms have the following meanings:

"infant" means a child under the age of 6 months;

"long-term prevention of diarrhea" means the reduction of episodes of diarrhea for at least eight months after the termination of the use of probiotic;

"probiotic" means preparations of microbial cells or components of microbial cells with a beneficial effect on the health or wellbeing of the owner. (Salminen S, Ouwehand A. Benno Y. et al "Probiotics: how should they be denned" Trends Food Sci. Technol. 1999:10 107-10);

"young child" means a child aged 6 to 36 months.

All references to percentages are percentages by weight, unless the establishment is about otherwise.

Probiotic Lactobacillus rhamnosus may be any species of Lactobacillus rhamnosus defined probiotic characteristics. Preferred species include Lactobacillus rhamnosus ATCC 53103, received, among other things, from Valio Oy of Finland under the trade name LGG, Lactobacillus rhamnosus CGMCC 1.3724.

Probiotic Bifidobacterium longum can be any species Bifidobacterium longum defined probiotic characteristics. The preferred form is Bifidobacterium longum ATCC BAA-999, derived from Morinaga Milk Industry Co. Ltd. from Japan under the trade name UV.

A suitable daily dose of the probiotic bacteria is from 105up to 1011colony forming units (CFU), more preferably from 107up to 1010SOME.

Probiotics Lactobacillus rhamnosus and Bifidobacterium longum preferably used in infants for at least the first three months of life, preferably within the first four to six months of life the infant.

Probiotic bacteria can be applied directly on the breast of the child or if the mother is breastfeeding, it is through the mother. If the probiotic bacteria used through the mother, you can apply them to the mother, for example, as an additive in the form of tablets, capsules, lozenges, chewing gum or liquid. The additive may further contain protective hydrocolloids (such as gums, proteins, m is definiowanie starches), binders, film forming agents, encapsulating agents/materials, wall materials/membranes, matrix compounds, shell, emulsifiers, surface-active agents, solubilizing agents (oils, fats, waxes, lecithins etc), adsorbents, carriers, fillers, co-compounds, dispersing agents, moisturizing agents, processing AIDS (solvents), agents for yield, taste masking agents, giving the mass of agents, gelling agents, geleobrazuyuschie agents, antioxidants and antimicrobial agents. The additive may also contain conventional pharmaceutical additives and adjuvants, excipients and diluents, including, without limitation, water, gelatin of any origin, vegetable gums, ligninsulfonate, talc, sugars, starch, gum Arabic, vegetable oils, polyalkylene glycols, flavoring additives, preservatives, stabilizers, emulsifying agents, buffers, lubricating agents, colouring agents, moisturizing agents, sealants, and the like. In all cases, these additional components are chosen with respect to their suitability for the appointment.

Alternatively, the probiotic bacteria can be used in the mother in the form of a therapeutic nutritional composition. The composition may be full of nutrient mixture.

Complete nutrient mixture for use in the ber the military women in accordance with the invention may include a source of protein. May be any suitable dietary protein, for example, animal proteins (such as milk proteins, meat proteins and egg proteins); vegetable proteins such as soy protein, wheat protein, rice protein, and pea protein); a mixture of free amino acids; or combinations thereof. Particularly preferred are milk proteins such as casein and whey, and soy proteins. The composition may also contain a source of carbohydrate and a source of fat.

If the recipe mixture comprises a source of fat in addition to docosahexaenoic acid, a source of fat preferably provides from 5% to 40% of the energy mix; for example, from 20% to 30% of calories. A suitable profile fats can be obtained by using a mixture of canola oil, corn oil and sunflower oil with high oleic acid content.

In the formulation of the mixture you can add a source of carbohydrates. It preferably provides from 40% to 80% of the energy mix. You can apply any suitable source of carbohydrates, such as sucrose, lactose, glucose solids corn syrup, maltodextrins and mixtures thereof. If necessary, you can also add dietary fiber. Dietary fibers pass through the small intestine, not perevarivaemy enzymes and function as a natural filler and laxative. Dietary fiber can be soluble Il is insoluble, and in the total mixture are preferred two types. Suitable sources of dietary fiber include soy, pea, oat, pectin, guar gum, gum Arabic, fructo-oligosaccharides, galacto-oligosaccharides, sialyl-lactose and oligosaccharides derived from milk of animals. The preferred mixture of fibers is a mixture of inulin with fructo-oligosaccharides with a shorter chain. Preferably, if the fibers are present, the fiber content is between 2 and 40 g/l consumption of the mixture, more preferably between 4 and 10 g/L.

The formulation mixture may also contain minerals and micronutrients, such as minerals and vitamins in accordance with the recommendations of government bodies, such as the USRDA (U.S.). For example, the mixture can contain at a daily dose of one or more of the following micronutrients in the following ranges: 300 to 500 mg calcium, 50 to 100 mg of magnesium, from 150 to 250 mg of phosphorus, 5 to 20 mg of iron, 1 to 7 mg of zinc, 0.1 to 0.3 mg copper, 50 to 200 mcg of iodine, 5 to 15 mcg of selenium, from 1000 to 3000 micrograms of beta-carotene, from 10 to 80 mg vitamin C, 1 to 2 mg of vitamin B1, from 0.5 to 1.5 mg of vitamin B6, from 0.5 to 2 mg of vitamin B2, from 5 to 18 mg Niacin, 0.5 to 2.0 µg of vitamin B12, from 100 to 800 mcg of folic acid, from 30 to 70 μg of Biotin, 1 to 5 μg of vitamin D, from 3 to 10 IU of vitamin E.

Optionally, the mixture can include one or more emulgator is s food quality; for example, the esters diacetylpyridine acids and mono - and diglycerides, lecithin and mono and diglycerides. Can be included suitable suitable salts and stabilizers.

The mixture is preferably applied enterline; for example, in the form of reconstituted powder with milk or water.

Alternative or in the case of children who are not breastfed, the probiotic can be applied in the form of additives, for example, in the form of a daily dose of 109SOME, dissolved in water and applied in a spoon.

For children who are not breastfed, probiotic bacteria can simply be used in infant formula.

Infant formula for use in accordance with the invention may contain a protein source in an amount of not more than 2.0 g/100 kcal, preferably from 1.8 to 2.0 g/100 kcal. It is believed that the type of protein is not critical to the present invention, ensuring that the minimum requirements in the content of essential amino acids and ensuring satisfactory growth, although it is preferable that more than 50% by weight of the protein source was the serum. Thus, there can be sources of protein on the basis of whey, casein and mixtures thereof, as well as protein sources based on soy. As for whey protein, the protein source may be based on acid whey or sweet savored is or their mixtures, and may include alpha-lactalbumin and beta-lactoglobulin in any desired proportions.

Proteins can be intact or gidrolizovannykh, or a mixture of intact and hydrolysed proteins. It may be necessary to provide a partially hydrolyzed protein (degree of hydrolysis of between 2 and 20%), for example for children at risk of developing allergies to cow's milk. If you need hydrolysed proteins, hydrolysis process may be conducted as needed and as is known in the art. For example, hydrolyzed whey protein can be prepared by enzymatic hydrolysis of the fraction of serum in one or more stages. It is established that if the whey fraction, used as starting material, essentially free of lactose, proteins are much less blockade of lysine during the process of hydrolysis. This reduces the degree of blockade of lysine from about 15% by weight of the total lysine to less than about 10% by weight of lysine; for example, up to about 7% by weight of lysine, which greatly improves the nutritional quality of the protein source.

Infant formula may contain a source of carbohydrate. You can apply a source of carbohydrates, usually found in infant formula, such as lactose, sucrose, maltodextrin, starch and mixtures thereof, although the preferred source of coal is W is lactose. Preferred sources of carbohydrates contribute between 35 and 65% of the total energy mix.

Infant formula may contain a source of lipids. The source of the lipid can be any lipid or fat, suitable for use in infant formula. Preferred sources of fat include palm olein, sunflower oil with a high content of aleinov, and safflower oil with a high content of aleinov. Can also be added essential fatty acids linoleic and a-linolenic acid in the form of small amounts of oils containing high amounts of pre-formed arachidonic acid and docosahexaenoic acids, such as fish oil and microbial oil. In General, the fat content is preferably such as to contribute between 30 and 55% of the total energy mix. The source of fat preferably has a ratio of n-6 to n-3 fatty acids from about 5:1 to about 15:1; for example, from about 8:1 to about 10:1.

Infant formula may also contain all the vitamins and minerals considered to be essential in the daily diet and nutritional significant quantities. For certain vitamins and minerals set out minimum requirements. Examples of minerals, vitamins and other nutrients, optional present in infant formula include vitamin a, vitamin B1, vitamin B2, vitamin B6, vitamin B2, vitamin E, vitamin K, vitamin C, vitamin D, folic acid, Inositol, Niacin, Biotin, Pantothenic acid, choline, calcium, phosphorus, iodine, iron, magnesium, copper, zinc, manganese, chloride, potassium, sodium, selenium, chromium, molybdenum, taurine and L-carnitine. Minerals are usually added in the form of salts. The presence and amount of specific minerals and other vitamins vary depending on the assigned population of infants.

If necessary infant formula may contain emulsifiers and stabilizers, such as soy lecithin, esters of citric acid and mono - and diglycerides, and the like.

Infant formula may optionally contain other substances which can have a beneficial effect, such as fiber, lactoferrin, nucleotides, nucleosides, and the like.

As children and nutrient mixture, described above, can be prepared in any suitable manner. For example, they can be prepared by mixing together with protein, carbohydrates and fat in the proper proportions. At this point can be included emulsifiers, if they apply. At this point can be added vitamins and minerals, but they are usually added later in order to avoid thermal degradation. Any lipophilic vitamins, emulsifiers and the like may be dissolved in the fat before smesi the tion. Then you can mix water, preferably water, is subjected to reverse osmosis, before the formation of the liquid mixture. The water temperature is conveniently from about 50°to about 80°C to achieve dispersion of the ingredients. Can be used commercially available thinners for the formation of a liquid mixture. The liquid mixture is then homogenized, for example, in two stages.

The liquid mixture can then be subjected to heat treatment to reduce the bacterial load by quickly heating the liquid mixture to a temperature in the range from about 80°to about 150°C. for, for example, from about 5 seconds to about 5 minutes. This can be accomplished by introducing steam, autoclave or by using a heat exchanger; for example, a plate heat exchanger.

Then, the liquid mixture can be cooled to a temperature of from about 60°to about 85°C.; for example, by instant cooling. The liquid mixture can then re-homogenized; for example, in two stages, from about 10 MPa to about MPa in the first stage, and from about 2 MPa to about 10 MPa in the second stage. Gomogenizirovannogo the mixture can then optionally be cool to add any heat sensitive components, such as vitamins and minerals. At this point it is convenient to regulate the pH and solids content.

Th is agonizirovala the mixture is transferred into a suitable apparatus for drying, such as a spray dryer or lyophilizator, and turned into powder. The powder should have a moisture content less than about 5% by weight.

Probiotic bacteria can be cultured according to any suitable method and prepared for addition to the feeding or infant formula, for example, by lyophilization or spray drying. Alternatively, bacterial preparations can be purchased from specialist suppliers, such as Morinaga and Valio, already prepared in a form suitable for addition to food products, such as nutritional and infant formula. More preferably, the Probiotic bacteria can be added to the formula in amounts of between 103and 1012CFU/g of powder.

The invention is further illustrated by reference to the following examples:

Example 1.

An example of a composition suitable for infant formula for use in the present invention, below.

td align="justify"> Biotin (µg)
Nutrient100 kcalPer liter
Energy (kcal)100670
Protein (g)1,8312,3
Fat (g)5,335,7
Linoleic acid (g)0,795,3
α-linolenic acid (mg)101675
Lactose (g)11,274,7
Minerals (g)0,372,5
Na (mg)23150
K (mg)89590
Cl (mg)64430
Ca (mg)62410
P (mg)31210
Mg (mg)750
Mn (µg)850
Se (µg)213
Vitamin a (µg retinol equivalent)105700
Vitamin D (µg)1,510
Vitamin E (µg Trolox equivalent)0,8of 5.4
Vitamin K1 (μg)854
Vitamin C (mg)1067
Vitamin B1 (mg)0,070,47
Vitamin B2 (mg)0,151,0
Niacin (mg)16,7
Vitamin B6 (mg)0,0750,50
Folic acid (µg)960
Pantothenic acid (mg)0,453
Vitamin B12 (µg)0,32
2,215
Choline (mg)1067
Fe (mg)1,28
I (g)15100
Cu (mg)0,060,4
Zn (mg)0,755
L. rbamnosus ATCC 531032,107CFU/g of powder, live bacteria
C. longum ATCC BAA-9992,107CFU/g of powder, live bacteria

Example 2.

284 healthy infants aged up to 14 days, whose mother refused to breastfeeding, participated in the study in five places in France, and were randomly assigned to one of four research groups in a prospective double-blind study.

The first group consisted of 70 infants receiving infant formula (commercially available starting formula Nestle NAN®)containing 2,107CFU/g Lactobacillus rhammsus ATCC 53103 and 2.107CFU/g Bifiobacterium longum was ATSS VA-999).

The second group consisted of 70 infants who received the same formula with the same probiotics and a prebiotic mixture of fibers (10% fructo-oligosaccharides with a short chain, 90% galacto-oligosaccharides) 4 grams per liter of prepared mixture.

The third group consisted of 74 children who received the same formula with the same prebiotic fibers and probiotics 2,107CFU/g Lactobacillus casei CNCM 1-2116 and 2.107CFU/g of Bifidobacterium longum ATCC VA-999.

The fourth group (the comparison group) received only infant formula without additives.

All groups were fed exclusively intended mixture before the age of 16 weeks. Weight was registered at the age of 16 weeks, as well as growth in the supine position and head circumference. Kept a diary for each child for the Desk chair, bloating, salivation and vomiting, frequency and duration of colic, frequency of episodes of morbidity (number of visits to healthcare professionals, other diseases). Observed in subjects up to the age of 12 months. It was found that children in the first group was statistically lower incidence of diarrhea per year than children in groups from the second to the fourth (OR=0,22, 95%CI=[0,07; 0,69], p=0,027), especially during the age period from 4 to 12 months.

1. The use of the probiotic Lactobacillus rhamnosus and probiotic Bifidobacterium longum in the industry is the tion of a drug or therapeutic nutritional composition for the introduction of the infant within, at least the first three months of life for long-term prevention of diarrhea, and probiotic enter a nursing baby through breast-feeding mother and probiotic Lactobacillus rhamnosus is Lactobacillus rhamnosus ATCC 53103 or Lactobacillus rhamnosus CGMCC 1.3724 and probiotic Bifidobacterium longum is Bifidobacterium longum ATCC BAA-999.

2. The use according to claim 1, where the drug or therapeutic nutritional composition is administered for a baby during the first 4-6 months of life.

3. The use according to claim 1 or 2, where additional specified probiotics introduce infant in the composition of infant formula.

4. The use according to claim 1 or 2, where the drug includes a total of 105-1011SOME probiotic bacteria on the daily dose.

5. The use according to claim 1 or 2, in which a therapeutic nutritional composition includes a total of 103-1012SOME probiotic bacteria per 1 g dry weight of the composition.

6. The use according to claim 3, in which infant formula includes a total of 103-1012SOME probiotic bacteria per 1 g of dry mass of the mixture.



 

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SUBSTANCE: invention refers to polyphenol derivative formulations. The polyphenol derivative formulation. A method of producing the formulation. A cosmetic composition containing an amount of one or more polyphenol derivative formulations effective for controlling the skin ageing. Using the formulation in nutrition science. The formulation used as a drug preparation. The pharmaceutical composition containing the polyphenol derivative formulation.

EFFECT: formulation effectively slows down the processes of ageing; it possesses antioxidant, antiradical activity, an ability to retain carbonyl compounds.

30 cl, 10 dwg, 5 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: group of inventions refers to medicine and aims at treating and preventing hepatic encephalopathies. There are presented composite formulations containing various combinations of L-carnitine, acetyl-L-carnitine, succinate, L-glutamate, L-arginine, betaine and creatine phosphate, N-acetylcysteine, coenzyme Q10 and dihydroquercetin; S-adenosylmethionine; coenzyme Q10 and dihydroquercetin, dihydroquercetin and lipoamide.

EFFECT: group of inventions enables relieving behavioural, neurological and psychic disorders by activating the osmoprotective and energetic systems, detoxification reaction systems of ammonium ions and other toxins, as well as the antioxidant systems of cerebral and hepatic cells.

5 cl, 3 ex, 4 tbl, 3 dwg

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to pharmaceutics and represents an agent for local treatment of periodontal diseases, on the basis of organosilicone gycerohydrogel Si(C3H7O3)4·6C3H8O3·24H2O, containing therapeutic supplements, differing by the fact that the therapeutic supplements are presented by ketoprofen and methyluracil in the following proportions, wt %: ketoprofen - 0.5 - 1.0; methyluracil - 1.0 - 1.5; organosilicone gycerohydrogel Si(C3H7O3)4·6C3H8O3·24H2O - up to 100.

EFFECT: invention provides creating the effective agent applicable in the integrated therapy for treating the inflammatory periodontal diseases.

6 ex

FIELD: medicine.

SUBSTANCE: claimed is group of inventions, which includes method of cosmetic treatment, intended for moistening epidermis, increasing derma elasticity, fight against skin ageing, regulation of sebum secretion, restoration of hair and/or improving hair growth, which includes stage of bringing composition, which includes mannoproteins, extracted from cell wall of Saccharomyces into contact with skin and/or skin appendices, and claimed composition does not contain polyphenols, as well as cosmetic composition for topic application, which includes mannoproteins and application of mannoproteins, extracted from cell wall of Saccharomyces, as texturing agent in cosmetic compositions for topic application.

EFFECT: inventions ensure effective cosmetic treatment with application of composition with certain mannoproteins, obtained from concrete cell walls of fungi.

13 cl, 3 tbl, 2 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to pharmaceutical industry, and represents a composite probiotic preparation containing probiotic lactic acid bacilli and bifidus bacteria cells, or mixtures thereof, and a polymer additive in an enterosoluble capsule, differing by the fact that the probiotic lactic acid bacilli and bifidus bacteria cells belong to the species Lactobacillus plantarum, Lactobacillus fermentum, Lactobacillus acidophilus, Lactobacillus casei, Bifidobacterium bifidum, Bifidobacterium longum, while the polymer additive used as a binding agent and being a polysaccharide, is specified in a group: amylopectin, waxy corn starch, native potato starch, soluble potato starch, wheat starch, maltodextrin, or mixtures thereof with the above ingredients of the composite preparation are taken in ratio 108-1012 probiotic lactic acid bacilli and bifidus bacteria cells per 0.01-1 g of the polymer additive.

EFFECT: invention provides creating more effective and stable probiotic preparation for preventing and treating intestinal dysbacterioses and intestinal infections, as well as increasing an ability of the preparation to produce nitrogen monoxide by NO-synthase mechanism.

2 cl, 1 ex, 1 tbl, 5 dwg

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