LT6202B - Composition for nutritional or pharmaceutical biopreparation - Google Patents

Abstract

The present invention relates to biotechnology field, namely, to the preparations of probiotics that may be used as food supplement and medicinal preparation for treatment and prophylaxis. Preparation comprises probiotics from bifidobacteria and lactobacteria wherein bifidobacteria are selected from the strains such as Bifidobacterium infantis, Bifidobacterium longum, Bifidobacterium bifidum Bifidobacterium breve, lactobacteria are selected from strains such as Lactobacillus acidophilus, Lactobacillus plantarum. To make their activity field wider the composition additionally comprises lactobacteria selected from strains Lactobacillus fermentum, Lactobacillus reuteri, Lactobacillus casei ir Lactobacillus rhamnosus. The total biological activity of probiotics from bifidobacteria and lactobacteria per gram of biomass is from approximately 1,5 x 1010 to approximately 1,5 x 1011 CFU (colony forming units). Probiotics comprise from approximately 40 to approximately 42 mass % of composition, the rest part of composition being additional materials.

Description

The present invention relates to the field of biotechnology, namely to probiotic preparations and may be used as a dietary supplement or as a therapeutic prophylactic preparation.

There is a known consortium of 5 bifid bacteria selected from the group of strains Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium adolescentis, Bifidobacterium infantis, Bididobacterium breve, which is used to make fermented milk non-fermented products 9 (see Patent Nos. 9). ).

The disadvantage of this consortium is its narrow application because it is only suitable for use in the manufacture of fermented dairy products and does not maintain stability and viability in liquid media. Aggressive media loses vitality and efficiency when exposed to gastrointestinal tract agents.

It is known Bifidobacteria and lactobacilli biopreparation basis for dysbacteriosis and infectious gastrointestinal tract disorders for the treatment of dry biomass containing a consortium of bifidobacteria comprising Bifidobacterium adolescentis strain B-1 10 ⁸ to 10 ¹ ° CFU Lactobacillus acidophilus AT41 from 10® to 10 ¹ CFU per gram of dry biomass and auxiliary materials for formulation, wherein the biomass components of the dry consortium consist of: bifidobacteria and lactobacteria 0.5 to 10.0% and the remainder of the auxiliary material (see Russian patent application no. 2003 136785).

The closest by composition is a biopreparation comprising probiotics from bifidobacteria and lactobacteria and adjuvants, probiotic bifidobacteria are selected from the group consisting of strains consisting of Bifidobacterium infantis, Bifidobacterium longum, Bifidobacterium bifidum 1, Bifidobacterium adolescentis, Bifidobacterium adolescentis, Lactobacillus acidophilus, Lactobacillus plantarum, and optionally, the additional substances include a probiotic viability enhancer, an antioxidant, and a filler having a total biological activity of probiotics from about 5 x 10 ⁹ to about 8 x 10 ¹⁰ CFU (colony forming units), and from about 25 to about 30% by weight of the composition, the remainder being supplemental materials (see description of the invention according to Lithuanian Patent No. 5578, August 20, 2007)

The disadvantage of this biopreparation is the narrow spectrum of action involved in metabolic processes because of the small amount of lactobacterial strains that complement each other with their beneficial properties.

The purpose of the invention is to provide a biopreparation which has a broader spectrum of activity in the metabolic process, better maintaining bacterial stability and viability.

It is an object of the present invention that a composition of a nutritional or pharmaceutical biopreparation comprising probiotics from bifidobacteria and lactobacteria and adjuvants wherein the probiotic bifidobacteria are selected from strains such as Bifidobacterium longum, Bifidobacterium lifidum, as Lactobacillus acidophilus, Lactobacillus plantarum, the composition further comprises lactobacteria strains selected from Lactobacillus fermentum, Lactobacillus reuteri, Lactobacillus casei and Lactobacillus rhamnosus in which the probiotic lactobacilli and bifidobacteria in the total biological activity per gram of biomass is about 1.5 χ 10 ¹⁰ to about 1 , 5 χ 10 ¹¹ CFUs (colony forming units), and from about 40 to about 42% by weight of the composition, with the remainder being selected from additional ingredients.

Selected additional ingredients in the composition include maltodextrin, magnesium stearate and silica, wherein maltodextrin represents about 35.19% by weight of the composition, magnesium stearate represents 1.17% by weight of the composition, and silica comprises about 0.29% by weight of the composition.

The composition is in a unit dosage form for oral administration, which may be in the form of a capsule, tablet, pellet, or powder and may be used as a dietary supplement or as a medicine for the prophylaxis or treatment of gastrointestinal dysbacteriosis, dynamic equilibrium between the microbiota of the body and the environment.

The proposed composition, due to the diversity and compatibility of bifidobacteria and lactobacteria, has a much broader spectrum of activity involved in metabolic processes and greater stability.

The proposed composition of a nutritional or pharmaceutical biopreparation comprises probiotics from bifidobacteria and lactobacteria selected from strains

Bifidobacterium bifidum, ATCC 29521;

Lactobacillus acidophilus, ATCC 4356;

Bifidobacterium brevis, product code: LactoStab, SGB01;

Bifidobacterium infantis, product code: LactoStab, SGB03;

Lactobacillus fermentum, product code: LactoStab, SGL10;

Lactobacillus reuteri, product code: LactoStab, SGL01;

Nutraceutica s.r.l. Via Idice 27 / 01,40050 Monterenzio, IT;

Bifidobacterium longum, product code 68936, 01-05-2010;

FERM 100351 FT CHR Hansen;

Chr. Hansen A / S, Boge Alle 10-12-2970 Horsholm, DK

Lactobacillus plantarum, prod. specification DuoLac-Lactobacillus plantarum LP1, 12/15/2008; FERM 300 500FT, CELL BIOTECH EUROPE A / S Havnegade 39, 1058 Copenhagen, DK

Lactobacillus rhamnosus, product code THT 030901, E-09-10 / 044 (16S / ITS),

FERM600200 FT THT;

THT s.a .. Chee dEghezee, 36-5081 La Bruyere, BE

Lactobacillus casei

Probiotic strains have been selected based on the research of scientists and biotechnologists on the characteristics of the strains and their particular importance in the metabolic processes in the body. The different antagonistic, enzymatic, immunogenic activity of the probiotic strains forms a broader spectrum of their activity - prevents the attachment and multiplication of bacteria causing infections and inflammatory processes, produces fungi, pathogenic and conditionally pathogenic bacteria, synthesizing enzymes, undigested nutrients, suppresses allergic reactions, reduces risk of atopic dermatitis, participates in synthesis of B and K vitamins, assimilates Ca, Mg, Zn, Fe, reduces risk of rickets and osteoporosis, stimulates ulcer healing, kills ulcerative bacteria Helicobacter p lowers cholesterol, influences bile acid metabolism, protects against atherosclerosis, helps in complex treatment of intestinal and urinary tract infections, vaginitis and vaginosis, decomposes toxic substances of environmental and endogenous origin, reduces intoxication, inhibits cancer cell growth, tumor formation, neutralizes carcinogenic properties of nitrite and nitrate, reduces risk of viral diseases, including sexually transmitted diseases, activates immunity, stimulates the synthesis of antibodies especially IgA, phagocytes, lymphocytes, iterferon, lysozyme, pH also inhibits the growth of pathogenic, decaying and fermenting bacteria, determines the constant gas composition and odor, reduces indole, skatole, H2S formation, assists with various origins of diarrhea, constipation, normalizes stool consistency and emptying, decomposes carbohydrates, lowers blood sugar, Converts lanolic acid into the much needed lanolin acid, removes free radicals, inhibits lipid oxidation in the liver.

All of the above strains are obtained in an analogous manner, namely, each is grown in a liquid medium with three crops. The cultured culture is concentrated by ultrafiltration, 6-10% by weight of sucrose and 0.5-2% by weight of gelatin are added to the resulting biomass and lyophilized. 100 g of dry biomass contains 5-20 g of gelatin, 60-70 g of sucrose, 7-8 g of bioculture cells and 9-10 g of medium salts. Bifidobacteria and lactobacteria are monitored for viability, purity for foreign microflora, and residual moisture.

The resulting dry microbial masses are pulverized and optionally mixed with excipients such as maltodextrin, magnesium stearate, silica in accordance with the specifications of the technical documentation.

The total biological activity per gram of biomass obtained shall be from about 1.5 χ 10 ¹⁰ to about 1.5 χ 10 ¹¹ CFU (colony forming units) and shall be from about 40 to about 42% by weight of the composition, with the remainder being selected from additional additives. materials. Selected additional ingredients in the composition include maltodextrin, magnesium stearate and silica, wherein maltodextrin represents about 35.19% by weight of the composition, magnesium stearate represents about 1.17% by weight of the composition, and silica comprises about 0.29% by weight of the composition.

When a unit dosage form of the composition is formulated as a capsule, the gelatin capsule will then comprise approximately 2.2% by weight of the composition.

An example.

The unit dosage form of the composition for oral administration in capsule form is 341 mg of dry biomass, the composition of which is as follows:

Component mg / capsule Quantity per capsule Bifidobacterium infantis 100x10 ⁹ CFU / g 20.00 2x10 ⁹ CFU Bifidobactenum breve 100x10 ⁹ CFU / g 20.00 2x10 ⁹ CFU Lactobacillus fermentum 100x10 ⁹ CFU / g 20.00 2x10 ⁹ CFU Lactobacillus reuteri 100x10 ⁹ CFU / g 20.00 2x10 ⁹ CFU Lactobacillus acidophilus 150x10 ⁹ CFU / g 15.00 2.25x10 ⁹ CFU Lactobacillus plantarum 100x10 ⁹ CFU / g 10.00 1x10 ⁹ CFU Lactobacillus casei 100x10 ⁹ CFU / g 10.00 1x10 ⁹ CFU Bifidobacterium longum 100x10 ⁹ CFU / g 10.00 1x10 ⁹ CFU Bifidobactenum bifidum 100x10 ⁹ CFU / g 10.00 0.5x10 ⁹ CFU Lactobacillus rhamnosus 250x10 ⁹ CFU / g 6.00 1.5x10 ⁹ CFU Maltodextrin 120.00 Magnesium stearate 4.00 Silica 1.00 Purified gelatin capsule 75

The exemplary capsule has a dry biomass of at least 1.5 10 ¹ ° .KSV and has a total bioactivity of about 40% by weight of the composition, the remainder being maltodextrin supplemental material, about 35.19% by weight of the composition, magnesium stearate at ca. 1.17% by weight of the composition, silica contains about 0.29% by weight of the composition, and the gelatin capsule contains about 2.2% by weight of the composition.

Claims (6)

DEFINITION OF INVENTION A composition comprising probiotics from bifidobacteria and lactobacteria and adjuvants, wherein the probiotic bifidobacteria is selected from strains such as Bifidobacterium infantis, Bifidobacterium longum, Bifidobacterium bifidum Bifidobacterium breve, lactobacteria such as Lactobacillus, Lactobacillus wherein the composition further comprises lactobacteria selected from Lactobacillus fermentum, Lactobacillus reuteri, Lactobacillus casei and Lactobacillus rhamnosus, wherein the total biological activity of probiotics from bifidobacteria and lactobacteria is from about 1.5 to 10 ¹⁰ per gram of biomass. 10 ¹¹ CFUs (colony forming units) and from about 40% to about 42% by weight of the composition, with the remainder being selected from auxiliary materials. 2. The composition of claim 1, wherein the selected additional agents include maltodextrin, magnesium stearate, and silica. 3. The composition of claim 2, wherein maltodextrin is present in an amount of about 35.19% by weight of the composition, magnesium stearate is present in an amount of about 1.17% by weight of the composition, and silica is present in an amount of about 0.29% by weight. Composition according to any one of claims 1 to 3, characterized in that it is in a unit dosage form for oral administration. 5. The composition of claim 4, wherein the oral dosage unit form is in the form of a capsule, or as a tablet, or as a pellet, or as a powder. The composition according to any one of the preceding claims, for use as a dietary supplement or as a medicament for the prophylaxis or treatment of gastrointestinal dysbacteriosis, for the suppression of infectious and inflammatory processes, and for the restoration of a dynamic microbiota and environmental balance.