RU2228184C2 - Complex preparation - Google Patents

Abstract

FIELD: medicine. SUBSTANCE: the suggested preparation is based upon probiotics enriched with microelements in the form of different salts, both organic and inorganic compounds available for metabolic processes in alive organism and introduced into probiotic foundation at different stages of biotechnological process. The quantity of microelements introduced is sufficient for development of microorganisms properly that take part in mineral exchange with a macroorganism, and additional supply of macroorganism with vitally important chemical elements. For example, calcium could be applied as gluconate to provide new range of curative and prophylactic action of probiotics based upon bifidobacteria in case of disorders of calcium exchange. The present innovation enables to obtain dosed forms of medicinal preparations of new class. EFFECT: higher efficiency. 4 cl, 4 ex, 1 tbl

Description

The invention relates to the field of biotechnology, namely to the production of probiotic preparations, and can be used in medicine, veterinary medicine.

Known medicinal product, including calcium lactate, calcium gluconate, calcium carbonate (active substances) and inactive ingredients: sodium bicarbonate, citric acid, sucrose, saccharin sodium salt ("Calcium Sandoz Forte", Registration number: P-8 242 No. 008988, NOVARTIS company).

The drug is intended for the prevention and treatment of acute and chronic calcium deficiency in the body, as well as for the treatment of various types of disorders of mineral metabolism, allergic reactions, to maintain the balance of electrolytes in the body and the adequate functioning of numerous regulatory mechanisms.

A disadvantage of the known means is the lack of influence on the restoration of the morphological structure of the gastrointestinal mucosa and on the indices of local immunity in inflammatory diseases of the gastrointestinal tract and intestinal infections.

Known drug bifidumbacterin forte, including living cells of bifidobacteria immobilized on activated carbon (RF patent No. 2017486, class A 61 K 31/00, 1991).

A disadvantage of the known biological product is the lack of macro- and microelements in a bioavailable form, for example, that have passed through microbial metabolism, namely, Zn, Mg, Ca, Se, Co, Mn, Cu, Fe ions, which reduces its cell-biological activity and It does not allow to supply the human body in the right amount with vital chemical elements.

Closest to the claimed solution is a complex preparation containing calcium carbonate, calcium citrate, calcium orotate, magnesium, zinc, vitamins D, C, vegetable proteins and amino acids (see Super Calcium supplement, IRWIN NATURALS, Cobra International distributor) .

A disadvantage of the known drug is the lack of supplying the human body with ions of microelements that have passed through microbial metabolism, and the influx of living microbes, which, along with antagonism to the pathogenic and conditionally pathogenic flora, participate in metabolic processes, for example, providing biotransformation of elements.

The objective of the present invention is the creation of a drug that corrects microbiocenosis by combining the components that make up its composition. Microelements of metals that make up the drug, not only increase its cellular biological activity, but also make up for the deficiency of trace elements in the human body.

This is achieved by the fact that the complex preparation, including macro- and microelements in a bioavailable form, amino acids, additionally contains a lyophilized biomass of probiotics, immobilized on a sorbent, an immobilizer-sorbent, a filler in the following ratio of the components of the drug, g: lyophilized biomass of probiotics - 1 × 10 ⁶ -1 × 10 ⁸ CFU / g, immobilizer-sorbent - 0.00001-0.0001, macro- and microelements in a bioavailable form - 0.1-1.0, filler - 0.1-0.2, except Moreover, as macro- and micronutrients in biologically in a blunt form, metal compounds are used in the form of oxides or mineral salts or organic metal compounds, moreover, along with Ca, Mg, Zn ions, metal ions are additionally used: Fe, Se, Mo, Mn, Cr, Si, Cu, Co, as an immobilizer - the sorbent uses metal compounds in the form of oxides or mineral salts or organic metal compounds, and bifidobacteria of the strains of Bifidobacterium Bifidum No. 1 or lactobacillus Lactobacillus plantarum 8P-A3 are used as probiotics.

A complex preparation for the treatment and prevention of dysbacteriosis and intestinal dysfunctions, various types of mineral metabolism disorders, that is, for the normal functioning of the human body, is a dry microbial mass of live antagonistically active bifidobacteria of the species Bifidobacterium bifidum No. 1 or lactobacilli of the species Lactobacillus plantarum 8P-A3, lyophilized cultivation medium with the addition of a protective sucrose-gelatin medium and an immobilizer-sorbent, which is used as calcium gluconate according to GF X ed., Art. 121 or glu iron conate, or other mineral salts or organic compounds of metals.

The drug is produced in the form of a porous granular mass of different shades of beige or gray or greenish in color with a neutral taste and a slight sour-milk smell in bags of airtight material.

One therapeutic dose of the drug contains: from 10 ⁶ to 10 ⁸ CFU / g of bifidobacteria or lactobacilli, macro-and micronutrients in a biologically accessible form (for example, calcium gluconate), sorbent, filler - lactose. When water is added at a rate of 50 ml per packet, an opaque suspension is formed.

Suitable trace elements utilized by microbes are, for example, gluconic acid salts containing calcium, iron, zinc, etc. or lactic acid salts. Added to the cultivation medium in an amount of from 0.1 to 5.0 g / l, they ensure the production of biomass that is complete for a specific microelement used for the preparation of the preparation. In this case, the amount of trace element introduced into the preparation must strictly correspond to the pharmacologically verified dose of a specific chemical element in the form of a medicinal product, which provides a therapeutic and / or preventive effect on the human body.

The complex preparation is made as follows.

Example 1. Up to 5 g / l of calcium gluconate is introduced into the composition of the medium for culturing bifidobacteria and a culture is grown with a concentration of at least 1 × 10 ⁹ living cells in ml. The culture is subsequently subjected to concentration, freeze drying, grinding, mixed with calcium powder of gluconate, which acts as an immobilizer, and Packed in bags of airtight material. The resulting preparation contains:

Live bifidobacteria from 5 × 10 ⁷ to 5 × 10 ⁸ CFU

Calcium gluconate 0.5 to 1.0 g

Filler from 0.1 to 0.2 g

Example 2. In the composition of the medium for cultivation of lactobacilli Lactobacillus plantarum 8P-A3 enter up to 0.1 g / l of iron gluconate and grow a culture with a titer of at least 3 × 10 ⁹ living cells in ml. Concentrated, lyophilized and ground biomass is mixed with ferrous iron lactate powder as an immobilizer and packaged in gelatin capsules. The resulting preparation contains:

Live lactobacilli,

at least 2 × 10 ⁸ CFU

Ferrous iron lactate 0.3 to 0.6 g

Filler from 0.1 to 0.2 g

Example 3. Lyophilized microbial mass of live antagonistically active bifidobacteria of the species Bifidobacterium bifidum No. 1, immobilized on particles of powdered activated carbon for medical purposes, sterile lactose and calcium gluconate are mixed and packaged. One package contains:

Biomass of bifidobacteria,

immobilized on

particles of activated

coal (GF X, Art. 134), at least 3 × 10 ⁷ CFU

Lactose (milk sugar according to GF X, Art. 589) up to 0.2 g

Calcium gluconate according to GF X, Art. 121 1.0 g

Example 4. Lyophilized microbial mass of live antagonistically active bifidobacteria of the species Bifidobacterium bifidum No. 1, sterile lactose and calcium gluconate are mixed and Packed. One package contains:

Lyophilized Biomass

bifidobacteria, at least 3 × 10 ⁷ CFU

Lactose (milk sugar according to GF X, Art. 589) up to 0.2 g

Calcium gluconate according to GF X, Art. 121 1.0 g

The results of physico-chemical and microbiological studies of the laboratory series of probiotic preparations with a trace element are given in the table.

The drug is harmless when administered orally to mice weighing (15 ± 1) g in an amount of at least 1 × 10 ⁷ CFU in a volume of 0.5 ml.

The method of use of the drug.

The contents of one packet are poured into 50 ml of boiled water or fermented milk products at room temperature. The drug is stirred and immediately drunk before the main meal.

The drug is prescribed: for children up to a year - 1 sachet per day, from one to four years - 1 sachet 2 times a day, from four to seven years - 1 sachet 2-3 times a day, from seven to nine years - 1 sachet 3 times a day, from nine to fourteen years old - 2 sachets 2-3 times a day. The drug is prescribed to adults for 1-2 sachets 2-3 per day. For prophylactic purposes, the drug is prescribed in half daily dose.

The proposed drug has a complex biological effect aimed at accelerating the normalization of microbiocenosis, accelerating the restoration of the morphological structure of the mucous membrane and cellular factors of local immunity, curing skin diseases (itching, eczema, psoriasis), allergic diseases, osteoporosis. In addition, the drug is a metabolic regulator.

Claims (5)

1. A complex preparation, including macro- and microelements in a bioavailable form, characterized in that it additionally contains a lyophilized biomass of probiotics, an immobilizer sorbent, a filler in the following ratio of the components of the drug, wt.%: Lyophilized biomass of probiotics, CFU / g 1 × 10 ⁴ -1 × 10 ¹¹ Immobilizer – sorbent 0.001 - 10 Macro- and microelements in bioavailable form 0.001 - 99 Filler 0.1 - 0.99 2. The complex preparation according to claim 1, characterized in that lyophilized biomass immobilized on a sorbent is used as probiotic biomass, and metal compounds in the form of oxides or mineral salts or organic metal compounds are used as macro- and microelements in a bioavailable form. 3. The complex preparation according to claims 1 and 2, characterized in that metal compounds in the form of oxides or mineral salts or organic metal compounds are used as an immobilizer-sorbent. 4. The complex preparation according to claims 1-3, characterized in that metal ions Fe, Se, Mo, Mn, Cr, Si, Cu, Co, Ca, Mg, Zn are used as macro- and microelements in a bioavailable form. 5. The complex preparation according to claims 1 to 4, characterized in that as probiotics use bifidobacteria of strains of Bifidobacterium bifidum No. 1 or lactobacillus Lactobacillus plantarum 8P-A3.