Antiviral and antimicrobial composition containing consortium of immunoglobulins

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to pharmaceutical industry and medicine. A composition represents a powder of a substance containing a consortium of immunoglobulins IgA, IgG and IgM and target additives able to form a stable foam structure, specified in: polyethylene glycol, albumin, gelatine, pectin, casein, caseinate, casein hydrolysate, hydroxypropyl cellulose, polyglucin, dextrin, tragacanth, aerosil, glycine, L-lysine monohydrochloride, L-arginine monohydrochloride, glucose, maltose, mannitol, lactose or their mixtures; it is characterised by porous structure and fragility, has a relative disintegration shrinkage at least 10 %, equivalent pore diameter 10-110 mcm at particle size no more than 100 mcm and a resting angle less than 50° and represented in the form of a solid capsule in the following proportions in 1.0 g of the composition: the consortium of immunoglobulins IgA, IgG and IgM 0.05-0.95 g; target additives - the rest with the capsule coated with a layer of a enterosoluble substance specified in: shellac, oleic acid, hydroxypropyl cellulose, cellulose acetate phthalate, bee wax, Tween-20, Tween-80, castor oil, polyethylene oxide or their mixture.

EFFECT: invention provides the isotropic filling of the 100% preset volume of the solid capsules that exceeds the effect of a similar composition by 5%, the maximum isotropic filling of the solid capsules ensures precise dosages of the consortium of immunoglobulins.

4 cl, 4 ex

 

The invention relates to pharmaceutical industry and medicine and can be used in the production and use of medical immunobiological preparations containing immunoglobulin.

The possibility of using dry compositions containing the antibodies, as filler solid capsules depends on the structural-mechanical properties of these dry compositions, ensuring their promotion without clogging the pipelines and isotropic filling a specified amount of capsules.

A method of obtaining dry immunoglobulin preparation comprising adding to the solution of immunoglobulins calcium phosphate rate of 0.4 grams per 100 ml of glucose to a final concentration of 2% and lyophilization (SU inventor's certificate 836831, AK 35/14; 1982).

A method of obtaining dry immunoglobulin preparation comprising adding to the precipitate purified immunoglobulin solution of sodium chloride at a pH of 7.2, glucose 2%, with subsequent bleaching and sterilizing filtration and lyophilization (RU patent 2084229 C1, AC 35/14; 1997).

A method of obtaining dry immunoglobulin preparation comprising adding to the concentrate purified immunoglobulins glycine glucose and maltose with subsequent bleaching and sterilizing by filtration and freeze-drying (RU patent 2189833 C2, AC 39/95, 35/16; 2002).

Known composition having antimicrobial action containing hydrophilic conglomerate consortium of immunoglobulins adsorbed polyethylene glycol 4000-6000 and the target additive selected from the range of: glycine, glucose, maltose, sodium chloride, with the following content of components in 1.0 g of the composition of the consortium of immunoglobulins 0,09-0.9 g, polyethylene glycol 4000-6000 0.001 to 0.02 g of the target additive and the rest (RU patent 2247578 C1, AC 39/395, 38/19, 9/14, OR 31/00; 2005).

A method of obtaining dry immunoglobulin preparation, including the dissolution of the precipitate immunoglobulins in chilled physiological solution (0.9%sodium chloride solution) to a protein content of about 5-6% (pH 6.3), the addition of glucose to a final concentration of 2%, holding clarifying filtration and lyophilization (RU patent 2255766 C2, AC 39/395, A61L 2/08; 2005).

A method of obtaining dry immunoglobulin preparation, including the dissolution of the precipitate immunoglobulins in 0.3 M glycine, bringing to a pH of 4.6, and after bleaching and sterilizing filtration of the implementation of virusencyclo at room temperature for 20-25 days and conduct of freeze drying (RU patent 2261112 C1, AC 39/395; 2005).

However, structural and mechanical properties of the above compositions, which enable their use as filler capsules, not specified

The task of the claimed invention is a composition containing a consortium of immunoglobulins IgA, IgG and IgM, providing when using isotropic filling a specified amount of solid capsules.

The problem is solved in that the composition is a powder comprising a substance containing a consortium of immunoglobulins IgA, IgG and IgM and targeted supplements, is capable of forming a stable instructure selected from a number of: polyethylene glycol, albumin, gelatin, pectin, casein, Caseinate, hydrolyzed casein, hydroxypropylcellulose, poliglyukin, dextrin, tragakant, Aerosil, glycine, L-lysine monohydrochloride, L-arginine monohydrochloride, glucose, maltose, lures, lactose or mixtures thereof, characterized by porous and fragile, has in the disintegration of the relative shrinkage of not less than 10%, the equivalent diameter then 10-110 μm in the particle size of not more than 100 μm and the angle of repose of less than 50° and is made in the form of a hard capsule with the following content of components of 1.0 g of the composition: a consortium of immunoglobulins IgA, IgG and IgM 0.05 to 0.95 g, targeted supplements - else, while the capsule is covered with a layer of enteric substance selected from the range: shellac, oleic acid, hydroxypropylcellulose, acetamidoacrylate, beeswax, tween-20, tween-80, castor oil, polyethylene oxide, or mixtures thereof. Consort the mind of immunoglobulins IgA, IgG and IgM can be obtained by using common methods of alcohol precipitate B (III fraction Kona when alcohol fractionation of serum) or from colostrum and milk (RU patent 2084229 C1, A61K 35/14; 1997; RU patent 2262350 C2, A61K 39/00, 39/112, 39/40, OR 31/04; 2005). The composition comprises a mixture of target components, capable of forming a stable instructure, preferably in equal proportions. The composition may further contain a substance selected from the range of: copper sulfate, salt, capable of forming an isotonic phosphate buffer solution, a salt capable of forming isotonic acetate buffer solution, a salt capable of forming isotonic carbonate buffer solution, and a salt capable of forming isotonic Tris-buffer solution. The composition may further contain additives that are not included in the powder substance selected from the range of: pectin, dextrin, albumin, gelatin, calcium stearate, titanium dioxide, lactulose, polyvinylpyrrolidone, microcrystalline cellulose, starch, talc, cellulose, methylcellulose, acetamidoacrylate, sodium carboxymethylcellulose, sodium croscarmellose, sodium starch glycolate, carboxymethylcellulose, crosspovidone cross-linked carboxymethyl-starch, or a mixture thereof. The shell is hard capsules can be made on the basis chosen from a number of: gelatin, with the polymers of polyacrylic acid, starch, starch derivatives, polymers of polyvinyl alcohol, copolymers of polyvinyl alcohol, cellulose, cellulose derivatives, or mixtures thereof.

In the first results of our studies have shown that the promotion of the powder without clogging the pipelines and isotropic filling a specified amount of solid capsules is provided by a combination of the required particle size, the equivalent diameter of pores in the composition, its fragility, sufficient for decomposition of the composition with a light shake (small mechanical load), the ability to shrink after disintegration, the determining further destruction of the structure of the powder at any small mechanical load, and a certain angle of repose of the powder. Data structure-mechanical properties of the composition takes when using selected parameters of the vacuum pinowski in combination with variants of the target additive composition capable of forming a stable prestructure.

The inventive composition containing a consortium of immunoglobulins IgA, IgG and IgM and targeted supplements, is new and is not described in literature.

The technical result of the claimed invention is the provision of using the composition isotropic fill 100% of a given volume of solid capsules, which exceeds the e less than 5% the results of the use of the composition for a similar purpose not possessing a combination of structural-mechanical properties of the claimed composition. Maximal isotropic fill a given volume of solid capsules ensures accurate dosage of the consortium of immunoglobulins IgA, IgG and IgM.

Composition, a powder, comprising a substance containing a consortium of immunoglobulins IgA, IgG and IgM and targeted supplements, is capable of forming a stable instructure, obtained by application of vacuum drying equipment (for example, upgraded vacuum drying Cabinet SSW-V/5,0, CJSC "MIUS", RF, http://www.zaomius.ru/thermal/products/detail.php?ID=1588&print=Y), in which is formed a stable instructor with the necessary combination of structural-mechanical properties, due to samosatene and degassing uniformly applied across the thickness of the layer on the working surface drying equipment drying of the composition in vacuum at infrared power supply and temperature regimes, the most exclusive inactivation of the consortium of immunoglobulins IgA, IgG and IgM.

Filling hard capsules powder substance containing a consortium of immunoglobulins IgA, IgG and IgM and targeted supplements, according to the operating instructions supplied with the machines for filling hard capsules (e.g., machine for filling hard gelatin capsules IN-CAP DOTT. BONAPACE &C. s.r.l., Italy, http://www.ift.ru/clients/products/index.php?c=108&m=8; capsule filling machine DGM-800, DGM PHARMA APPARATE, Switzerland, http://www.dgmrussia.ru/catalog.php?item=27).

The invention is illustrated in the following examples, showing the software using the composition isotropic fill a given volume of solid capsules. While the examples of the combination of ingredients of the inventive compositions show a specific implementation of the invention but do not limit the scope of the claims of the formula of the claimed invention.

Example 1. Received antiviral and antimicrobial composition, a powder, comprising a substance containing a consortium of immunoglobulins IgA, IgG and IgM and supplements: albumin and dextrin in equal proportions, copper sulfate and salt that can form an isotonic phosphate buffer solution, characterized by porous and fragile, with the disintegration of the relative shrinkage of 50%, the equivalent diameter of pores 60-110 μm in the particle size of 80-100 μm and the angle of rest with three replications of measurements 35-40° and is made in the form of hard capsules, the next component content of 1.0 g of the composition: a consortium of immunoglobulins IgA, IgG and IgM 0.95 g and additives target is to 1.0, the hard Shell capsule was made on the basis of gelatin and was covered with a layer of cereceres the action of the coating, containing shellac.

This composition differed isotropic filling 100% of the specified amount of solid capsules unlike compositions similar purposes, not with the above combination of structural-mechanical properties of the filler, with isotropic filling only 93% of the set amount of solid capsules.

Example 2. Received antiviral and antimicrobial composition, a powder, comprising a substance containing a consortium of immunoglobulins IgA, IgG and IgM and additives include polyethylene glycol, Aerosil and lures in equal proportions, and salt capable of forming isotonic acetate buffer solution, characterized by porous and fragile, with the disintegration of the relative shrinkage of 10%, the equivalent pore diameter of 10-30 μm in the particle size of 50-100 μm and the angle of rest with three replications of measurements of 45-50°. The composition additionally contains an additive which is not included in the powder substance, namely talc. The composition was made in the form of hard capsules with the following content of components of 1.0 g of the composition: a consortium of immunoglobulin - 0.3 g and additives target is to 1.0, the hard Shell capsule was made on the basis of derivatives of starch and was covered with a layer of enteric coating containing shellac and oleic acid.

The song ex who started isotropic filling 100% of the specified amount of solid capsules unlike compositions similar purpose, not with the above combination of structural-mechanical properties of the filler, with isotropic filling only 95% of the set amount of solid capsules.

Example 3. Received antiviral and antimicrobial composition, a powder, comprising a substance containing a consortium of immunoglobulins IgA, IgG and IgM and additives include polyethylene glycol, poliglyukin, dextrin, Aerosil and glucose in equal proportions, copper sulfate and salt capable of forming isotonic carbonate buffer solution, characterized by porous and fragile, with the disintegration of the relative shrinkage of 30%, the equivalent pore diameter of 30-80 μm in the particle size of 60 to 90 μm and the angle of rest with three replications of measurements 37-45°. The composition additionally contains additives that are not included in the powder substance, namely, calcium stearate, titanium dioxide, polyvinylpyrrolidone and cellulose microcrystalline, starch. The composition was made in the form of hard capsules with the following content of components of 1.0 g of the composition: a consortium of immunoglobulin - 0.05 g and additives target is to 1.0, the Shell is hard capsules was performed on the basis of copolymers of polyacrylic acid and was covered with a layer of enteric coating containing acetamidoacrylate, beeswax and tween-80.

The song ex who started isotropic filling 100% of the specified amount of solid capsules unlike compositions similar purpose, not with the above combination of structural-mechanical properties of the filler, with isotropic filling only 95% of the set amount of solid capsules.

Example 4. The composition according to example 2, which has antiviral and antimicrobial activity containing a consortium of the antibodies used in the treatment of 8 individuals cynomolgus macaques with diarrhoeal syndrome viral and bacterial etiology (rotavirus-Salmonella etiology). The composition is administered orally once a day. Diarrheal syndrome in all animals was resolved within 5 days, which confirmed the antiviral and antimicrobial activity of the composition.

1. The composition having antiviral and antimicrobial activity containing a consortium of immunoglobulins and the target additives, characterized in that it is a powder substance containing a consortium of immunoglobulins IgA, IgG and IgM and targeted supplements, is capable of forming a stable instructure selected from a number of: polyethylene glycol, albumin, gelatin, pectin, casein, Caseinate, hydrolyzed casein, hydroxypropylcellulose, poliglyukin, dextrin, tragakant, Aerosil, glycine, L-lysine monohydrochloride, L-arginine monohydrochloride, glucose, maltose, lures, lactose or mixtures thereof, characterized by porous and fragile, the disintegration of the relative shrinkage not what the Eney 10%, the equivalent diameter of pores 10-110 μm in the particle size of not more than 100 μm and the angle of repose of less than 50° and is made in the form of a hard capsule with the following content of components of 1.0 g of the composition:

The consortium of immunoglobulins IgA, IgG and IgM0.05 to 0.95 g
Additives targetThe rest,

when this capsule is covered with a layer of enteric substance selected from the range: shellac, oleic acid, hydroxypropylcellulose, acetamidoacrylate, beeswax, tween-20, tween-80, castor oil, polyethylene oxide or mixtures thereof.

2. The composition according to claim 1, characterized in that it further comprises a substance selected from the range of: copper sulfate, salt, capable of forming an isotonic phosphate buffer solution, a salt capable of forming isotonic acetate buffer solution, a salt capable of forming isotonic carbonate buffer solution, and a salt capable of forming isotonic Tris-buffer solution.

3. The composition according to claim 1 or 2, characterized in that it additionally contains additives that are not included in the powder substance selected from the range of: pectin, dextrin, albumin, gelatin, calcium stearate, titanium dioxide, lactulose, polyvinylpyrrolidon is he, microcrystalline cellulose, starch, talc, cellulose, methylcellulose, acetamidoacrylate, sodium carboxymethylcellulose, sodium croscarmellose, sodium starch glycolate, carboxymethylcellulose, crosspovidone cross-linked carboxymethyl-starch, or a mixture thereof.

4. The composition according to claim 1, characterized in that the shell is hard capsules made on the basis chosen from a number of: gelatin, copolymers of polyacrylic acid, starch, starch derivatives, polymers of polyvinyl alcohol, copolymers of polyvinyl alcohol, cellulose, cellulose derivatives, or mixtures thereof.



 

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FIELD: medicine, pharmaceutics.

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1 tbl

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47 cl, 14 ex, 35 tbl

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1 tbl, 6 ex

FIELD: medicine.

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30 cl, 6 ex, 32 dwg, 39 tbl

FIELD: medicine, pharmaceutics.

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5 tbl, 7 ex

FIELD: medicine, pharmaceutics.

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52 cl, 18 dwg, 11 tbl, 9 ex

FIELD: medicine.

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10 cl, 20 dwg, 8 tbl, 3 ex

FIELD: medicine.

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1 tbl, 1 ex

FIELD: medicine.

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3 ex

FIELD: medicine, pharmaceutics.

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73 cl, 7 dwg, 2 tbl, 4 ex

FIELD: genetic engineering, immunology, medicine.

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EFFECT: improved preparing methods, valuable medicinal properties of antibody.

33 cl, 5 dwg, 1 ex

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