Drug

 

(57) Abstract:

The invention relates to medicine and the pharmaceutical industry and relates to encapsulated or tableted form of pharmaceutical preparations containing recombinant interferon. The inventive drug coated liner contains alpha-, or beta-, or gamma-interferon, stabilizer biological, physico-chemical properties and/or resistance to microbial contamination and pharmaceutically acceptable additives target. The drug may contain additional immunomodulator, ribavirin, vitamins, anti-inflammatory medication, Riboxin. Effect: expanding Arsenal of drugs. 16 C.p. f-crystals, 8 PL.

The invention relates to medicine and the pharmaceutical industry and relates to encapsulated or tableted form of pharmaceutical preparations containing recombinant interferon.

Known drug in tablet form containing recombinant interferon with filler coated.

(RU, patent 2083222 And 61 To 31/21, 1999).

The technical result of the invention is to develop carsbecause good penetrating ability and have antiviral, antibacterial, anti-inflammatory, detoxifying effect.

To achieve the technical result of the medicinal preparation containing recombinant interferon with filler, coated according to the invention as recombinant interferon alpha, or beta, or gamma-interferon, and additionally contains a stabilizer biological, physico-chemical properties and/or resistance to microbial contamination and pharmaceutically acceptable additives target.

Shell product contains acid or water-soluble coating.

Acid-resistant shell tablet form of the drug consists of a solution of cellulose acetate or acetylcellulose and castor oil mixed with acetone and alcohol, and a capsulated form contains gelatin.

Water-soluble shell encapsulated forms of the drug contains one or more ingredients from the group comprising sodium alginate, a copolymer of acrylic and methacrylic acids, polyvinylpyrrolidone, polystyrene and polyvidone.

The shell of a capsulated form of the drug is made on the basis of the composition of gelatissimo-chemical properties, selected from the group: polyethylene oxide, glycerin, methyl cellulose in an amount of 0.0001-0.09 g per 1 g of the drug.

It contains the stabilizer of resistance to microbial contamination, selected from the group of nipagin, Quaternary ammonium compounds, chlorhexidine, silver-containing component in an amount of 0.001 to 0.01 g per 1 g of the drug. As Quaternary ammonium compounds it contains atony, or benzathine chloride or benzalkonium chloride.

As pharmaceutically acceptable target components the product contains one or more ingredients from the group of: witepsol, soklin, tallow type CH, cocoa butter, paraffin, petrolatum, lanolin, glycerin, gelatin, polyethylene oxide, propylene glycol, aluminum hydroxide, cellulose acetate, hypromellose, microcrystalline cellulose, hydroxide methylcellulose, emulsifiers, polymers, polyacrylic acid, vysokomehanizirovannoe vegetable oil, lactose, sucrose, polyvinyl alcohol, methylparaben, castor oil, starch, dimethyl sulfoxide, oleic acid, proxanol is chosen-268, silicon dioxide, calcium stearate, magnesium, glucose.

He further comprises an immunomodulator selected from the group of cytokines, ridot is in the amount of 0.003 to 0.05 g per 1 g of the drug, pyrogens in the amount of 50-300 μg per 1 g of the drug, Poludan in the amount of 50-400 IU per 1 g of the drug, Amiksin in the amount of 0.005-0.015 g per 1 g of the drug metronidazole in the amount of 0.001-0.01 g per 1 g of the drug.

As it contains cytokines interleukin-2 in the amount of 1000-20000 ME and/or tumor necrosis factor alpha or beta in the number 1000-10000000 ME on 1 g of the drug.

The drug further comprises ribavirin in the amount of 0.005-0.05 g per 1 g of the drug.

It contains vitamins selected from the group of: vitamin E, vitamin C, vitamin B1, vitamin b6, vitamin b12the vitamin e in the amount of 0.001-0.05 g per 1 g of the drug.

The preparation additionally contains retinoids: synthetic retinoids include vitamin a and/or beta-carotene in the amount is 0.0002-0.02 g per 1 g of the drug.

It contains anti-inflammatory drug selected from the group: diclofenac sodium, indomethacin, ibuprofen, naproxen, corticosteroids: hydrocortisone, fludrocortisone, flumetazon, betamethasone, mometazon, perkantoran, triamcinolon, in the amount of 0.002-0.01 g per 1 g of the drug.

The drug further comprises Riboxin in the amount of 0.001-0.06 g n is the reamers.

Example 1. Production technology of medicinal drug. To obtain the drug in pill form or in dispersed form, take the following components per 1 g of the drug (see tab.1)

To obtain the drug in pill form take acid membrane from a solution of cellulose acetate or acetylcellulose and castor oil mixed with acetone and alcohol.

For obtaining of the drug encapsulated in the form of use gelatin or composition of gelatin, glycerine, emulsifier and water, or one or more ingredients from the group of: sodium alginate, a copolymer of acrylic and methacrylic acids, polyvinylpyrrolidone, polystyrene, polyvidone.

Example 2. Carried out analogously to example 1.

Take the following components per 1 g of the drug (see tab.2).

Example 3. Take the following components per 1 g of the drug (see tab.3)

Example 4. Take the following components per 1 g of the drug (see tab.4)

Example 5. Take the following components per 1 g of the drug (see tab.5)

Example 6. Take the following components per 1 g of the drug (see tab.6)

Example 7. Take the following components per 1 g of the drug (see tab.7)

Example 8. Take the following components 1 g Preah showed that it is non-toxic retains its physico-chemical and biological properties.

Clinical trials on human volunteers aged 18-20 years of age show that the drug is safe, well tolerated, does not cause allergic reactions.

1. Drug coated with antiviral, antibacterial, anti-inflammatory, detoxifying effect, characterized in that it contains alpha-, or beta-, or gamma-interferon, and the stabilizer of biological, physico-chemical properties and/or resistance to microbial contamination and pharmaceutically acceptable additives target.

2. Drug under item 1, characterized in that the shell of the preparation contains acid or water-soluble coating.

3. Drug under item 2, wherein the acid-resistant shell tablet form of the drug consists of a solution of cellulose acetate or acetylcellulose and castor oil mixed with acetone and alcohol, and a capsulated form contains gelatin.

4. Drug under item 2, wherein the water-soluble shell capsulated form preparaciones acids, polyvinylpyrrolidone, divinylbenzene and polyvidone.

5. Drug under item 2, characterized in that the shell of a capsulated form of the drug is made on the basis of the composition of gelatin, glycerine, emulsifier and water.

6. Drug under item 1, characterized in that it contains the stabilizer of biological, physico-chemical properties selected from the group: polyethylene oxide, glycerin, methyl cellulose in an amount of 0.0001-0.09 g per 1 g of the drug.

7. Drug under item 1, characterized in that it contains the stabilizer of resistance to microbial contamination, selected from the group of nipagin, Quaternary ammonium compounds, chlorhexidine, silver-containing component in an amount of 0.001 to 0.01 g per 1 g of the drug.

8. Drug under item 7, characterized in that the Quaternary ammonium compounds it contains atony, or benzathine chloride or benzalkonium chloride.

9. Drug under item 1, characterized in that as a pharmaceutically acceptable target additives it contains one or more ingredients from the group of: witepsol, soklin, tallow type CH, cocoa butter, paraffin, petrolatum, lanolin, glycerin, gelatin, polyeth Lucescu cellulose, hydroxide methylcellulose, emulsifiers, polymers, polyacrylic acid, vysokomehanizirovannoe vegetable oil, lactose, sucrose, polyvinyl alcohol, methylparaben, castor oil, starch, dimethyl sulfoxide, oleic acid, proxanol is chosen-268, silicon dioxide, calcium stearate, magnesium, glucose.

10. Drug under item 1, characterized in that it further comprises an immunomodulator selected from the group of cytokines, Radostin in the number 0,006-0.04 g per 1 g of the drug, polyoxidonium in the amount of 0.003-0,012 g per 1 g of the drug, sodium nukleinat in the amount of 0.003 to 0.05 g per 1 drug, pyrogens in the amount of 50-300 μg per 1 g of the drug, Poludan in the amount of 50-400 IU per 1 g of the drug, Amiksin in the amount of 0.005-0.015 g per 1 g of the drug, metronidazole in the amount of 0.001-0.01 g per 1 g of the drug.

11. Drug under item 10, characterized in that it contains cytokines interleukin-2 in the amount of 1000-20000 IU and/or tumor necrosis factor alpha or beta in the number 1000-10000000 IU per 1 g of the drug.

12. Drug under item 1, characterized in that it further comprises ribavirin in the amount of 0.005-0.05 g per 1 g of the drug.

13. Drug under item 1, otlichayushiesya6, vitamin b12the vitamin e in the amount of 0.001-0.05 g per 1 g of the drug.

14. Drug under item 1, characterized in that it additionally contains retinoids: synthetic retinoids and/or vitamin a in number is 0.0002-0.02 g per 1 g of the drug.

15. Drug under item 1, characterized in that it additionally contains beta-carotene in the amount is 0.0002-0.02 g per 1 g of product.

16. Drug under item 1, characterized in that it additionally contains anti-inflammatory drug selected from the group: diclofenac sodium, indomethacin, ibuprofen, naproxen, corticosteroids: hydrocortisone, fludrocortisone, flumetazon, betamethasone, mometazon, perkantoran, triamcinolon in the amount of 0.002-0.01 g per 1 g of the drug.

17. Drug under item 1, characterized in that it further comprises Riboxin in the amount of 0.001-0.06 g per 1 g of the drug as an activator of metabolism.

 

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