Remedy

 

(57) Abstract:

The invention relates to medicine and the pharmaceutical industry and relates to dosage forms containing recombinant interferon. The inventive therapeutic agent contains alpha-, or beta-, or gamma-interferon, acyclovir, stabilizer biological, physico-chemical properties and/or resistance to microbial contamination and pharmaceutically acceptable additives. The tool may further comprise immunomodulator, vitamins, anti-inflammatory medication, anti-microbial, and/or Antiprotozoal and/or antifungal agent, an antioxidant, a local anesthetic agent, ribavirin. Technical result: the expansion of the means of antiviral, antibacterial, anti-inflammatory action. 29 C. p. F.-ly, 8 PL.

The invention relates to medicine and the pharmaceutical industry and relates to formulations for the prevention and treatment of viral diseases.

Known antiviral agent containing alpha-or beta-, or gamma-interferon for prevention and treatment of viral diseases.

(RU, patent 2073522, a 61 K 38/21, 1997).

(RU, patent 2057544, a 61 K 38/21, 1996).

Known drug for the treatment of viral infections, a single dosage form of a mixture of interferon and substances containing not less than 2.2% of polyunsaturated fatty acids. The drug may be in the form of rectal capsules or candles and is introduced rectally.

(RU, patent 2097061, a 61 K 38/21, 1997).

Known drug "Locteron for the treatment and prevention of viral diseases on the basis of human leukocyte interferon. The drug "Locteron contains interferon synthesized by leukocytes of donor blood under the influence of the virus inductor strain of parainfluenza virus 1 Sadi GKV 2339.

(RU, patent 2108804, a 61 K 38/21, 1998).

Known antiviral drug actions, including human interferon and a synergist. As a synergist it contains human immunoglobulins. As human is lobuono person it contains a mixture of IGA, IGM and IGG. And also additionally contain pharmaceutically acceptable additives target.

(RU, patent 2073522, a 61 K 38/21, 1997)

The closest is a therapeutic antiviral agent containing alpha-or beta-, or gamma-interferon, stabilizer biological, physico-chemical properties and/or resistance to microbial contamination and consistentread basis.

(RU, patent 2150291, a 61 K 38/21,1999).

The technical result of the invention is to provide means prolonged action as ointment, gel, suppository, paste, cream, liniment, tablets based on recombinant interferon, ensuring good penetration ability and possessing antiviral, antibacterial, anti-inflammatory, detoxifying, local anesthetic action.

To achieve the technical result remedy containing alpha-or beta-, or gamma-interferon, stabilizer biological, physico-chemical properties and/or resistance to microbial contamination and pharmaceutically acceptable additives target, according to the invention additionally contains acyclovir.

Lecern immunomodulator, selected from the group of cytokines, metronidazole, in the amount of 0.001-0.01 g to 1 g of product, Radostin in the number 0,006-0.04 g per 1 g of product, polyoxidonium in the amount of 0.003-0,012 g per 1 g of product, sodium nukleinat in the amount of 0.003 to 0.05 g per 1 g of product, pyrogens in the amount of 50-300 μg per 1 g of product, Poludan in the amount of 50-400 IU per 1 g of product, Amiksin in the amount of 0.05-0.15 g per 1 g of product.

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 product.

Additionally, the product contains vitamins selected from the group of: vitamin E, vitamin C, vitamin D3the vitamin e in the amount of 0.005-0.12 g per 1 g of product.

As vitamin E. it contains Adha-tocopherol.

Therapeutic agent additionally contains retinoids: synthetic retinoids, vitamin a and beta-carotene in the amount is 0.0002-0,0006 g per 1 g of product.

It also contains anti-inflammatory drug selected from the group: diclofenac sodium, indomethacin, ibuprofen, naproxen, corticosteroids: hydrocortisone, fludrocortisone, flumetazon, atamazon, mometasone, perkantoran, triamcinolon, in the amount of 0.002-0.01 g on a is selected from the group of polyethylene oxide, glycerin, gelatin, polyvinylpyrrolidone, polyvinyl alcohol, a derivative of methylcellulose (Na), in the amount of 0.0001-0.09 g per 1 g of product.

It contains the stabilizer of resistance to microbial contamination, selected from the group of nipagin, Quaternary ammonium compounds, chlorhexidine, in the amount of 0.0001-0.04 g per 1 g of product.

As Quaternary ammonium compounds it contains atony, or benzathine chloride or benzalkonium chloride.

Therapeutic agent further comprises an antimicrobial agent, and/or Antiprotozoal agent and/or antifungal agent.

It contains an antimicrobial agent selected from the group Miramistin in the amount of 0.0001-0.04 g per 1 g of the agent, broad-spectrum antibiotics in the amount of 0.025-0.05 g per 1 g of product, methylbenzethonium in the amount of a 0.012-0.025 g per 1 g of product, cetylpyridinium in the amount of 0.025-0.03 g per 1 g of product, alkyltrimethylammonium in the amount of 0.025-0.03 g per 1 g of product, chlorhexidine in the amount of a 0.012-0.02 g per 1 g of product, iodopovidone in the amount of 0.025-0.035 g per 1 g of product, imidazolidinedione in an amount of 0.01-0.05 g per 1 g of product, thiazolidinedione in an amount of 0.01-0.05 g per 1 g of product.

As a silver-containing component it contains paverpol.

Remedy contains broad-spectrum antibiotics selected from the group: amoxicillin, ampicillin, oxacillin, methicillin, cephalexin.

As pharmaceutically acceptable target additives it contains one or more ingredients from the group of additives, including witepsol, soklin, tallow type CH, cocoa butter, paraffin, petrolatum, lanolin, gelatin, dimethylsulfoxide, glycerine, polyethylene oxide, propylenglycol, aluminum hydroxide, cellulose acetate, hypromellose, hydroxide methyl cellulose, polymers of polyacrylic acid, castor oil, polyvinyl alcohol, oleic acid, vegetable oil, essential oil, proxanol is chosen-268, lactose, sucrose, silicon dioxide, calcium stearate, acetylcellulose.

The tool contains antioxidant: Trilon B and/or butylacetyl in the amount of 0.0001-0,0006 g per 1 g of product.

It additionally contains a topical anesthetic drug in the amount of 0.001-0.05 g per 1 g of product.

As a locally-unsetting of the drug it contains lidocaine.

Therapeutic agent additionally contains Ribas is or solid dosage forms.

His soft medicinal forms submitted by the ointment, or gel, or cream, or suppository, rectal or vaginal.

Its dosage forms in the form of ointment, gel, cream, suppository, intended for vaginal use, contain spermatocidal agent.

As spermatocide agent it contains nonoxynol 9 or octoxynol 9, taken in an amount of 0.025-0.05 g per 1 g of product.

Its dosage form in the form of a vaginal suppository contains a buffer mixture, supporting the pH of the suppository 3,0-5,0.

Therapeutic agent further comprises an activator metabolism.

As activator of metabolism tool contains Riboxin in the amount of 0.001-0.06 g per 1 g of product.

His solid dosage forms contain acid or water-soluble coating.

The invention is illustrated in the following examples.

Example 1. The technology of obtaining a remedy.

To obtain gel prepare a solution of the stabilizer: 1 % nipagina, 6% polyvinyl pyrrolidone and polyethylene oxide. Take antioxidant from trylon B and butylacetyl. Add acyclovir, alpha-, or beta-, or gamma-recombinantly the spruce additives, above. Ready the product Packed in the required capacity (e.g., tubes), seal and label. These components take the following ratio PA 1 g of product (see table.1)

Example 2. Carried out analogously to example 1.

Take the components in the following ratio of 1 g of product (see table.2).

Example 3. Carried out analogously to example 1.

Take the components in the following ratio of 1 g of product (see table.3).

Example 4. For more ointment take of polyvinyl alcohol, 10% solution etoniya, or benzathine chloride or benzalkonium chloride. Add a 10% solution of the trylon B, synthetic retinoids, vitamin D3, C, PP, acyclovir, polyoxidonium, gelatin, ibuprofen, paverpol, Riboxin. Mix everything with the required pharmaceutically acceptable targeted supplements. Sterilize and add alpha, or beta, or gamma-interferon, interleukin-2, and next, as in example 1.

These components take the following ratio of 1 g of product (see table.4).

Example 5. For preparation of cream mixed solution Na and chlorhexidine with butylacetophenone. Then add beta-carotene, broad-spectrum antibiotics, metavante is considered pharmaceutically acceptable targeted supplements. Then add alpha, or beta, or gamma-interferon, tumor necrosis factor alpha or beta. Next, as in example 1. These components take the following ratio of 1 g of product (see table.5)

Example 6. To obtain a rectal suppository mixed solution etoniya with butylacetophenone. Then add acyclovir, corticosteroids, gelatin, cetylpyridinium, alkyltrimethylammonium, chlorhexidine, pyrogenes, Poludan, Riboxin, beta-carotene, vitamin A. Connect with molten necessary pharmaceutically acceptable targeted supplements and add alpha, or beta, or gamma-interferon, metronidazol. The mixture is then poured into molds for candles, cooled and packaged.

These components take the following ratio of 1 g of product (see table.6)

Example 7. To obtain a vaginal suppository mixed solution etoniya with butylacetophenone. Then add nonoxynol 9 or octoxynol 9, Amiksin, beta-carotene, vitamin a, iodopovidone, imidazolidinedione, thiazolidinedione, lidocaine, buffer mixture, supporting the pH of the suppository 3,0-5,0, acyclovir, corticosteroids, gelatin, PI reginal, Poludan, Ribalta-, or beta-, or gamma-recombinantly interferon, interleukin-2, tumor necrosis factor alpha or beta. The mixture is then poured into molds for candles, cooled and packaged.

These components take the following ratio of 1 g of product (see table.7).

Example 8. To obtain a solid form of the drug (tablets, capsules) is mixed nipagin and benzalconi chloride with Trilon B and butylacetophenone. Add vitamins a and C, acyclovir, broad-spectrum antibiotics, corticosteroids, paverpol. Connect with the required pharmaceutically acceptable targeted supplements and add alpha, or beta, or gamma-interferon and interleukin-2. The mixture is molded in the form of tablets and put them acid-based coating, for example, acetylcellulose taken in the amount of 4.5% of the total mass above the base.

To obtain capsules these components fill gelatin capsules.

These components take the following ratio of 1 g of product (see table.8).

Received antiviral agent is kind of hard, soft or liquid forms.

Laboratory testing tool on the model of cell cultures, e the environmental 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. A therapeutic agent containing alpha-or beta-, or gamma-interferon, stabilizer biological, physico-chemical properties and/or resistance to microbial contamination and pharmaceutically acceptable additives target, characterized in that it additionally contains acyclovir.

2. A remedy under item 1, characterized in that it contains acyclovir in the amount of 0.005 to 0.04 g per 1 g of product.

3. A remedy under item 1, characterized in that it further comprises an immunomodulator selected from the group of cytokines, metronidazole in amounts of 0.001 to 0.01 g per 1 g of product, Radostin in the number 0,006-0.04 g per 1 g of product, polyoxidonium in the amount of 0.003-0,012 g per 1 g of product, sodium nukleinat in the amount of 0.003 to 0.05 g per 1 g of product, pyrogens in the amount of 50-300 μg per 1 g of product, Poludan in the amount of 50-400 IU per 1 g of product, Amiksin in the amount of 0.05-0.15 g per 1 g of product.

4. A remedy under item 3, characterized in that it contains cytokines interleukin-2 in the amount of 1000-20000 ME and/or factor necroses fact, it also contains vitamins selected from the group of: vitamin E, vitamin C, vitamin D3the vitamin e in the amount of 0.005-0.12 g per 1 g of product.

6. A remedy under item 5, characterized in that as the vitamin E it contains alpha-tocopherol.

7. A remedy under item 1, characterized in that it additionally contains retinoids: synthetic retinoids or vitamin a in number is 0.0002-0,0006 g per 1 g of product.

8. A remedy under item 1, characterized in that it additionally contains beta-carotene in the amount is 0.0002-0,0006 g per 1 g of product.

9. A remedy 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, atamazon, mometazon, perkantoran, triamcinolon in the amount of 0.002-0.01 g to 1 g of product.

10. A remedy under item 1, characterized in that it contains the stabilizer of biological, physico-chemical properties selected from the group: polyethylene oxide, glycerin, gelatin, polyvinylpyrrolidone, polyvinyl alcohol, a derivative of methyl cellulose (Na CMC) in the amount of the R resistance to microbial contamination, selected from the group of nipagin, Quaternary ammonium compounds, chlorhexidine in the amount of 0.0001-0.04 g per 1 g of product.

12. Therapeutic agent for p. 11, characterized in that the Quaternary ammonium compounds it contains atony, or benzathine chloride or benzalkonium chloride.

13. A remedy under item 1, characterized in that it further comprises an antimicrobial agent, and/or Antiprotozoal agent and/or antifungal agent.

14. Therapeutic agent for p. 13, characterized in that it contains an antimicrobial agent selected from the group: Miramistin in the amount of 0.0001-0.04 g per 1 g of the agent, broad-spectrum antibiotics in the amount of 0.025-0.05 g per 1 g of product, methylbenzethonium in the amount of a 0.012-0.025 g per 1 g of product, cetylpyridinium in the amount of 0.025-0.03 g per 1 g of product, alkyltrimethylammonium in the amount of 0.025-0.03 g per 1 g of product, chlorhexidine in the amount of a 0.012-0.02 g per 1 g of product, iodopovidone in the amount of 0.025-0.035 g per 1 g of product, imidazolidinedione in an amount of 0.01-0.05 g per 1 g of product, thiazolidinedione in an amount of 0.01-0.05 g per 1 g of product.

15. Therapeutic agent for p. 13, characterized in that as antimicrob,15 g per 1 g of product.

16. A remedy under item 15, characterized in that as a silver-containing component it contains paverpol.

17. A remedy under item 14, characterized in that it contains broad-spectrum antibiotics selected from the group: amoxicillin, ampicillin, oxacillin, methicillin, cephalexin.

18. A remedy under item 1, characterized in that as a pharmaceutically acceptable target additives it contains one or more ingredients from the group of additives, including witepsol, soklin, tallow type CH, cocoa butter, paraffin, petrolatum, lanolin, gelatin, dimethylsulfoxide, glycerine, polyethylene oxide, propylenglycol, aluminum hydroxide, cellulose acetate, hypromellose, hydroxide methyl cellulose, polymers of polyacrylic acid, castor oil, polyvinyl alcohol, oleic acid, vegetable oil, essential oil, proxanol is chosen-268, lactose, sucrose, silicon dioxide, calcium stearate, acetylcellulose.

19. A remedy under item 1, characterized in that it additionally contains an antioxidant: Trilon B and/or butylacetyl in the amount of 0.0001-0,0006 g per 1 g of product.

20. A remedy under item 1, characterized in, Thu 21. Therapeutic agent for p. 20, characterized in that as a local anesthetic drug it contains lidocaine.

22. A remedy under item 1, characterized in that it further comprises ribavirin in the amount of 0.005-0.05 g per 1 g of product.

23. Therapeutic agent for PP.1-22, characterized in that it is a liquid, or soft, or solid dosage forms.

24. Therapeutic agent for PP.1-23, characterized in that it is soft medicinal forms submitted by the ointment, or gel, or cream, or suppository rectal or vaginal.

25. Therapeutic agent for p. 24, characterized in that its dosage forms in the form of ointment, gel, cream, suppository, intended for vaginal use, contain spermatocidal agent.

26. Therapeutic agent for p. 25, characterized in that as spermatocide agent it contains nonoxynol 9 or octoxynol 9, taken in an amount of 0.025-0.05 g in 1 g of product.

27. Therapeutic agent for PP. 23 and 24, characterized in that its dosage form in the form of a vaginal suppository contains a buffer mixture, supporting the pH of the suppository 3,0-5,0.

28. Therapeutic agent for PP.1-27 different ones the same time, as activator of metabolism it contains Riboxin in the amount of 0.001-0.06 g per 1 g of product.

30. Therapeutic agent for p. 23, characterized in that its solid dosage forms contain acid or water-soluble coating.

 

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