Cryoprotective ointment

FIELD: pharmaceutics.

SUBSTANCE: the present innovation deals with cryoprotective ointment containing recombinant interferon-α2. The suggested cryoprotective ointment contains recombinant interferon-α2, glycerol, polyethylene glycol 300-6000, polyglucin, buffered 0.02%-Trilon B solution at pH of 5.5-7.0 and ointment foundation at a certain content of components per 1.0 g ointment. Additionally, cryoprotective ointment could contain glycine 3,7-bis(dimethylamino)phenothiazonium chloride, dry immunoglobulin preparation or dry immunoglobulin preparation for enteral application. Ointment foundation of cryoprotective ointment could contain water-free lanolin, Vaseline and Vaseline oil, at the following ratio of components: 2.5;3.5:1 - 6.5:0.5:1. The innovation provides maximal safety of recombinant interferon-α2 activity in cryoprotective ointment at multiple alteration of positive and negative environmental temperature and at keeping cryoprotective ointment under these conditions.

EFFECT: higher efficiency of application.

8 cl, 8 ex

 

The invention relates to medicine and the pharmaceutical industry and relates to the cryoprotective ointments containing recombinant interferon-α2.

Known antiviral, antimicrobial and protivokariosnoe tool that contains a cytokine in an effective amount and the target additives presented in the form of liquid or soft dosage form, optionally containing glycerol in the amount of 10-90 wt.%. As a cytokine known means may contain recombinant interferon in the amount of 103-107ME for 1 g of product and/or recombinant tumor necrosis factor-α 103-107ed 1 g of product. Known means may further comprise immunoglobulins in the amount of 1-60 wt.%, including a mixture of IgA, IgG and IgM (RU, patent No. 2144832 C1, A 61 K 38/19, 39/395, a 61 P 31/00, 27.01.2000).

Known antiviral, antimicrobial and protivokariosnoe tool that contains cytokines, stabilizer resistance to microbial contamination, glycerin and targeted supplements. Known means may further comprise an antioxidant (Trilon B and/or butylacetyl in the amount of 0.0001-0,0006 g per 1 g of product), immunomodulator, antibacterial or Antiprotozoal or antifungal agent, vitamins, anti-inflammatory drug, a local anesthetic agent, is boxin. As the target additives known means 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, propylene glycol, 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. Known antiviral, antimicrobial and protivokariosnoe tool can be represented ointment (RU, patent No. 2187328 C1, a 61 K 38/19, 20.08.2002).

The two tools are not intended for storage during the repeated change of positive and negative temperature. They do not provide sufficient conservation activity of recombinant interferon-α2the means for repeatedly changing the positive and negative environmental temperature.

The basis of the invention is of maximum preservation of the activity of recombinant interferon-α2in cryoprotective ointment when repeatedly changing the positive and negative ambient temperature during storage of bioprotectors ointment in these conditions.

The problem is solved by the fact that the cryoprotective ointment contains recombinant interferon-α2, glycerin, polyethylene glycol 3000-6000, poliglyukin, buffered solution of 0.02% of the trylon B with a pH of 5.5-7.0 and ointment based on the following content of components of 1.0 g ointment: recombinant interferon-α2- 10000-200000 ME; glycerol - 0.05-0.1 g; polyethylene glycol 3000-6000 - 0,001-0,005 g; poliglyukin - 0,001-0,005 g; buffered solution of 0.02% of the trylon B with pH 5,5-7,0 - 0,04-0,15 g; ointment base - the rest. Cryoprotective ointment may further comprise glycine in the amount of 0.005-0.01 g to 1.0 g of ointment. Cryoprotective ointment can additionally include 3,7-bis(dimethylamino)phenthiazine chloride in the amount of 0,0000015-0,002 g per 1.0 g of ointment. Cryoprotective ointment may further comprise immunoglobulin medicine dry or immunoglobulin medicine dry for enteral application in the amount of 0.02-0.3 g 1.0 g ointment. Ointment base cryoprotective ointments may contain anhydrous lanolin, vaseline and liquid paraffin in the following ratio of components: 2,5:3,5:1-6,5:0,5:1.

As a result of our research was first defined composition claimed cryoprotective ointment, which components in selected us quantitative ratio optimally complement and negate the properties of each other, allowing a maximum of Sokh unity activity of recombinant interferon-α 2in cryoprotective ointment when repeatedly changing the positive and negative ambient temperature and storage cryoprotective ointment in these conditions.

Declare cryoprotective ointment is new and is not described in literature.

The technical result of the invention is to preserve the activity of recombinant interferon-α2in cryoprotective ointment when repeatedly changing the positive and negative ambient temperature during storage of the claimed cryoprotective ointment in these conditions.

The invention is illustrated in the following examples, showing the preservation of the activity of recombinant interferon-α2in cryoprotective ointment when repeatedly changing the positive and negative ambient temperature during storage of the claimed cryoprotective ointment in these conditions.

Example 1.

Cryoprotective ointment containing 1 g ointment recombinant interferon-α2- 10000 ME, glycerol, 0.05 g, polyethylene glycol 3000 - 0.005 g, poliglyukin - 0.005 g, buffered solution of 0.02% of the trylon B with pH 5,5-7,0 - 0.04 g and ointment base - the rest. After a five-fold change of the ambient temperature with(+5)-(+18)° $ (-12)-(-18)°and storing within 30 days, the activity of recombinant interferon-α2in cryopro attorney ointment was ME 10000 in 1 g of ointment.

Example 2.

Cryoprotective ointment containing 1 g ointment recombinant interferon-α2- 50000 ME, glycerin - 0.08 g polyethylene glycol 4000 - 0.002 g, poliglyukin - 0.002 g, buffered solution of 0.02% of the trylon B with pH 5,5-7,0 - 0.15 g and ointment base - the rest. Ointment base contains anhydrous lanolin, vaseline and liquid paraffin in the following ratio of components: 2,5:3,5:1. After six changes of ambient temperature with(+5)-(+18)° $ (-12)-(-18)°and storing within 30 days, the activity of recombinant interferon-α2in cryoprotective ointment was 50,000 ME in 1 g of ointment.

Example 3.

Cryoprotective ointment containing 1 g ointment recombinant interferon-α2- 200000 ME, glycerin 0.1 g polyethylene glycol 6000 - 0.001 g, poliglyukin - 0.001 g, buffered solution of 0.02% of the trylon B with pH 5,5-7,0 - 0.04 g and ointment base - the rest. Ointment base contains anhydrous lanolin, vaseline and liquid paraffin in the following ratio of components: 6,5:0,5:1. After six changes of ambient temperature with(+5)-(+18)° $ (-12)-(-18)°and storing within 30 days, the activity of recombinant interferon-α2in cryoprotective ointment was 200000 ME in 1 g of ointment.

Example 4.

Cryoprotective ointment containing 1 g ointment recombinant interferon-α2- 10000 ME, glycerol, 0.05 g, polyethylene glycol 3000 - 0005 g, poliglyukin - 0.005 g, buffered solution of 0.02% of the trylon B with pH 5,5-7,0 - 0.15 g, glycine - 0.005 g and ointment base - the rest. Ointment base contains anhydrous lanolin, vaseline and liquid paraffin in the following ratio of components: 3:3:1. After a five-fold change of the ambient temperature with(+5)-(+18)° $ (-12)-(-18)°and storing within 30 days, the activity of recombinant interferon-α2in cryoprotective ointment was ME 10000 in 1 g of ointment.

Example 5.

Cryoprotective ointment containing 1 g ointment recombinant interferon-α2- 50000 ME, glycerol, 0.06 g, polyethylene glycol 4000 - 0.004 g, poliglyukin - 0.004 g, buffered solution of 0.02% of the trylon B with a pH of 5.5-7.0 and 0.1 g, glycine - 0,006 g, 3,7-bis(dimethylamino)phenthiazine chloride - 0,0000015 g ointment base - the rest. Ointment base contains anhydrous lanolin, vaseline and liquid paraffin in the following ratio of components: 2,5:3,5:1. After six changes of ambient temperature with(+5)-(+18)° $ (-12)-(-18)°and storing within 30 days, the activity of recombinant interferon-α2in cryoprotective ointment was 50,000 ME in 1 g of ointment.

Example 6.

Cryoprotective ointment containing 1 g ointment recombinant interferon-α2- 200000 ME, glycerin - 0.08 g polyethylene glycol 6000 - 0.002 g, poliglyukin - 0.002 g, buffered solution of 0.02% of the trylon B with pH 5,5-7,0 - 0.08 g, gli is in 0.01 g, 3,7-bis(dimethylamino)phenthiazine chloride - 0,00001 g, immunoglobulin medicine dry - 0.02 g and ointment base - the rest. After six changes of ambient temperature with(+5)-(+18)° $ (-12)-(-18)°and storing within 30 days, the activity of recombinant interferon-α2in cryoprotective ointment was 200000 ME in 1 g of ointment.

Example 7.

Cryoprotective ointment containing 1 g ointment recombinant interferon-α2- 100000 ME, glycerin and 0.08, polyethylene glycol 4000 - 0.003 g, poliglyukin - 0.003 g, buffered solution of 0.02% of the trylon B with a pH of 5.5-7.0 and 0.1 g, glycine - 0.005 g, 3,7-bis(dimethylamino)phenthiazine chloride - 0.002 g, immunoglobulin medicine dry for enteral application - 0.3 g ointment base - the rest. After six changes of ambient temperature with(+5)-(+18)° $ (-12)-(-18)°and storing within 30 days, the activity of recombinant interferon-α2in cryoprotective ointment amounted to 100000 ME in 1 g of ointment.

Example 8.

Cryoprotective ointment containing 1 g ointment recombinant interferon-α2- 100000 ME, polyethylene glycol 3000 - 0.005 g, poliglyukin - 0.005 g, buffered solution of 0.02% of the trylon B with a pH of 5.5 to 7.0 - 0.3 g, glycine - 0.005 g, 3,7-bis(dimethylamino)phenthiazine chloride, 0.02 g, immunoglobulin medicine dry for enteral application of 0.15 g and glycerol - rest. Ointment bases which contains lanolin anhydrous, vaseline and liquid paraffin in the following ratio of components: 6,5:0,5:1. After a seven-time change of the ambient temperature with(+5)-(+18)° $ (-12)-(-18)°and storing within 30 days, the activity of recombinant interferon-α2in cryoprotective medium was 100000 ME in 1 g of product.

1. Cryoprotective ointment, characterized in that it contains recombinant interferon-α2, glycerin, polyethylene glycol 3000-6000, poliglyukin, buffered solution of 0.02% of the trylon B with a pH of 5.5-7.0 and ointment based on the following content of components of 1.0 g ointment:

recombinant interferon-α210000-200000 ME

glycerol 0.05-0.1 g

the glycol 3000-6000 0,001-0,005 grams

poliglyukin 0,001-0,005 grams

buffered solution of 0.02%trylon B with pH 5,5-7,0 0,04-0,15 g

ointment base - the rest.

2. Cryoprotective ointment according to claim 1, characterized in that it further comprises a glycine in the amount of 0.005-0.01 g to 1.0 g of ointment.

3. Cryoprotective ointment according to claim 1, characterized in that it further comprises a 3,7-bis(dimethylamino)phenthiazine chloride in the amount of 0,0000015-0,002 g per 1.0 g of ointment.

4. Cryoprotective ointment according to claim 1, characterized in that it further comprises a glycine in the amount of 0.005-0.01 g to 1.0 g of ointment and 3,7-bis(dimethylamino)phenthiazine chloride in the amount of 0,0000015-0.002 g to 1.0 g mA is I.

5. Cryoprotective ointment according to claim 1, characterized in that it further comprises immunoglobulin medicine dry or immunoglobulin medicine dry for enteral application in the amount of 0.02-0.3 g 1.0 g of ointment.

6. Cryoprotective ointment according to claim 1, characterized in that it further comprises a glycine in the amount of 0.005-0.01 g to 1.0 g of ointment and immunoglobulin medicine dry or immunoglobulin medicine dry for enteral application in the amount of 0.02-0.3 g 1.0 g of ointment.

7. Cryoprotective ointment according to claim 1, characterized in that it further comprises a 3,7-bis(dimethylamino)phenthiazine chloride in the amount of 0,0000015-0,002 g 1.0 g ointment and immunoglobulin medicine dry or immunoglobulin medicine dry for enteral application in the amount of 0.02-0.3 g 1.0 g of ointment.

8. Cryoprotective ointment according to claim 1, characterized in that it further comprises a glycine in the amount of 0.005-0.01 g to 1.0 g of ointment, 3,7-bis(dimethylamino)phenthiazine chloride in the amount of 0,0000015-0,002 g 1.0 g ointment and immunoglobulin medicine dry or immunoglobulin medicine dry for enteral application in the amount of 0.02-0.3 g 1.0 g of ointment.

9. Cryoprotective ointment according to claim 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8, wherein the ointment base contains anhydrous lanolin, vaseline and liquid paraffin in the following sootnoshenie the components: 2,5:3,5:1-6,5:0,5:1.



 

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