Remedy

 

(57) Abstract:

The invention relates to medicine, in particular to the pharmaceutical industry. The inventive therapeutic agent contains recombinant interferon as a stabilizer biological and physico-chemical properties of the polyethylene glycol or polyvinyl alcohol as a stabilizer resistance to microbial contamination - silver nitrate. As consistentarea fundamentals of therapeutic agent contains a gel of aluminum hydroxide. The technical result of the invention is to provide a preparation with prolonged action on the basis of recombinant interferon, ensuring good penetration ability and possessing antiviral, antibacterial, anti-inflammatory, detoxifying, local anesthetic and regenerating effect and stable during storage. 2 C.p. f-crystals.

The invention relates to medicine, in particular to the pharmaceutical industry, for example, to the composition of dosage forms, including recombinant interferon and silver-containing component.

Known ointment on the basis of interferon alpha-2, additionally containing VI is="ptx2">

Known genetically engineered drug gamma-interferon, including interferon, stabilizing additives, biologically inert filler, amino acid or its salt and salt buffer system in a specific ratio of components.

(RU patent 2077336, 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 N 2339. The preparation contains not less than 8000 ME in an ampoule antiviral activity of alpha interferon and cellular mediators with m m 1 - -100 KD, ovalbumin - less than 1 ng/mg, free from antibiotics and heparin, and also contains sodium chloride to a final concentration of 0.9 wt.% and stabilizer.

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

Known drug for the treatment of urogenital infections comprising as active ingredients alpha, beta and gamma interferons and various additives target. The drug is a suppositories, ointment or cream.

(RU patent 2073520, a 61 K 35/74, 1997).

And what of Lista it contains human immunoglobulins. As human interferon it contains recombinant alpha-or beta-, or gamma-interferon person. As human immunoglobulins 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 one is an antiviral agent-based recombinant interferon in the form of an ointment, gel, suppository, cream, liniment containing alpha-or beta - or gamma-interferon, stabilizer biological, physico-chemical properties and/or resistance to microbial contamination and consistantness based in a certain mixing ratio.

(Application EN N 99109379/14, class a 61 K 38/21, 1999).

Accumulated in recent years, the experience of clinical application of interferons indicate the possibility of improving their efficiency by the use of dosage forms for local use prolonged action, for example, ointment or gel.

The technical result of the invention is to provide a preparation with prolonged action on the basis of recombinant interferon, ensuring good penetration ability and the possession and regenerating effect, as well as having storage stability.

To achieve the technical result remedy containing recombinant interferon, stabilizer biological, physico-chemical properties and resistance to microbial contamination and consistantness basis, according to the invention as a stabilizer resistance to microbial contamination it contains silver nitrate, and as consistentarea basics - gel aluminum hydroxide in the following ratio, wt.%:

Recombinant interferon, ME - 500-5000000

Silver nitrate is Not more than 3.0

The stabilizer biological and physico-chemical properties - 1-3,0

Gel aluminium hydroxide - Rest

As the stabilizer of biological and physico-chemical properties of therapeutic agent contains a polyethylene glycol or polyvinyl alcohol

The invention is illustrated in the following examples.

Example 1. The technology of obtaining a remedy.

To obtain the gel mix silver nitrate, polyethylene glycol and gel aluminium hydroxide. Mix the components, and sterilize by autoclaving. Then add the recombinant is t Packed in the required capacity (for example, tubes), seal and label. These components are taken in the following ratio, wt.%:

Recombinant interferon, ME - 500

Silver nitrate - 0,5

The glycol - 1

Gel aluminium hydroxide - Rest

Example 2. To obtain Masi mix a 10% solution of polyvinyl alcohol, silver nitrate and gel aluminium hydroxide. Sterilize and add recombinant interferon, for example, alpha-2-interferon and forth as in example 1.

These components are taken in the following ratio, wt.%

Recombinant interferon, ME - 5000000

Silver nitrate - 3,0

Polyvinyl alcohol - 3,0

Gel aluminium hydroxide - Rest

Example 3. Carried out analogously to example 2, except that the specified components are taken in the following ratio, wt.%:

Recombinant interferon, ME - 1000000

Silver nitrate and 1.5

Polyvinyl alcohol and 1.5

Gel aluminium hydroxide - Rest

The introduction of the film-forming polyvinyl alcohol in the composition of ointments gives it flexibility and due to the formation of films with applications to the skin increases with prolonging the action of ointment.

Received medical sreejith shells 2 times a day for 3-5 days.

Clinical trials ointment on 19 volunteers aged 18-20 show that the drug is effective, safe, well tolerated, does not cause allergic reactions.

1. A therapeutic agent containing recombinant interferon, stabilizer biological, physico-chemical properties and resistance to microbial contamination and consistantness base, characterized in that the stabilizer is resistance to microbial contamination it contains silver nitrate, and as consistentarea basics - gel aluminum hydroxide in the following ratio of components, wt.%:

Recombinant interferon, ME - 500-5000000

Silver nitrate is Not more than 3.0

The stabilizer biological and physico-chemical properties - 1-3,0

Gel aluminium hydroxide - Rest

2. A remedy under item 1, characterized in that the stabilizer of biological and physico-chemical properties it contains polyethylene glycol.

3. A remedy under item 1, characterized in that the stabilizer of biological and physico-chemical properties it contains polyvinyl alcohol.

 

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