Cytokine-containing medication, possessing antiviral, antimicrobial, immunomodulating and anti-inflammatory action for prevention and treatment of infection diseases

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention relates to pharmacology, in particular, to medication, possessing antiviral, antimicrobial, immunomodulating and anti-inflammatory action, in form of drops, spray, gel and solution for injection for treatment and prevention of infection diseases: herpes, acute respiratory viral infections, hepatitis, HIV-infections, viral disease. Medication according to invention contains complex of cytokines with Trilonum B, immobilised on biologically compatible polymer as carrier.

EFFECT: obtaining medication, possessing antiviral, antimicrobial, immunomodulating and anti-inflammatory action.

3 cl, 6 ex

 

The invention relates to pharmacology, specifically to cytokinemia drug, antiviral, antimicrobial; immunomodulatory and anti-inflammatory effects in the form of drops, spray, gel and solution for injection for the treatment and prevention of infectious diseases: herpes, acute respiratory viral infections, hepatitis, HIV, viral diseases.

Widely known medicinal product with the content as cytokines - the interferons both natural and recombinant or genetically engineered origin, who have not only antiviral activity but also a strong immunomodulatory effects, causing a number of positive changes in homeostasis, anti-tumor effect, etc. for the treatment and prevention of influenza and SARS (RU application 94042742, AK 38/21, 1997; RU 2057544, AK 38/12, 1996, EN 2033180, AK 38/21, 1995; SU, 297296, AK 38/21, 1977; RU 2108804, AC 38/21, 1998, FS 42-3279-96; VFS 42-2989-97; EN 2073522, AK 38/21, 1997).

These drugs are effective and in Oncology practice in the application of injecting massive doses (from 3 to more than 10 million IU in a day) prolonged and repeated courses. But these dosages are often cause side effects - violation of blood, oppression of the immune system, the formation of antibodies to interferon, etc.

Od�ako gained in recent years experience in clinical application of interferons show that it is possible to increase their effectiveness using a combination of dosage forms (including pathogenetic features specific diseases) to ensure high levels of cytokines in the hearth viral lesions, while providing antiviral, immunomodulatory effects, but without showing any cytotoxic or other side effects. This leads to the feasibility of the different combined cytokinemia dosage forms in the form of drops, spray, gel and solution for injection.

Known antiviral agent for intranasal application containing human interferon, biologically compatible polymer - polyglukin 6% solution and buffer mixture with the following content of components in 1 ml solution:

Interferon, ME(1-6 of 6)·106
Biologically compatible polymer (polyglukin)5-30
Buffer mixture until the pH of the solution7,0-7,6

(EN 2095081, A61K 38/21, 1997).

The closest analogue of the present invention proposed by essence and the achieved result is an antiviral agent containing genetically engineered interferon as a cytokine, polyvinylpyrrolidone and/or polyethylene oxide as a biologically compatible polymer, Trilon B and buffer cm�camping as a grease-forming base, taken in a certain ratio of components in 1 ml of buffer mixture (RU 2140285, AK 38/21, 1999).

However, this tool is not effective in the treatment of mixed viral-bacterial infections, does not have a prolonging effect, has a low remission in cases of chronic diseases.

Solved by the invention the task and the expected technical result is the development of the combined funds in the form of drops, spray, gel and solution for injection for the treatment and prevention of a wide range of infectious diseases: herpes, acute respiratory diseases, hepatitis, HIV, viral diseases, and in improving the efficiency of the above remedies known due to the expansion of the spectrum of therapeutic applications, prolonging the action of the product by increasing the time it comes into contact with a mucous membrane, reducing the duration of therapy and increase the period of remission up to 8 months, in comparison with the prototype, in cases of chronic infectious diseases.

The claimed means no toxic effects on the human body, is used as an energy source.

To achieve the said technical result of the drug, antiviral, antimicrobial, immunomodulatory, etc�televisiefilm action for the prevention and treatment of infectious diseases, containing cytokines, antioxidants, biologically compatible polymer and buffer mixture as consistentarea basis, according to the invention contains a complex of cytokines with Trilon B, immobilized on a biocompatible polymer as a carrier, wherein the cytokine is selected from the group: interferon-alpha, interferon-beta, interferon-gamma, interleukin, and a biologically compatible polymer is selected from the group: polyvinylpyrrolidone, polyethylene oxide, dextran, polymer and borate-phosphate buffer as the buffer mixture, taken in a ratio of 1 ml buffer mixture, g:

Cytokines ME100-10000000
Trilon B0,00001-a 0.1
Biocompatible polymeric carrierOf 0.0005 to 0.2
Borate phosphate bufferelse

In addition, the medicament further comprises an antioxidant selected from the group: alpha-tocopherol acetate, BHT, Mexidol, emoxipin in the amount of 0.0001-0.1 g

In addition, the medicament additionally contains the preservative benzalkonium chloride or boric acid in an amount of 0.001-0.2 g, the analysis of the prior art, including searching by the patent and scientific and technical information sources and identify sources that contain information about the equivalents of the claimed medicinal product has allowed to establish that the petitioners have not found an analogue, characterized by features identical to all the essential features of the claimed medicinal product.

Therefore, the claimed combined drug meets the criterion of "novelty."

To verify compliance of the claimed drug prior art, the applicants conducted an additional search of the known solutions to identify signs that match the distinctive features of the prototype features of the claimed invention.

The search results showed that the claimed invention not apparent to the expert explicitly from the prior art, certain applicants have not identified impact provided the essential features of the claimed combined medicines transformations to achieve a technical result. Therefore, the claimed invention meets the criterion of "inventive step".

The criteria of the invention "industrial applicability" is confirmed by the fact that the claimed medicinal product used for the treatment and p�of opractice a wide range of infectious diseases: herpes, acute respiratory viral infections, hepatitis, HIV, viral diseases. The tool has a high therapeutic effect by expanding the range of therapeutic applications, prolonging its action by increasing the time it comes into contact with a mucous membrane, reducing the duration of therapy and increase the period of remission up to 8 months, in comparison with the prototype, in cases of chronic infectious diseases and can be successfully used for the treatment of various infectious diseases.

The present invention is illustrated by concrete examples, which, however, are not only possible, but clearly demonstrate the possibility of achieving the desired technical result.

The technology of obtaining funds is the same for all following examples. Prepared complex (composite) is a cytokine with Trilon B. Immobilized her on the biologically compatible polymer as a carrier. Moreover, the cytokine is selected from the group: interferon-alpha, interferon-beta, interferon-gamma, interleukin, and a biologically compatible polymer is selected from the group of: polyvinylpyrrolidone, polyethylene oxide, dextran, polymer. As a grease-forming bases use borate-phosphate buffer. These components are combined Emotiv the given sequence and sterilized.

Example 1. Mixed with Trilon B cytokine, which for this example we take the interferon-alpha and immobilized mixture of the biologically compatible polymer is polyvinylpyrrolidone. To the resulting add borate-phosphate buffer at the following ratio of 1 ml buffer mixture, g:

This mixture is sterilized. Received the tool has the form of a clear liquid.

The results of testing the drug on patients with influenza and acute respiratory viral infections (ARVI) was shown to reduce the duration of treatment until full recovery in two times in comparison with the prototype and increase remission to 8 months.

Example 2. Carried out analogously to example 1. Except that the medicament further comprises an antioxidant selected from the group: alpha-tocopherol acetate, BHT, Mexidol, emoxipin in the amount of 0,00001-0.1 g, as a cytokine using interferon-beta, and take the polymer polyethylene oxide.

These components reduce in the following ratio of 1 ml buffer mixture, g:

The resulting mixture is sterilized. The tool has the form of a clear liquid.

The results of testing the drug on patients with hepatitis A and b showed reduced�e duration of treatment until complete recovery one and a half times compared with the prototype and the increase in the remission period up to 6 months.

Example 3. Carried out analogously to example 1. Except that the medicament additionally contains the preservative benzalkonium chloride or boric acid in an amount of 0.001-0.2 g, and as a cytokine using interferon-gamma, and take the polymer dextran. These components reduce in the following ratio of 1 ml buffer mixture, g:

This mixture is sterilized. Received the tool has the form of a clear liquid.

The results of testing the drug on patients with herpes have shown to reduce the duration of treatment until full recovery in two times in comparison with the prototype and increase remission to 8 months.

Example 4. Carried out analogously to example 1. Except that the medicament further comprises an antioxidant selected from the group: alpha-tocopherol acetate, BHT, Mexidol, emoxipin in the amount of 0,00001-0.1 g, as a cytokine using interleukin, and as the polymer take hypromellose.

These components reduce in the following ratio of 1 ml buffer mixture, g:

This mixture is sterilized. Received the tool has the form of a clear liquid.

The results of testing the drug on patients with SARS showed juice�ashenia the duration of treatment until full recovery in two times in comparison with the prototype and increase remission to 8 months.

Example 5. Mixed with Trilon B cytokine, which for this example, take a mixture in equal proportions of interferon-alpha, interferon-beta, interferon-gamma and immobilized mixture of the biologically compatible polymer is polyvinylpyrrolidone. To the resulting add borate-phosphate buffer at the following ratio of 1 ml buffer mixture, g:

This mixture is sterilized. Received the tool has the form of a clear liquid.

The results of testing the drug on patients with hepatitis was shown to reduce the duration of treatment until full recovery in two times in comparison with the prototype and increase remission to 8 months.

Example 6. Mixed with Trilon B cytokine, which for this example, take a mixture in equal proportions of recombinant interferon-Alfa and interleukin immobilized mixture of the biologically compatible polymer is polyvinylpyrrolidone. To the resulting add borate-phosphate buffer at the following ratio of 1 ml buffer mixture, g:

This mixture is sterilized. Received the tool has the form of a clear liquid.

The results of testing the drug on patients with influenza and herpes was shown to reduce the duration of medical�tion to a full recovery in two times in comparison with the prototype and increase remission to 8 months.

Conducted research with the data of the quantities of active substances allowed to achieve the best therapeutic effect. Used the tool in the form of drops, spray, gel and solution for injection for the treatment and prevention of infectious diseases: herpes, acute respiratory infections, hepatitis, HIV, viral diseases. This preparation is harmless, good move, it is the production of antibodies to interferon.

Laboratory tests of the funds showed in model cell cultures, experimental animals that it is non-toxic, has a prolonging effect, ensuring an increase in the remission period in cases with chronic

diseases, with a much expanded range of therapeutic applications for the treatment of mixed infections.

The effectiveness of treatment declared by means with unique matching of components in a variety of forms depending on the type of disease was investigated in 13 patients volunteers aged 20-30 years by 5 people in each group. In the case of influenza and SARS patients entered the claimed means intranasally into each nasal passage 3 drops (or 3 injections of 1 cm of gel) 3 times a day. In the case of infectious diseases, such as hepatitis, patients were injected with the claimed remedy 1-5 ml solution for injection 3-4 times � day. The dose of administered funds varied depending on the severity of the disease, gender, age. In the control group (the prototype) was injected by means of the same scheme. The course of treatment lasted 12 days. After 5 days in patients who claimed the means, there was a significant improvement, improvement in parameters of blood and urine. On examination of patients after 12 days it is found that in the experimental groups was not required additional therapy, whereas in the control group it was necessary to appoint additional therapy.

Timing the duration of the disease has decreased twice in comparison with the prototype due to the prolonging of the action of the claimed funds. At the control examination after 8 months of complaints from patients were reported. During the survey it was noted achievement of positive result of all treated patients.

For the prevention of infectious diseases the medication was taken twice daily at a dose of 3-4 drops (or injections) for contact with a sick person.

Thus, the inventive tool provides improved therapeutic efficacy of prevention and treatment by prolonging the actions that contribute to reduce the time duration of the disease and increase the period of remission up to 8 months in cases of chronic Zabol�unsustainable. In addition, the use of the claimed means allows to extend the range of domestic drugs for the treatment and prevention of infectious diseases.

1. Drug, antiviral, antimicrobial, immunomodulatory and anti-inflammatory action for the prevention and treatment of infectious diseases, containing cytokines, Trilon B, biologically compatible polymer and a buffer mixture, characterized in that it comprises a cytokine selected from the group: interferon-alpha, interferon-beta, interferon-gamma, interleukin with Trilon B, immobilized on a biocompatible polymer as a carrier, the biologically compatible polymer is selected from the group: polyvinylpyrrolidone, polyethylene oxide, dextran, polymer, and as the buffer mixture contains borate-phosphate buffer, with the following ratio of components per 1 ml buffer mixture, g:

Cytokines, ME100-10000000
Trilon B0,00001-a 0.1
Biologically compatible polymerOf 0.0005 to 0.2
Borate phosphate bufferElse

2. Drug with�adsto according to claim 1, characterized in that it additionally contains antioxidants selected from the group: alpha-tocopherol acetate, BHT, Mexidol, emoxipin in the amount of 0.0001-0.1 g per 1 ml buffer mixture.

3. Medicament according to claim 1, characterized in that it further contains the preservative benzalkonium chloride or boric acid in an amount of 0.001 to 0.2 g per 1 ml of buffer mixture.



 

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2 cl, 3 dwg, 6 tbl, 6 ex

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