Cycloferon-containing medicinal agent, method for its preparing and using

FIELD: medicine, pharmacy.

SUBSTANCE: invention relates to a cycloferon-containing medicinal agent used in prophylaxis and treatment of influenza and acute respiratory diseases, herpetic infection, chronic viral hepatitis B and C and prophylaxis of oncological diseases. Agent comprises a physiological solution in the following ratio of components: 10-29 - 10-2 mg of cycloferon in 1 ml of physiological solution. Also, invention relates to a method for preparing this medicinal agent. Proposed medicinal agent enhances antiviral and antitumor activity of natural killers by 1.8-fold, not less.

EFFECT: improved preparing and using method, valuable medicinal properties of agent.

7 cl, 1 dwg, 19 ex

 

The invention relates to medicine, in particular to medicines intended for prevention and treatment of acute and chronic respiratory viral infections, and the prevention of cancer processes.

Natural killer cells are the first "barrier" on the path of development of oncologic process. They are able without prior sensitization to destroy a wide range of tumor cells, and also to provide a pronounced antiviral effect (1-10). Factors affecting the activity of these cells can be attributed interferon, prostaglandins, hormones, interleukins, lipids, minerals, toxins and psycho-emotional background[6, 1, 4, 7, 8, 10, 5].

Interferon, interleukin-2 and a number of trace elements such as Li, Zn, Mg, Se, Fe, - increase the activity of natural killer cells [6, 10, 1]. Conversely, Ecotoxic factors, lipid imbalance and depression reduce the activity of natural killer cells[7, 8, 5].

Especially changes dramatically the activity of natural killer cells exposed to interferon. Quite a ten-minute contact to activity of natural killer cells has increased several times [6]. Identified a direct correlation relationship between the concentration of interferon and activity of natural killer cells [3]. While low doses of interferon protects normal cells from exposure to the of lerow, but at the same time increase the sensitivity of tumor and virus-infected cells to their impact [9]. In addition, low-dose interferon is able to protect the natural killer cells of cancer patients from the depressing effects of cytostatics.

The possibility of increasing the sensitivity of tumor cells to the effects of the killers under the action of low doses of interferon is very important in practical terms because prolonged use of immunomodulators, and any other pharmacological agents, is not indifferent to the body.

In this regard, the urgent task is to develop methods for using low doses of interferonogenous.

The closest to the functional purpose of the drug to the claimed means of the method of its preparation and application is the drug "Cold", consisting of acids, greenexpo 0.15 g of N-methylglucamine - 0,146 g, excipients - methylcellulose, calcium stearinovokisly [11].

The objective of the invention is the creation of medicines on the basis of physiological solution using micro-doses of interferon inducer - cycloferon. For this proposed tool and method of its manufacture and application.

Drug, including cycloferon, characterized in that it contains cold and saline solution in the following ratio, wt./hours: 10 -29-10-2mg of cycloferon in 1 ml of physiological solution.

Method of preparation of medicines, including cold, characterized by the fact that cycloferon serially diluted in physiological solution, is applied from 1 to 30 cycles of breeding.

The preparation method is characterized by the fact that during each cycle cycloferon bred no less than 100 times in saline.

The preparation method is characterized by the fact that at each cycle the solution is stirred by shaking.

The method of preparation of a medicinal product is characterized by the fact that dissolved drug cycloferon in saline solution mixed with alcohol in the ratio of 58.3 ml - 41.7 ml 96% alcohol, making it is 40% alcohol solution of the drug.

The method of preparation of a medicinal product is characterized by the fact that 0.4 ml of 40% alcohol solution is mixed with not less than 8 grams of bases made from milk sugar. This basis may consist of not less than 30 wafers mass of 0.27 grams or 200 grains weight of 0.04 gram.

The method of use of a medicinal product is characterized by the fact that the patient is prescribed a single dose of not less than 0.25 and not more than 1 second wafer (0.003 ml - 0,013 ml of 40% solution of the drug) or not less than 2 not more than 8 Krupin is to (0,004-0,016 ml of 40% solution of the drug).

The method of use of a medicinal product is characterized by the fact that these single doses are prescribed 1-2 times per day.

The method of use of a medicinal product is characterized by the fact that the daily dose indicated is used in the course of 1 week up to 2 months.

The drug is characterized by the fact that it enhances antiviral and antitumor activity of natural killer cells is not less than 1.8 times.

The method of storage of the medicinal product is characterized by the fact that it does not lose its medicinal properties for at least one week.

The method of storage of the medicinal product is characterized by the fact that it does not lose its medicinal properties for at least two years.

The experiments assessed the influence of cold on the natural cytotoxic activity of splenocytes of mice.

The experiments were carried out on containany mice - males, SSNA, weighing 18-20 g, which intravenous method was introduced solutions of cycloferon. To evaluate the activity of natural killer cells was used a modified isotope cytotoxic test Hapsoro and Shipbuilding (Malygin, A. M. et al., 1984). "Targets" in the test were the cells of chronic erythroleucus K-562, labeled with 3H-uridine. To assess the cytotoxic activity of splenocytes was calculated index of cytotoxicity (IC), reflecting the th in % the percentage of dead cells. The data was processed statistically using t-student test.

In our experiments we used 6 variants concentrations of cycloferon:

40 mg/ml;

20 mg/ml;

10 mg/ml;

1 mg/ml;

- 10-2mg/ml;

- 10-11mg/ml

24 hours after injection of cycloferon in concentrations of 10 mg/ml cytotoxic activity of killer cells was significantly increased (drawing). Index of cytotoxicity was equal to 39.4±3,0%; p<0,05.

By increasing the concentration of the injected cold up to 20 mg/ml ITZ even more increased (45,8± and 2.4%; p<0,001; the drawing).

The highest activity of cycloferon observed at a concentration of 40 mg/ml (52,7±2,2%; p<0,001; the drawing).

Upon decrease of the concentration of cycloferon to 1 mg/ml index of cytotoxicity was decreased to the level in the control group, i.e. the effect of cold was absent (25,1±3,0%; p>0,05).

However, further reduction in the number of input cycloferon to 10-2mg/ml cytotoxic activity of natural killer cells again increased significantly (drawing).

Upon decrease of the concentration of cycloferon to 10-11mg/ml the activity of natural killer cells remained significantly increased and exceeded the level in the control group twice (see drawing).

The drawing shows the index of cytotoxicity of splenocytes (CI %) depending on the concentration of introduced cycloferon fit)

Note:

A - CI in control;

B - CI at a concentration of CP -10 mg/ml;

In - CI at a concentration of ZF - 20 mg/ml;

G - CI at a concentration of CP - 40 mg/ml;

Dr. CI at a concentration of CP - 1 mg/ ml;

E - CI at a concentration of CP -10-2mg/ml;

W - CI at a concentration of CP - 10-11mg/ml;

* - reliability of differences with the indicator in the control at p<0,05; ** - significance of differences at p<0,001; in the control group and in each breeding n<12.

Thus, experimental data suggesting that the use of the drug, including saline and ultra-low doses of cycloferon, allowed 1.8-1.9 times increase phytotoxicity the activity of natural killer cells.

Examples

Implementation examples of the invention below.

Examples of the drug,

Example 1. Drug containing 10-1mg of cycloferon in 1 ml of physiological solution

Example 2. Drug containing 10-5mg of cycloferon in 1 ml of physiological solution

Example 3. Drug containing 10-11mg of cycloferon in 1 ml of physiological solution

Example 4. Drug containing 10-23mg of cycloferon in 1 ml of physiological solution

Example 5. Drug containing 10-29mg of cycloferon in 1 ml of f is zoologicheskogo solution

Examples of the preparation method.

Example 1. Prepare the drug, including cycloferon, characterized in that the cycloferon in a concentration of 10 mg/ml diluted in physiological solution in 100 times that corresponds to one cycle of cultivation. The drug mix by shaking. The resulting preparation of cycloferon in saline solution mixed with alcohol in the ratio of 58.3 ml - 41.7 ml 96% alcohol, making it is 40% alcohol solution preparation containing 10-1mg of cycloferon in 1 ml.

Example 2. Prepare the drug, including cycloferon, characterized in that the cycloferon in a concentration of 10 mg/ml diluted in physiological solution in 1000000 times, which corresponds to 3 cycles of breeding. The drug mix by shaking. The resulting preparation of cycloferon in saline solution mixed with alcohol in the ratio of 58.3 ml - 41.7 ml 96% alcohol, making it is 40% alcohol solution preparation containing 10-5mg of cycloferon in 1 ml.

Example 3. Prepare the drug, including cycloferon, characterized in that the cycloferon in a concentration of 10 mg/ml diluted in physiological solution in 1012time, which corresponds to 6 cycles of breeding. The drug mix the shake. The resulting preparation of cycloferon in saline solution mixed with alcohol in the ratio of 58.3 ml - 41.7 ml 96% alcohol, making it is 40% alcohol solution preparation containing 10-11mg of cycloferon in 1 ml.

Example 4. Prepare the drug, including cycloferon, characterized in that the cycloferon in a concentration of 10 mg/ml diluted in physiological solution 10 times, which corresponds to 12 cycles of breeding. The drug mix by shaking. The resulting preparation of cycloferon in saline solution mixed with alcohol in a ratio of 58.3 ml - 41.7 ml 96% alcohol, making it is 40% alcohol solution preparation containing 10-23mg of cycloferon in 1 ml.

Example 5. Prepare the drug, including cycloferon, characterized in that the cycloferon in a concentration of 10 mg/ml diluted in physiological solution in 1030time, which corresponds to 15 cycles of breeding. The drug mix by shaking. The resulting preparation of cycloferon in saline solution mixed with alcohol in the ratio of 58.3 ml - 41.7 ml 96% alcohol, making it is 40% alcohol solution preparation containing 10-29mg of cycloferon in 1 ml.

Example 6. Prepare medication for any of the at of the above examples 1-5. In a further 0.4 ml of 40% alcohol solution is mixed with 8 grams of bases made from milk sugar. This basis may consist of not less than 30 wafers mass of 0.27 grams. When one wafer mass of 0.27 gram contains 0,013 ml of 40% solution of the drug.

Example 7. Prepare medication for any of the above examples 1 to 5. In a further 0.4 ml of 40% alcohol solution is mixed with 8 grams of bases made from milk sugar. This basis may consist of 200 grains weight of 0.04 gram. One speck of mass 0.04 gram contains 0.002 ml of 40% solution of the drug.

Examples of the method of application.

The patient is prescribed a single dose is not less than 0.25 wafer (0,00325 ml of 40% solution) not more than 1 wafer (0,013 ml of 40% solution of the drug), or 2-8 grains (0,004-0,016 ml of 40% solution of the drug).

Example 1. Single dose given to a patient, is 0.25 wafer (0,00325 ml of 40% solution of the drug).

Example 2. Single dose given to a patient, is 0.5 wafer (0,0065 ml of 40% solution of the drug).

Example 3. Single dose given to a patient, is 1 wafer (0,013 ml of 40% solution of the drug).

Specified in the previous examples for the application of (1-3) single doses are prescribed 1-2 times per day rate from 1-2 weeks to 1-2 months.

PR is measures 4. Single dose given to a patient is 2 grains (0,004 ml of 40% solution of the drug).

Example 5. Single dose given to a patient, is 4 grains (0,008 ml of 40% solution of the drug).

Example 6. Single dose given to a patient, is 6 grains (0,012 ml of 40% solution of the drug).

Example 7. Single dose given to a patient, is 8 grains (0,016 ml of 40% solution of the drug).

Specified in the preceding examples on the method of application (4-7) single doses are prescribed 1-2 times per day rate from 1-2 weeks to 1-2 months.

When using the proposed drug, in which the interferon inducer contained in midget doses, side effects are almost completely eliminated, while therapeutic effect is maintained, which is an obvious advantage produced by the pharmaceutical industry similar to.

The drug is characterized by the fact that it enhances antiviral and antitumor activity of natural killer cells is not less than 1.8 times.

Store the drug in a dry, protected from light place at temperature not above 25°C.

Indications for use.

The drug is used in:

the prevention and treatment of influenza and acute respiratory viral infections.

herpes infection;

chronic viral hepati the Ah, b and C;

cancer prevention.

Sources of information

1. Zhavoronkova A.A., Kudrin A.V. Minerals and natural killer activity// Arch. pathol., 1996, 58, N6, p.65-70.

2. Malygin, A. M., N. Pogodin., Chernyshov PPM, Portfolio VIA Study of antitumor lymphocytes of young and hepatectomized mice of SSNA// Immunology, 1984, N4, p.46-49.

3. Slavina EVGENIY Lymphocytes - natural killer cells (NK cells) - effector cells natural antitumor resistance / Immunology of tumors. M: VINITI, 1984, volume 13, p.98-141.

4. Asea, A., Hansson M, Czerkinsky C., Houze So, Hermodsson S., Strannegard O., Hellstrand K. Histaminergic regulation of interferon-gamma (BFN-y) production by human natural killer (NK) cells// Clin. and exp.hnmunol., 1996, 105, N2, p.376-382.

5. Finkelstein B.B., E.V. Shevchenko Pathomembranons alterations for a decrese the ability of mononuclears to kill oncotransformed cells// Exp.Oncology, 1998, v.20, N1, p48-52.

6. R.B. Herberman, Ortalado J.R., Timonen T., Reynolds CW, Djeu J.Y., S. Petska, Stanton J. Interferon and natural killer (NK) cells. Texas Reports on Biology and Medicine, 1982, vol. 41, p.390-395.

7. Ross, P.S., De Swart R.L., Timmerman H.H., Reijaders P.J.H., Vos J.G., Van Loveren H., Osterhaus A.D.M.E. Supression of natural killer cell activity in harbor seals (Phoca vitulina) fed Baltic sea herring// A quat. ToxicoL, 1996, 34, N1, p.71-84.

8. Schleiter Steven J., Keller, Steven E., Bartlett Jacqueline A., Eckhold Hattan M., Delaney Beveriy R. Immunity in young adults with major depressive disorder// Amer. J.Psychiatr., 1996,153, N 4, R-482.

9. Trinchieri G., Santoli D., D. Granato, Perussia B. Antagonistic effects of interferons on the cytotoxity mediated by natural killer cells. Fed. Proc., 1981, vol.40, p.2705-2710.

10. Yomeda K., Osaki T., Yamamoto T. IL-2 signalling T and natural kiler (NK) cells associated with their class I - non - restricted killing activity// Clin. and exp.hnmunol., 1996, 106, N1, p.179-186.

11. The drug "Cold", tablets, enteric-coated shell 0.15 g per. room: P No. 001049/02-2002.

1. Drug for prophylaxis and treatment of influenza and acute respiratory infections, herpes infections, chronic viral hepatitis b and C and the prevention of cancer, containing cycloferon and characterized in that it contains a physiological solution in the following ratio: 10-29-10-2mg of cycloferon in 1 ml of physiological solution.

2. The method of preparation of a medicinal product according to claim 1, characterized in that the cold serially diluted in physiological solution, with an initial concentration of cycloferon is 1 mg/ml, is applied from 1 to 15 cycles of breeding, and during each cycle cycloferon bred no less than 100 times in saline.

3. The method of preparation according to claim 2, characterized in that at each cycle the solution is stirred by shaking.

4. The method of use of a medicinal product according to claim 1, characterized in that the patient is prescribed a single dose of not less than 0,003-0,013 ml of 40% solution of the drug or not less than 0,004-0,016 ml of 40% solution of the drug.

5. The method of use of a medicinal product according to claim 4, characterized by the fact that these ar okrutny doses are prescribed 1-2 times per day.

6. The method of use of a medicinal product according to claim 5, characterized in that the specified daily dose used in the course of 1 week up to 2 months.

7. The drug according to claim 1, characterized in that it enhances the antiviral and antitumor activity of natural killer cells is not less than 1.8 times.



 

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5 cl, 5 dwg

FIELD: medicine, pharmacology, pharmacy.

SUBSTANCE: antiviral agent comprises aciclovir as an active substance and special additives wherein agent comprises potato starch, talc, stearic acid or stearates as special additives taken in the definite ratio of components. Antiviral agent is made as a tablet. Also, invention relates to a simple method for preparing an antiviral agent and invention provides rapid release of active component. Invention can be used for treatment of skin and mucosa viral diseases induced by herpes simplex virus or herpes zoster virus, and for prophylaxis of these diseases in patients with damage of the immune system.

EFFECT: improved method for preparing, valuable medicinal properties of agent.

4 cl, 1 tbl

FIELD: organic synthesis.

SUBSTANCE: invention provides group of novel antiviral nitrogen-containing compounds, in particular adamantane derivatives having general formula:

, wherein R represents chlorine or ethyl.

EFFECT: increased choice of biologically active compounds suitable for use in medicine as antiherpetic agents.

2 cl, 6 tbl, 3 ex

The invention relates to the field of pharmaceutical industry and relates to pharmaceutical compositions for the treatment of herpes virus infection

FIELD: biotechnology.

SUBSTANCE: claimed strain is obtained by hybridization of epidemic virus with cold adapted and temperature sensitive virus, which represents attenuation donor and is harmless for adults, and infants of 3-14 years old. Said virus makes it possible to obtain reassortant vaccine strains from new epidemic viruses. Strain is effectively cultivated in germinative hen embryos at 32°C, and has temperature sensitivity and cold adaptation. Reassortant has two genes derived from epidemic virus encoding surface proteins (hemagglutinin and neuroamidinase) and six genes derived from attenuation donor encoding non-glycosilated proteins. Strain has no reactogenicity in relation to adults and infants of 3-14 years old at intranasal application.

EFFECT: strain for living influenza intranasal vaccine with good biological properties and reactogenicity.

3 tbl, 2 ex

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