Antiviral and antibacterial "interlatin"

 

(57) Abstract:

The invention relates to medicine, refers to a medicinal product in the form of a solution and can be used in ophthalmology, otorinolaryngology, Pediatrics and gynecology. The tool contains liquid human leukocyte interferon and lysozyme in the following ratio of components: interferon 2500 -5000 IU/ml) and lysozyme 2.5 to 5.0 mg/ml Technical result - the tool has a high storage stability and increases the efficiency in the treatment of viral diseases of broad etiology, reduces the treatment time and the risk of complications. 3 table.

The invention relates to medicine and can be used in ophthalmology, otolaryngology, Pediatrics, gynecology, as well as for treatment and prevention of influenza and acute respiratory viral infections (ARVI).

It is known the use of antiviral and antibacterial drugs in the treatment of influenza, viral diseases of the eyes, skin and mucous membranes and their complications. Of antiviral biological products most widely used drugs-interferon, the principle of which is based on the identification and elimination of alien nucleic acid kiltiernan.-1998.-I. 7.- 1.- C. 16-17]. The interferon system "...puts a barrier at the point of initiation of the foreign nucleic acid. [Soloviev, C. D., Bektemirov T. A. Interferons in theory and practice of medicine - M.: Medicine, 1981; Ershov, F. I. the interferon System in normal and pathological conditions. - M.: Medicine, 1996].

These drugs are available in dry form and after their recovery (dissolved in water) can maintain its activity is not more than a day. To overcome this drawback in the composition of grapperon produced in liquid dosage form with activity 10000 ME, introduced synthetic preservative.

Other natural drug for many years used in ophthalmology, otolaryngology, inflammatory processes other localization is lysozyme (reg. 76/506/6, FS 42-2585-97), which is used as parenterally, or topically in the form of instillation or application as antibacterial and anti-inflammatory agent, stimuliruete reparative regeneration processes and anti-infective organism resistance [Mashkovsky M. D. Medicines, T. 2.- M - 2000.; Instructions for use of lysozyme, appr. FC USSR Ministry of health, 29.03.1991,].

Lysozyme is an enzyme that is a universal natural factor especillay a wide range of valuable biological properties, among which the most important for clinics are immunocorrigirutee (including hyposensitizing), membrane stabilizing, antioxidant actions, the ability to stimulate reparative regeneration and erythropoiesis, correction of the oxygen metabolism and morphofunctional state fugacity lapsed cells (macrophages, neutrophils). Shows part of lysozyme in the regulation of mitotic and metabolic activity of the cells, the induction of the production of immune cells and mediators, such as interferon, interleukins, tumor necrosis factor and others, regulation of plasma proteolysis - correction activity of granulocyte elastase and proteinase [E. Shcherbakov, / / New medicines, M., 1998.- C. 8-18; Shcherbakov, E. G., Rostunova, A., Shcherbakov, I. T. and others) / / ibidem, S. 19-32; A. A. Baranov, V., Dorofeyuk. - Lysozyme: theory and practice.- M - Nizhny Novgorod, 1999.- 128 C.]. Lysozyme is used in the food industry as a preservative and to enhance biological value baby and medical nutrition [E. Shcherbakov, and other Children's milk products enriched with lysozyme (overview)// M: Granitee MMP,1986.-40 C.; p. P. Zakharov, etc. // cheese making, 1999, 3, S. 22-24].

Depletion is a significant deficit of lysozyme was observed in viral diseases of the eye [A. A. Baranov, V., Dorofeyuk.- Lysozyme: theory and practice.- M - Nizhny Novgorod, 1999.].

As the closest analogue accepted tool for the treatment of viral eye diseases, treatment and prevention of influenza - locteron possessing antiviral activity and represents a lyophilized powder containing alpha-interferon purified human leukocyte concentrated 8000 ME in a bottle and lactose as a stabilizer [akushevich Y. E., etc.// V ROS.the NAC.Congress "Man and medicine", M., 1999.- C. 27.]. The use of locteron in viral keratitis provides a good healing of the cornea and reduces infiltration of stroma, reduces recovery time on average 1.9 days compared to other drugs of this series. For prophylactic use in epidemic influenza period locteron significantly reduces the incidence of influenza and ARVI in children and adults. The drug is practically not cause allergies.

However, locteron not effective in the treatment of mixed bacterial-viral infections of different localization and purulent complications of viral diseases. In viral diseases of the eye in 10% of cases locteron proved ineffective. As with other drugs which jenko M. A. // Eye magazine.-1998.- 6.- C. 447-451].

The data analysis indicates the feasibility of introducing into the composition an additional component of the drug, which could enhance the antibacterial effect of interferon, which is manifested in the body by improving the adhesion of microbes and their digestion by macrophages, to compensate for a deficiency of endogenous lysozyme, to mobilize other local factors protect the mucous membrane of the affected habitat, to facilitate correction of cellular and humoral mechanisms of regulation of homeostasis.

The objective of the invention is the creation of highly effective antiviral and antibacterial agents, allowing to obtain more persistent and pronounced therapeutic effect in viral and bacterial and viral diseases.

The essence of the invention lies in the fact that antiviral and antibacterial agent containing the interferon liquid human leukocyte additionally contains lysozyme in the following ratio of components, 1 ml:

Interferon - 2500-5000 IU/ml

Lysozyme is 2.5-5.0 mg/ml

The use of the invention allows to obtain the following technical result:

- to increase effective the organization,

to expedite the normalization of the functional condition of the skin and mucous membranes during viral and bacterial-viral lesions;

- to reduce the risk of destructive complications of keratitis, keratoconjunctivitis, conjunctivitis, stomatitis, laryngitis, traheobronhity viral and viral-bacterial etiology, viral lesions of the skin and mucous membranes, especially in trophic disorders, deficiency of endogenous lysozyme and high anastasopoulou activity;

- reduce the time of treatment of influenza and other acute respiratory infections and their complications secondary immunodeficiencies in children and adults;

to reduce the incidence of influenza and SARS epidemic influenza period of risk for prophylactic use;

- reduce the frequency and severity of, reducing the duration of treatment of bacterial complications of viral diseases of the eyes, skin, mucous membranes and respiratory tract;

- limit the use of antibiotics for prevention of bacterial complications of viral infections;

to avoid loss of activity of interferon in the production process by eliminating the step of drying the product;

to improve Frankopan the economic result is achieved due to the additional introduction of the preparation of lysozyme, which provides compensation of the deficit of endogenous lysozyme, an antibacterial effect, improve the metabolism and functioning of faguoqitirute (neutrophils, macrophages) and immunocompetent cells of the mucous membrane of this biotope, correction of other factors maintain homeostasis, the improvement of reparation, the enhancement of nonspecific anti-infective and anti-toxic resistance of the organism.

The authors first established the new properties of the combination of lysozyme with interferon in the body causing the excess effect of split application of separate components: a pronounced antibacterial effect associated with synergies direct damaging effects of lysozyme on opportunistic microorganisms (table. 1) and indirect (through phagocytes) antimicrobial activity of interferon, as well as with the stimulation of the growth of lactobacilli and bifidobacteria (table. 2), which belong to the most important representatives normoflora principal habitats of the body (mouth, genital, gastrointestinal tract, skin); stabilization of the activity of interferon in the presence of lysozyme during storage of the drug (table. 3).

New tool "Interlatin is expected to release in the glass the ora at the next components in the vial (ml):

Interferon - 5000,0-10000,0 ME

Lysozyme - 5,0-10,0 mcg

Interlatin made as follows.

At the beginning of the process have the human leukocyte interferon from peripheral blood leukocytes using virus-inductor Sendai. After inactivation of the virus interferon subjected to further purification and concentration [Soloviev, C. D., Bektemirov T. A. Interferons in theory and practice of medicine, M. : Medicine, 1981; Avdeeva J. I. , Medunitsyn N. In., Krylov, O. R. and others.... //Immunology. -1987.- 4.- S. 82-85; Kuznetsov, C. P..//Immunology.- 1987.- 4.- C. 30-34. ] . Then the intermediate product is transferred into a sterile container and add under stirring with a solution of lysozyme in water for injection or saline solution (isotonic NaCl) for injection based final concentration of 0.025%to-0.05% (2.5 to 5.0 mg/ml) at 2500-5000 IU/ml of interferon. The filling of the drug is performed in 2 ml sterile vials, sealed and checked for tightness and sterility.

The technological process is carried out in aseptic conditions with implementation of all controls on interferon and lysozyme.

Example 1. To 100 ml of sterile products human leukocyte interferon purified kontsentrirovannoe injection in the amount of 50.0 mg dissolved in 1 series ml of water for injection or isotonic Nad, add in the amount of 0.5 ml of prefabricated interferon and mix thoroughly.

Example 2. To 100 ml of sterile products with interferon activity 2500 IU/ml and a pH of 6.7 add lysozyme to a final concentration of 0.05%. To do this, lysozyme hydrochloride (e.g., the production company "Belovo", Belgium) in an amount of 50 mg dissolved in 1 ml of water for injection or isotonic sodium chloride, then add the entire volume (1 ml) in prefabricated interferon and mix thoroughly.

The proposed tool has high stability and the local application will provide a high efficiency in the treatment and prevention of influenza and acute respiratory viral infections, viral diseases of the eye (herpes keratitis and keratoconjunctivitis, adenoviral conjunctivitis), skin and mucous membranes of different localization (herpes zoster, recurrent aphthous stomatitis, herpetic lesions of the lips, nose, genitalia; bacterial and viral respiratory and other).

Antiviral and antibacterial agent containing the interferon liquid human leukocyte, characterized in that it additionally contains lysozyme in the following ratio of components 1 ml:

Interfere the

 

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