Treating viral infections

FIELD: medicine.

SUBSTANCE: invention provides a stable composition for treating damages associated with herpes-virus infections in a form specified in creams and gels containing low-level trichloroacetic acid. The amount of trichloroacetic acid makes less than 6% (wt / wt) of the cream or gel.

EFFECT: extending the range of products for treating the damages associated with herpes-virus infections.

25 cl, 3 ex

 

This invention relates to the treatment or control viral infections. In particular, but not exclusively, the invention relates to treatment of viral infections type of herpes, including, in particular, herpes simplex virus I, herpes simplex virus II and herpes zoster.

Man, as such, is a reservoir of the virus of herpes person. In one study it was reported that antibodies to the herpes virus have been detected in 30-37% of College students, 62% of private patients and more than 80% of patients sanitary service. Despite the fact that the virus is maintained as a latent infection in most individuals, the other an acute attack of activated virus comes in different forms and can be caused by various factors, including traumatic factors such as sunlight, menstruation, and family problems. It is believed that herpes virus or bubble versicolor is the herpes simplex I and herpes simplex II is considered to be an agent of genital herpes infection.

Herpes zoster (or simply zoster) causes disease of the skin known as shingles. Is a viral disease characterized by a painful skin rash with blisters in a limited area on one side of the body, often in the form of a strip. Initial infection with the virus in�tranoi pox (VZV) causes the acute, short-lived illness chickenpox and usually occurs in children and young people. At the end of attack of chickenpox the virus is not eliminated from the body and can be maintained, causing shingles, which has very different symptoms, often many years after initial infection.

The varicella zoster virus can become latent in the body nerve cells and less frequently in non-neuronal satellite cells of dorsal root of spinal cord, cranial nerve or autonomic ganglion without causing any symptoms. An individual with a weakened immune system, perhaps several years or decades after infection with chickenpox, the virus may break out of the body of nerve cells and propagate along the axons of nerve cells, causing a viral infection of the skin in the nerves. The virus may spread from one or more ganglia along nerves of an affected segment and infect the corresponding dermatome (area of skin that is represented by one spinal nerve) causing a painful rash. Although the rash usually heals within two to four weeks, some patients experience residual pain in the nerves for several months or years. This condition is called postherpetic neuralgia. Exactly how the virus remains latent in the body and subsequently again encouraged�that, remains unclear.

Worldwide, the annual incidence of herpes zoster ranges from 1.2 to 3.4 cases per 1,000 healthy individuals, increasing to 3.9-11.8 per per year per 1,000 people among those older than 65 years. The antiviral drug treatment can reduce the severity and duration of herpes zoster if a seven-to-ten day course of these drugs within 72 hours after the appearance of the characteristic rash. Amino acid lysine, which is part of the proteins in natural food products, is described in the literature as an anti-herpes agent.

A characteristic feature of herpetic infections is their occurrence in patients for whom it is known that they have an appreciable titer of antibodies to herpes. The presence of antibodies, therefore, does not guarantee protection against acute outbreaks. Method of infection by the herpes virus, apparently, is through direct contact, as may occur between sexual partners, mother and child and even the patient and the doctor.

Oral herpes may take the form of recurrent labeling lesions. Some patients have strong oral lesions that cause significant difficulties during the meal. It has been estimated that up to one third of the population have recurrent poistoperative infection and that more than half of these patients each year has more than one exacerbation. The herpes viruses also cause severe disease in patients with immunological failure, for example, patients with HIV infections and, in particular, in patients undergoing treatment for cancer using drugs with immunosuppressive properties.

Eye herpes and herpes encephalitis are additional forms of infections caused by the herpes virus, requiring longer and more intensive medical attention that does not include the described treatment. Genital herpes, which had a frequency of occurrence, with an estimated 100,000 cases in the U.S. in 1973, 1980, is estimated to affect 30% of the sexually active population. Thus, the problem of herpetic infections is serious and growing.

The present invention describes the application of trichloroacetic acid in the manufacture of a medicine for treatment of viral infections by topical administration of therapeutically effective amounts of a drug to a human or animal in need of treatment.

The prototype composition with trichloroacetic acid was a composition in the form of liquids or thin gels, which are easily washed off after use. The applicant is aware of WO 00/71 105(A2) (Mezzoli) Trichloroacetic acid for the preparation of solutions and/or compositions for the treatment of erosive and/or ulcerative lesions, which is the group�makes closest to the present invention the prior art, known to the applicant. Mezzoli describes the use of aqueous solutions of trichloroacetic acid for the treatment of erosive and/or ulcerative lesions, in which the concentrations of trichloroacetic acid in aqueous solution are in the range of at least 10% to a maximum of 90%, preferably from 10% to 50% and more preferably, about 50%. Mezzoli indicates (see page 5, lines 12 and 13) that the solutions of trichloroacetic acid with concentrations below 30% are unstable and should be used for a very short time. Mezzoli also describes compositions of trichloroacetic acid in alcohol and ether, and indicates that the higher the concentration of trichloroacetic acid, the more active is the solution, the shorter the period of treatment and, therefore, requires a smaller number of local applications during the day. Mezzoli describes the local application, which replaces one to three times a day, and reports that minor aphthous ulcerative lesions disappear within one to three days, and the lesion heals within two to four days. In the case of ulcerative lesions of the AFL from large Mezzoli reports that the pain and signs of inflammation disappear within three to five days, and the lesion heals within seven to eight days. Erosive or ulcerative lesions of the mucosa or of the cutis, subjected to local treatment with liquid� trichloroacetic acid Mezzoli in aqueous solution, or pharmaceutical compositions containing the same, become whitish due to the action of trichloroacetic acid on the lesions and mucous and cutis around the lesions. The action of trichloroacetic acid and of a whitish color due to increase in intensity with increasing concentrations of trichloroacetic acid in aqueous solution or pharmaceutical composition.

The applicant now unexpectedly found that the composition in the form of cream or gel that contains only 5% trichloroacetic acid, is very effective for the treatment of herpetic lesions, despite a widespread belief among doctors that are treating such lesions, the concentration of 5% trichloroacetic acid in the pharmaceutical composition may be ineffective. The results obtained with the composition of the present invention, are, therefore, unexpected, in light of the widespread perception that the formulations containing trichloroacetic acid at low concentration, can be ineffective for the treatment of herpetic lesions.

In accordance with the first aspect of the invention, is provided a stable composition for treating lesions associated with herpes viral infections, the composition, which is a composition in a form selected from creams and gels containing trichloronate�th acid in low concentration, the amount of trichloroacetic acid constituting less than 6% (wt./wt.) masses of cream or gel.

The abbreviation% (wt./wt.)" means the percentage weight of trichloroacetic acid in a given weight of the composition. Under the "low concentration" in the context of this description refers to the concentration of trichloroacetic acid, which is less than 6% and preferably from about 2.5 to 5% (wt./wt.). Under "stable composition" means a composition which is stable at least within 12-18 months. Prototype compositions containing less than 30% trichloroacetic acid were much less stable, with a limit of not more than 6 months.

The amount of trichloroacetic acid can be from about 1% to 5.5% (wt./wt.), preferably from about 1.5% to 5% (wt./wt.) and more preferably, from about 2.5% to 5.0% (wt./wt.). In a preferred embodiment of the invention, the composition is a composition in the form of a cream, and the amount of trichloroacetic acid in the cream is about 5% (wt./wt.). In another preferred embodiment of the invention, the composition is a composition in gel form, and the amount of trichloroacetic acid in the gel is about 2.5%.

The advantage of the compositions according to the invention is�, that a low concentration of trichloroacetic acid allows the composition to remain on the market as the brand-name drug that can be safely used by the buyer and which does not require the introduction with the help of a qualified physician. The second important advantage of the invention is that since the composition is a composition in the form of cream or gel, it can easily and accurately be applied with the defeat. Prototype formulations, such as Mezzoli, are liquid or thin gels, which cannot be accurately applied and which have a tendency to spread, and therefore come into contact with the skin around the lesions. Because these liquids or thin gels have a concentration of trichloroacetic acid, which is much higher than the concentration in the compositions according to the invention, they affect the skin at the site of the lesion, causing a burning sensation and flaking. The composition according to the invention can be placed exactly on the defeat, and it will not spread under the influence of gravity, so that it stays where it is applied in continuation of the treatment. Because of the accuracy of the application and the lack of spreading of the composition according to the invention, generally you need to apply only once, after which the lesion dries up and heals quickly with minimal peeling within 24 to 48 hours. �prototype formulations such as the composition of the Mezzoli require one to three treatments a day for two to four days, and around the lesions there is a significant burning and peeling. The applicant is an expert in the field of the invention and understands that Mezzoli is not successful and can be very painful and uncomfortable process. The applicant also believes that higher concentrations of trichloroacetic acid can be an obstacle for trains from Mezzoli in the sale as patented medicines.

The composition may include pharmaceutically acceptable fillers selected from thickeners, moisturizers (or wetting agents), emulsifying agents, complexing agents and mixtures thereof. Emulsifying agents are the components that contribute to maintaining the stability of the oil and water phases in an emulsion, such as cream.

The thickener may be selected from xanthan gum, oxypropylation the guar resin, magnesium silicate of aluminum, hydroxyethylcellulose and mixtures of two or more of this. The humectant can be selected from propylene glycol, butyleneglycol, petalingjaya, glycerol, sorbitol and mixtures of two or more of these. The emulsifiers can be selected from fatty alcohols, polyethylene glycol esters of fatty alcohols, glycerol� esters of long chain fatty acids, polyethylene glycol esters of long chain fatty acids and mixtures. The complexing agent can be selected from ethylenediaminetetraacetic acid (EDTA), preferably in the form of its sodium salt, tetratriacontane, Ethylenediamine-N,N'-dinternal acid (EDDS) and mixtures of two or more of this.

The fatty alcohol may be an alcohol (C16-C18such as Cetearyl (or cetosteatil) alcohol. Polyethylene glycol ester of fatty alcohol may represent ceteareth-20. Glycerol ester may constitute glicerinstearat. Polyethylene glycol ester may be polyethylenoxide, such as a stearate, PEG-40.

In an embodiment, the composition may contain about 0.5% to 6.0% (wt./wt.), trichloroacetic acid, from about 5% to 15% (wt./wt.) emulsifying agent, from about 0.2% to 1.2% (wt./wt.), xanthan gum, from about 1% to 5% (wt./wt.) propylene glycol and about 0.25% to 0.35% (wt./wt.) EDTA (sodium salt form).

The composition may contain about 0.3% (wt./wt.) EDTA.

In another embodiment of the invention, the composition may contain from 1.0% to 5% (wt./wt.) trichloroacetic acid and can be used in a gel with properties of slow drying.

According �about the second aspect of the invention, provided is a method of treating lesions associated with herpes viral infections, the method comprising topical administration of a stable composition selected from creams and gels, and containing trichloroacetic acid at low concentration, the amount of trichloroacetic acid is less than 6% (wt./wt.) masses of cream or gel, in an amount sufficient to control the infection.

The composition may be a composition as described above.

Viral infection may be a herpes viral infection and may, in particular, infection caused by the herpes simplex I, the herpes simplex II, or shingles.

The applicant found that the drug and the method of the invention are effective in the treatment of lesions of the lips, mouth, gums, genitals, trunk and limbs, when used in the form of a cream. The applicant is aware that a viral infection can be aborted in the early stages by reducing the skin pH to a pH of about 2. The applicant also know that trichloroacetic acid at low concentrations well tolerated by the tissues and the surrounding tissues are not damaged by brief exposure to trichloroacetic acid. Paradoxically, higher concentrations of trichloroacetic acid are known to increase herpes info�functions. The applicant has now determined that all of the herpetic lesions are treatable and can be terminated using songs with trichloroacetic acid, such as cream containing from 1% to 5% trichloroacetic acid, or gel, containing about 2.5% trichloroacetic acid.

For local use, trichloroacetic acid, preferably dispersed in the form of fine powder in a conventional cream base at a concentration from about 0.5% to about 5% (wt./wt.), preferably about 5%. The cream is applied on the skin of affected parts and gently rubbed into the fabric. Applications can be made once or in the case of severe infections, every 12 hours for one to two days. Cream form also can be used for local application intrabuccal and vaginally. The applicant is aware that the herpes virus, you first need to join the receptor on the cell surface before it can penetrate. This requires intracellular alkalizing, and if there is a change of the pH value in the direction of acidosis, the virus will not be able to join and be replicated. This prevents the spread of infection. The applicant believes that low doses of trichloroacetic acid according to the invention act in a manner and provide efficient, convenient and cost-effective treatment of the herpes virus�Oh infection. Changing the pH of the skin caused by local application of acid, is the action responsible for therapeutic effects.

Advantages of the invention can be summarized as follows. The composition according to the invention is, firstly, not the solution, and cream which can be easily and safely used by the end user, while the prototype compositions are liquids that can be used only by qualified doctors. The cream according to the invention does not cause pain and, at most, causes a slight burning sensation, while the prototype composition causes a sharp pain or severely burn and can be extremely uncomfortable. The cream according to the invention is also stable and does not spread, whereas prototype products in the form of solutions or gels easy flow down from the skin surface under the action of gravity and affect the skin adjacent to the lesion being treated.

The cream according to the invention can also be easily Packed in small containers, such as tubes that make it easy to dispense a small amount of cream, then as a prototype formulations generally packaged in bottles, of which the solution is not easy to dose. The cream according to the invention also is not hazardous if it is spilled, whereas prototype formulations are potentially e�ezinye acidic liquid. The skin around the lesion may come into contact with the cream according to the invention, however, due to the low concentration of trichloroacetic acid in the cream surrounding skin is not affected, whereas the prototype formulations injure the surrounding skin and lead to cell death and potentially deep peeling. Because the surrounding skin is protected by its normal surface-barrier properties of the Horny layer (stratum corneum), which is not destroyed by low concentration of trichloroacetic acid, basal cells keratinocytes (growing) layer of the epidermis (upper skin layer) is not damaged, and so the healing process is accelerated. Higher concentrations of trichloroacetic acid, as found for the prototype formulations, destroy the barrier of the epidermis and do possible damage to deeper layers of the growing cells and slow down the healing process.

The cream according to the invention is stable for at least one year and are therefore available in retail stores, whereas the prototype formulations, such as the composition described in Mezzoli are unstable if the concentration of trichloroacetic acid is less than 30%. In addition, the cream is about four to five minutes, whereas for the prototype formulations with a high concentration exposure time of�areeda in seconds. Even if the cream according to the invention is incorrectly used, for example, it stays on the skin for ten minutes, the applicant found that it still doesn't appear to have any harmful effects. If the compositions of the prototypes, such as Mezzoli, used with a "double" exposure on the skin can occur quite serious complications and such exposure may result in the appearance of scars.

The cream according to the invention typically requires only once, after which the lesion dries up and, as a rule, there is no need to use cream in the following days. Prototype formulations require one to three treatments per day until, until the wound heals, and this process takes two to four days. In the healing process of the invention the lesion dries up and only peel off, and in the case of the prototype formulations peeling are an important component of the healing phase. In addition, the cream according to the invention does not require the applicator of a certain type and can easily be applied using a fingertip, while for the prototype structure described Mezzoli, requires a certain type applicator (see, for example, paragraphs 12, 13 and 14 of the claims at Mezzoli).

The invention is now described by means of example with reference to the following Examples.

EXAMPLE 1

In various embodiments, p�implementing the invention, gels or creams were prepared using trichloroacetic acid (from 1% to 5% wt./wt.), complexing agents disodium EDTA or tetratriacontane (from 0.05 to 2% wt./wt.), the emulsifier of glycerylmonostearate (from 0.5 to 10% wt./wt.) or emulsifiers, Cetearyl alcohol, glycerylmonostearate, PEG-40 stearate and ceteareth-20 (1 to 10% wt./wt.), thickener xanthan gum (0.1 to 1% wt./wt.), wetting means propylene glycol (0.5 to 5% wt./wt.) and water (to 100%). Tetratriacontane is commercially available.

For the production of cream, the components were weighed in the balance with a calibrated digital scale. Depending on the size of the batch, for small parties with a mass of individual components up to 3 kg were used Mettler Toledo PB 3002-5, and for large parties used the large scales Mettler. The various components were mixed in stainless steel tanks or plastic buckets.

Xanthan gum and propylene glycol are first mixed to form a paste, and the paste was added to parts of water and thoroughly mixed using a Silverson homogenizer for hydration of xanthan gum. Glicerinstearat and PEG-100 stearate, Cetearyl alcohol, glicerinstearat, PEG-40 stearate and cetearate-20 were weighed and heated on a hot plate at 80°C in a container of stainless steel with a copper bottom. Digital thermometer IP�was oltvai to measure temperature.

Complexing agent, disodium EDTA and the emulsifiers glicerinstearat, Cetearyl alcohol, glycerol stearate, PEG-40 stearate and cetearate-20 was then added to the volume of water at 80°C and homogenized using a Silverson homogenizer at high speed (usually between 50,000 and 60,000 rpm) for 2-5 minutes depending on the size of the batch to obtain the emulsion. The gum was added to the emulsion, and the mixture is homogenized at medium speed (usually about 25,000 rpm) to form a homogeneous material.

The material was left to cool down naturally to <50°C. the Active ingredient is trichloroacetic acid, dissolved in equal quantity of cold water was added during the homogenization, and the average velocity (usually 25000 rpm) until then, until the mixture became shiny.

Example 2

Treatment of herpes I (herpes simplex)

and herpes II (genital herpes)

Affected skin is cleansed and a cream containing 2.5% trichloroacetic acid, prepared as described in Example 1 was used in a small, pea-sized, amount (more for more extensive lesions) to cover the contaminated area. The cream was applied in an amount sufficient to produce a white opaque layer over the defeat. The cream left on the skin for 4 minutes and then washed with water. Lesions significantly izmenyalis� by drying and education in light of a scab. If necessary, the lesion was treated again in the same way, after the 24 hour period.

Example 3

The treatment of herpes zoster

Affected skin is cleansed and a cream containing 2.5% trichloroacetic acid, prepared as described in Example 1 was applied using a soft brush to cover the contaminated area. The cream left on the skin for 4 to 10 minutes, and then washed with water. Lesions were significantly changed by drying. The lesion was treated again in the same way after a 24-hour period. If there has been a slight change in the lesions, and they were uncomfortable, the cream re-applied after 12 hours, and then again after 24 hours. The procedure was repeated daily until it became clear that every loss has stabilized. Typically, herpes zoster would require no more than four days.

1. A stable composition for treating lesions associated with herpes viral infections in a form selected from creams and gels containing trichloroacetic acid at low concentration, the amount of trichloroacetic acid is less than 6% (wt./wt.) masses of cream or gel.

2. A composition according to claim 1, in which the amount of trichloroacetic acid is from 1.0% (wt./wt.) to 5.5% (wt./wt.).

3. A composition according to claim 2, where the composition is �Wallpaper composition in cream form and the amount of trichloroacetic acid in the cream is 5% (wt./wt.).

4. A composition according to claim 2, where the composition is a composition in the form of a gel and the amount of trichloroacetic acid in the gel is 2.5%.

5. A composition according to claim 1, which includes pharmaceutically acceptable excipients selected from thickeners, humectants, emulsifiers, complexing agents and mixtures thereof.

6. A composition according to claim 5, in which the thickener is selected from xanthan gum, oxypropylation the guar resin, magnesium silicate of aluminum, hydroxyethyl cellulose and mixtures of any two or more of these.

7. A composition according to claim 5, in which the humectant is selected from propylene glycol, butyleneglycol, petalingjaya, glycerol, sorbitol and mixtures of any two or more of these.

8. A composition according to claim 5, in which the emulsifier is selected from fatty alcohols, polyethylene glycol esters of fatty alcohols, glycerol esters of long chain fatty acids, polyethylene glycol esters of long chain fatty acids and mixtures of any two or more of these.

9. A composition according to claim 5 in which the complexing agent is selected from ethylenediaminetetraacetic acid (EDTA), salts of ethylenediaminetetraacetic acid, tetratriacontane, Ethylenediamine-N,N'-dinternal acid (EDDS) and mixtures of any two or more of these.

10. Com�azizia according to any one of claims. 6, 7 and 9, which contains from 0.5% to 6.0% (wt./wt.) trichloroacetic acid, from 5% to 15% (wt./wt.) emulsifier, from 0.2% to 1.2% (wt./wt.) xanthan gum, 1% to 5% (wt./wt.) propylene glycol, and from 0.25% to 0.35% (wt./wt.) EDTA (sodium salt form).

11. A composition according to claim 8 in which the fatty alcohol is a Cetearyl alcohol, polyethylene glycol ester of fatty alcohol is ceteareth-20, glycerol ester of long-chain fatty acid is glicerinstearat and polyethylene glycol ester of long-chain fatty acid is a stearate, PEG-40.

12. A method of treating lesions associated with herpes viral infections comprising topical administration of a stable composition selected from creams and gels containing trichloroacetic acid at low concentration, the amount of trichloroacetic acid is less than 6% (wt./wt.) masses of cream or gel, in an amount sufficient to control the infection.

13. A method according to claim 12, in which the composition is a composition according to claim 1.

14. The application of trichloroacetic acid to obtain drugs, which includes less than 6,0% (wt./wt.) trichloroacetic acid for the treatment of lesions associated with herpes virus infections.

15. The use according to claim 14, where the product in�includes from 1.0% (wt./wt.) to 5.5% (wt./wt.) trichloroacetic acid.

16. The use according to claim 15, where the product is in cream form and include a 5% (wt./wt.) trichloroacetic acid.

17. The use according to claim 15, where the product is in gel form and includes a 2.5% (wt./wt.) trichloroacetic acid.

18. The use according to claim 14, where the medication is in the form of stable cream or gel.

19. The use according to claim 14, where the product comprises pharmaceutically acceptable excipients selected from the group consisting of thickeners, humectants, emulsifiers, complexing agents and mixtures thereof.

20. The use according to claim 19, where the thickener is selected from the group consisting of xanthan gum, oxypropylation the guar resin, magnesium silicate of aluminum, hydroxyethyl cellulose and mixtures of any two or more of these.

21. The use according to claim 19, where the humectant is selected from the group consisting of propylene glycol, butyleneglycol, petalingjaya, glycerol, sorbitol and mixtures of any two or more of these.

22. The use according to claim 19, where the emulsifier is selected from the group consisting of fatty alcohols, polyethylene glycol esters of fatty alcohols, glycerol esters of long chain fatty acids, polyethylene glycol esters of long chain fatty acids and mixtures of any two or more of the transferred�granted.

23. The use according to claim 19, where the complexing agent is selected from the group consisting of ethylenediaminetetraacetic acid (EDTA), salts of ethylenediaminetetraacetic acid, tetratriacontane, Ethylenediamine-N,N'-dinternal acid (EDDS) and mixtures of any two or more of these.

24. The use according to any one of claims. 20, 21 and 23, where the product comprises from 0.5% to 6.0% (wt./wt.) trichloroacetic acid, from 5% to 15% (wt./wt.) emulsifier, from 0.2% to 1.2% (wt./wt.) xanthan gum, 1% to 5% (wt./wt.) propylene glycol, and from 0.25% to 0.35% (wt./wt.) EDTA (sodium salt form).

25. The use according to claim 22, where the fatty alcohol is a Cetearyl alcohol, polyethylene glycol ester of fatty alcohol is ceteareth-20, glycerol ester of long-chain fatty acid is glicerinstearat and polyethylene glycol ester of long-chain fatty acid is a stearate, PEG-40.



 

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2 cl, 2 tbl, 2 ex

FIELD: medicine.

SUBSTANCE: therapeutic agent contains recombinant interferon specified in a group of: recombinant interferon alpha, recombinant interferon beta, recombinant interferon gamma, metronidazole, fluconazole and/or voriconazole, and a pharmaceutically acceptable base in the following proportions, g per 1 ml of the mixture: recombinant interferon, international units 100-10,000,000; metronidazole 0.00001-0.5; fluconazole and/or voriconazole 0.00001-0.5; pharmaceutically acceptable base - the rest. Besides, the therapeutic agent contains boric acid in an amount of 0.00001-0.5 g and hypromellose in an amount of 0.00001-0.5 g. As a pharmaceutically acceptable base, it contains macrogol 400 or macrogol 1500, or macrogol 4000.

EFFECT: higher efficacy of the compound.

2 cl, 5 ex

FIELD: medicine.

SUBSTANCE: invention represents an antibacterial pharmaceutical composition containing clotrimazole, propylene glycol, macrogol 400, macrogol 1,500, macrogol 4,000, poloxamer 338, cetostearyl alcohol, macrogol 20 cetostearyl alcohol, disodium edetate, purified water with the ingredients of the compositions taken in certain proportions, g/100 g.

EFFECT: higher antibacterial and antifungal action.

3 cl, 3 dwg, 5 tbl

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to the pharmaceutical industry and represents a therapeutic agent used for treating or preventing palmar-plantar erythrodysesthesia syndrome (PPES) induced by a multifunction kinase inhibitor (MKI) therapy and containing a therapeutically effective amount of allopurinol or its pharmaceutically acceptable salt.

EFFECT: invention provides extending the range of products for treating or preventing palmar-plantar erythrodysesthesia syndrome (PPES) induced by the multifunction kinase inhibitor (MKI) therapy.

21 cl, 5 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to pharmaceutics and represents a vaccine composition for inducing an immune response in animals. The composition contains an antigen and a 40% oil-in-water emulsion diluted to 2.5%, wherein the above 40% oil-in-water emulsion contains 30 vl/vl % of light hydrocarbon non-metabolic oil, 10 vl/vl % of lecithin, 0.6 vl/vl % of sorbitan monooleate, 1.4 vl/vl % of polyoxyethylene sorbitan monooleate; the oil component is dispersed in an aqueous component by emulsification, while the vaccine composition is prepared by a microfluidiser. An average drop size in the composition makes less than 0.3 mcm.

EFFECT: composition possesses improved physical characteristics, enhanced immunising action, as well as high safety.

10 cl, 20 ex, 17 tbl, 11 dwg

FIELD: medicine.

SUBSTANCE: as an active substance, the composition contains butoconazol, a base that is a combination of a hydrophobic ingredient, a hydrophilic ingredient and an emulsifier, and also a gel-forming polymer. Hydroxypropylstarch phosphate is preferentially used as the gel-forming polymer. A method for preparing the declared composition consists in the fact that a mixture of butoconazol with a portion of the hydrophilic ingredient, the hydrophobic ingredient and emulsifier is added with a dispersion of the gel-forming polymer in the rest of the hydrophilic ingredient; the produced mixture is agitated homogenously with a preserving agent added where it might be necessary.

EFFECT: new pharmaceutical composition is characterised by a high level of antifungal activity, stability both at a storage temperature, and at a use temperature, and good pack extrusion.

14 cl, 2 tbl, 10 ex

FIELD: medicine.

SUBSTANCE: composition contains tacrolimus as an active substance in a therapeutically effective amount, a hydrophobic ingredient, a hydrophilic ingredient, an emulsifier and a stabiliser - disodium edentate and phenoxyethanol. As tacrolimus, the composition contains tacrolimus monohydrate. The composition contains phenoxyethanol in a combination with ethylhexyl glycerol in a ratio of 9:1. The composition is presented in the form of a semi-solid dosage form.

EFFECT: formulation is characterised by stability, uniform distribution of the active substance, usability and good pack extrusion.

6 cl, 2 tbl

FIELD: medicine.

SUBSTANCE: invention represents a drug for treating osteoarthrosis presented as a soft dosage form, containing glucosamine and methyl salicylate as active substances, and additive agents.

EFFECT: enhanced anaesthetic action and lower toxicity of methyl salicylate.

10 cl, 1 tbl, 4 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to chemical-pharmaceutical industry and represents a composition for treating anal fissures in the form of a hydrous gel, containing an active compound in the form of isosorbide dinitrate, a gelation agent, a neutralising agent and a solvent differing by the fact that the composition contains triethanolamine as the neutralising agent taken in equal proportions with the gelation agent which is presented by a lightly crosslinked polymer; the solvent is presented with a mixture of polyethyleneoxide and ethanol in ratio 5-6:1:3-4 with the ingredients of the composition taken in certain proportions, wt %.

EFFECT: invention provides higher clinical effectiveness and reduced length of treatment.

3 ex, 2 tbl

FIELD: chemistry.

SUBSTANCE: claimed is application of fat emulsion for parenteral feeding as solvent for compounds which are poorly soluble in water. Fat emulsion contains in 1 l of solution: 30 g of refined soybean oil, 30 g of triglycerides with the average chain length, 25 g of olive refined oil, 15 g of purified fish oil.

EFFECT: obtaining solvent for compounds, poorly soluble in water, which makes it possible to determine parameters and spectrum of biological activity of novel compounds of chemical nature at the stages of pre-clinical and clinical tests, which does not change basic biological constants and possesses biological inertness.

2 tbl, 2 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to medicine, particularly to a method for ferrocene encapsulation characterised by the fact that a microcapsule coating is carrageenan, whereas a non-solvent is ethanol when producing microcapsules by physical-chemical non-solvent addition.

EFFECT: implementing the invention enables simplifying and accelerating the process of encapsulation and increasing weight yield.

7 dwg

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