Gel with sulfur and method for the treatment of scabies

 

The invention relates to pharmacy and medicine. The gel contains sulfur as an active ingredient and a hydrophilic base, which is a gel Recoletos acrylic polymer with a sulfur content of 5.0-33.0 weight. %. The composition may additionally contain glycerin or PEO 400, and chloramphenicol as a preservative or a mixture of nipagin and nipazola 3: 1 for the treatment of scabies by drawing on a skin gel once daily for 4-5 days without a change of underwear and bed linen, after which wash it away with warm water and linen change. 2 S. and 4 C. p. F.-ly, 1 table.

The invention relates to pharmacy and medicine and relates to means acaricidal action, which can be used for the treatment of skin diseases, including scabies.

In connection with the migration of the population, an increasing number of patients with immunodeficiencies and other factors in recent years have significantly increased morbidity among the population, including children, parasitic dermatoses, in particular scabies caused cessationism mite Sarcoptes scabiei [Sokolova T. C., Fedorovskaya R. F., Lange A. B. Scabies. - M. Medicine, 1989].

In the treatment of various skin diseases: scabies, psoriasis, seborrhea, is beremennymi requirements requirements protivochesotocnaya drugs are the speed and reliability of acaricide effect, no irritating to the skin, as well as stability during long-term storage. In the concentration used for the treatment of scabies (10-33%), sulfur has a strong keratolytic effect, which promotes better access to the pathogen [Skin and venereal diseases: Guide for physicians. / Edited by Y. K. Skripkin, V. N. Mordovtsev's. - M.: Medicine, 1999. S. 426-436].

Known ointments sulphur simple, sulfur-tar, sulfur-naftalina, ointment of Wilkinson and a number of other [Mashkovsky M. D. Medicines. In 2 hours 12 ed. Ch. II. - M.: Medicine, 1993]. Known more complex sulfur ointment with antipruritic effect. It consists of sulfur, nipagin, nipazol, mink oil, ethyl alcohol, wax emulsion, citral, fragrance, glycerin and water [Patent 2112505 of the Russian Federation, IPC 6 a 61 K 9/06, 33/04, 47/44. Sulphur ointment] . Known drug sulfodekortem - ointment containing sulfur precipitated 10 g, hydrocortisone acetate 0.4 g, medical vaseline, lanolin, stearic acid, etc. to 100 g [Mashkovsky M. D. Medicines. In 2 hours 12 ed. Ch. II. - M.: Medicine, 1993. S. 484]. The ointment is rubbed with a thin layer 2 times a day on Protamine.

All these drugs have a common drawback. Their ointment bases are hydrophobic, preventing gas and to heat the skin and cause allergic reactions, especially in children, their use is often accompanied by complications, mainly dermatitis of varying severity.

As carriers of various drugs widely used hydrophilic copolymers of acrylic acid and a polyfunctional cross-linking agents. Reconstitue acrylic polymers (PMA) produced abroad under the name of carbopol - 934, 940, 941, 2020 and so on, They easily form a viscous and transparent gel. Gels RAP have several advantages over various ointment bases: they provide high bioavailability, prolonging effect and usability, they are not toxic, do not undergo hydrolysis and oxidation, resistant to environmental factors [Bashura, S., Klimenko, O. I., Musco H. N., The Bashura A. G., Lyapunov N. A., Alushin MT Surfactants and high-molecular compounds in pharmaceutical // Medicines. Economy, technology, the prospects of obtaining: a Review. inform. - M.: UNISANTE, 1988. Century 12. S. 52; Overview: Medicine and health // f is zskwu and International Pharmacopoeia under the name "Carbonari".

In recent years, developed domestic reconstitue acrylic polymers - Aresol, Mars, studied the possibility of obtaining gels Aresol and their technological properties. Using Aresol developed a number of drugs [Alekseev, K. C., Lee, C. N., Demichev Century. N. and other Reconstitue acrylic polymers in pharmacy // pharmacy. 1987. 5. C. 15-18; Alekseev, K. C., Starodubova M. C., Sliusar O. I. Respol - new excipient in technology ointments // VII Russian national Congress "Man and medicine": Abstracts. - M. , 2000. S. 598; Astranova M. M., Starodubova M. C., K. Alekseev, I. Elagin A. New drugs have anti-inflammatory actions for external use // VI Congress "Man and medicine": Abstracts. - M., 1999. S. 383; Kudryakov E. A., Moldaver B. L., Marchenko, L. G., Y. Tsvetkov A. Research opportunities gels new domestic Recoletos acrylic polymer "Aresol" // Sat. proceedings of the FIP. So 39. S. 212-217; Mayorov, A. C., K. Alekseev Century, Suslin S. N. Experience using Recoletos acrylic polymer Aresol as part of new dermatological preparations // Mat. scient. are the practice. proc. "Topical issues of cosmetology". - St.-Petersburg, 2000. S. 80].

Closest to the proposed releasewe water/jelly (vaseline 6 o'clock, water 3 hours, emulsifier T-2 1 o'clock) [Mashkovsky M. D. Medicines. In 2 hours 12 ed.H,II. - M.: Medicine, 1993. S. 484]. This drug is characterized by a common ointment on hydrophobic bases disadvantages - after applying ointments often develop dermatitis, eczema in addition, the ointment is characterized by an unpleasant odor that is difficult to remove from skin and stain underwear.

The objective of the invention is to create a new composition acaricidal action on a hydrophilic base, i.e., devoid of the above disadvantages, the expansion of the range of funds for a specified purpose.

The invention is also developing a treatment for scabies using the declared gel.

Tasks are being proposed composition with gray on hydrophilic gel base with RAP when the sulfur content of 5.0-33.0 wt.% and by the way it is applied.

Gelling components are RAP, selected from the group Aresol, Mars, carbopol. As a neutralizing agent contains sodium hydroxide. The composition includes water and optionally prevent drying glycerin or polyethylene oxide (PEO) 400 and as preservatives - chloramphenicol or a mixture of nipagin and nipazola 3:1 in General the following ratio of ingredients, wt. %: sulfur 5,0 who offer 3:1 nipagina and nipazola 0.1 to 0.3; water - the rest.

Treatment of patients with uncomplicated scabies is carried out according to the General method: everyday once rubbing ointment into the skin for 4-5 days without a change of underwear and bed linen, followed by a shower (bath), boiling and a change of underwear and bed linen.

Local application of funds has no allergic effect and does not cause dermatitis. The treatment is virtually disease free.

Gel with sulfur receive the following technology. Aresol (Mars, carbopol) under stirring contribute to the calculated amount of purified water, then add a solution of sodium hydroxide and stirred to obtain a homogeneous transparent gel. Sulfur grind about half the amount of gel, then add parts remaining gel and mixed until a homogeneous mass.

The invention is illustrated by the following examples of completed compositions (see table).

The resulting gels are characterized by satisfactory lubricating properties (nativemenu and extrusion), thixotropic properties, colloidal and thermal stability.

Comparative study of pharmacological effects on Guinea pigs showed no mo is the relevant action prototype - ointment sulfuric simple grease water emulsion base/petrolatum.

The resulting gels with grey hydrophilic on the basis of passing the test in the clinic of skin diseases SPb. State Medical Academy n.a. I. I. Mechnikov (State Medical Academy).

The study included 21 patients with scabies, including 6 children aged 6 to 14 years. Adult patients were used 20% and 10% sulfur ointment on a gel base.

12 patients had contracted scabies for the first time; in 9 patients previously treated in outpatient clinics and ARCS, there was a recurrence of the disease, complicated by dermatitis. In 16 patients was found Sarcoptes scabiei.

Treatment of patients with uncomplicated scabies was carried out according to the General method: everyday once rubbing ointment into the skin for 4-5 days without a change of underwear and bed linen, followed by a shower (bathtub) and a change of underwear and bed linen. At the same time were examined persons in contact with patients, which if necessary also conducted an appropriate treatment.

Treatment of patients with scabies, acute dermatitis, began with the elimination of the medical treatment of dermatitis conventional anti-inflammatory drugs (agitated suspension, indifferent credit adult patients, the first cases of scabies were used 20% sulfur ointment on a gel base immediately after diagnosis. Children used 10% ointment.

All patients tolerated treatment well. In any case, was not observed in dermatological complications, side effects. Clinical manifestations of scabies was resolved after 5-7 days, 6 patients had a so-called posttectonic itching for 6-9 days. Relapses were noted.

Examples of treatment.

1. Patient C., age 38, Builder, he complained of severe itching all skin, especially at night. Himself suggests that he had scabies, which became infected, while in a long trip in Siberia. Not treated. Objectively: the skin lesions become more widespread. On the skin of the body, mainly in the lower abdomen, genitals, back, upper extremities - typical seropurulent elements.

Microscopic examination of the scales of the elements found Sarcoptes scabiei. Treatment 20% sulfuric ointment gel on the basis of the method described above. Already at 3-4 day itching has decreased sharply, and soon stopped. After 7-8 days all cestocide items were resolved. Sick for duhaney well. Dermatological complications were noted. Almost healthy. Family members healthy.

2. Patient J. 37 years, the janitor, had complained of widespread itching, especially in the evening and at night. Sick for about two months. In the ARC at the place of residence was diagnosed with scabies. Simultaneously with her mother ill and her daughter 9 years. Were assigned to the treatment the usual 20% sulfur ointment. Itching gradually decreased, were allowed and cestocide elements. But on day 3-5 of both patients appeared widespread erythematous, scaly items in large folds with phenomena soak. Diagnosed: posttectonic dermatitis. Treatment with sulfuric ointment on the basis of water/vaseline was terminated, assigned antisense funds, calcium gluconate, gadgets in the pockets soak, zinc mash on the skin of the trunk. Gradually phenomenon dermatitis resolved. But after 2 weeks the mother and her daughter reappeared itchy elements on the hands, lower abdomen, genitals.

These phenomena both patients were examined in the clinic of skin disease state medical Academy n.a.Mechnikov.

Diagnosed with a recurrence of scabies (incomplete treatment after the initial treatment), posttectonic resolved dermatitis. the e sulphur ointment in gel base (mother of 20%, and her daughter 10%) by the above method. Itching has decreased by 3-4 day cestocide items were resolved on a 6-7 day. Two control inspections are no manifestations of scabies and its complications were found. A cycle of preventive measures at the place of residence.

Thus, 20% and 10% sulfur ointment, made on a new bezveselniy base containing RAP is very effective protivochesotocnaya tool and is essential (fundamental) advantages compared with the usual 20% sulfur ointment, prepared on the basis that contain petrolatum. According to the observations the new composition of ointments certainly more effective compared with 20% benzyl benzoate emulsion.

Sulphur ointment, hydrophilic on the basis has a number of related advantages: does not have an unpleasant smell, does not stain lingerie, which after use is easily washed using ordinary detergents.

The economic efficiency of a new drug currently defined.

Thus, for the treatment of scabies proposed gel with sulfur-based redkostej acrylic polymer, which has a strong acaricidal action; does not provide irritant and allergic days, colloidal and thermal stability; - easy to use; can be manufactured by the pharmaceutical companies and pharmacies.

As a result of approbation gel and method of its application at the Department of dermatology at Saint-Petersburg state medical Academy.And.And.Mechnikov in the treatment of scabies in adults and children, it was found that treatment of the claimed composition is virtually disease free, has no irritant and allergic action. After applying the gel was not observed occurrence of dermatitis in both adults and children in any case.

Claims

1. Formulated with acaricide action containing sulfur as the active substance and the base, wherein the base is hydrophilic and is a gel Recoletos acrylic polymer, and the sulfur content is 5.0-33.0 wt.%.

2. Composition under item 1, characterized in that the hydrophilic gel base includes redkosty acrylic polymer, sodium hydroxide and water in the following ratio, wt.%:

Aresol, or Mars, or carbopol 0,2-2,0

The aqueous NaOH solution To a pH of 5.0 to 8.0

Water the Rest

3. The composition of p is p>4. The composition according to any one of paragraphs.1-3, characterized in that it further contains the chloramphenicol as a preservative in the amount of 0.25 to 1.0 wt.%.

5. The composition according to any one of paragraphs.1-3, characterized in that it further comprises as a preservative mixture nipagina and nipazola 3:1 in the amount of 0.1-0.3 wt.%.

6. The treatment of scabies by applying to the skin of a composition containing sulphur, wherein said once daily for 4-5 days without a change of underwear and bed linen rubbing the composition according to any one of paragraphs.1-5, after which wash it away with warm water, and linen is changed on decontaminated.

 

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