Pharmaceutical composition for treating trophic ulcers and persistent wounds of various origins in form of ointment

FIELD: medicine.

SUBSTANCE: pharmacological composition contains a therapeutic agent and a pharmaceutically acceptable base. As a therapeutic agent, it contains recombinant interferon specified in a group: recombinant interferon alpha, recombinant interferon beta, recombinant interferon gamma, as well as hypromellose, boric acid as an antiseptic, anesthesin or lidocaine as local anaesthetics in the following proportions, g per 1 ml of the mixture: recombinant interferon, IU 100-10,000,000, hypromellose 0.00001-0.5, boric acid 0.00001-0.5, anesthesin or lidocaine 0.00001-0.5, a pharmaceutically acceptable base - the rest. Besides, the pharmaceutical composition contains heparin in an amount of 0.00001-0.5 g; antibiotics specified in a group of: baneocin, levomycin, tetracycline, amoxicilline in an amount of 0.00001-0.5 g. And as a pharmaceutically acceptable base, the pharmaceutical composition contains macrogol 400, or macrogol 1500, or macrogol 4000.

EFFECT: more effective treatment.

4 cl, 9 ex

 

The invention relates to medicine, namely to the composition of ointments for the treatment of venous ulcers and nonhealing wounds of different etiology.

Widely known ointments for the treatment of venous ulcers and nonhealing wounds (Mashkovsky M. D. Medicines, M, Medicine, 1982, T. 2, S. 46-52, 60, 474, 475, 417, 471; Pokryshkin A. C. Alisol - new healing tool, e-And Minneapol, 1982, 36; RU 2169004 C1, 2001; EN 2146922 C1, 2000; EN 2221550 C1, 2004, EN 2221550 C1, 2004).

Known topical wound healing compositions on various body basics - fats, lanolin, waxes, vaseline, grease and other (Kogan, J. Technology of medicinal forms, Medgiz, 1992, S. 209-244; Reference pharmacist, M, Medicine, 1973, S. 63).

Closest to the claimed invention is an ointment for the treatment of venous ulcers, containing the active substance in a hydrophilic base, where the active substances are used emoxipin, and the hydrophilic base contains polyethylene oxide in the following ratio, wt.%: the emoxipin 1-2; hydrophilic emulsion base: polyethylene oxide 400 10-30; emulsifier N 17-8; castor oil 15-30; preservative 0.1 to 0.2; purified water rest. (EN 2058775 C1, 1996).

General shortcomings described above and others known and used in modern medicine ointments is that they do not allow for effective treatment of all studies is the treatment of venous ulcers and prolonged non-healing infected wounds.

The objective of the invention is to provide a highly effective ointment that has both anti-inflammatory, regenerative and reparative action, which allows to treat sores and nonhealing wounds of various etiologies, without causing allergic reactions.

The technical result, which directed the establishment of this invention is to increase the efficiency of treatment of patients with trophic ulcers and nonhealing wounds, reduction of treatment time by using the combined tools, can increase the activity of the action, and the prolongation.

The technical result is achieved by the fact that the pharmacological composition for the treatment of venous ulcers and nonhealing wounds of different etiology in the form of ointments containing the drug and a pharmaceutically acceptable basis, according to the invention as a medicine contains recombinant interferon selected from the group: recombinant interferon-alpha, interferon-beta, interferon-gamma, hypromellose, boric acid as an antiseptic agent benzocaine or lidocaine as a local anesthetic in the following ratio of components in g per 1 g of a mixture of:

recombinant interferon, ME100-10000000
hypromellosewithin 0.00001 to 0.5
boric acidwithin 0.00001 to 0.5
benzocaine or lidocainewithin 0.00001 to 0.5
pharmaceutically acceptable baserest

In addition, the pharmaceutical composition comprises heparin in number within 0.00001 to 0.5,

In addition, the pharmaceutical composition comprises an antibiotic selected from the group: baneuoqin, limitin, tetracycline, amoxicillin in number within 0.00001 to 0.5,

In addition, the pharmaceutical composition comprises a pharmaceutically acceptable bases macrogol 400, or macrogol 1500, or macrogol 4000.

Spent an 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 pharmaceutical compositions, has allowed to establish that the petitioners have not found a similar, characterized by signs, identical to all the essential features of the claimed means.

The definition from the list of identified unique prototype helped identify the set of essential in relation to perceived technical result of the distinctive features in the claimed pharmaceutical compositions set forth in the claims.

Therefore, the claimed pharmaceutical composition meets the criterion of “novelty.”

For verification of the compliance of the pharmacological compositions of the prior art, the applicants conducted an additional search of the known solutions to identify signs that match the distinctive features of the prototype of the characteristics of the claimed invention.

The search results showed that the claimed invention not apparent to the expert in the obvious way from the prior art, certain applicants have identified no impact envisaged the essential features of the claimed pharmaceutical compositions of 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 pharmaceutical composition that has both anti-inflammatory, regenerative and reparative action, allows to treat sores and nonhealing wounds of various etiologies, increases the efficiency of treatment of patients with trophic ulcers and nonhealing wounds, reduces treatment time by using the combined tools, can increase the activity of the action, and the prolongation.

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

Example 1. For the manufacture of a pharmaceutical composition mixed with recombinant interferon-alpha, hypromellose, boric acid, benzocaine and macrogol 400 in the following ratio of components in g per 1 g of a mixture of:

Options:1234
recombinant interferon-alphaME 1001000010000010000000
hypromellose0,000010,00010,0010,5
boric acid0,50,0010,00010,00001
benzocaine0,0010,010,000010,5
macrogol 400rest

Example 2. Carried out analogously to example 1, except that use of recombinant interferon-beta, lidocaine and macrogol 1500.

Example 3. Carried out analogously to example 1, except that use of recombinant interferon-alpha, interferon-gamma and macrogol 4000.

Example 4. Carried out analogously to example 1, except that use of recombinant interferon-gamma, macrogol 1500, and lidocaine.

Example 5. Carried out analogously to example 1, except that use of recombinant interferon-alpha, interferon-beta and heparin in number within 0.00001 to 0.5,

Example 6. Carried out analogously to example 1, except that the use of antibiotics, selected from the group baneuoqin, limitin, tetracycline, amoxicillin in number within 0.00001 to 0.5,

Example 7. Patient Z., 48 years of age, was treated in MBUS GKB №18, Ufa in 2013 with a diagnosis of Venous wound right leg. Diabetes mellitus type 1, severe. Micro-macroangiopathy. Hypertension II stage, I phase, risk 3. Sick for the last 3 years. Size of the wound 6×7 cm on the rear surface of the lower third of the right tibia. The Department conducted vascular therapy and bandaging the use of a pharmaceutical composition as in example 1. Headbands with the claimed ointment did not cause pain. After 2-3 applications there has been a marked improvement: decreased swelling and redness of the tissue. On the 4th day was stopped inflammation. The proposed composition is easily carried without allergic reactions in hospitals and polyclinics.

Conducted autodermoplasty split mesh flap 1:2 60 cm2. Continued bandaging with a thin layer of the claimed ointment. On the 12 days of engraftment in full. Was discharged in good condition.

When examining a patient after 2 months there was no recurrence of sores.

Example 8. Patient K., 50 years of age, was treated in MBUS GKB №18, Ufa in 2013 with a diagnosis of a nonhealing wound of the left tibia. The consequences of injuries sustained in a traffic accident. Sick for the last 2 months after discharge from the trauma of separation, were outpatients. Size of the wound 3×5 cm on the anterior surface of the lower third of the left tibia. The Department conducted vascular, symptomatic and physical therapy and bandaging using pharmacological compositions of examples 2 and 6. There was good tolerability ointment without allergic reactions. On the 3rd day was stopped inflammation. In the process of treatment and bandaging the wound decreased in two times. In a number of the time reduced the terms of reparative and regenerative processes.

Complete wound healing was carried out in the period from 7 to 14 days. Nonhealing wound of the left tibia completely epithelials. Was discharged in good condition.

Example 9. Patient I., 52 years of age, was treated in MBUS GKB №18, Ufa in 2013 with a diagnosis of Trophic and nonhealing wound right leg and foot. Sick for the last 2 years. Size of the wound 3×4 cm on the rear surface of the lower third of the right tibia, the area of the wound on the right foot 1×2, see the Department conducted vascular therapy and bandaging using pharmacological compositions of examples 3 and 4. There was good tolerability ointment without allergic reactions. On the 3rd day was stopped inflammation. After autodermoplastiki split mesh flap 1:2 with a total area of RAS 40 cm2continued bandaging with the proposed pharmacological composition. In the process of treatment and bandaging the wound decreased in two times. Several times reduced terms of reparative and regenerative processes.

Complete wound healing was carried out in the period from 10 to 15 days.

Was discharged in good condition on the 20th day from the date of admission.

When examining a patient after 3 months there was no recurrence of ulcers and long-unhealed wounds right leg and foot.

We offer the song easily applicable in hospitals and polyclinics.

Thus, the claimed pharmaceutical composition for the treatment of venous ulcers and nonhealing wounds of different etiology in the form of ointment is highly effective, has both anti-inflammatory, regenerative and reparative action. The claimed tool increases the efficiency of treatment of patients with trophic ulcers and nonhealing wounds, reduces treatment time and does not cause allergic reactions.

1. Pharmaceutical composition for the treatment of venous ulcers and nonhealing wounds of different etiology in the form of ointments containing the drug and a pharmaceutically acceptable base, characterized in that as a medicine contains recombinant interferon selected from the group: recombinant interferon-alpha, interferon-beta, interferon-gamma, and also contains hypromellose, boric acid as an antiseptic agent benzocaine or lidocaine as a local anesthetic in the following ratio of components in g per 1 g of a mixture of:

recombinant interferon, ME100-10000000
hypromellosewithin 0.00001 to 0.5
boric acidwithin 0.00001 to 0.5
benzocaine or lidocainewithin 0.00001 to 0.5
pharmaceutically acceptable baserest

2. The pharmaceutical composition under item 1, characterized in that it contains heparin in number within 0.00001 to 0.5,

3. The pharmaceutical composition under item 1, characterized in that it contains antibiotics, selected from the group baneuoqin, limitin, tetracycline, amoxicillin in number within 0.00001 to 0.5,

4. The pharmaceutical composition according to paragraphs.1-3, characterized in that as a pharmaceutically acceptable bases contains macrogol 400, or macrogol 1500, or macrogol 4000.



 

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