For the treatment of cutaneous lesions in patients with diabetes mellitus

 

(57) Abstract:

The invention relates to medicine, namely to dermatology. The proposed tool contains superoxide dismutase, emulsifier, wetting agent, a mixture of vegetable oils including wheat germ oil, preservative, water, Agidol, the odorant at a certain content of components. The tool has a high activity and harmless to use. 4 C.p. f-crystals, 1 table.

The invention relates to the field of medicine and relates to funds intended for the treatment of cutaneous lesions in patients with diabetes mellitus 1-St and 2-nd type.

Diabetes mellitus is one of the most common endocrine diseases affecting people of all ages and causes severe disability. According to who, the prevalence of diabetes among the population is under 5%.

Diabetes is quite common skin lesions, and microscopic changes they can reach 100%. The severity of lesions can be both moderate and fatal. Skin manifestations can take place and with good control of diabetes. In addition, they can be harbingers of yet undiagnosed diabetes /Haroon T. S. Diabe, associated with all organs and systems of the body. The disruption of the latter causes the violation of certain functions of the skin, which is manifested in various skin lesions. On the other hand, the skin is constantly exposed to various environmental factors that affect the development of such lesions.

Vascular complications represent the most severe complications of the underlying skin pathologies in patients with diabetes mellitus. Emerging diabetes micro - and macroangiopathies cause diabetes dermatopathy and diabetic necrobiosis lipoidica, granuloma, robes, redeployable erythema.

Typically, for the treatment of dermatopathy appoint agents, improving blood circulation by removing spasm of peripheral vessels and normalizes microcirculation and hemicircular improving lipid metabolism: lipoic acid, b vitamins, nicotinic acid, parmidin, etamzilat etc. When necrobiosis full clinical recovery occurs very rarely. Known methods of treatment are anti-inflammatory therapy, for example, corticosteroid ointments, anticoagulant therapy, for example, heparin is tion only suspend further spread of the disease.

Skin infections in individuals with good control of diabetes occur more frequently than healthy. However, such infections in patients with diabetes mellitus flow harder and harder treated. At the present time to treat them use adequate antibiotic therapy and surgical intervention.

Skin lesions in diabetes mellitus may be due to neurological complications and are manifested in the form of numbness in the fingers, loss of softening functions soles of the feet, hyperhidrosis of the upper half of the body and dryness of the skin of the lower half.

Diabetes revealed a tendency to thickening of the skin, which is probably connected with the non-enzymatic glycosylation of collagen. The hardening of the skin usually detected in patients with non-insulin-dependent diabetes are overweight. In some cases, the diabetes control improves, but currently effective ways of treatment scleredema diabetes does not exist.

Relatively rare diabetic bullous lesions (blisters). A symptomatic therapy. However, effective methods of treatment of these lesions has not to date with metabolic disorders, their treatment was associated with treatment of these disorders. For example, it was suggested that local application of insulin /WO 8505036 A1, 21.11.1985, A 61 K 37/36/. However, this tool is not efficient enough and can be used for a limited number of lesions.

Compared with the above means the ability to treat a broader range of diabetic dermatological diseases were observed for derivatives aryloxyalkanoic acid /US48771752 A, 03.10.1989, A 61 TO 31/235/. However, the tool is not sufficiently effective and safe in long-term use.

Thus, until the present time the problem of treatment and prevention of skin lesions in diabetes remains one of the urgent problems of modern dermatology.

The aim of the present invention is the creation of new and more effective means of treatment and prevention of skin lesions in patients with diabetes.

This goal is achieved by using the composition of the following composition, wt.%:

superoxide dismutase - 0,01-0,05

emulsifier - 2-8

Agidol - 0.2

vegetable oil, including wheat germ oil - 3-8

preservative - 0,3-1

odorant - 0.2

moisturizing AG is tion of vegetable oil.

Analysis of scientific-technical and patent literature in this area revealed no sources describing a set of data characteristics, and the proposed solution is not obvious to a person skilled in the prior art, therefore, it meets the criteria of the invention of "novelty" and "inventive step". The present invention can be used in medicine and cosmetology, therefore, it meets the criteria of the invention "industrial applicability".

The proposed tool has a high pharmacological activity and are less toxic than those used in this part means. It can be used for lesions of varying severity, including patients with persistent long lesions.

Active basic components of the proposed compositions are superoxide dismutase and wheat germ oil.

Superoxide dismutase (SOD) is an enzyme inactivating superoxide anion radical, which represents the oxygen atom with the adjacent unpaired electron that enters into a chemical reaction with the formation of harmful free radicals. Free radicals have ZMA, including nucleic acids, proteins, fats. When it affects the cell membrane, leading to cell death. The normal processes of free radical oxidation are regulated antioxidant system, which consists of enzymes - catalase, peroxidase, superoxide dismutase and glutathion reductase.

SOD is a natural antioxidant and can be obtained from various natural sources of human tissues and biological fluids, bacteria and plants, such as sprouted barley, spirulina, legumes and cereals, as well as by genetic engineering. The last source is the most appropriate because it allows to obtain recombinant SOD person closest to the body and at the same time not perceived them as an antigen. Superoxide dismutase represent the whole family, including Cu, Zn-SOD, Mn-SOD, Fe-SOD, Cu. According to the invention may use any SOD, but most preferably the use of recombinant human Cu, Zn-SOD person, obtained from Baker's yeast.

Previously it was assumed that SOD may be imposed only in the form of liposomes or polymers /Michelson A. M. Pharmacological note is AB, refuting conventional wisdom.

The wheat germ oil is also a natural antioxidant. In addition, the introduction of it in combination with other vegetable oils allows to obtain the required moisture level of the skin. This aspect is very important because in case of diabetes, there is increased skin dryness.

Introduction to the composition of the emulsifier is necessary because as topical preparations (creams, or), namely stability, consistency, uniformity, etc. largely depend on his presence. As emulsifiers may be used esters of high molecular weight alcohols and higher fatty acids such as stearate PEG-400, oleate PEG-400, sorbifolia and emulsion waxes, phosphate oleate, ethylene glycol. When the oil content of from 3 to 8% by weight of the emulsifier is contained in an amount up to 8% by weight of the composition. The best effect is achieved by using as the emulsifier of the following composition in wt.% the total weight of the cream: stearic acid 2-5, triethanolamine 0.2 to 1, emulsion wax 2-5.

As a vegetable oil vehicle may contain various used in pharmacy and cosmetics oils, such as olive, poda is such.

As a moisturizing agent, the introduction of propylene glycol, glycerol, urea. Most preferably the use of glycerol in the amount of 1-5% by weight of the composition in combination with urea, taken in an amount of 0.2-0.5% by weight of the composition.

The introduction of odorants is possible to make certain marketable qualities, but not necessarily. Can be used, for example, aromatic oils, such as peppermint, lemon, geranium, etc.

Below are examples of compounds of the proposed tools.

Example 1

Superoxide dismutase - 0,03

Stearic acid - 3,3

Emulsion wax - 3,3

Triethanolamine - 0,4

Agidol - 0,2

The wheat germ oil - 0,15

Sunflower oil - 4

Nipagin - 0,3

Glycerol - 2

Urea - 0,2

Oil of lemon - 0.02

Water - the rest

Example 2

Superoxide dismutase - 0,05

Sorbifolia - 3

Emulsion wax - 2

Olive oil - 3

The wheat germ oil - 0,15

Nipagin - 0,1

Nipazol - 0,3

Glycerin - 5

Water - the rest

Example 3

Superoxide dismutase - 0,03

Stearic acid - 2,7

Triethanolamine - 0,3

Emulsion wax - 5,0

Agidol lepicol - 1

Peppermint oil - 0,05

Water - the rest

The tool has a uniform creamy consistency, easy to apply and does not cause discomfort when applied to the skin.

The proposed tool has been tested in clinical practice. The test results obtained when used in patients with diabetes mellitus 1-St and 2-nd type in the month, are shown in table 1.

As can be seen from the table, despite the short duration of the drug, it is effective and can be recommended in clinical practice.

1. For the treatment of skin lesions in patients with diabetes, characterized in that it contains superoxide dismutase, emulsifier, wetting agent, preservative blend of plant oils including wheat germ oil and water in the following ratio, wt.%:

Superoxide dismutase - 0,01 - 0,05

Emulsifier - 2 - 7

A mixture of vegetable oils including wheat germ oil - 3 - 8

Preservative - 0,3 - 1

The moisturizing agent is 0.2 - 5

Water - the Rest

moreover, the oil content of the wheat germ is 3 - 5% of total vegetable oil.

2. Means under item 1, ot, characterized in that it additionally contains the odorant in the amount of up to 0.2 wt.%.

4. A tool according to any one of the preceding paragraphs, characterized in that it contains as a wetting agent glycerine in amounts of 1 to 5 weight. % and/or urea in a quantity of 0.2 - 0.5 wt.%.

5. A tool according to any one of the preceding paragraphs, characterized in that it contains as an emulsifier mixture of 2 - 5% wt. stearic acid, 2 to 5 wt.% emulsion of wax and 0.2 - 1 wt.% triethanolamine taken based on the total weight of the components.

 

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FIELD: medicine, pharmacology, pharmacy.

SUBSTANCE: invention relates to the agent comprising the following components: lidazum (16-32 U), proserinum 0.05% solution, 0.00025-0.0005 g; methylprednisolone succinate sodium, 0.02-0.04 g; lidocaine 10% solution, 0.05-0.1 g, and glucose 40% solution, 3-4 ml. Also, invention relates to a method for administration of agent and a method for treatment of inflammatory diseases. Invention provides expanding assortment of medicinal agents and improving the regional transport of medicinal preparations.

EFFECT: improved and valuable properties of agent.

6 cl, 5 ex

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