BG1650U1 - Means for skin treatment - Google Patents

Abstract

The means is applied for dermatological diseases treatment and prophylaxis. It represents gel or cream and contains as active ingredient dry extract from the roots of Saponaria officinalis from 40 to80 % of weight, with suitable for the aim cosmetics or pharmaceutics vehicle.

Description

The use of a therapeutic soap opera (Saponaria officinalis L.) is known, but in combination with other medicinal drugs in the form of an aqueous solution for eczema. / N. Churolinov, Phytotherapy in Dermatology and Cosmetics, Sofia, 1976, 44 /. Also known are shampoo and lotion with regenerating scalp containing Saponaria officinalis, but also in combination with other medicinal plants and biologically active substances / FR 1443889 /.

A skin treatment, in the form of a healing gel or cleansing cosmetic cream, has been developed for the treatment and prevention of eczema, keratosis, psoriasis, lichen, and others, containing as an active ingredient a dry extract of the roots of a healing soap / Saponaria officinalis L. / , in an amount of from 40 to 80% by weight, together with a suitable pharmaceutical vehicle.

The vehicle contains gel-forming agents or oily components and emulsifiers such as Carbapol-400, liquid paraffin, petroleum jelly, preservatives nipagin and nipazol, moisture-retaining factor PEG 400 or glycerin, distilled water, perfume composition and others.

The therapeutic form of the agent as a gel is applied externally by smearing the skin 2-3 times a day. The cosmetic form, which is a cream like M / B emulsion, is applied as a skin cleanser in the morning and evening.

The active ingredient is obtained by aqueous-alcoholic extraction of the roots of Saponaria officinalis L., in a ratio of 1 part of the roots of the soap to 3 parts of ethyl alcohol 96% to 3 parts of water. The extract was concentrated and dried in a spray dryer. The dry extract thus obtained is standardized on the sapogenins content.

The active ingredient of the agent, dried root extract of a healing soap, is applied in the form of gel or cream in the amount of 40 to 80% by weight. The tool is comfortable for skin treatment, has a well-curative and prophylactic effect. In the dosage used, the dry extract is practically non-toxic as opposed to the aqueous extract of the plant, which is toxic in overdose and internal administration. Preparing the finished gel and cream forms is easy and convenient.

The following examples illustrate the utility model without limiting its possible implementation forms.

Example 1. Composition of gel in g:

Dry extract of curative roots soap (Saponaria officinalis) 70,00 Carbopol 940 0.70 Nipagin 0.07 Range 0.03 Sodium hydroxide 0.28 Glycerin 20,00 Distilled water up to 100.00 The gel is packed into suitable tubes and

it is used to treat eczema, lichen, keratosis, psoriasis and other dermatological diseases by smearing 2-3 times a day on the diseased skin area.

Example 2. Composition of cleansing cosmetic cream for prophylactic skin treatment eg:

Dry root extract of curative with Apunice (Saponaria officinalis) 40, 00 Emulsifier AM 1/3 MD 2.00 Lanewax 2.00 Polyethylene glycol 400 3.00 Nipagin 0.35 Range 0.35 Liquid paraffin 10,00

Vaseline25,00

Perfume composition0.30

Distilled water17.00

The oily components melt in a water bath. The aqueous phase, with the preservatives dissolved therein, PEG 400 and the perfume composition, is heated to the temperature required for emulsification. The oily phase emulsifies the dry extract of therapeutic soap. Emulsifiers are added and the two phases are emulsified.

The cosmetic cream is used as a skin cleanser with prophylactic action.

Example 3. The active ingredient of the utility model was obtained by water-alcohol extraction of dry roots of Saponaria officinalis in a ratio of 1 part of dry roots to 3 parts of ethyl alcohol 96 degrees to 3 parts of distilled water, followed by concentration and spray drying.

The product thus standardized with respect to the content of sapogenins has an anti-inflammatory and keratological effect.

Characteristics of the dry extract of therapeutic soap.

Appearance fine dust Color light brown The smell specific Response of 10% aqueous suspension (pH) A in V Loss on drying no more by 7% Content heavy metals no more by 0.01% Foaming agent ability not less by 15% Content of sapogins (such as oleanolic acid) not less by 14% Microbial content in pcs / g Total number of microorganisms- we - no more from 10 to a third Molds and mushrooms no more

from 10 to two

Example 4. Toxicity tests of the dry extract and the finished form.

The acute toxicity of the preparation in the form of a gel and of the dry extract of the roots of the therapeutic soap, which is a pharmacologically active ingredient of the preparation, has been determined.

Studies were performed on two animal species: Wistar rats and guinea pigs. Mortality in treated animals and changes in survivors' behavior up to the seventh day after single administration of test substances were monitored.

Overall toxicity was investigated by oral administration of the dry extract in 5 successively increasing doses of 500 to 5,000 mg / kg body weight.

The gel preparation and the soapy extract were tested for acute toxicity in rats and the dermal route of treatment, and the application was performed on a depilated area of the back of animals about 9 square cm in size at increasing doses.

The data obtained indicate that the soap extract is toxic when administered intraperitoneally (LD ₅₀ = 96.36 mg / kg). These results are consistent with the literature data for a high hemolytic index of saponins in therapeutic soap.

The oral and dermal route of administration of all doses used in both animal species did not lead to mortality and apparent toxicity, demonstrating that the dry soap extract and the gel and cream preparations containing this extract were practically non-toxic in oral and dermal route of administration.

Example 5. Results of clinical studies of the preparation in the form of a gel.

The gel formulation according to Example 1 was tested on 26 patients 10 women and 16 men aged 6 to 65. Patients were selected with chronic dermatoses (eczema chronic, dermatitis artificialis, neurodermatis disseminate, lichen ruber planus, etc.). .), which are not in the stage of exacerbation, with moderate itching and without severe erythema and erosive changes.

The gel called "Distin-gel" is applied for 10 days, 3 times a day. Upon completion of treatment in 10 patients (38.5%) complete clinical recovery (disappearance of rash and complete management1650 U1 itching) was observed. In 8 patients (30.7%), a significant improvement (residual rash and complete itching control) was observed. Improvement was reported in 4 patients (15.3%) and no change was reported in 4 patients (15.3%). 5 No patients have reported side effects of photosensitization. Distin-gel is well tolerated by the skin. The preparation can be successfully used in the treatment of eczema, keratosis, lichen, etc., as an alternative medicine in the form of continuous corticosteroid therapy.

EXAMPLE 6 Clinical trials of a cosmetic herbal cleansing cream containing a dry extract of the roots of a herbal soapy composition of Example 2 were performed on 100 healthy subjects by Yadasson-Bloch epicutant testing. Samples were counted at 48 hours. Sensitivity to the cream tested has not been reported.

The cream is applied to 50 probants with dry, oily and mixed skin type. When treating the skin, the abdomen does not irritate the face and does not cause redness. It is easy to wash and the skin is softened, refreshed, with improved turgor and complexion.

The cleaning effect is excellent. The phototoxic effect of the cleansing cream is negative.

Claims (1)

CLAIMS 1. A skin or gel treatment, characterized in that it contains from 40 to 80% by weight as active ingredient. a dry extract of the roots of Saponaria officinalis L. and a suitable pharmaceutical or cosmetic vehicle.