BG5Y1 - MEANS OF TREATMENT OF SKIN - Google Patents

Abstract

The product is used for the treatment and prevention of dermatological diseases. It is in the form of a gel or cream and contains as an active ingredient a dry extract of the roots of Saponaria officinalis in an amount of 40 to 80% by weight with a suitable pharmaceutical or cosmetic vehicle for the purpose. _

Description

The use of a therapeutic soap (Saponaria officinalis L.) is known, but in combination with other drugs in the form of an aqueous extract for the treatment of eczema (P. Churolinov, Phytotherapy in Dermatology and Cosmetics, Sofia, 1976, 44). Also known are shampoo and lotion with a 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 a cosmetic cleansing 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 40 to 80% by weight, together with a suitable pharmaceutical or cosmetic vehicle.

The vehicle contains gel-forming agents or oily components and emulsifiers such as Carbopol 400, liquid paraffin, petrolatum, preservatives - nipagine 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 water-alcohol extraction of the roots of Saponaria officinalis L., in a ratio of 1 part of roots 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, a dry extract of the roots of a healing soap, is applied in the form of gel or cream in an 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 root extract of healing 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 in g:

Dry root extract of healing soap (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;

Vaseline - 25,00;

Perfume composition - 0.30;

Distilled water -17,00.

The oily components melt in a water bath. The aqueous phase, with the preservatives dissolved therein, the 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 ° to 3 parts of distilled water, followed by concentration and spray drying.

The product thus standardized for the sapogenins content has anti-inflammatory and keratolytic action.

Characteristics of the dry extract of le-

soapy water. Appearance - fine powder; Color - light brown; Odor - specific; Reaction to 10% aqueous suspension (pH) from 4 to 6; Loss on drying - no more than 7%; Content of heavy metals - not more than 0,01%; Foaming agent ability - not less than 15%; Content of sapogins (such as oleanol acid) - non-crystalline from 14%; Microbial content in units / g - total number microorganisms - not more than 10 ³ ; - molds and sponges - not more than 10 ² .

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.

Acute toxicity was investigated by oral administration of the dry extract in 5 successively increasing doses of 500 to 5000 mg / kg body weight.

The gel preparation and the soapy extract were tested for acute toxicity in rats and the dermal route of treatment, with application to a depilated area of the back of animals about 9 cm ² in increasing doses.

The data obtained indicate that the soapy extract is toxic when administered intraperitoneally ( _LD10 = 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 at 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 Trials of a Gel Formulation.

The gel formulation of the composition of 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 artifialis, neurodermatis disseminate, lichen ruber planus and others), 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 management of 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%). None of the patients reported side effects as well as photosensitization phenomena. Distingel is well tolerated by the skin. The preparation can be successfully used in the treatment of eczema, keratosis, lichen and the like as an alternative medicine instead of continuous corticosteroid therapy.

Example 6 Clinical trials of a cosmetic herbal cleansing cream containing a dry extract of the roots of the plant soapy composition of Example 2 were performed on 100 healthy individuals 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 cream does not irritate the face and 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

Claims (1)

Gel or cream skin 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. Publication of the Patent Office of the Republic of Bulgaria Sofia - 1113, 52-B GM Dimitrov Blvd.