RU2097017C1 - Composition for stimulation hair growth and dermal regeneration - Google Patents

Abstract

FIELD: medicine; may be used for treatment of all forms of alopecia and hair shedding. SUBSTANCE: composition contains the following components, mas.%: chlormethylsilatrane (Mival), 3-5; dimexyde, 2-5; ethanol, 5-15; sunflower oil, 10-20; sea buckthorn, 5-10; lavender oil, 2-3; water-free lanolin, the balance. EFFECT: higher efficiency.

Description

 The invention relates to medicine, namely to dermatology and cosmetology, and can be used to treat all types of baldness and hair loss, including post-burn alopecia and congenital hypotrichia, fresh and long-healing wounds, trophic ulcers, dermatitis of allergic origin, psoriasis, and also skin rejuvenation.

 It is known to use polyethylsiloxane liquids as a base for ointments. In pure form, these liquids (Esilon-4, Esilon-5) can only be used to obtain liquid ointments.

 To obtain consistent ointment bases, they are mixed with paraffin, wax, ceresin or mineral thickeners (zinc oxide, kaolin).

 However, the bases thus obtained are not sufficiently stable during storage, especially at temperatures other than room temperature, and cannot be considered completely physiologically indifferent.

It is known to use a mixture of polyethylsiloxane liquid and amorphous silica as a base for ointments [1]. This base has a vaseline consistency, which can be stored at temperatures from - (30-40) ^o C to + (30-40) ^o C. The base does not irritating effect on the skin, physiologically completely indifferent and does not interact with various medicinal components, including antibiotics.

 However, siloxane-based ointments do not allow the active substance to pass through the biomembranes of the skin and connective tissue stroma.

 It is known that for the treatment of ulcers that occur at the site of skin damage - cuts, wounds, burns apply compressor dressings with an ointment containing pepsin, hydrochloric acid.

 For a more effective treatment of trophic ulcers, a well-known ointment [2] is used containing the following components, wt.

Camphor dextrorotatory 1.5-6.0;
Ethyl ether 7.5-10.0;
Basic bismuth nitrate 3.0-7.0;
Salicylic acid 0.5-3.0;
Amidochloride mercury 1.5-7.0;
Vaseline oil 7.5-10.0;
Vaseline medical 56.0-30.0;
Lanolin water Else.

 The specified ointment does not have a stable effective effect, since it does not contain components involved in collagen formation.

 Known wound healing agent [3] containing the following components, wt.

Stearic acid 5.6-2.8;
Glycerin 9.3-1.6;
Triethanolamine 0.5-4.0;
Lanolin 0.2-0.8;
Chloramphenicol 2.0-3.5;
Boric acid 0.4-0.8;
Sea buckthorn oil 3.0-12.0;
Propellant 3.0-12.0;
Distilled water Else.

 The specified tool does not contain trace elements necessary for the regeneration of damaged biomembranes and the formation of collagen.

 Known tool [4] for the treatment of trophic ulcers in patients with leprosy, containing the following components, wt.

Rifampicin 2.0-5.0;
Dimexide 10.0-20.0;
Vaseline-lanolin base The rest.

 The super-solvent dimethyl sulfoxide (dimexide) used here is a transporter of the active substance (rifampicin) into the deeper layers of the skin. However, microorganisms quickly adapt to the active substance and its effectiveness drops sharply, that is, there is a well-known fact in medicine of the "addiction" of viruses to antibiotics.

 The closest to the essence of the proposed tool is a tool to stimulate hair growth [5] (liniment "Silocast"), containing the following components, wt.

1-Chloromethylsilatran 2.0-5.0;
Dimexide 20.0-50.0;
Castor Oil Else.

 However, clinical trials of this well-known means, taken as a prototype, confirm its therapeutic efficacy in the treatment of only seborrheic and small focal forms of alopecia and do not give results in total and universal forms of alopecia.

 In addition, the well-known product has an unpleasant odor (garlic) due to the presence of dimexide and a liquid consistency, which is not always convenient in practice. The use of the drug causes allergy in some patients, a metallic taste in the mouth.

 The aim of the invention is the development of highly effective cosmetic and medicinal products to stimulate hair growth and skin regeneration, healing of wounds, ulcers, dermatitis and skin rejuvenation.

 This goal is achieved by the fact that the tool for stimulating hair growth and skin regeneration, including chloromethylsilatran, dimexide and vegetable oil, additionally contains ethyl alcohol, anhydrous lanolin, sea buckthorn and lavender oil, and sunflower oil is used as vegetable oil, with the following ratio of components, wt.

Mival (chloromethylsilatran) 3-5;
Alcohol ethyl rectified 5-15;
Refined sunflower oil 10-20;
Sea-buckthorn oil 5-10;
Lavender oil 2-3;
Dimexide 2-5;
Anhydrous Lanolin Else
The organosilicon component Mival (chloromethylsilatran), which is part of the proposed agent, has a membranotropic effect and promotes collagen formation in various connective tissue defects.

 Dimexide is used as the Mivala transporter to the hair follicle, ethyl alcohol for the homogenization of fatty bases and as a mild antiseptic.

 The proposed tool, called in practice "Mival Balm", is prepared as follows.

 Use Mival according to the temporary pharmacopoeial article (VFS) 42-2083-92, ethyl alcohol according to the standard GOST 5962-67, sea buckthorn oil according to the pharmacopeia article (FS) 42-1730-86, lavender oil according to the OST standard 10-56-87, lanolin anhydrous according to FS 42-2520-88.

 The calculated quantities of Mival, dimexide, sunflower, sea buckthorn, lavender oils and ethyl alcohol (ethanol) are loaded into a round-bottom flask with a stirrer. The mixture is stirred until a homogeneous light orange solution is obtained.

In a fume hood in an enameled container, lanolin is heated to 45-50 ^o C and the resulting alcohol-oil solution of Mival is added to it.

The mixture is stirred for 10-15 minutes at 45-50 ^o C and dosed in plastic jars or bottles, which are pre-treated with ethyl alcohol and dried. Twice a week (for example, on Friday and Monday), chemical dishes, consumables, and plastic jars are irradiated for 0.5 h with a PRK-2 UV lamp.

 Each batch of ointment (Mival balm) undergoes analysis and control according to the tests and standards of certification laboratories. The resulting Mival balm meets the technical specifications TU 6-02-816-96.

 The following are specific examples of treatment using the proposed tool (Mival balm).

 Clinical trials of the drug were carried out in a number of leading institutions of the country: Central Scientific Research Skin and Venereology Institute (TsNIKVI), Moscow Medical Academy (Sechenov MMA), Kirov Medical Academy (St. Petersburg), Republican Burn Center, Research Institute of Traumatology and Orthopedics ( N. Novgorod) and others. As well as in private medical centers. Moscow, Belgorod, St. Petersburg.

 Some clinical trial data are provided below.

 Example 1. MMA them. I.M.Sechenova, laboratory for the study of reparative processes in the skin.

 Evaluation of the formulation, the study of the harmlessness and biological activity of Mival balsam was carried out on 100 white male rats (180-200 g), 50 white adult male mice (18-20 g), 20 male guinea pigs (350-400 g) and 10 rabbits (1500-2000 g).

 Clinical trials were conducted on 20 patients aged 19-62 years, of which 8 people had signs of dry seborrhea, 4 people had alopecia areata, 8 people had dandruff and increased hair loss.

 In experiments on guinea pigs and rabbits, before the start of the experiment, the hair was sheared and daily, for 3 months, 0.5 g of Mival was applied dermally. On day 7,14,21 and day 90, 50 hairs were pulled out from each animal, the length and structure of the pulled hairs were measured, and the data of the control and experimental groups were compared.

 In the study of subacute toxicity, the general condition of the animals, their behavior, appetite, weight gain, skin, coat, edema, hyperemia, desquamation were observed. We took biopsies of the skin and internal organs (heart, liver, kidneys, spleen, lungs) for pathomorphological studies.

 In the clinic, patients underwent patchwork under a closed bandage. We studied the function of the sebaceous glands, the presence of dandruff, hyperemia, itching, abundance and growth rate of hair, the condition of the skin, scalp (dryness, peeling, redness, grease, itching).

 Mival Balm was applied to all patients with a thin layer every other day (for 2-3 months), followed by a light massage.

Thus:
the formulation of Mival balm does not cause comments and objections. The oil-fat base (lanolin, vegetable and sea-buckthorn oils) was successfully selected. As preservatives, the components selected are lavender oil and ethyl alcohol.

the balm has a good consistency, pleasant smell and attractive yellow-orange color;
The balm is non-toxic, does not have an irritating and allergenic effect, does not have a negative effect on the skin and internal organs. The number of eosinophils, mast cells, the cellular composition of the epidermis and dermis did not differ from the control. An increase in the functional activity of histocytes and mast cells in the dermis was noted;
the calculation of hairs per 1 cm ² in experimental skin areas gave an increase of 42% and in the control 7%
morphologically established a positive effect on the structure of the hair and hair, strengthening the hair bag, hair matrix and root vagina;
in the clinic in all patients after 3 weeks. the appearance of a natural shine of hair, the disappearance of dandruff, itching, and hair loss are noted. The growth of cannon hair was observed after a 30-day application of the balm. After a 2.5-month follow-up, all patients with focal alopecia experienced normal hair growth in previously affected areas.

 Conclusion

 ".Mival Balm can be recommended for release as a hair care product, prone to hair loss and dandruff, with anti-inflammatory properties, stimulating hair growth." (Extract from the report of the MMA named after Sechenov, 1994).

 Example 2. Medical treatment and rehabilitation limited partnership "Firm Blagovest". Clinical studies were conducted on 1410 patients with various pathologies.

The following patient groups were identified:
group 1 with enhanced hair loss 168 (11.95%)
group 2 with circular and nesting baldness 423 (30%)
group 3 with subtotal baldness 282 (20%)
group 4 with premature baldness 478 (33.9%)
group 5 other forms 59 (4.15%)
During the treatment, a manual massage of the scalp with Mival balm was performed using dosed mechanical action with a special individual multi-needle roller used in reflexology.

 The number of treatment courses and breaks between them was set individually, in one treatment course of 10 sessions.

As a result of the treatment, results were obtained that indicate the effectiveness of the treatment:
in group 1, a complete cure was observed in 86% of patients, a significant slowdown in the process of hair loss in 12%, a slight effect or its absence in 2%
in group 2, respectively, 74% 18% and 6% of patients;
for group 3 58% 28% and 14%
for group 4 36% 40% and 24%
for group 5 19% 42% and 39%
Conclusion

 ".The use of Mival balm can be considered justified in the treatment of any form of baldness." (Report of Firm Blagovest LLP, 1993-1994).

 Example 3. In the clinic TsNIKVI under the supervision were 28 women aged 16-72 years and 2 men (52 and 55 years old) with violations of turgor and skin elasticity. Prescription of diseases from 3 months to 25 years. In the control were 10 women aged 30-65 who used the same ointment base without chloromethylsilatran.

 The balm was applied to the skin 2-3 times a day with a thin layer, followed by rubbing and light massage for 2-3 months. As a result, 80% of women’s patients showed a decrease in dryness, sagging and improved turgor and elasticity of the skin of the face and neck. Side effects and complications were not observed in any case.

 12 people fully recovered, a significant improvement was noted in 10 people, an improvement in 7 people.

 Patients older than 50 years especially noted a decrease in dryness, smoothing small wrinkles in the eyes and on the neck. Large wrinkles, especially on the skin of the forehead, became less pronounced. A new property of Mival balm has been discovered that has a whitening effect on facial skin.

Thus:
Mival balm is effective in treating various types of skin (dry, oily, mixed);
balm has regenerating, whitening properties, improves trophism, skin elasticity;
the product is well tolerated, absorbed into the skin, convenient to use.

 Conclusion

 ". Cream-balm (Mival) can be recommended for practical use." (Report TSNIKVI, N 2134, 1994 Yu.K. Skripkin, S.M. Fedorov, G.G. Timoshin).

 Example 4. The Republican Burn Center Research Institute of Traumatology and Orthopedics.

 A clinical study of Mival balm (5% ointment) was conducted on a group of 4 patients with superficial burn wounds ranging from 1 to 15% of the body surface and a group of 3 patients with unhealed wounds of donor sites formed as a result of suppuration of certain areas after cutting with a dermatome split skin flaps.

 In the treatment of Mival, the balm was used in the form of applications on the wound surface of 1-2 layers of gauze soaked with it from 2 to 11 times against the background of the general complex treatment.

 Under the influence of balm, wounds in patients were well epithelized. The wound healing time was 10-15 days.

 Conclusion

 ". this drug (5% Mival balm) can be used in the local treatment of fresh superficial burn wounds." (Report N 1063 Research Institute of Traumatology and Orthopedics, 1974).

 Example 5. Clinic of the USSR sports committee system, Laboratory of pre-pathological and pathological conditions in sports.

 Investigations of the effect of Mival balm on the growth of connective tissue in injuries sustained in sports were conducted.

 In the first group of athletes operated on for a false joint of the tibia and subcutaneous rupture of the Achilles tendon with a postoperative period of skin necrosis, the balm was applied to the wound in the form of ointment bandages every other day.

 For the treatment of the control group, synthomycin emulsion and Vishnevsky ointment were used.

 In the group using Mival balm, after 2-3 days, growth of granulation tissues and epithelization of the edges of the wound were observed. The crust formation went without suppuration and the healing period was 15-17 days, whereas in the control group it was 22-26 days.

 In the second group of cyclist athletes, the subjects had damage to the thigh tissues and after treating the wound with hydrogen peroxide, Mival was applied in the form of ointment dressings daily.

 An alcohol solution of iodine and a synthomycin emulsion were used to treat the control group.

In the group using Mival balm in a patient with an area of damaged tissue of 42 ² cm, healing occurred on the 16th day, in a patient with 37cm ² damage on the 14th day, in patients with 46.5cm ² and 39cm ² damage in The 18th day.

In the control group, in a patient with a damaged tissue area of 35 cm ^2, healing occurred on the 25th day, in a patient with 30cm ² injuries on the 22nd day, and in a patient with 48cm ² injuries on day 27.

 The average duration of wound healing in the test group was 16.5 days, and in the control group 24.7 days.

 Conclusion

 ". Mival as an ointment has a stimulating effect on wound healing. And is recommended for implementation in sports and medical practice." (Report of the laboratory of pre-pathological and pathological conditions in sports, 1975).

Sources of information
USSR author's certificate N 253299, publ. BI N 30, 1969

 USSR author's certificate N 495549, publ. BI N 1979

 USSR author's certificate N 884189, publ. BI N 7, 1985

 USSR author's certificate N 1196001, publ. BI N 45, 1985

 USSR author's certificate N 1822769, publ. BI N 23, 1993

Claims (1)

 A tool for stimulating hair growth and skin regeneration, including chloromethylsilatran, dimexide and vegetable oil, characterized in that it additionally contains ethyl alcohol, anhydrous lanolin, sunflower, sea buckthorn and lavender as a vegetable oil in the following ratio of components, wt. Chloromethylsilatran 3 5
Dimexide 2 5
Ethyl alcohol 5 15
Sunflower oil 10 20
Sea buckthorn oil 5 10
Lavender oil 2 3
Anhydrous Lanolin