RU2448683C1 - Milk-wax walnut and buckeye ointment - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to preparing drugs in the form of a herbal ointment for fibrocystic disease (mastopathy). As active substances, the ointment contains an alcoholic extract of milk-wax green walnut and pericarp, walnut and buckeye leaves in equal proportions of the active substances, an ointment base containing vegetable oil, emulsion wax, interior fat, purified water and parabens.

EFFECT: ointment provides hormone balance control in females.

3 cl

Description

The invention relates to medicine, namely to the creation of medicines in the form of an ointment based on plant components, intended for the treatment of fibrocystic breast disease (mastopathy).

Mastopathy is a pathological condition of the mammary gland, characterized by compaction, focal hypertrophy, structural changes, proliferation of connective and glandular tissues of the mammary gland, the formation of benign seals, nodes and cysts of different sizes. The disease is dishormonal and occurs in connection with endocrine disorders in a woman's body.

Risk factors for the development of diseases of the mammary glands are abortion, late birth and improper feeding, the use of hormonal contraceptives, disorders of the thyroid gland, diseases of the uterus and ovaries, as well as the liver and other organs involved in the metabolism of female sex hormones (the main biological processes in the mammary gland occur under the influence of various hormonal factors, by their direct interaction with each other through various mechanisms). Unstable nervous system, frequent stresses, osteochondrosis, obesity, diabetes, chronic hepatitis, smoking and alcohol, abuse of the sun (tanning), chronic infectious diseases exacerbate the development of the disease.

The treatment of various forms of mastopathy involves a complex effect on both the tumor itself and the work of the most important organs and systems of the body responsible for the onset and development of the disease.

Thus, the development of new effective herbal medicines for the treatment and prevention of mastopathy is relevant.

Known anti-mastopathic ointment "Mammaton" containing vegetable oil, emulsifier, glycerin, lanolin, beeswax, borax, ethyl alcohol, benzyl alcohol, tamoxifen, perfume and water in the following ratio, wt.%: Vegetable oil - 15-17; emulsifier - 7-9; lanolin - 2-4; beeswax - 1-3; distilled glycerin - 2-4; borax - 0.2-0.4; benzyl alcohol - 0.5-1.5; ethyl alcohol - 0.5-2.0; tamoxifen - 0.5-3.0; perfume - 0.3-0.5; purified water - the rest [patent RU 2076699, 1997]. The skin of the mammary gland is applied evenly, and in the places of the lesion more concentrated, the proposed anti-mastopativ ointment and placed in a magnetic field for 10-20 minutes. The session is repeated 4-8 times every day. As a result of treatment, 90% of patients had a significant therapeutic effect.

The advantages of herbal medicine over synthetic products are undeniable: drugs created on the basis of medicinal plants have good tolerance, low frequency of adverse reactions, the possibility of prolonged use, and a small number of contraindications. Herbal medicine is compatible with the methods of modern medicine, but it should be monitored by specialists in all prescribed drugs, because the main effect in the treatment of mastopathy is on the hormonal and immune systems of the body, so the doctor’s appointments must be strictly observed.

Famous cream-ointment "Fitol-1" is mastopathy, containing ferulas of the Dzungarian, aconite of the Dzungarian, Japanese Sophora, common gooseberry as a vegetable base, and vegetable oil, beeswax, glycerin, lanolin, purified water as an ointment base [http: // www.alfitplus.ru/product/fitol-1-mastopatijnyj].

Known ointment based on walnut. It consists of: an alcoholic extract of green walnuts, Ferrum metallicum 0.4%, lanolin, glycerin, the base is palm oil [http://www.sbev.narod.ru/mazi/greeceor.htm]. Ointment is recommended for the treatment of fibrocystic masses and nodes of the mammary gland, thyroid gland, mastopathy and breast adenoma, rheumatism, as an additional treatment for malignant tumors. This ointment has a forming and structuring effect on various organs and tissues of the body, an activating effect on blood circulation and processes associated with the exchange of iron. The disadvantage of the proposed tool is the lack of effectiveness of the tool.

The closest analogue of the invention is a cream-gel "Mastokrel" for the treatment and prevention of mastopathy manufactured by LLC Alfit-plus [http://www.alfitplus.ru/product/krem-gel-mastokrel]. It consists of: walnut, horse chestnut, celandine, aloe, nettle, soybean oil, beeswax, glycerin, vitamin C, hydrogenated castor oil, purified water. The main indications for use are: various forms of mastopathy (fibrotic, fibrocystic, diffuse fibroadenosis), cicatricial changes in the mammary glands (a consequence of surgery and acute purulent mastitis), mastalgia (premenstrual; as a complication of osteochondrosis of the thoracic spine). However, soybean oil as a base has insufficient absorption in body tissues.

The objective of the invention is to expand the arsenal of funds for the treatment and prevention of mastopathy.

EFFECT: obtaining a new medicinal herbal medicine in the form of an ointment for the treatment and prevention of fibrocystic formations and mammary gland nodes (mastopathy), lowering the level of female sex hormones in the blood.

The specified technical result is achieved by the fact that an ointment based on plant components, intended for the treatment of fibrocystic breast disease (mastopathy), containing alcoholic extracts of fruits of walnut and horse chestnut as an active substance, an ointment base including vegetable oil, wax, water purified and preservatives, according to the invention additionally contains, as an active ingredient, an alcoholic extract of walnut leaves, green walnuts are used as walnuts minutes with pericarp nut milk-wax maturity at equal proportions of the active ingredients, ointment base further comprises a visceral fat, and wax as a wax emulsion comprises the following component ratio, g:

Green Walnut Fruit Extract with pericarp milky-waxy maturity 12 Walnut leaf extract 12 Horse Chestnut Fruit Extract 12 Emulsion wax 16.5 Vegetable oil 6 Interior fat 0.5 Preservative one Water 40

Moreover, as a preservative, the ointment contains parabens, and the duration of extracts is 21 days.

The proposed ointment is prepared as follows.

To obtain plant materials, green walnuts are harvested during the milky-wax maturity (21-23 days after flowering) together with pericarp, pre-washed with water and ground into small fractions into a powder with particles from 10 to 20 mm. Then, extraction of the fruits crushed into a homogeneous mass is carried out, pouring the raw materials with a 40% aqueous solution of ethyl alcohol at a mass ratio of ingredients of 1:10, the mixture is insisted for 21 days without access to light. The extract obtained has immunomodulatory, anti-sclerotic, antioxidant properties that contribute to the replacement of iodine deficiency properties, promotes wound healing, is non-toxic [Kiseleva et al. Medicinal properties of food plants. - M.: Publishing House FNECEC TMDL Roszdrav, 2007. - 533 p.]. Similarly, extracts of walnut leaves and horse chestnut are prepared. The obtained extracts are filtered through a gauze three-layer filter and poured into glass containers. Emulsion wax, vegetable oil, internal fat, alcohol extract of walnut, alcohol extract of walnut leaves, alcohol extract of horse chestnut and preservatives (parabens) are added to distilled water. Further, this mixture is mixed on a homogenizer to a homogeneous consistency for 30-40 minutes. The ointment is a homogeneous gel-like mass in which the presence of air bubbles is allowed and which has a specific plant smell, light brown or brown.

Method of application: ointment is used by applying it with a thin layer on the projection of a diseased organ for 20 days, 2 times a day (morning and evening). The resulting ointment is stored in tightly closed packaging in a cool dark place (at a temperature of 1-15 ° C), shelf life up to 1 year.

The proposed ointment was tested on patients with an established diagnosis - mastopathy, who used the ointment both in complex treatment and as the only drug. It was shown that, having anti-inflammatory and antimicrobial effects, the ointment, in addition to the main purpose for the treatment of fibrocystic formations and mammary gland nodes, can be effectively used in the treatment of thyroid diseases, glands, dermatological diseases, in the treatment of hardly healing ulcers, burns, hemorrhoids, acne, acne, cuts, bruising, wounds. In addition, as an additional drug, ointment is recommended for use in combination with specific drugs in the treatment of radiculitis, osteochondrosis, osteomyelitis, joint disease of non-specific origin, arthritis, calcaneal spurs, gout. Ointment can be used in the treatment of vascular lesions of the lower extremities, gynecological diseases. The effect of using the ointment is achieved quickly enough, it has no contraindications, it is recommended to repeat treatment courses.

Walnut (Juglans regia L.) is a medicinal plant that is well described in the literature (more than 10 thousand literature sources reflecting its use in scientific and folk medicine and veterinary medicine [Strelyaeva A.V. Diss. Pharmaceutical Sciences “The study of the toxicity and pharmacological activity of drugs based on medicinal plant materials and new extractants. M., 2003]). Used in medicine and veterinary medicine Todikamp, Cheblin-SK-1, homeopathic drug Yuglans. The release of preparations based on walnut leaves is carried out on the territory of Ukraine (Karion preparation, tincture, suspension and Yuglon ointment). In Russia, on the leaves, on the unripe fruits of walnut and on their tinctures there is no regulatory documentation.

However, decoctions, tinctures, extracts of ripe and milk-wax ripeness of walnuts, their leaves and bark are used in folk and scientific medicine for wound healing, treatment of colds, skin, oncological diseases [Kortikov V.N., Kortikov A.V. Secrets of healing herbs. Popular encyclopedia. T.1. Herbs. - Minsk, 1995, p.3272; RF patent 2033803, 1993, cl. A61K 35 / 78.3].

According to the literature [Troyan Z.A., Lychkina L.V., Mikhaylyuta L.V. et al. Fatty acid composition and bactericidal properties of CO ₂ extracts from walnut fruit // Storage and processing of agricultural raw materials. - 1999. - No. 7. - p.24; Strelyaev A.V. 2003, see above; Kiseleva et al., See above], fresh and dried fruits, leaves, pericarp, walnut walls, contain fat-soluble vitamins A, E, K, as well as vitamins B ₁ , B ₂ , P, PP, carotene and quinones, unsaturated fatty acids - linoleic, linolenic, oleic, palmitic and other organic acids, quercetin, juglandin, juglon, trace elements - iodine, zinc, cobalt, potassium, magnesium, iron and other biologically active substances. The unripe shell contains phenylcarboxylic acids, tannins and coumarins; Pellicle (peel covering the fetus) - steroids, tannins. All of these ingredients together determine the following properties of green walnut extract: bactericidal, restorative, anti-sclerotic, astringent, hemostatic, anti-inflammatory, wound healing, epithelizing. Walnut-based preparations do not have autogenic, immunotoxic, teratogenic activity.

From the literature it is known that ellagic acid, one of the components of walnut, belongs to antioxidants - compounds that are inhibitors of free radical reactions [Mancini V., Carbonera A.O., Haremand T.F. Immunochemical quantitation of antigens by single radial immunodiffusion // Immunochemistry. - 1965. - Vol. No. 2. - P.235-254; Bunyatyan N.D. Hepatoprotective effect of plant antioxidants // M., 1999. - 116 p.]. Ellagic acid is active against Ehrlich ascites carcinoma and other neoplasias. In the above works, the proposed mechanism of the antitumor effect is described, which consists in creating a deficiency of kinins in the capillaries of the tumor, which disrupts normal blood supply in it. The antitumor effect of plant ellagotannins and polyflavones was also studied on experimental systems. Studies have shown the absence of toxicity of plant ellagotannins when used as an antitumor drug. Based on the literature data cited by the authors, it is known that in the experiment, ellagic acid, yuglon, and isolated fractions (strong and weak acids, alkaloids) caused growth retardation. The authors also point to the literature data on the ability of water-soluble polyphenol and quinone compounds to inhibit the growth of some experimental neoplasms.

In the literature, it is noted that naphthoquinones, including yuglon, lauson, lapachol and plumbagin, have pronounced antitumor activity. Moreover, the antitumor effect is achieved both by alkylation of the DNA of tumor cells, and by the action of nucleic acid synthesis on enzymes [Barabay V.A. Plant phenols and human health. - M., 1984. - 160 p.].

In the monograph Nikitina T.I. It is also noted that walnuts are used to treat malignant tumors [Nikitina TI Medicinal plants. Application. Contraindications Fees: phytotherapist reference book. Ufa, Publishing House Bashkirsk. state University, 2000. - 236 p.].

Tannins, which are abundant in the fruits of green walnuts, are also evaluated as possible medicines with antioxidant properties [Barnaulov OD Detoxification herbal medicine, or the antidote properties of medicinal plants. - St. Petersburg: Polytechnic, 2007. - 409 p.]. It is known that tannins have a bactericidal, general strengthening, anti-sclerotic, astringent, hemostatic, anti-inflammatory, wound healing, epithelizing effect. It is assumed that tannins penetrate into the intercellular spaces and bind enzyme proteins that cause local inflammatory reactions.

Walnut leaves are widely used in folk and official medicine of foreign countries in both allopathic and homeopathic practice as anti-inflammatory, wound healing, antimicrobial agents. Walnut leaves in powder form for powders, decoction for compresses, lotions, rinses or baths are used for diseases such as rheumatism, gout, gum disease, skin dermatitis or purulent wounds, lymphadenitis and mastitis. For diseases of the gastrointestinal tract, furunculosis, tuberculosis, hemorrhoids, helminthic infestations, diseases of the female reproductive system, as well as for childhood rickets, various extracts from the leaves are used (infusion, tincture, extract, juice). In homeopathic practice in a number of foreign countries (Germany, France, Great Britain, India, etc.), homeopathic matrix walnut tincture is used, obtained from leafy shoots during the flowering period, and its cultivation as a means of anthroposophic therapeutic direction of treatment [R. Enikeeva. Abstract. diss. for the competition Art. Cand. farm. Sciences "Study on the pharmacognostic study and standardization of raw materials and preparations of Walnut (Juglans regia L.)." M., 2008].

The pharmacological effect of horse chestnut extract (Aesculus hippocastanum L.) is associated with the presence in it, first of all, of glycosides - esculin and escin [Sokolov S.Ya., Zamotaev I.P. Handbook of Medicinal Plants (Herbal Medicine). - M .: Medicine, 1990. - 464 p.]. Horse chestnut extract and preparations prepared from it, increase the tone of the venous vessels, accelerate blood flow in the veins, which prevents the formation and growth of thrombosis. In addition, these drugs reduce capillary permeability, improve microcirculation, and have pronounced anti-inflammatory properties. Esculin stimulates the antithrombotic activity of blood serum, increases the production of antithrombin in the reticuloendothelial system of blood vessels. Aescin lowers blood viscosity. Horse chestnut extract slows blood clotting.

Alcohol tincture of horse chestnut fruits gives excellent results in the treatment of mastopathy in connection with the normalization of blood circulation, choleretic, anti-inflammatory, lymphogonous and vitamin action, improving the condition of blood vessels and capillaries, as well as reducing their permeability [Akhmedov RB Plants are your friends and foes. - Ufa: Kitap, 2007. - 480 p.].

Horse chestnut preparations are used to prevent and treat postoperative thrombosis, post-traumatic edema, inflammation and thromboembolism. Thus, the drug AECCIN (Poland), in one tablet of which contains 20 mg of a mixture of saponins from horse chestnut seeds, is recommended as a venotonic and antithrombotic agent for hemorrhoids, venous stasis, leg ulcers, varicose veins of the lower extremities, especially in pregnant women and parturient woman.

Interior fat is mainly used in folk medicine. The nutritional and medicinal benefits of animal fats are evident over petroleum jelly and other mineral ointment bases. However, ointments made on the basis of interior fat require storage in the refrigerator due to the tendency to quickly rancid. In this regard, preservatives are added to the ointment, for example, from the paraben group.

The invention is illustrated by the following clinical example.

Patient P. 36 years old, a child 3 years old, breast-fed up to 2 years. Before the last two menstrual cycles, both mammary glands swelled and hurt in 1.5 weeks, with the onset of menstruation the pain disappeared. An ultrasound of the mammary glands was done. Mammary glands of mixed structure due to adipose and fibrous tissue. Echoes of diffuse mastopathy with a cystic component, reactive lymphadenitis, ducts of the paranasal zones were expanded to 1.8-2 mm on the right, to 2.1-2.2 mm on the left. Unexpressed fibrous stiffness and cystic inclusions along the ducts up to 2-3 mm in size are noted, more in the paralosal areas and outer quadrants, more on the left. Lymph nodes in both axillary areas are not enlarged. Conclusion of ultrasound: signs of fibrocystic mastopathy with a predominance of the cystic component.

An outpatient treatment using medicinal herbs was carried out according to the method described by N.V. Kudashkina. and others [Kudashkina N.V. et al. Phytotherapy in gynecology, Ufa, Guillem, 2009, 116 pp.] with simultaneous application of ointment based on green walnut and horse chestnut on both mammary glands, including lymph nodes, as well as the thyroid region, 2 times a day. Important - do not warm the chest. After completing a full course of treatment with herbs and ointment for 2 months, patient P. did a second ultrasound: there were no signs of diffuse mastopathy, the ducts of the paralosa were reduced to 0.2 mm on the right, to 0.4 mm on the left, the lymph nodes were not enlarged. For preventive purposes, the continuation of phytotherapy with the use of ointment was recommended. Patient P. feels well.

A clinical study of the ointment was conducted on 67 women with suspected mastopathy who are on outpatient treatment. All had a x-ray and ultrasound mammography. Ultrasound of the thyroid gland and pelvic organs was performed in some patients, the concentration of T3, T4, TSH, titer of antibodies to thyroglobulin, FSH, LH, prolactin, estradiol, progesterone and dehydroepiandrosterone was determined. During the complex treatment using the ointment as a component of local treatment, it was shown that the majority of patients (85%) disappeared signs of the disease. It was found that in a group of women (23 patients) with a normal ovulatory cycle when conducting only local treatment (ointment is applied to both breasts and the thyroid gland) by the end of the course (3 months), in addition to the disappearance of signs of mastopathy, a decrease in the level of estradiol and progesterone was observed , in some cases to normal values. The above suggests that the ointment has the ability to reduce the level of female sex hormones in the blood. After conducting full-scale clinical trials and developing quality control methods, a pharmacopeia article is planned.

To conduct test studies on possible individual allergic reactions to the plant components that make up the ointment, it is recommended to apply a small amount of the drug to the elbow bend skin area before use.

As a result of experimental studies, it was found that the claimed original composition of the ointment provides a sufficiently high therapeutic efficacy. Giving the drug the form of an ointment provides a good local effect and ease of use. The introduction into the composition of the ointment of an alcoholic extract of walnut leaves in equal proportion with the alcoholic extracts of unripe walnut and horse chestnut fruits increases the regenerating, anti-inflammatory, tonic properties of the ointment, and also provides a vitamin (vitamin C content of 600 mg / ml extract), wound healing effect on breast tissue.

In addition to the manifestation of known properties, each component of the claimed composition in the aggregate enhances its effect, which is explained, obviously, by the effect of their synergism. In addition, during studies it was shown that the ointment in this combination of active substances has a new effect - the ability to regulate the hormonal balance in women.

Claims (3)

1. An ointment based on plant components, intended for the treatment of fibrocystic breast disease (mastopathy), containing as active ingredients alcoholic extracts of walnut and horse chestnut, ointment base, including vegetable oil, wax, purified water and preservatives, characterized by the fact that it additionally contains alcohol extract of walnut leaves as an active substance, green walnut with a milky-wax pericarp is used as a walnut. At equal proportions of active substances, the ointment base additionally contains interior fat, and as a wax contains emulsion wax in the following ratio of components, g:
green walnut fruit extract with pericarp milky-waxy maturity 12 walnut leaf extract 12 horse chestnut fruit extract 12 emulsion wax 16.5 vegetable oil 6 interior fat 0.5 preservative one water 40 2. Ointment according to claim 1, characterized in that it contains parabens as a preservative. 3. Ointment according to claim 1, characterized in that the duration of extracts is 21 days.