RU2205019C1 - "mamoclam" preparation for treating mastopathy - Google Patents

Abstract

FIELD: medicine, mammology, gynecology, endocrinology. SUBSTANCE: medicinal preparation is suggested to be used in treating mastopathy based upon laminaria concentrate and other additional substances. The suggested preparation is obtained out of thallus, rhizoid and leaf stalks of brown algae of laminaria type, it contains not less than 0.1 mg iodine and 9 mg highest fatty acids per 1 tablet or capsule. "Mamoclam" is of pronounced curative action in mastopathy- suffering patients - diffuse fibrous-cystic disease of mammary glands: decreases mastalgia phenomena, syndrome of premenstrual tension and disalgomenorea, normalizes menstrual cycle, leads to regression of palpatory signs of fibroadenomatosis and cysts in mammary glands, improves mammographic picture. Thus, positive effect is observed in 94% patients. "Mamoclam" causes no side and toxic actions. EFFECT: higher efficiency of therapy. 2 cl, 2 tbl

Description

 The invention relates to medicine, namely to mammology, gynecology, endocrinology.

 Mastopathy is one of the most common diseases in women, its frequency is 30-90%, depending on the diagnostic methods. Clinically, mastopathy is usually most pronounced in the reproductive age of a woman. Mastopathy is a group of heterogeneous diseases manifested by mastalgia, premenstrual tension syndrome, the presence of seals in the mammary glands during palpation, cysts and fibroadenomatous changes during ultrasound and x-ray mammography examinations. There is no consensus in domestic and foreign literature regarding terminology, classification, approaches to the diagnosis and treatment of mastopathy, there are only more than 30 names of this most common disease of women. In domestic medicine, the term mastopathy is officially proposed for this disease, which is divided into two forms: diffuse (with a predominance of glandular, fibrous or cystic components; mixed glandular-cystic) and nodular (fibroadenoma, cyst) [Treatment of patients with benign hormone-dependent diseases of the uterus and breast cancer / Methodical recommendations. - General Directorate of Maternal and Child Health. - 1989. - 30 p.]. According to the WHO definition, mastopathy is called fibrocystic breast disease, characterized by proliferative and regressive tissue changes with an abnormal ratio of epithelial and connective components [Goryushina O.G. Mastopathy Ed. V.F. Semiglazova. - SPb .: Kare, 2000. - 109 p.]. According to modern concepts, mastopathy is a disease of a dishormonal nature that appears against the background of changes in the hormonal background in women as a result of various causes: adverse social conditions, impaired reproductive and sexual function, diseases of the genital organs, impaired endocrine balance and metabolic processes, liver disease, genetic predisposition [Sidorenko L.N. Mastopathy - L .: Medicine, 1991. - S. 95-215]. For a long time, the question of the relationship of mastopathy to breast cancer was debated. Currently, it is generally accepted that mastopathy is not a precancer or stage of an oncological process in the mammary glands, and women suffering from mastopathy should not be considered to be at increased cancer risk [Li L.A., Martynyuk V.V., Sobolev A.A. Tasks and possibilities of drug treatment and medical examination of patients with mastopathy // Vopr. onkol. - 1998. - T. 44, 4. - S. 452-454].

 For the treatment of mastopathy, hormonal agents are currently used: gestagens (norkolut, depot-proofer), androgens (methyltestosterone, testobronlecid), thyroid hormone preparations (thyroxine), low-dose combined estrogen-gestagen drugs (marvelon, silest, femoden, rigide) ; antagonists and inhibitors of hormone production: antigonadotropins (danazol), antiestrogens (tamoxifen), dopamine agonists (parlodel, norprolak); non-hormonal drugs: vitamins (A, E, Aevit, multivitamin preparations), adaptogens (tincture of ginseng and eleutherococcus, pantocrine extract), diuretics (veroshpiron, triampur, tincture of field horsetail), sedatives (diazepam, bromocamphor, tincture, and tinctures) (essentiale, methionine), potassium preparations (potassium orotate), enzymes (wobenzym), non-steroidal anti-inflammatory drugs (aspirin, indomethacin, brufen), iodine preparations (potassium iodide, sodium iodide, protein-bound iodine) [Burdina L. M. Basic principles of treatment differential fusal benign pathological changes in the mammary glands // Mammology.-1996. - 4.- S. 9-14; Goryushina O.G. Mastopathy Ed. V.F. Semiglazova.- SPb .: Kare, 2000 .-- 109 p .; Sidorenko L.N. Mastopathy. - L .: Medicine, 1991. - S. 95-215; Chumakova S.S., Nagovitsina O.V., Glukhikh A.P. et al. The use of depot-medroxyprogesterone acetate in the treatment of diffuse benign diseases of the mammary glands // Mammology. - 1996. - 3. - S. 41-44; Rammer E., Friedrich F. Enzymotherapy in the treatment of mastopathy. Randomized Double Blind Clinical Experience // Mammology. - 1997. - 3. - S. 13-17; Ghent W.R., Eskin B.A., Low D.A., Hill L.P. Iodine replacement in fibrocystic disease of the breast // Can. J. Surg. - 1993. - Vol. 36. - P. 453-460; Kaunitz A.M. Oral contraceptive health benefits: perception versus reality // Contraception. - 1999. - Vol. 59 (1 Suppl). - P. 29-33; Schweppe K. W. The significance ofgestagens in treatment of mastopathy // Zentralbl. Gynakol. - 1997. - Vol. 119 (Suppi 2). - P. 54-58; von Fallois J., Etterli-Billenkamp U., Schindler E.M., Schindler A.E. Danazol for treatment of fibrocystic mastopathy // Zentralbl. Gynakol. - 1995. - Vol. 117. - P. 457-465].

 In the treatment of mastopathy, herbal medicine and drugs based on natural biologically active substances are widely used. Extracts of medicinal plants are used both in the form of monotherapy and in the form of fees; for the treatment of mastopathy, such medicinal plants are recommended as immortelle, valerian, oregano, ginseng, St. John's wort, calendula, nettle, lemongrass, raspberries, dandelion, plantain, ergot, yarrow, violet, horsetail, chaga, string, sage, rosehip, eucalyptus et al. [Pinhosevich EG, Burdina L. M., Goryacheva L.A. et al. Phytotherapy for diseases of the mammary glands and clinical and radiological evaluation of treatment results // Mammology. - 1996. - 4. - S. 15-19].

 In recent years, biologically active food additives (BAA) have begun to be used in the treatment of mastopathy. The most well-known use for the treatment of mastopathy is the Mastodinon dietary supplement (Bionorica, Germany), which is an alcohol extract from several medicinal plants: Agnus castus (rod), Caulophyllum thalictroides (cornflower stalk), Cyclamen (alpine violet), Ignatia (bitter chestnut) , Iris (colorful iris), Lilium tigrinum (tiger lily); mastodinone is recommended for the treatment of fibrocystic mastopathy, 30 drops 2 times a day for at least 3 months [Russian Drug Register - encyclopedia of drugs. Ed. Yu.F. Krylov, G.L. Vyshkovsky, M.K. Evstigneev et al. - M.: RLS-2000, 2000. - P. 537]. Mastodinone has no contraindications, dyspepsia is noted from the side effects. Mastodinone, used in 360 patients with diffuse fibrocystic disease, with mastodynia and with the presence of filled cysts, was effective in 76% of cases [Burdina L.M., Burdina I.I. Mastodinon N and its role in the treatment of benign diseases of the mammary glands // Mammology. - 1998. - 4. - S. 28-34]. Mastodinone, used in 125 patients with mastopathy, had a positive therapeutic effect in 78% of patients with fibrocystic mastopathy, in 69% with fibrotic mastopathy, in 60% with breast cysts [Kantsaliev A.L. The efficacy of mastodinone N and vetoron in the treatment regimens for dishormonal breast pathology // Mammology. - 1998. - 4.- S. 35-39].

 The disadvantages of the above funds include the fact that most hormonal and non-hormonal drugs used to treat mastopathy have various side effects and toxic effects. Phytopreparations and dietary supplements used in the treatment of mastopathy, in most cases, have no toxic and side effects, but their disadvantages are not very high efficiency, variability of the content of biologically active substances in the extracts and the difficulty of standardizing drugs. The disadvantages of the above funds is also that with monotherapy, none of them is effective enough, therefore, in the treatment of mastopathy, as a rule, various combinations of drugs are used. Mastodinone has a high therapeutic activity in various forms of mastopathy, is well tolerated, has no contraindications and serious side effects. However, the disadvantages of mastodinone are scarce raw materials, the difficulty of standardizing the drug due to the content of a large number of various substances in the extract, lack of clarity regarding the main active substance or substances, high cost. The disadvantage of using dietary supplements in general for the treatment of mastopathy is that today dietary supplements are officially recognized by the Ministry of Health of the Russian Federation not as therapeutic or prophylactic agents, but as means for correcting food deficiencies, reducing the risk of chronic diseases, and maintaining the functions of organs and systems.

 The closest analogue to the claimed invention is a cancer prevention agent obtained from kelp [Patent 2034560 (RF). Means for the prevention of cancer "Klamin" / V.B. Nekrasova, T.V. Nikitina, V.T. Kurnygina, A.I. Fragina, V.G. Bespalov, V.A. Weinstein, V.V. Ivanova. - Declared. 05/18/93 93019880; Publ. in BI, 1995, 13], which contains saponified kelp concentrate and physiologically acceptable excipients and is available in tablet form under the name "Klamin". It is known that clamin exhibits a therapeutic effect in patients with mastopathy [Ivanova OA, Barash N.Yu., Bespalov V.G. and others. The use of the drug "Klamin" in patients at risk of breast cancer // In the book: The study and use of therapeutic and prophylactic drugs based on natural biologically active substances / Ed. V. G. Bespalov and V. B. Nekrasova, - St. Petersburg: Aesculapius, 2000. - S. 279-284].

 The analogue has several disadvantages. To obtain dietary supplements "Klamin" used kelp concentrate saponified Arkhangelsk algae plant. In the production of dietary supplements, only saccharine kelp - Laminaria saccharina (L.) Lam., Which grows in the coastal regions of the White and Barents Seas, was used, and not Japanese kelp - Laminaria japonica Aresch., Which grows in the waters of the Sea of Okhotsk and Japan in the Far East. It is known that these two types of kelp differ in the chemical composition of biologically active substances [G. Barashkov. Comparative biochemistry of algae. - M.: Food industry, 1972. - 335 S.]. Japanese Laminaria is the most valuable algae from the kelp family with the highest content of beneficial components. In addition, unlike kelp, sugary kelp, Japanese has thicker, longer and thick rhizoids. Laminaria concentrate for the production of clamin was obtained only from saccharine laminaria thalli, while substances such as polysaccharides laminaran and fucoidan with therapeutic and prophylactic properties were found in cuttings and rhizoids of laminaria [see Barashkov G.K., ibid.]. In the thallus of kelp, these substances are present only in trace amounts. Klamin is registered as a dietary supplement, so it cannot be officially recommended by doctors for use as a therapeutic agent, including for patients suffering from mastopathy. The main purpose of the dietary supplement "Klamin" is the use in people with increased oncological risk in order to prevent cancer, and not in patients with mastopathy, which, as mentioned above, do not belong to the group of increased oncological risk. Clamin also does not have sufficient effectiveness for the treatment of mastopathy.

 The technical result consists in providing a therapeutic effect on the manifestations of mastalgia, premenstrual tension syndrome, dysalgomenorrhea, echographic and mammographic pathological changes in patients with matopathy, as well as expanding the range of funds for the treatment of mastopathy. To ensure a technical result, kelp concentrate obtained from thalli, rhizoids, and cuttings of kelp of two kinds, Laminaria saccharina (L.) Lam, is essential. and Laminaria japonica Aresch., which additionally contains substances such as lamaran up to 8% and fucoidan in an amount up to 6%.

 The technical result is achieved by the fact that as a means of treating mastopathy based on kelp concentrate and excipients, the drug Mamoklam is proposed, characterized in that the kelp concentrate in hydrolyzed and non-hydrolyzed form is obtained from thalli, cuttings and rhizoids of the brown algae of the kelp family, in particularly Laminaria saccharina (L.) Lam. and / or Laminaria japonica Aresh. laminarev; the product additionally contains in 1 tablet or capsule 0.1-0.3 mg of iodine and 9-20 mg of higher fatty acids in the following ratio of components in kelp concentrate, wt.%: fatty acids 20-60; unsaponifiable substances 2-8; chlorophyll derivatives 1-12; aminoxylates, proteins 1-15; alginic acid and its salts 1-16; sugar 1-10; minerals 4-15; iodine 0.1-2.1; laminaran 0.5-8; fucoidan 0.5-6; water - the rest is up to 100. The agent for treating mastopathy is available in tablet and capsule form under the name "Mamoklam".

 Lamaria lipid concentrate obtained from brown algae of the kelp family, namely, thalli, rhizoids and cuttings of sugary kelp - Laminaria saccharina (L.) Lam., And Japanese kelp - Laminaria japonica Aresch, is used as a substance for the Mamoklama drug . , Laminariaceae [GF XI ed., No. 2, p. 83] according to the method of [RU, 2132622, Cl, A 23 L 1/0532, A 61 R 35/80]. As a raw material, the bulk of the algae by volume are Japanese kelp and sugar kelp, but other species of the kelp family can be present. Lipids of the total mass of algae make up only 1-3%, that is, from one ton of algae receive only 10-30 kg of kelp concentrate. Lipids are obtained by extraction with an organic solvent with the number of carbon atoms from 1 to 6 at a ratio of raw materials / extractant = 1 / 1-20; the lipid fraction - kelp concentrate (KL) - is separated by complete distillation of the solvent. KL is hydrolyzed with a solution of sodium hydroxide or another alkaline reagent, thereby obtaining a saponified kelp concentrate (CLO). CL and CLO obtained only from thalli of saccharine kelp contain less than 0.3% laminaran and fucoidan, and new CL and CLO obtained from thalli, rhizoids and cuttings of Japanese kelp and saccharose contain up to 8% laminar and up to 6% fucoidan.

 The composition of new CL and CLO includes such components as omega-3 and omega-6 polyunsaturated fatty acids, iodine, and other minerals derived from chlorophyll, namely chlorophyllin, polysaccharides - laminaran, fucoidan, which is organically linked to amino acids. Laminaran is present mainly in the form of a water-insoluble form with a molecular weight of about 3500. The comparative chemical composition of the kelp concentrate used for the production of dietary supplements "Klamin" (CL and CLO from the thallus of saccharose kelp) and the claimed drug - drug "Mamoklam" (CL and CLO from thalli, rhizoids and cuttings of Japanese and kelp kelp) are given in table 1.

 As can be seen from table 1, CL and CLO obtained from thalli, rhizoids, and cuttings of a mixture of saccharine and Japanese kelp are characterized by a higher content of polysaccharides of laminaran and fucoidan, as well as a higher content of iodine.

 The combination of all the above biologically active components in one drug "Mamoklam" and gives a pronounced therapeutic effect in mastopathy, and the drug can be used as monotherapy, successfully replacing complex treatment regimens for mastopathy using combinations of various drugs. The main active ingredients in the new CL and CLO are polyunsaturated fatty acids, iodine, polysaccharides laminaran and fucoidan. Polyunsaturated fatty acids normalize the hormonal balance in a woman's body. Iodine in kelp concentrate is contained in a bound state with amino acids and proteins, which ensures its good bioavailability and non-toxicity to the body. Iodine deficiency in the body often leads to hormonal imbalance and is one of the important causes of mastopathy. In the new kelp concentrate, the iodine content is almost 2 times higher due to the use of Japanese kelp, which contains more iodine. So, in CL obtained from sugary White Sea kelp, the iodine content is usually 1420-1680 μg / g, and in CL from Japanese Far Eastern laminaria - 2200-3320 μg / g. As a result, 1 tablet of the drug Mamoklam contains at least 100 micrograms of iodine, and 1 tablet of dietary supplements Klamin contains 50 micrograms of iodine. The polysaccharides laminaran and fucoidan have antioxidant and immunomodulating properties, which gives an additional therapeutic effect in patients with mastopathy.

 Two substances are obtained from brown algae of the kelp family: in the non-hydrolyzed form, CL, and in the hydrolyzed form, CLO. Non-hydrolyzed concentrate is produced according to TU 9284-153-00472012-99 under the name "KL Laminaria Concentrate - Prefabricated", which is used in the manufacture of food products and cosmetics. According to organoleptic, physical and chemical indicators, CL is a pasty mass from brown to green with a smell characteristic of seaweeds, with a mass fraction of water of not more than 30%, ash 2%, absorption in the visible region of the spectrum with maxima 405-415 and 660-670 nm Hydrolyzed concentrate is produced according to TU 9319-040-11152173-99 under the name "Saponified Laminaria Concentrate". It is a thick pasty product from green to brown in a thin layer with a characteristic odor of algae, with a mass fraction of water of not more than 50%, ash - not less than 4%, pH of a 1% aqueous solution of 7.5-10.0, with a spectral characteristic of visible spectrum at 400-430 nm, 620-670 nm. This substance is used for the production of dietary supplements "Klamin", but the active substances are not regulated in it; the content of active substances can vary greatly depending on the time of year, the place of growth of the algae, batch and production conditions, etc.

 For the production of the drug Mamoklam, only that part of CL and CLO is used, which corresponds to the Pharmacopoeia article, where the content of fatty acids and iodine are strictly regulated. CL and CLO should have at least 7 peaks of fatty acids. Peaks of fatty acids are determined by gas chromatography, including the peak of oleic acid methyl ester and the peaks of myristic, palmitic, linoleic and linolenic acids methyl esters with a relative retention time of 0.34, respectively; 0.5 5; 1.22 and 1.58 relative to the peak of oleic acid methyl ester. The fatty acid content determined by gas-liquid chromatography is at least 9 mg in 1 tablet. The iodine content is also regulated in the drug Mamoklam. When sodium nitrite is oxidized in the presence of sulfuric acid, a violet staining of the chloroform layer is observed (reaction to iodine). The iodine content in one tablet or capsule is at least 0.1 mg. KL and KLO in the medicine "Mamoklam" are standardized products in comparison with dietary supplement "Klamin".

 At a meeting of the Pharmacological Committee of the Ministry of Health of the Russian Federation (extract from protocol 8 of 7.10.1999), the drug "Mamoklam" was allowed for clinical trials as a means for the treatment of fibrocystic disease of the mammary glands. The name "Mamoklam" is recommended by the commission according to instructions and nomenclature (Minutes 27 of July 4, 2000). Clinical trials of the drug "Mamoklam" were carried out according to the protocol approved by the chairman of the expert commission of the Pharmacological Committee of the Ministry of Health of the Russian Federation on drugs used in obstetrics, gynecology and perinatology 01/13/2000

 Mamoklam tablets are prepared as follows. CL or CLO is mixed with microcrystalline cellulose and other components, the resulting mass is moistened with a granulating solution, the mixture is dried, granulated and dusted, and tablet cores are pressed. Application of a protective polymer shell from an aqueous solution of methylcellulose to the tablet cores is carried out in a fluidized bed installation. As a dye, copper derivatives of chlorophyll are used. The dosage form is a biconvex tablet, covered with a light green shell. The content of CL or CLO in 1 tablet is 0.1 g. One tablet or capsule of the Mamoklam preparation contains at least 0.1 mg of iodine and 9 mg of fatty acids.

 On the basis of the Research Institute of Oncology. prof. N.N. Petrova Ministry of Health of the Russian Federation conducted clinical trials of the drug "Mamoklam" in the dosage form: coated tablets, 0.1 g, in patients with fibrocystic breast disease. For studies, 33 women of premenopausal age, mainly of late reproductive age, were recruited, the average age of patients was 42.5 ± 1.1 years. Mamoklam was administered orally before meals, 2 tablets 3 times a day for 3 months. The examination of patients was carried out before treatment and after treatment according to the following scheme: analysis of anamnestic data; examination, palpation of the mammary glands with an assessment of clinical symptoms; X-ray mammography ultrasound of the mammary glands with the measurement of the volume of cysts. All 33 women were diagnosed with diffuse fibrocystic disease of the mammary glands during clinical, echographic, and mammographic examinations; in addition, 21 of them showed ultrasound and mammography cysts in the mammary glands, 10 had enlargement of the milk ducts, and 3 had fibroadenoma.

 Mamoklam had a therapeutic effect on the manifestations of mastalgia, premenstrual tension syndrome and dysalgomenorrhea. In 31 of 33 patients (93.9%) as a result of treatment with mamoclam, a complete disappearance or attenuation of these pathological manifestations was observed. In 18 observed patients, before the start of treatment, the duration of the ovarian cycle was more than 28 days and / or the duration of menstruation was more than 5 days, menstruation was plentiful. As a result of treatment with mamoclam in 13 patients (72.2%), the duration of menstruation decreased, they became less plentiful, in 7 patients (38.8%) the duration of the ovarian cycle became shorter. This can be assessed as a positive effect of mamoclam on the clinical manifestations of dishormonal changes. 28 of 33 patients (84.8%) experienced weakening of palpation signs of fibrocystic disease: reduction and "softening" of the seals in the mammary glands, weakening of pain on palpation. According to ultrasound data, in 15 out of 21 patients (71.4%), as a result of treatment with mamoclam, one or all measured cysts in the mammary glands were regressed, and in 4 patients (19.0%) a complete cyst regression was observed. According to sonography, in 2 patients, as a result of treatment with mamoclam, the diameter of the enlarged milk ducts decreased, in 8, the diameter of the enlarged ducts remained the same. In a second study after a course of treatment with mammoclam, the mammographic picture in 31 patients remained stable, in 2 patients (6.1%), a marked decrease in the intensity and area of fibroadenomatous changes was noted.

 Thus, mamoklam showed a pronounced therapeutic effect in patients with fibrocystic breast disease, in general, a positive therapeutic effect was observed in 94% of patients. In all 33 patients, mammoclam did not have any side and toxic effects. The results of clinical trials of the drug "Mamoklam" allow us to recommend it as an effective tool for the treatment of mastopathy - fibrocystic disease of the mammary glands.

 Comparative results of treatment of patients with mastopathy with the closest analogue of dietary supplement "Klamin" [published in the article: Ivanova OA, Barash N.Yu., Bespalov V.G. and others. The use of the drug "Klamin" in patients at risk of breast cancer // In the book: The study and use of therapeutic and prophylactic drugs based on natural biologically active substances / Ed. V.G. Bespalova and V. B. Nekrasova. - St. Petersburg .: Aesculapius, 2000. - S. 279-284] and the claimed drug drug "Mamoklam" are shown in table 2.

 As can be seen from table 2, the drug "Mamoklam" showed a more pronounced therapeutic effect in patients with mastopathy compared with dietary supplement "Klamin". In a larger number of patients, as a result of treatment, a regression of the clinical symptoms of mastopathy and a decrease in palpation of breast fibroadenomatosis were observed; it is important to note that in 6% of patients, as a result of a rather short-term treatment with mammoclam, a decrease in the intensity and area of fibroadenomatous changes was observed during mammography examination, while when applying the Klamin dietary supplement there was no positive dynamics of the mammographic picture. In addition, the drug "Mamoklam" showed a more pronounced therapeutic effect in patients with mastopathy when used in a lower dosage. Klamin dietary supplement contained 0.3 g of CLO in one tablet and was prescribed 3 tablets per day. The drug "Mamoklam" contained 0.1 g of CLO in one tablet and was prescribed 6 tablets per day. The dose of active substances when using the drug "Mamoklam" was 1.5 times lower compared with the dietary supplement "Klamin". Mamoklam has a more pronounced therapeutic effect at a lower dosage compared to clamin due to the use not only of the thallus sugary kelp, but the entire algae biomass of a mixture of sugary and Japanese kelp.

 The claimed technical solution in comparison with the closest analogue has distinctive essential features, which allows this solution to be considered as meeting the patentability condition - novelty. An analysis of the similar technical solutions known in science and technology shows that the claimed composition for the treatment of mastopathy is not found and the combination of distinctive essential features is not known.

 It was not obvious that CL and CLO obtained from thalli, rhizoids and cuttings of Japanese and kelp kelp would exhibit greater biological activity and a more pronounced therapeutic effect for the treatment of mastopathy, without causing side effects. Thus, the claimed technical solution meets the condition of patentability - inventive step.

 The following are examples of the use of hydrolyzed (KLO) and non-hydrolyzed (KL) kelp concentrate in tablet and capsule form in a clinic for the treatment of patients with mastopathy.

 Example 1. Patient S. va N.A., 48 years old. When applying complained of severe mastalgia and premenstrual tension syndrome. The duration of the ovarian cycle is 28 days, the duration of menstruation is 5 days, and the periods are plentiful. On palpation of the mammary glands, the phenomena of diffuse fibroadenomatosis, pronounced compaction in the upper outer quadrants of the mammary glands, moderate pain on palpation. With mammary echography and mammography, the picture of diffuse fibroadenomatosis with expansion of the milk ducts, against this background there are single small cysts in both mammary glands, a cyst in the right mammary gland - 0.02 ml, and 0.05 ml in the left mammary gland were measured. Based on a set of examinations, a diagnosis of diffuse fibrocystic mastopathy was made. Prescribed drug "Mamoklam" 2 tablets 3 times a day for 3 months. One tablet of mamoclama contains 0.1 g of CLO, 0.1 mg of iodine and 9 mg of higher fatty acids. At the end of treatment with mamoclam, the patient makes no complaints, the phenomena of mastalgia and premenstrual tension syndrome completely disappeared. Monthly periods during the treatment were reduced to 3-4 days, and became much less abundant. With palpation of the mammary glands, a significant decrease in the area of the foci of seals and a significant weakening of the seals, the mammary glands are painless on palpation. With mammography, a complete regression of the cysts. The result of treatment is the pronounced therapeutic effect of mamoclam.

 Example 2. Patient F-va MV, 44 years old. Upon treatment, she complained of severe mastalgia and premenstrual tension syndrome, moderate dysalgomenorrhea, and discharge from the nipples. The duration of the ovarian cycle is 30 days, the duration of menstruation is 7 days, menstruation is very plentiful. On palpation of the mammary glands, the phenomena of diffuse fibroadenomatosis, pronounced compaction in the upper outer quadrants of the mammary glands, moderate pain on palpation, discharge from the nipples of a serous nature. With breast ultrasound and mammography, the picture is diffuse fibroadenomatosis, against this background there are two cysts in the left mammary gland - 0.22 ml and 0.30 ml, on the right - small fibroadenoma 3x5x6 mm. Based on a set of examinations, the diagnosis was made: diffuse fibrocystic mastopathy, breast fibroadenoma. Prescribed drug "Mamoklam" 2 tablets 3 times a day for 3 months. One tablet of mamoclama contains 0.1 g of CLO, 0.1 mg of iodine and 9 mg of higher fatty acids. At the end of treatment with mamoclam, the patient does not show any complaints, the phenomena of mastalgia, premenstrual tension syndrome and dysalgomenorrhea completely disappeared. During treatment, the ovarian cycle decreased to 27-28 days, menstruation decreased to 4-5 days, became less plentiful and painless, discharge from the nipples stopped. With palpation of the mammary glands, a significant decrease in the area of the foci of the seals and a significant weakening of the seals, the mammary glands are painless on palpation, no discharge from the nipples. With breast ultrasound, complete regression of one cyst and a decrease in the volume of another cyst by 2 times. The result of treatment is the pronounced therapeutic effect of mamoclam.

 Example 3. Patient T-va EP, 49 years old. Upon treatment, she complained of moderate mastalgia and dysalgomenorrhea, a pronounced syndrome of premenstrual tension. The duration of the ovarian cycle is 28 days, the duration of menstruation is 4 days, and the periods are painful. On palpation of the mammary glands, the phenomena of diffuse fibroadenomatosis, pronounced compaction in the upper outer quadrants of the mammary glands, severe pain on palpation. With breast ultrasound and mammography, the picture is diffuse fibroadenomatosis, against this background there are small cysts in both mammary glands, a cyst on the left of 0.05 ml was measured. Based on a set of examinations, the diagnosis was made: diffuse fibrocystic mastopathy. Prescribed drug "Mamoklam" 2 tablets 3 times a day for 3 months. One tablet of mamoclama contains 0.1 g of CLO, 0.1 mg of iodine and 9 mg of higher fatty acids. At the end of treatment with mamoclam, the patient complains only of minor manifestations of the syndrome of premenstrual tension, the phenomena of mastalgia and dysalgomenorrhea completely disappeared. The ovarian cycle of 28 days, monthly 4 days, became painless. With palpation of the mammary glands, a significant decrease in the area of the foci of seals and a significant weakening of the seals, the mammary glands are painless on palpation. With breast ultrasound, a significant decrease in the number of cysts, complete regression of the measured cyst. With mammography, a decrease in the density of the mammogram compared to the mammogram before treatment. The result of treatment is the pronounced therapeutic effect of mamoclam.

 Example 4. Patient N-on T.V., 50 years old. When handling complained of moderate mastalgia and premenstrual tension syndrome, manifestations of dysalgomenorrhea. The duration of the ovarian cycle is 28 days, the duration of the period is 5 days, the periods are plentiful, moderately painful. On palpation of the mammary glands, the phenomena of diffuse fibroadenomatosis, pronounced compaction in the upper outer and upper inner quadrants of the mammary glands, moderate pain on palpation. With breast ultrasound and mammography, the picture of diffuse fibroadenomatosis, against this background there are cysts in the right mammary gland - 0.1 ml, and the left mammary gland - 0.1 ml. Based on a set of examinations, a diagnosis of diffuse fibrocystic mastopathy was made. The capsule preparation "Mamoklam" was prescribed, 2 capsules 3 times a day for 3 months. One capsule of mamoclama contains 0.1 g of CL, 0.1 mg of iodine and 9 mg of higher fatty acids. At the end of treatment with mamoclam, the patient makes no complaints, the phenomena of mastalgia and premenstrual tension syndrome completely disappeared. Monthly periods during the treatment decreased to 3-4 days, became less plentiful and painless. With palpation of the mammary glands, a significant decrease in the area of the foci of seals and a significant weakening of the seals, the mammary glands are painless on palpation. With mammography, a complete regression of the cysts. The result of treatment is the pronounced therapeutic effect of mamoclam.

 Thus, the drug "Mamoklam" has a pronounced therapeutic effect in patients with diffuse fibrocystic mastopathy, which is manifested by a complete regression or a significant weakening of mastalgia, premenstrual tension syndrome, dysalgomenorrhea, normalization of the menstrual cycle, regression or a significant weakening of palpatory signs of fibroadenomatosis regression of cysts in the mammary glands during ultrasound examination, improvement of the x-ray picture in mammography been concerned.

 Means "Mamoklam" for the treatment of mastopathy compares favorably with analogues in the availability of raw materials and its large reserves, higher quality and quantity of biologically active substances in the active substance, standardization of the drug for the main active substances - iodine and fatty acids, low cost and availability for most patients, higher efficacy in the treatment of mastopathy, the possibility of treating mastopathy in the form of monotherapy, the absence of serious side effects and toxic effects.

Claims (2)

1. The tool for the treatment of mastopathy, containing kelp concentrate, characterized in that the kelp concentrate obtained from thalli, rhizoids and petioles by its extraction with an organic solvent with the number of carbon atoms from 1 to 6 in the ratio of raw materials: extractant 1: 1-20, lipid separation fraction contains the following components, wt. %:
Fatty Acids - 20-60
Unsaponifiables - 2-8
Chlorophyll Derivatives - 1-12
Amino acids, proteins - 1-15
Alginic acid and its salts - 1-16
Sugar - 1-10
Minerals - 4-15
Iodine - 0.1-2.1
Lamaran - 0.5-8
Fucoidan - 0.5-6
Water - Else
2. The tool according to p. 1, characterized in that it is made in the form of tablets or capsules.  3. The tool according to p. 1 or 2, characterized in that the concentrate is obtained from Laminaria saccharina (L.) Lam. or Laminaria japonica Aresh. or mixtures thereof.

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