RU2317713C1 - Bioactive additive for prophylaxis of female genital organs - Google Patents

Abstract

FIELD: plant-based prophylaxis agents.

SUBSTANCE: claimed agent represents two separately administering preparation forms. The first preparation form contains Orthilia secunda grass, marsh cinquefoil grass and roots, elecampane rootstocks and roots, sulla (Hedysarum theinum) rootstocks and roots, milfoil dry extract, vitamins B1 and B6 in specific component ratio. The second form contains Orthilia secunda grass, calendula flowers, knot grass, button roots, tutsan dry extract, vitamins C and E in specific component ratio.

EFFECT: bioactive additive with optimum component composition.

3 cl

Description

The invention relates to prophylactic drugs based on herbal raw materials used for diseases of the female genital area, in particular inflammatory diseases, uterine fibroids, endometriosis, as well as menstrual irregularities, primary infertility, menopause syndrome.

The problem of inflammatory diseases of the female genital area is one of the most complex and relevant in gynecology. Its relevance is due to the high frequency of these diseases, which can lead to the most serious consequences. The launched inflammatory process is dangerous not only by the appearance of infertility, but can also cause bleeding, ectopic pregnancy, uterine fibroids and even cancer pathology.

Overcooling, diseases of the organs of the gastrointestinal tract, urinary system, ultraviolet radiation, smoking, alcohol abuse and also a common cold can provoke inflammation.

Diseases of the female genital area involve the entire body of a woman in the pathological process, disrupting the functions of almost all organs of the female body. Often, diseases of the female genital area cause temporary, and sometimes persistent disability.

In this regard, the urgent question is the development of tools and techniques to solve this problem.

The Cristina remedy is known in the art for the prophylaxis and postoperative treatment of gynecological diseases (RF patent N 2074001), which contains valerian (root), decopus, cancer necks, calamus root, white step, horseradish root, cinquefoil root, upright root, marshmallow root, root lobaznik, creeping wheatgrass rhizome, barberry root, hemophilus root, hybrid butterbur root, rosehip root, horse sorrel root, licorice root, horse chestnut, comfrey, tatar leaves, 40% aqueous alcohol solution if appropriate ratio of components.

Known tincture of barberry leaves for the treatment of uterine bleeding associated with inflammatory processes (Mashkovsky M.D. Medicines. - M .: Medicine, 1988, p.529).

Known drug for the treatment of diseases of the Viennese genital area (RF patent N 2217157), containing the oil fraction of water-alcohol-oil extraction from the root with rhizomes of valerian, elecampane root, blood root, thyme, marjoram, St. John's wort, immortelle flowers and linseed oil. The drug is effective in the treatment of dysfunctional uterine bleeding in women of reproductive age, menopause, as well as in the treatment of uterine fibroids.

However, all of the above drugs are medicinal and require medical prescription and control, strict adherence to dosage, and contraindications.

A promising area is the development and development of a wide production of biologically active additives (BAA) - concentrates of natural or biologically active substances identical to natural, intended for direct intake and / or incorporation into food products. Their ingestion allows you to quickly make up for the deficiency in the substances necessary for the body - vitamins, mineral salts, macro- and microelements, individual amino acids, dietary fiber and other compounds within their physiological norm.

It should be emphasized that dietary supplements are not pharmaceuticals and belong to the group of OTC food and prophylactic agents.

Characteristic features of the supplements are the gentle action on the body, the absence of adverse reactions, the possibility of a complex effect, which is especially important in the presence of several diseases at the same time. They implement the mechanism of a non-pharmacological safe way of regulating and supporting the functions of individual organs and systems of the human body, which ensures an increase in the level of health and a decrease in the incidence of disease.

This approach is especially relevant due to the fact that drug treatment, often giving side effects, allergic reactions, does not solve the problem, if the body's defenses are not enough to restore its normal functions or drug therapy itself weakens the protective functions (for example, when using potent drugs , radiation, surgical methods of treatment).

The creation of biologically active additives based on natural raw materials, characterized by low toxicity and the possibility of prolonged use without the risk of side effects, allows us to solve problems that are not amenable to modern pharmacotherapy. Their use makes it possible to provide an affective prophylactic and healing effect at the initial stage of treatment and at the stage of recovery, as well as in the complex treatment of sluggish chronic diseases between the main treatment courses.

Known biologically active food supplement herbal tea "Aphrodite" (Federal dietary supplement dietary supplement. - M .: Kogelet, 2000, p.338), which includes chamomile flowers, calendula flowers, motherwort grass, oak bark, sage leaf, leaf plantain leaf eucalyptus. The additive is used as a general strengthening agent with anti-inflammatory effect in chronic diseases of the genitourinary system in women. Release form - powder.

Known biologically active herbal supplement "Marya" (Federal Register of dietary supplements for food. - M .: Kogelet, 2000, p.342), which includes rose hips, birch leaves, marigold flowers, licorice root, chamomile flowers, grass series, lobaznik flowers or echinacea grass, oregano grass. It is used as an adjunct in chronic inflammatory diseases of the genitourinary system in women. Release form - powder.

For the prototype, the biologically active additive "Dobrodeya" was taken, which is a powder containing burdock root, licorice root, kelp, one-sided orthilium (pine uterus), evasive peony root, broccoli cabbage, kohlrabi cabbage, four-leaved rhodiola root (http: // stana .nsknet.ru / statya12.html). Supplements are recommended for the prevention and adjunctive therapy of diseases of the female genital area in women of different ages. Reception is carried out in the form of infusion: 1 dessert spoon (5 g) in a small amount of boiling water 1 time per day.

The disadvantage of this dietary supplement is its powder form, which complicates dosing and does not provide ease of use in any environmental conditions.

The objective of the present invention is to expand the range of dietary supplements of domestic production, providing a preventive effect in diseases of the female genital area. Supplements should have a form convenient for the consumer, storage and reception. The result achieved by using the invention is to develop a prophylactic dietary supplement that meets the above requirements.

The problem is solved by the proposed dietary supplement formulation for the prevention of diseases of the female genital area, which contains one-sided ortilia grass, grass and roots of the marsh cinquefoil, rhizomes and roots of elecampane, rhizomes and roots of tea penny, dry yarrow extract, calendula flowers, bird of the mountaineer, burdock root, oregano grass, St. John's wort dry extract, vitamins B ₁ , B ₆ , C and E. Moreover, the dietary supplement is made in the form of two solid preparation forms taken separately in time. In this case, the first solid preparative form contains one-sided orthilia grass, grass and roots of the marsh cinquefoil, rhizomes and roots of elecampane, rhizomes and roots of tea lyphenia, dry extract of yarrow, vitamins B ₁ , B ₆ , in the following ratio, mg:

Ortilian grass one-sided 114.3 grass and roots of the marsh cinquefoil 90.0 rhizomes and roots of elecampane 80.0 rhizomes and roots of tea penny 100.0 dry yarrow extract 15.0 Vitamin B ₁ 0.3 vitamin b ₆ 0.4

and the second solid preparative form contains one-sided orthilia grass, calendula flowers, bird of highlander grass, burdock roots, oregano grass, St. John's wort dry extract, vitamins C, E in the following ratio of components, mg:

Ortilian grass one-sided 100.0 marigold flowers 50,0 Highlander's grass 50,0 burdock roots 100.0 oregano grass 50,0 dry hypericum extract 15.0 vitamin C 14.0 vitamin e 1,5

Moreover, the mentioned preparative forms:

- made in the form of tablets or capsules;

- contain excipients;

Excipients are standard excipients that are widely used in the pharmaceutical industry in the manufacture of solid formulations, in quantities that provide known technologies for their manufacture.

In the preparation of tablets, microcrystalline cellulose or other auxiliary substances, for example, calcium or magnesium stearate and aerosil, can be added to the composition to eliminate excessive hygroscopicity and improve the tabletting ability. Tablets are made in a known manner on tablet presses. Another, more modern preparative form of the dietary supplement is gelatin capsules containing the powder of the claimed composition.

The analysis of the prior art showed that all the components that make up the dietary supplement are widely used in the art for various purposes.

Orthilium is one-sided - contains tannins, arbutin, hydroquinone, flavonoids, resins, coumarins, saponins, bitter substances, acids (tartaric and citric). In medicine, it is widely used as a diuretic, disinfectant in inflammatory processes in the kidneys and bladder, with cystitis, pyelonephritis.

Marsh cinquefoil - tannins, flavonoids (up to 10%), free gallic acid, catechins, flavonoid gossipertin, essential oil, saponins, ash, macrocells - potassium, calcium, magnesium, iron were found in the roots and rhizomes. trace elements - manganese, copper, zinc, cobalt, chromium, aluminum, barium, vanadium, selenium, nickel, lead, boron. In traditional medicine, rhizomes with roots are used for rheumatism, osteochondrosis, radiculitis, stomach pains, bleeding, liver diseases, tuberculosis, thrombophlebitis, uterine bleeding, and bites of rabid dogs.

Elecampane - rhizomes and roots contain inulin (up to 44%), inulinin, saponins, resins, gum, mucus, pigment, acetic and benzoic acids, a small amount of alkaloids, vitamin E and essential oil. The healing properties of elecampane have been known since antiquity. Mention of him is in the writings of Hippocrates. It was used by the Greeks and Romans. Elecampane preparations are used as a good expectorant, diuretic and anthelmintic. In folk medicine, the plant is very popular, and therefore it was given the name nine forces. It is used as an expectorant for various diseases of the respiratory tract, for diabetes mellitus, for scrofula, jaundice, hemorrhoids, as a blood purifying and metabolic agent, for joint diseases, thrombophlebitis, anemia, hypertension, gynecological diseases (painful menstruation and their absence) omission of the uterus). In homeopathy, elecampane is known as a uterine remedy. It is a source for the preparation of the formulinic preparation "Inulin" used for diabetes (RF patent N 1214104).

Tea penny (red root) - is a valuable medicinal plant. In the underground part of the tea penny, phenolic compounds of a catechin and leukoanthocyanine structure are contained in large quantities, which are known to have high P-vitamin activity - strengthen and restore the walls of capillaries, remove heavy metals from the body. This explains the widespread use of tea penny in the treatment and prevention of various diseases: tumors, leukemia, chronic inflammation of the reproductive sphere (prostatitis, infertility), neurological and cardiovascular pathologies.

Yarrow - the aerial part of the plant, in which the glycoalkaloid achilene, essential oil (containing chamazulene, camphor, cineole, isovalerianic acid, menthol, etc.), volatile, tar, tannins, flavonoids, organic acids, vitamins C and K, are found for medical use , carotene and significant amounts of aluminum, chromium, iron, copper, manganese and potassium.

Yarrow has been known in folk medicine for several centuries as a medicinal plant. It was used as a means of improving digestion, and later as a wound healing and hemostatic. The ability of the plant to increase blood coagulability was confirmed by experiments, while it was found that the yarrow also has a painkiller.

Preparations from a mixture of yarrow and nettle are used as hemostatic, soothing and painkillers, especially with uterine bleeding due to inflammatory processes, with fibromyoma.

Yarrow is very popular in folk medicine. It is used as a hemostatic, diaphoretic, and strengthening agent for pulmonary tuberculosis, peptic ulcer disease, kidney stone disease, malaria, hemorrhoids, female diseases (heavy menstruation, etc.), and nighttime urinary incontinence. It is a raw material for obtaining "Azulen" - an effective tool for the treatment of radiation injuries, tumors and as an antiseptic.

Calendula - Calendula has long been known as a medicinal plant. In medicine, its inflorescences are used, in which triterpene and tannins are found, carotenoids (carotene, lycopene, rubixanthin), flavonoids (quercetin, isoralcetin and their glycosides), traces of alkaloids and essential oil, the bitter substance calendine, saponins, resins, mucus, coumarins , sterols, salicylic, malic, caffeic and chloroic acid, polysaccharides, etc.

Clinical trials have shown the beneficial effect of calendula preparations in case of neurosis, gastric ulcer, and duodenal ulcer, liver and biliary tract disease, menopause and upper respiratory tract diseases. Some doctors prescribe calendula for delayed menstruation.

In folk medicine, calendula is very popular and has long been used for diseases of the liver, gastrointestinal tract and spleen, for cardiovascular diseases, breast cancer and female genital organs, and externally for the destruction of acne, warts, corns, lichens, skin cancer .

Highlander bird - the grass of the mountaineer contains flavonoids (quercetin, rutin, kempferol, moteomin, etc.), vitamins C, K, E, carotene, tannins, macro- and microelements (calcium, phosphorus, zinc), silicates, protein, traces of essential oils. Highlander bird has anti-inflammatory, diuretic, choleretic, restorative, antipyretic, astringent, hemostatic, wound healing and tonic effect.

Burdock - roots - contain inulin, mucus, a fatty oil consisting of palmitic and stearic acids, as well as sitosterol and sigmasterol, tannins and bitter substances, mineral salts, vitamins. Burdock roots have antitoxic, blood purifying, diuretic, choleretic, diaphoretic, anti-febrile properties, stimulate mineral and carbohydrate metabolism, promote glycogen deposition in the liver, improve the pancreatic insulin-forming function and stimulate the production of proteolytic enzymes. The latter, in turn, reduce inflammation, destroy free radicals.

Burdock roots are used for diseases of the prostate gland. Their activity with respect to tumor growth retardation was noted. Burdock preparations are widely used for gastric ulcers, chronic gastritis, kidney stone and gallstone diseases, rheumatism and gout, diabetes mellitus, impaired salt metabolism, and chronic pancreatitis. In Chinese medicine, burdock roots are used to treat syphilis.

Oregano - in the grass contains an essential oil containing thymol (up to 1.2%), carvacrol and other substances. The plant also found tannins and bitter substances, vitamin C, volatile, flavonoids (quercetin, lutesolin and their glycosides), phenol carboxylic acids.

In folk medicine, oregano grass is widely used in various diseases: as a sedative for mental disorders, for epilepsy, as a sleeping pill, for headaches, angina pectoris, hypertension, and diseases of the gastrointestinal tract. It is used internally for female diseases (regulates menstruation, moderate excessive pain), as well as scrofula, sore throat, etc.

St. John's wort - St. John's wort grass contains flavonoids, anthocyanins and leukoanthocyanins, tannins, carotene, essential oils, vitamins C, P, PP, trace elements - manganese, zinc. It is known that, thanks to a large set of biologically active substances of various chemical groups, St. John's wort herb has a variety of pharmacological properties, the main of which are anti-inflammatory, antimicrobial, antispasmodic and stimulating tissue regeneration processes. St. John's wort improves venous circulation and blood supply to internal organs.

In medicine, preparations from St. John's wort are known as astringents, hemostatic, anti-inflammatory and disinfectants and are often used for acute and chronic colitis.

In folk medicine, St. John's wort has long been famous as a remedy, it is called the herb "from ninety-nine diseases." The herb of the plant is used as an astringent for gastrointestinal diseases, which reduces the separation of profuse sputum in diseases of the respiratory tract, as a tonic for cardiovascular diseases, hemostatic for uterine bleeding, and as an anti-inflammatory for angina. St. John's wort is also included in a mixture of herbs used in diseases of the liver and gallstones, with inflammation of the kidneys, with gout, cystitis, bronchitis, furunculosis, acne, with female diseases, etc.

Vitamin B ₁ (thiamine chloride and / or thiamine bromide) is one of the most important vitamins of group B. It is part of enzymes that regulate carbohydrate metabolism, as well as amino acid metabolism. Its deficiency leads to a violation of the oxidation of carbohydrates, inhibition of the exchange of vital functions, to the accumulation in the blood and tissues of under-oxidized metabolic products, which in turn leads to pathophysiological changes in the nervous and cardiovascular systems. In addition to the preventive and therapeutic effect with appropriate hypo- and vitamin deficiency, indications for the use of vitamin B are neuritis, sciatica, neuralgia, muscle weakness, upset gastrointestinal tract, sleep disturbances, fatigue, etc.

Vitamin B ₆ , (pyridoxine hydrochloride) - participates in the synthesis of hemoglobin, takes part in more than 100 biochemical reactions, provides synthesis and metabolism of carbohydrates. fats, amino acids; an essential component of sixty enzyme systems.

Its deficiency contributes to liver obesity, atherosclerosis, is a cause of impaired nervous system function, causes loss of appetite, nausea, toxicosis of pregnancy, etc.

Vitamin E or tocopherol (bearing offspring) is a vital vitamin that affects the activity of the whole organism, especially the development and functioning of the hormonal and reproductive system. It is a strong antioxidant that protects the body from the damaging effects of free radicals.

Vitamin E provides the maturation of germ cells, contributes to the preservation of pregnancy. It has a vasodilating effect, so it is used for hypertension, angina pectoris, as well as for violations of the function of the sex glands, diseases of the skin, liver, inflammatory diseases of the retina, as well as neuromuscular dystrophies.

Vitamin C (ascorbic acid) - its absence in food causes the development of scurvy, and deficiency leads to hypovitaminosis. The properties of vitamin C are very diverse. In the human body, this vitamin regulates blood coagulation and the level of lipids in the blood, the formation of bone and connective tissue (collagen), and regulates carbohydrate metabolism. Vitamin C stimulates the immune system, as well as the production of interferon. preventing the reproduction of viruses. In addition, it is one of the strongest antioxidants since binds free radicals, preventing their destructive effect on body tissues. In addition, vitamin C has the ability to increase the activity of other antioxidants, such as vitamin E, the latter being quickly restored in the presence of vitamin C from the oxidized form. Thus, vitamin C promotes the speedy healing of wounds, strengthens teeth, bones, improves skin condition, gives elasticity to blood vessels, strengthens the body's ability to resist infections.

A significant difference of the claimed dietary supplement is that it is made in the form of two formulations taken separately in time. Supplements are taken two tablets twice a day with meals according to the following scheme: first, from the 1st day of the sexual cycle, take the first preparative form, then from 12-15 days (from the middle of the cycle, depending on the duration of the individual sexual cycle), preparative form.

For women during menopause and with a cycle disorder, the complex can be used starting from any day sequentially: the first preparative form, then the second preparative form. During the year, two to three courses are possible.

In this case, it is very important to correctly select a complex of medicinal plants and vitamins, which are included in the first and second preparative form. In the claimed dietary supplement, medicinal plants and vitamins that are part of each formulation are selected taking into account the correct approach to the characteristics of the female body - two-phase cyclic functioning of the reproductive system.

As can be seen from the above, each of the plants and each of the vitamins included in the proposed dietary supplement has properties that are useful in terms of the preventive effect on the female genital area. In addition, the ingredient and quantity composition of each formulation is determined on the basis of a comprehensive assessment of beneficial properties, possible side effects and contraindications.

The first preparative form (formula 1)

The composition of formula 1 includes herbs that have anti-inflammatory, hemostatic effect. The pronounced anti-inflammatory effect on the organs of the female genital area is due to the P-vitamin activity of flavonoids (in particular flavonoids and catechins), which are part of the one-sided orthilium, saberfoot, tea penny (red root), yarrow, which strengthen and restore the walls of the capillaries, as well as improve microcirculation blood and blood supply in the pelvic organs and the supply of tissues of the organs of the reproductive system with oxygen and nutrients, which helps to reduce the inflammatory process.

Iridoids, coumarins, saponins, tannins, polysaccharides also have anti-inflammatory and antimicrobial effects. By stimulating the activity of leukocytes, they help strengthen immunity.

Hemostatic effect due to the presence of a wide range of bioactive medicinal plants. Three mechanisms of their action can be distinguished:

- capillary-protective effect of flavonoids, in particular catechins of one-sided orthilia, tea penny, yarrow;

- the effect of iridoids and saponins of one-sided ortilia, saber-eared, elecampane, yarrow, which enhance the reduction of the smooth muscles of the uterus

- the effect of tannins and Achillein yarrow, which increase blood coagulability.

In addition, the antioxidant activity of biological substances of medicinal plants that are part of the formula 1, helps to neutralize free radicals that are produced in the course of life and are responsible for the occurrence of many diseases, including neoplasms.

It should also be noted that in addition to the already known properties, a new valuable quality of iridoids was discovered - their hormonal biological activity, which makes it possible to exert a normalizing effect on hormonal disorders in a woman's body.

In harmony with the biologically active substances of medicinal plants, vitamins B ₁ and B _{6 work} , combining well and complementing each other. These vitamins are necessary for women of reproductive age in the first half of the sexual cycle, because promote egg maturation in the ovarian follicles, improve tissue nutrition, regulate protein metabolism and hemoglobin synthesis. In the climacteric period of a woman’s life, vitamins B ₁ and B ₆ contribute to the normalization of the state of the nervous system, which makes it possible to alleviate the general condition, reduce the feeling of anxiety, and smooth out mood swings. Thus, the first preparative form:

- normalizes the functional state of the female genital area and optimizes the balance of sex hormones in the first phase of the sexual cycle of women of reproductive age;

- has a pronounced anti-inflammatory, hemostatic effect;

- enhances immunity and helps prevent the development of benign tumors.

The second preparative form (formula 2)

The main function of the composition of formula 2 is the stimulation of the gonads, the equalization of the menstrual cycle, as well as the antitumor effect.

Biologically active substances - sterols, iridoids and other glycosides, which are part of the one-sided orthilium, marjoram, St. John's wort, calendula, burdock, and mountaineer bird, showing hormonal activity, improve the functional state of the sex glands. No wonder these plants have long been used in folk medicine as a means to regulate menstruation during their delay, as well as painful and heavy menstruation.

St. John's wort stimulates the production of androgens of male sex hormones, which helps to reduce the increased activity of estrogens of female sex hormones (this is one of the basic principles for the treatment of benign formations: fibromyomas, endometriosis, which arise precisely due to increased activity of estrogens).

Bioactive substances - orthilium iridoids, essential oils of oregano, hypericin and St. John's wort pseudo-hypericin have a calming, antidepressant effect, help relieve feelings of anxiety, irritation, and smooth out mood swings. They also have anesthetizing, antispasmodic effect, help reduce breast engorgement before menstruation.

The presence of biologically active substances such as lactone calendula lolliolide, flavonoids, catechins, coumarins, carotenoids, which have antioxidant activity, determine the antitumor effect of medicinal plants included in formula 2. They inhibit the development of mastopathy, fibromyomas and other neoplasms of the female genital area. The antitumor properties of medicinal plants are enhanced by the presence of vitamins C and E, which are one of the most powerful antioxidants. In addition, these vitamins, in addition to antioxidant, have a gonadotropic effect (stimulate ovarian function). Their use in the second phase of the sexual cycle has a positive effect on the formation of hormones in the ovaries, and this contributes to the alignment of the sexual cycle.

Thus, the second preparative form:

- normalizes the functional state of the female genital area in the second phase of the sexual cycle: optimizes the balance of sex hormones in the second phase of the sexual cycle, stimulate the onset of the next cycle;

- improve overall health, smoothing out the unpleasant symptoms of premenstrual and menopausal syndrome;

- helps prevent the development of benign tumors;

A distinctive feature of the claimed dietary supplement in relation to the prototype is that it can) be made in the form of two preparative firms:

- either in the form of tablets;

- either in capsule form.

This gives her a number of advantages.

Firstly, a tablet or capsule form is very convenient for taking the drug in any specific application conditions: tablets or capsules can always be carried and taken at any time of the day in trains, public places, etc. With prolonged maintenance therapy, this factor is of great importance.

Secondly, the implementation of preparative forms in the form of tablets or capsules gives an extension of the product range in form and the choice for the buyer of the most convenient, acceptable form of the drug for him.

Thus, the inventive biologically active supplement is a natural preparation based on the use of medicinal plants and vitamins, which is effective in any of the age periods of the Vienna organism and is necessary:

- for the prevention of functional disorders of the Vienna genital area;

- in the complex treatment of diseases of the female genital area as an auxiliary substance in:

- menstrual irregularities;

- inflammation of the ovaries, fallopian tubes, endometriosis, uterine myoma;

- to reduce pain, bleeding, which are often accompanied by fibroids, endometriosis;

- for rehabilitation in the recovery period in order to consolidate the anti-inflammatory effect of the main treatment and prevent the transition of inflammatory diseases into chronic forms,

On the basis of the municipal health institution in Biysk "Diagnostic Center" (Department of Gynecology), studies were conducted on the effectiveness of the claimed biologically active additives in the prevention and complex treatment of gynecological diseases under the trade name "Ortilida" (formula 1 and formula 2).

The influence of dietary supplements on the following clinical indicators was studied: pain syndrome, inflammatory syndrome, dynamics of changes in hematological parameters, hemorrhagic syndrome, menstrual irregularity.

The study belonged to a variant of an open clinical experiment, pursued therapeutic and prophylactic goals, and included clinical, laboratory, and instrumental evaluation of the results. Complex therapy of gynecological diseases using dietary supplements "Ortilida" (Formula 1 + Formula 2) was carried out on an outpatient basis after a comprehensive examination of patients. All patients were informed about the essence of the upcoming clinical experiment.

The drug was taken for 2-3 sexual cycles according to the following scheme:

"Ortilida" (Formula 1): from the first day of the cycle, 2 tablets 2 times a day. Duration of admission is 12-15 days (depending on the duration of the cycle).

Ortilida (Formula 2) 2 tablets 2 times a day. Duration of admission is 12-15 days following the administration of Ortilide (Formula 1).

A total of 40 women were examined aged from 22 to 51 years (average age 36.5 years) with a clinically established diagnosis of uterine fibroids, adenomyosis, polycystosis, chronic endometritis, menstrual dysfunction, endometrial hyperplasia, primary infertility, combined form. The experimental group included 20 people, the control group also included 20 people with similar diseases. Patients of the experimental group received drug treatment and dietary supplement plant complex "Ortilida" (Formula 1 + Formula 2). The control group received only traditional drug treatment.

Before the start of the course and immediately after graduation, a conversation was held with all patients, their complaints were clarified, medical history was assessed, their general condition, general clinical blood test, and ultrasound examination of the internal genital organs were evaluated.

After a 2-3-month course of taking Ortilida dietary supplement (Formula 1 + Formula 2) in patients with a diagnosis of uterine fibroids, adenomyosis, polycystosis, chronic endometritis, menstrual dysfunction, endometrial hyperplasia, primary infertility, infertility, a combined form is noted: a decrease in pain and hemorrhagic syndromes, increasing hemoglobin to normal levels, normalizing the regulation of the menstrual cycle. Dietary supplement "Ortilida" (Formula - 1 + Formula 2) helps to improve overall well-being, normalize sleep, reduce psychological lability.

According to the results of the study, the Ortilida dietary supplement (Formula 1 + Formula 2) is shown as a general strengthening agent effective in the complex treatment of uterine fibroids, adenomyosis, polycystic, chronic endometritis, menstrual dysfunction, endometrial hyperplasia, primary infertility, combined form infertility improving the functional state of the female genital area. Recommended doses: 2 tablets 2 times a day. The course of admission is 1-3 months. Repeated courses are possible.

As a result of clinical trials of dietary supplements "Ortilida" (Formula 1 + Formula 2), data were obtained confirming the effectiveness of the use of dietary supplements in the following scheme:

Ortilida (Formula 1) from the first day of the cycle for 12-15 days (depending on the individual duration of the cycle), Ortilida (Formula 2) in the second half of the cycle following the Ortilida pium (Formula 1).

Studies have shown pronounced effectiveness of dietary supplements: anti-inflammatory "Ortilida" (Formula 1) already in the first phase of the cycle of the first course of treatment; beneficial effect on gynecological status (normalization of the menstrual cycle) "Ortilida" (Formula 2).

Studies of dietary supplements "Ortilida" (Formula 1 + Formula 2) confirmed that this particular dietary supplement regimen meets the requirements of the existing practice of treating gynecological diseases with the use of phyto- and vitamin therapy (in the first phase of the cycle, treatment with B vitamins, in the 2nd phase with antioxidants E, C).

Patients who underwent a 3-month course of treatment received the most positive reviews. It should be noted the convenience of the form of release: combines medicinal herbs and vitamins in the required dosage, does not require brewing, 2 tablets are used 2 times a day, which is important for the regularity of dietary supplement intake. All women noted an improvement in their general well-being and positive dynamics in the treatment of the disease, all of them expressed a desire to use the dietary supplement "Ortilida" (Formula 1 + Formula 2) to reduce the risk of exacerbation in the future.

For women with fibroids and chronic inflammatory processes, Ortilida dietary supplement (Formula 1 + Formula 2) is recommended to be used as a means of increasing the effectiveness of basic therapy during exacerbation and in remission.

In more detail, the proposed technical solution is described using an example of a specific implementation, not limiting the invention.

Production Example.

The first stage involves the separate preparation of the first and second solid preparative forms of the claimed dietary supplement by mechanical grinding of powders of plant materials in a mill UI-2 and mechanical mixing of powder of plant materials, vitamins, in a mixer SPU-20 in the required quantities in accordance with the formulations of the first and second preparative forms . When performing dietary supplements in the form of tablets, microcrystalline cellulose is added to the main components as an auxiliary substance in the required amount. Mixing is carried out for at least 30 minutes.

Next, the semi-finished product is unloaded and checked for uniformity of mixing by sieving through a sieve with a hole diameter of 1 mm

If there are agglomerates (lumps) on the sieve of dry extracts or vitamins, the semi-finished product is additionally passed through a UI-2 mill through a mesh with a mesh size of 1 × 1 mm.

The resulting material may be compressed to form tablets or capsule packaging.

The preparation of the claimed dietary supplement is carried out on known equipment, using known means, therefore, the technical solution has industrial applicability.

The beneficial effect of using the invention is that the range of domestic preventive drugs based on plant materials is expanding.

Claims (3)

1. A biologically active additive for the prevention of diseases of the female genital area, containing one-sided ortilia grass, burdock roots, characterized in that the additive further comprises grass and roots of the marsh cinquefoil, rhizome and root of elecampane, rhizome and roots of tea lycis, dry yarrow extract, calendula flowers , Polygonum grass avian, marjoram, St. John's wort dry extract, vitamins _{B1, B6,} C and E, wherein the additive is in the form of two separated in time taken of solid formulations, the first solid I formulation contains ortiliya sided grass, grass, marsh cinquefoil roots, rhizomes and roots elecampane, rhizomes and roots of Hedysarum tea, dry extract of yarrow, vitamin B _1, B _6, with the following ratio, mg: Ortilian grass one-sided 114.3 grass and saber roots swamp 90.0 rhizomes and roots of elecampane 80.0 rhizomes and roots of tea 100.0 dry yarrow extract 15.0 Vitamin B ₁ 0.3 vitamin b ₆ 0.4 and the second solid preparative form contains one-sided orthilia grass, calendula flowers, bird of highlander grass, burdock roots, oregano grass, St. John's wort dry extract, vitamins C, E in the following ratio of components, mg: Ortilian grass one-sided 100.0 marigold flowers 50,0 Highlander's grass 50,0 burdock roots 100.0 oregano grass 50,0 dry hypericum extract 15.0 vitamin C 14.0 vitamin e 1,5 2. The dietary supplement according to claim 1, characterized in that the said forms are made in the form of tablets or capsules. 3. The dietary supplement according to claim 1, characterized in that the said forms contain excipients.