RU2310343C1 - Biologically active additive for prophylaxis of mail genitourinary system diseased - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: claimed additive represents two separately administering solid preparations. The first preparation contains orthilia secunda grass 152.5 mg; burdock root 100.0 mg; knotgrass grass 75.0 mg; cowberry leaves 50.0 mg; foxberry extract 15.0 mg; vitamin E 2.5 mg; zinc oxide 5.0 mg. The second preparation contains orthilia secunda grass 70 mg; tick trefoil rootstocks and roots 107.5 mg; prince's pine grass 70 mg; rhodiola rosea rootstocks and roots 50 mg; nettle leaves 50 mg; salvia leaves 30 mg; tutsan extract 15 mg; vitamin E 2.5 mg; zinc oxide 5.0 mg.

EFFECT: effective additive for enhancing of sexual potency.

3 cl, 1 ex

Description

The invention relates to prophylactic agents based on medicinal plant materials used in diseases of the urogenital sphere in men, in particular prostatitis.

Diseases of the genitourinary sphere, in particular the pathology of the prostate gland, is one of the most common diseases in middle-aged and elderly men. This is due to a violation of the hemodynamics of the prostate gland, which leads to changes in the biochemical and bactericidal properties of the secretion, a decrease in the barrier function of the prostate, and this, in turn, becomes a prerequisite for both the penetration of the infection and the aggravation of the course of inflammation.

Currently, the treatment of diseases of the prostate and related pelvic organs is represented by various methods of treatment, in particular, using antibiotics. However, these drugs inevitably affect not only the pathogens of infection, but also affect the normal intestinal microflora, which in turn contributes to the inhibition of the immunobiological reactivity of the body.

Recently, for these purposes, complex preparations based on medicinal plants are increasingly being used, such as Prostagut (Germany), which contains ethyl ester of fatty acids of finely serratus cinquefoil extract, Canadian aspen leaf extract, dioecious nettle rhizome extract; collection "Antiprostin", which includes nettle roots, thyme grass, goldenrod grass, chamomile inflorescences; "Prostanorm" (RF patent No. 2098119), made in the form of a collection containing the roots of licorice, perforated St. John's wort, Canadian goldenrod grass and Echinacea purpurea.

On the basis of preclinical and clinical trials, Prostanorm has a prostatotropic effect due to moderate androgenic activity, antimicrobial, anti-inflammatory and analgesic properties, as well as the ability to improve microcirculation of prostate tissue. In addition, the drug has a gastro- and hepatoprotective, sedative and diuretic effect.

However, Prostanorm and all of the above drugs relate to medicines and require medical prescription.

Recently, biologically active additives (BAA) are widely used, the status of which, according to regulatory provisions, is different with respect to drugs. Supplements are compositions of natural or identical to natural biologically active substances. They are not drugs and belong to the group of OTC food and prophylactic agents. Supplements implement the mechanism of non-medicinal, safe way of regulation and support of the functions of individual organs and systems of the human body.

There are known dietary supplements for normalizing the functions of the prostate gland: Prostate Rex (USA), Aurita (Austria), Prostate (Netherlands), Prostate (Peru) and others.

Panfitem M, taken by us as a prototype (Federal Register of Supplements for Food, Moscow, 2002, p. 410), which contains wheat bran, oatmeal, soy flour, pantohematogen, and red root (tea penny) belongs to similar preparations. ), calamus root, incense root, Rhodiola rosea, St. John's wort perforated, lingonberry leaf, black currant leaf, blueberry leaf. Supplements are intended as a general strengthening agent for persons with chronic prostatitis. A disadvantage of the known drug is its powdered consumer form, which must be steamed before use, which in some cases creates significant inconvenience in its use. The drug is impossible or difficult to use in public places, when traveling by transport, etc.

The technical task underlying the present invention is the expansion of the range of dietary supplements of domestic production, providing high efficiency for the prevention of diseases of the male urogenital sphere. Supplements should be in a convenient consumer form, allowing reception in any environmental conditions.

The technical result when using the inventive product is the improvement of the functional state and prevention of organic changes in the male urogenital area.

The problem is solved by the proposed dietary supplement formulation for the prevention of diseases of the male urogenital sphere, which contains one-sided ortilia grass, burdock roots, bird mountaineer leaves, cowberry leaves, bearberry extract, rhizome and tea root roots (red root), umbrellas, rhizomes and rhizome roots pink, nettle leaves, sage leaves, St. John's wort extract, vitamin E, zinc oxide, moreover, dietary supplement is made in the form of two separately taken solid preparative forms. In this case, the first solid preparative form contains one-sided orthilia grass, burdock roots, bird mountain grass, lingonberry leaves, bearberry extract, vitamin E, zinc oxide in the following ratio, mg:

Ortilian grass one-sided 152.5 burdock roots 100.0 Highlander's grass 75.0 lingonberry leaves 50,0 bearberry extract 15.0 vitamin e 2,5 zinc oxide 5,0

and the second solid preparative form contains one-sided orthilia grass, rhizomes and roots of tea lypheme, umbelliferous grass, rhizomes and roots of Rhodiola rosea, nettle leaves, sage leaves, St. John's wort, vitamin E, zinc oxide in the following ratio, mg:

Ortilian grass one-sided 70.0 rhizomes and roots of tea penny 107.5 umbrellas grass 70.0 rhizomes and roots of Rhodiola rosea 50,0 nettle leaves 50,0 sage leaves 30,0 hypericum extract 15.0 vitamin e 2,5 zinc oxide 5,0

Moreover, the mentioned preparative forms:

- made in the form of tablets and 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 prepared 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.

One-sided ortilium 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, pylonephritis.

Burdock - the 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 against tumor growth retardation was noted. Burdock preparations are widely used for gastric ulcers, chronic gastritis, kidney stone and cholelithiasis, rheumatism and gout, diabetes, impaired salt metabolism, and chronic pancreatitis. In Chinese medicine, burdock roots are used to treat syphilis.

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

Lingonberry - in medicine, mainly leaves are used, which contain glycoside, arbutin, tannins, flavonoids, proanthocyanides and catechins, gallic, quinic, ursolic, malic, acetic, citric, oxalic and other acids, as well as carotene, vitamin C and trace elements - Manganese, barium, lead, copper, silver. Manganese in lingonberries is hundreds of times more than in other plants. Leaf preparations are recommended for inflammation of the bladder and urinary tract, with kidney stones and the bladder.

Bearberry - bearberry leaves, which contain glycoside, arbutin (up to 16%), methylarbutin, tannins (up to 35%), flavonoids, hydroquinone, organic acids (malic, formic, quinic and others), vitamin C and trace elements, are of therapeutic value - Manganese, aluminum, copper, zinc, barium, lead. It is used in medicine as a diuretic and disinfectant, for bleeding and inflammation of the kidneys, for bleeding and stones of the bladder.

In folk medicine, bearberry is used for chronic nephritis, painful urination, urinary incontinence and chronic diarrhea, as well as for strengthening nerves and sexually transmitted diseases.

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.

Umbrellas are Umbrella - the grass contains glycosides, arbutin, erikokhin, tannins, Urozon, bitter substances, resins, methyl esters of salicylic and urolic acids, sotosterol, flavonoids. The plant is included in the pharmacopeia of Germany and the United States. Chamomile grass is used for diseases caused by excessive weight lifting (nadezda, omission of the abdomen, kidney, uterus), painful uterine bleeding, diabetes mellitus, colitis, stomach cancer, to prevent epileptic seizures, rheumatism, gout, liver diseases, and disinfection urinary tract, with pyelitis and cystitis, inflammation of the prostate gland.

Rhodiola rosea - for its medicinal properties, the plant was called the golden root. It has long been used in folk medicine in the countries of Southeast Asia. He was known and highly valued by the lamas of ancient Tibet. The main active ingredients of the roots of Rhodiola rosea are cinnamoyl glycosides - rosavin and rosavidin, as well as the phenol alcohol tyrosol and its glycoside rhodioloside. In addition to them, the roots contain up to 20% of tannins, anthraquinones, flavonoids, essential oil, phenolic acids (gallic, coffee, etc.), wax, sterols, organic acids (succinic, citric, malic, oxalic), quite a lot of manganese. Pharmacological and clinical studies of the golden root revealed its stimulating, antihypnotic effect and ability to enhance the body's resistance to adverse effects. Tests of recent years have also shown anti-tuberculosis and antitumor activity of the root.

In folk medicine, it is used for nervous and stomach diseases, as a tonic, for nasadas, diabetes, scrofula, with heavy uterine bleeding, for the treatment of anemia, impotence.

Nettle - in medicine, nettle is used as an anti-inflammatory, vitamin-containing (found in significant quantities vitamins C, K, B, carotene) and hemostatic. Nettle also contains tannins, flavonoids, alkaloids, phytoncides, formic, coffee, ferulic acids, gums, sterols, histamine, urcosane glycoside and trace elements - chromium, iron, copper, manganese, vanadium and others.

In folk medicine, nettle is used for gout, rheumatism, kidney and bladder diseases, for thinness, dropsy, liver, gall bladder diseases. In the ancient "herbalists" nettle is referred to as an anti-cancer and anti-venom remedy. Nettle is a valuable medicinal plant. Nettle leaves were officially adopted by the USSR Pharmacopoeia in 1961 and are used as a hemostatic agent for various bleeding (uterine, pulmonary, renal, intestinal and others). Nettle extract is a part of allahol, used in diseases of the liver and gall bladder.

Sage - the leaves contain essential oils, tannins, flavonoids, bitterness, volatile, with a strong bactericidal effect. The plant has a calming, disinfecting, expectorant, astringent, hemostatic, anti-inflammatory, choleretic, diuretic effect. Antimicrobial properties are associated with essential oil, anti-inflammatory - with tannins, flavonoid compounds and vitamin P, which tighten epithelial tissues, reduce the permeability of cell membranes, walls of blood and lymph vessels. The antiseptic properties of sage leaves are due to the plant-based antibiotic Salvin. Sage is widely used in scientific and folk medicine in many countries for the treatment of gastrointestinal diseases, cholecystitis, hepatitis, kidney diseases, diabetes, bronchitis, hypertension, atherosclerosis, etc. It is also used to treat inflammatory diseases of the genitourinary organs, including and prostatitis.

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 has various 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 a mixture with other plants, St. John's wort is used for prostate adenoma, vesiculitis, prostatitis, atony of the prostate against a background of chronic prostatitis. St. John's wort herb extract is part of the Inconturin preparation used for prostate adenoma, cystitis, and bedwetting.

Zinc oxide (ZnO) - Zinc has a normalizing effect on the prostate and is important for the development of all reproductive organs, helping to avoid problems with the prostate gland. The prostate needs zinc to protect itself from the effects of the 5-alpha reductase enzyme, which converts testosterone to dihydrotestosterone. With a lack of zinc in the prostate, the hormone dihydrotestosterone accumulates, which causes the iron to swell, and this, in turn, prevents the outflow of urine in older men and causes prostate adenoma.

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 normalizes blood pressure, strengthens the walls of blood capillaries, and prevents the emergence of cancer cells. Vitamin E deficiency causes nervous and muscle disorders, such as weakening reflexes, difficulty walking, and weakening of the muscles of the eyes. In addition, a lack of vitamin E causes a reduction in the lifespan of red blood cells. Studies have shown that with vitamin E deficiency, heart muscles and reproductive tracts can also suffer.

A significant difference of the claimed dietary supplement, not only from the prototype, but also from all known analogues, is that it is made in the form of two formulations taken separately in time. First, the first preparative form (formula 1) is taken within 20 days, and then the second (formula 2) within the next 20 days.

In this case, it is very important to correctly select the complex of medicinal herbs that are included in the first and second preparative form. In the claimed dietary supplement, the medicinal plants that make up each formulation are selected taking into account the correct phased approach to solving the problem of functional disorders of the male genitourinary tract. The effect of taking dietary supplements is based on the fact that first the first preparative form eliminates the causative factor of harmony in a man’s life - relieves inflammation in the urinary tract and prostate gland, and then the second preparative form leads to an increase in potency.

As you can see, each of the plants included in the proposed dietary supplement has properties that are useful in terms of the preventive effect on the urogenital sphere of men. However, the ingredient and quantitative composition of each formulation was determined on the basis of a comprehensive assessment of beneficial properties, possible side effects and contraindications.

The first preparative form.

The composition of formula 1 includes anti-inflammatory, diuretic herbs, which can relieve inflammation and restore the functional state of the prostate and urinary tract. The main active substances, such as arbutin, hydroquinone, iridoids, tannins, ursolic acid, volatile, part of the one-sided orthilia, lingonberries, bearberry, poultry, have anti-inflammatory, diuretic, antimicrobial effects, which allows the use of these herbs in combination for treatment various colds and infectious diseases of the genitourinary system in men.

Flavonoids, coumarins, iridoids, carotenoids, inulin, which are part of the one-sided ortilia, burdock, bird highlander, lingonberry, bearberry, have antioxidant activity, inhibiting the onset and inhibiting the development of benign neoplasms, increase immunity, stimulate phagocytosis and other protective forces of the body.

Coumarin, the scopoletin of the mountaineer of birds stimulate the production of testosterone - the male sex hormone necessary for the normal functioning of the prostate.

In harmony with the biologically active substances of medicinal plants, vitamin E and zinc oxide work, combining well and complementing each other, so the first preparative form:

- has a pronounced anti-inflammatory effect;

- reduces pain;

- normalizes urination.

The second preparative form.

Formula 2, in addition to anti-inflammatory herbs, contains adaptogens: tea penny (catechins, flavonoids) and Rhodiola rosea (salidrosides, alkopoids, glycosides), which have a tonic effect on the central nervous system, contribute to the normalization of metabolic processes, and increase resistance to stress. In addition, the biologically active substances (coumarin, scopoletin, steroid complex) that make up nettle, sage, and St. John's wort stimulate the production of testosterone, the male sex hormone. Also, the biologically active substances of nettle and sage enhance spermatogenesis (the formation and development of sperm) and sexual desire.

Tea catechins, possessing P-vitamin activity, improve blood microcirculation and blood circulation in the pelvic organs, supplying tissues of the genital organs with oxygen and nutrients and removing toxic substances in a timely manner.

Flavonoids, catechins, coumarins of the one-sided ortilia, umbelliferus, umbrellas, tea penny, nettle, St. John's wort, sage inhibit the growth and development of benign neoplasms.

Iridoids, flavonoids, saponins, gallic acid, tannins of one-sided ortilia, umbilical anus, have an anti-inflammatory, antimicrobial, diuretic effect.

As well as in the first preparative form, here in harmony with the biologically active substances of medicinal plants, zinc oxide and vitamin E work, thanks to which the second tablet form:

- enhances the production of sex hormones;

- stimulates potency, spermatogenesis;

- helps to prevent prostatic hyperplasia, preventing the development of prostate adenoma.

A distinctive feature of dietary supplements in relation to the prototype is that it can be made in the form of two preparative forms:

- either in pill form

- 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 and 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 claimed biologically active additive is a natural preparation based on the use of medicinal plants, vitamin E and the trace element zinc, is effective in any of the age periods of a man’s life and is necessary:

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

- in the complex treatment of diseases of the male genital area as an aid in prostatitis, prostate adenoma, urethritis;

- for rehabilitation during the recovery period in order to prevent the transition of inflammatory diseases into chronic forms.

Studies of the impact of the claimed biologically active additives as an adjuvant in the complex treatment of diseases of the genitourinary system and men under the trade name "Ortilius" were carried out in the urology department of the Biisk Central City Hospital.

The experimental study group included 32 people with chronic prostatitis aged 30 to 57 years. In addition to the traditional drug treatment of dietary supplements "Ortilius", patients received throughout the treatment.

The control group consisted of 27 people with similar diseases aged 27 to 59 years. Patients in this group received only medication.

During the study, the drug was taken in dosage: 2 tablets 2 times a day with meals. Duration of use is 40 days. According to the results of the study, it was concluded that in the group of patients using the dietary supplement "Ortilius" a more pronounced therapeutic effect was revealed, manifested in a decrease in pain symptoms, symptoms of dysuria, activity of the inflammatory process, in improving the quality of life and positive trends to restore vascularization.

Among patients, not a single negative effect of dietary supplement "Ortilius" on the studied tests and their dynamics was revealed.

According to the results of the study and the effectiveness of the use of dietary supplements "Ortilius" as an additional tool in the standard treatment and preventive measures in patients with chronic prostatitis, good tolerability of this drug was found without complications and side effects. There was an increase in the effectiveness of standard therapy when taking this drug in patients with chronic prostatitis in the phase of exacerbation of diseases.

Dietary supplement "Ortilius" in the form, dosage and method of administration proposed by JSC "Balsam" (Biysk) can be recommended as a therapeutic and prophylactic agent, either alone or in combination with drugs in patients with chronic prostatitis in the phase of exacerbation and remission.

In addition, on the basis of the city hospital in Biysk, clinical studies were conducted to justify the effectiveness of the use of dietary supplements "Ortilius" (formula 1 and formula 2) in the complex treatment of diseases of the genitourinary system in men. Supplements were taken according to the following scheme: "Ortilius" (formula 1) - in the first 20 days; Ortilius (formula 2) - the next 20 days.

The studies were carried out in two groups. The main group consisted of 40 patients with chronic prostatitis. The main group received traditional treatment and dietary supplement "Ortilius" (formula 1 + formula 2), the control group received only traditional treatment.

According to the results of the studies, it was concluded that when conducting a comparative analysis of the complex of clinical, functional and laboratory parameters in patients with chronic prostatitis in the group taking the dietary supplement "Ortilius" (formula 1 + formula 2), for the majority of the studied parameters, a similar positive treatment effect with the same type is seen the dynamics of reducing the symptoms of diseases and their extinction, as in the group with drug therapy, but without dietary supplements.

However, in the main group of patients when using the dietary supplement "Ortilius" (formula 1 + formula 2), a more pronounced therapeutic effect was revealed, while the results of the study confirm that "Ortilius" (formula 1) has anti-inflammatory activity, manifested in the reduction of pain symptoms, improved composition secretion of the prostate gland, and improves urinary function, and the action of Ortilius (formula 2) is manifested by a positive tendency to restore spermatogenesis. However, most patients noted an increase in potency, an improvement in the psycho-emotional mood.

According to the results of studying the effectiveness of the use of dietary supplements "Ortilius" (formula 1 + formula 2), as an additional tool in the ongoing standard treatment and prophylactic measures, patients with chronic prostatitis showed good tolerability of this drug without complications and side effects. There was an increase in the effectiveness of standard therapy when taking this drug in patients with chronic prostatitis in the phase of exacerbation of the disease.

For men with chronic prostatitis, the dietary supplement "Ortilius" (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 mixing of plant materials, vitamin E, zinc oxide in the SPU-20 mixer in the required quantities in accordance with the receptors 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 UP-2 mill through a mesh with a mesh size of 1 × 1 mm.

The resulting material can be compressed to form tablets or dosed and packaged in capsules.

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

The effect obtained from the use of 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 male genitourinary sphere, containing rhizomes and roots of tea tea, rhizomes and roots of Rhodiola rosea, lingonberry leaves, St. John's wort, characterized in that St. John's wort is used as an extract, the additive additionally contains one-sided orthilia grass, burdock roots, Highlander grass, bearberry extract, Umbrellis herb Umbrella, nettle leaves, sage leaves, Vitamin E, zinc oxide, and the additive is made in the form of two solid preparations taken separately in time forms, while the first solid preparative form contains one-sided ortilia grass, burdock roots, bird mountain grass, lingonberry leaves, bearberry extract, vitamin E, zinc oxide in the following ratio, mg: Ortilian grass one-sided 152.5 burdock roots 100.0 Highlander's grass 75.0 lingonberry leaves 50,0 bearberry extract 15.0 vitamin e 2,5 zinc oxide 5,0 and the second solid preparative form contains: one-sided orthilia herb, rhizomes and roots of tea apis, umbrellas grass, rhizomes and roots of Rhodiola rosea, nettle leaves, sage leaves, St. John's wort, vitamin E, zinc oxide in the following ratio, mg: Ortilian grass one-sided 70.0 rhizomes and roots of tea penny 107.5 umbrellas grass 70.0 rhizomes and roots of Rhodiola rosea 50,0 nettle leaves 50,0 sage leaves 30,0 hypericum extract 15.0 vitamin e 2,5 zinc oxide 5,0 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 auxiliary substances.