Biologically active supplement for prophylaxis of cardiovascular diseases

FIELD: medicine, cardiology, phytotherapy, pharmacy.

SUBSTANCE: invention relates to the field in development of an agent of vegetable origin used for improvement of the functional state and prophylaxis of organic alterations in cardiovascular system, in particular, atherosclerosis. The biologically active supplement used for prophylaxis of cardiovascular diseases, in particular, atherosclerosis comprises clover dry extract, haw-thorn flowers powder, ascorbic and nicotinic acids, and accessory substances taken in the definite ratio. The biologically active supplement is made in the form of tablet or capsule. No adverse responses observed in intake of the supplement. The blood cholesterol level was reduced to the normal value in 68% of patients and reducing morbidity with acute respiratory-viral infections has been noticed. In patients with ischemic heart disease with cholesterolemia the improvement of the state is noted on the background of conventional therapy: the moderate reducing the arterial pressure value in its elevation, improved in the state of health, enhanced working capacity, reduced retrosternal pains, ear noise, vertigo, headache.

EFFECT: valuable medicinal properties of supplement.

1 ex

 

The invention relates to the pharmaceutical industry, namely to funds on the basis of medicinal plants to improve functional status and prevention of organic changes in the cardiovascular system, in particular atherosclerosis.

It is known that cardiovascular diseases such as atherosclerosis, in recent years began to affect not only the elderly, but also people fairly young age. In this regard, the issue of prevention of such diseases. Despite the large number of drugs for the treatment of atherosclerosis, there is a lack of “soft” prophylactic agents that do not have side effects. Such means can be, first and foremost, means on the basis of medicinal plants, in particular on the basis of clover.

Known medicinal gathering for the treatment of cardiovascular diseases according to the patent of Russian Federation №2163132, which contains the hawthorn flowers, herbs, mint, mistletoe, clover, motherwort, thyme and Valerian root, wherein the collecting further comprises the root of Scutellaria baicalensis, herb, chamomile flowers, clover pink, lilac, cornflower, aboveground part of St. John's wort, tansy flowers, herbs cudweed herb and Pasternak, the root of peony, herb verbena drug is authorized, burdock root, herb Rue, hops, grass knotweed and lady's bedstraw, elecampane root and groundsel, berries, Astragalus woolly, grass treacle, the herb Arnica Montana and spring Adonis, and used the flowers of the hawthorn blood-red flowers of yellow melilot.

It is known that firms in the United States Sureal International, Neways Inc., Nature's Sunshine Products Inc. produce encapsulated biologically active additives based on red clover, also known homeopathic substance clover, plow and creeping for use in homeopathic preparations.

In Pyatigorsk state pharmaceutical Academy, together with the state enterprise “Pharmaceutical factory” , Volgograd designed and produced clover extract liquid (Extractum Trifolii fluidum), 70% alcohol, which is recommended for use as anti-sclerotic tools.

In addition to the liquid extract of clover Pyatigorsk state pharmaceutical Academy in collaboration with the Institute of Experimental medicine of the Russian Academy of medical Sciences (St. Petersburg) was developed sclerotic and hypolipidemic drug, “Trioplan”, which is a dry purified extract of the herb red clover (RF patent No. 2068269).

The disadvantage of this drug is high hygroscopic substance, causing the production of tablets in an industrial environment was satr dnano. Therefore, on the basis of the substance of trisilane were developed granules with pectin and inclusion complexes with β-cyclodextrin (Kompancev VA and other Receipt and biological activity of the complex include trisilane with β-cyclodextrin and its compositions with pectin - pharmacy. - 1998. No. 4. - P.40).

Object of the invention is the expansion of the range and preparative forms of funds based on clover for prevention of cardiovascular diseases, particularly atherosclerosis. The technical result is obtained when using the proposed product, improving functional status and prevention of organic changes of the cardiovascular system by pronounced hypolipidemic and cardiotonic action.

The problem is solved in that the proposed dietary Supplement for the prevention of cardiovascular diseases, particularly atherosclerosis, containing dry clover extract powder, hawthorn, ascorbic and nicotinic acid and excipients in the following ratio, wt.%:

dry extract of clover - 15,0-27,5

powder of the flowers of the hawthorn - 15,0-27,5

ascorbic acid - 15,0-27,5

nicotinic acid - 6,0-11,0

auxiliary substances to 100.

The proposed dietary Supplement has TableRow is full or capsulated form. In addition, tablets, if necessary, coated with a special pharmacologically acceptable shell.

It is known that the main cause of atherosclerosis is a disorder of lipid metabolism, and flavonoids perform the role of natural antioxidants in the regulation of processes of lipid peroxidation in the cells. This determines the possibility of use as etiopathogenetic means plants containing flavonoids, have shown protective properties for the treatment of atherosclerosis. One such plant is the clover. Clover is used in folk medicine for vitamin deficiency, anemia, asthenia and atherosclerosis, acute respiratory diseases, kidney diseases, malaria, and various tumors. It is added in fees in the treatment of bronchial asthma. Externally clover is used for burns, abscesses and boils on the skin. In addition, grass and clover flowers are widely used in folk medicine as a capillary tool.

Rod clover legume in Russia almost 70 species. The most available and widely used in folk medicine types of red clover red clover creeping (white), pink clover.

In the inventive biologically active additive, we propose to use grass clover from the sort of meadow (red) and creeping (white), site is preferably clover (red), as it is universally introduced to the culture and its resource base is virtually unlimited. According to the State Pharmacopoeia of the USSR (the global Fund of the USSR. General methods of analysis. Medicinal plant raw materials./The USSR Ministry of health, Ed. 2nd supplementary), Medicine, 1989. - V.2. - s.400) main pharmacological activity of clover due to flavonoid compounds. Total flavonoid complexes clover and creeping reduce cholesterol and triglycerides in the blood, thereby showing hypolipidemic activity.

In addition to flavonoid compounds aboveground part of the clover contains saponins, organic acids, carotene, vitamins, minerals, tannic and resinous substances, essential and fatty oils, protein, fiber.

Hawthorn (flowers and fruits) is an excellent cordial tool. It can be used for a variety of cardiovascular diseases, and, very importantly, it is an excellent preventive tool that supports the heart muscle. As part of the proposed BAD use flowers of the hawthorn, which are harvested during flowering and quickly dried. The effect of hawthorn is primarily due to the flavonoids, oligomeric procyanidin, biogenic amines and certain other substances. The flowers of hawthorn are also cardiotonic and anti-sclerotic effect. Put the AUX effect is the interaction of all contained in hawthorn substances, not just act summarily, but mutually balance each other.

Ascorbic acid (vitamin C) is a powerful antioxidant, which neutralizes the effect of water-soluble free radicals. At deficiency of vitamin C in the first place violated the strength of blood vessels, so it is important in the prevention of cardiovascular diseases as a means of strengthening the blood vessels. In addition, in the presence of vitamin C significantly enhanced the pharmaceutical activity of flavonoids.

Nicotinic acid (vitamin PP) has gipolipidemicescoy activity. It causes a decrease of total cholesterol, low-density lipoprotein and especially triglycerides. In medicine nicotinic acid is used in spasm of the limbs, kidneys, brain, as well as in neuritis of the facial nerve, atherosclerosis, infectious diseases.

Excipients that ensure the flowability of the powder, direct pressing and mechanical strength of the tablets is primarily microcrystalline cellulose (MCC). In addition to MCC for forming tablets use other auxiliary substances, such as calcium stearate or magnesium and Aerosil. The number of auxiliary substances selected from the calculation of the optimal characteristics of the powder in the ratio of hygroscopicity, SIPO is the input of and ability to molding.

On the basis of the conducted research it was proposed to combine the drug two kinds of plants: clover and hawthorn and to enhance the vitamin activity to complement the composition of ascorbic and nicotinic acids, and for optimum formation and reduce the hygroscopic substance proposed to add excipients in the following ratio, wt.%:

dry extract of clover - 15,0-27,5

powder of the flowers of the hawthorn - 15,0-27,5

ascorbic acid - 15,0-27,5

nicotinic acid - 6,0-11,0

auxiliary substances to 100.

Preparative forms of the proposed biologically active supplements are tablets and capsules. When preparing tablets to eliminate excessive hygroscopicity and improved ability to pelletizing the composition is added in the required amounts of microcrystalline cellulose (MCC) and other auxiliary substances, such as calcium stearate or magnesium and Aerosil. Tablets are prepared in a known manner on tablet presses. Another, more modern, preparative form of the BAD gelatin capsules containing powder of the proposed structure. Another form of the proposed biologically active additives are film-coated tablets. The shell is performed by known methods from known is the materials. The need to create such preparative forms, such as capsules and tablets, coated, due to the fact that encapsulated form and coated tablets, digested in the large intestine, without irritating the esophagus and the small intestine and causing an unpleasant taste.

The applicant has conducted clinical testing of water-alcohol extract of red clover, which confirmed its hypolipidemic activity. Also conducted clinical testing BAD under the trade name “Heteroclitic” based on the dry extract of red clover, powder hawthorn, ascorbic and nicotinic acid in the inventive ratios, which showed a good hypolipidemic activity of the drug: in 68% of patients showed a reduction of cholesterol in the blood to normal.

Experimental and clinical trials have established good hypolipidemic activity of the drug containing the dry clover extract powder, hawthorn, ascorbic acid, nicotinic acid and excipients (including MCC), in form of tablets or capsules.

Flavonoid complexes clover and rose hips blend well and complement each other, enhancing stated hypolipidemic effect, allowing you to recommend dietary SUPPLEMENTS for the prevention of atherosclerosis is. The additional introduction of the ascorbic acid (vitamin C) in an amount of from 15.0 to 27.5 wt.% and nicotinic acid (vitamin PP) from 6.0 to 11.0 wt.% also complements and enhances the positive effect, since vitamin C is a powerful antioxidant in synergy with flavonoids, strengthens blood vessels, and nicotinic acid has gipolipidemicescoy activity and is used to spasms of the blood vessels as a vasodilator agent. Therefore, the content of pharmacologically acceptable quantities in the same drug ingredients aimed at reducing the level of lipids in the blood, strengthening and widening of the blood vessels in combination with antioxidant activity, to maintain and strengthen heart muscles, allows to achieve the claimed technical result.

The invention is illustrated is not limiting the invention, examples of industrial implementation of the SUPPLEMENTS in the form of tablets and capsules. Example 1. Cook the mixture is based on one tablet SUPPLEMENTS weight of 300 mg 50,0±5.0 mg of dry extract of red clover, of 50.0±5.0 mg of fine powder of the flowers of the hawthorn, 50,0±5.0 mg of ascorbic acid, 20,0±2.0 mg of nicotinic acid, not more than 2.0 mg calcium stearate or magnesium, not more than 8.0 mg of Aerosil grades a-380 and the rest is microcrystalline cellulose. The resulting mixture was thoroughly mixed and pressed. Example 2. Goto the Yat mixture from the calculation: one capsule a BAD mass of 200 mg take to 50.0±5.0 mg of dry extract of red clover, 50,0±5.0 mg of fine powder of the flowers of the hawthorn, 50,0±5.0 mg of ascorbic acid, 20,0±2.0 mg of nicotinic acid, not more than 2.0 mg calcium stearate or magnesium and the rest is microcrystalline cellulose. The resulting mixture was thoroughly stirred and capsulebuy.

Methods of qualitative chemical analysis confirmed the presence of flavonoids and tannins. The recommended dosage for oral administration of 1 tablet or capsule 2 times a day during meals.

It is known that atherosclerosis develops over years and decades, so as its prevention and treatment can be very long. In this regard, the proposed drug is ideal for long-term use as a prophylactic anti-sclerotic, as side effects of its constituent ingredients is not installed.

Preparation invented by the BAD conduct on the well-known equipment, using known means, therefore, a technical solution has industrial applicability.

The composition and manufacturing technology SUPPLEMENTS allow you to get a quality product with therapeutic effect, satisfy the security requirements SanPiN 2.3.2.1078-01. When storage conditions in accordance with GOST 29189-91 product preserves the organoleptic, physico-chemical and microbiological parameters in p is adalah requirements of GOST.

The benefits from the use of the invention is that expanding the range of domestic treatment-and-prophylactic preparations based on vegetable raw materials.

1. Dietary Supplement for the prevention of cardiovascular diseases, particularly atherosclerosis, containing dry clover extract powder, hawthorn, ascorbic and nicotinic acid, and excipients in the following ratio, wt.%:

Dry extract of clover 15,0-27,5

Powder of the flowers of the hawthorn 15,0-27,5

Ascorbic acid 15,0-27,5

Nicotinic acid 6,0-11,0

Auxiliary substances To 100

2. Biologically active additive according to claim 1, characterized in that it has a tableted or encapsulated form.

3. Biologically active additive according to claims 1 and 2, characterized in that the film-coated tablets.



 

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SUBSTANCE: invention relates to the field in development of an agent of vegetable origin used for improvement of the functional state and prophylaxis of organic alterations in cardiovascular system, in particular, atherosclerosis. The biologically active supplement used for prophylaxis of cardiovascular diseases, in particular, atherosclerosis comprises clover dry extract, haw-thorn flowers powder, ascorbic and nicotinic acids, and accessory substances taken in the definite ratio. The biologically active supplement is made in the form of tablet or capsule. No adverse responses observed in intake of the supplement. The blood cholesterol level was reduced to the normal value in 68% of patients and reducing morbidity with acute respiratory-viral infections has been noticed. In patients with ischemic heart disease with cholesterolemia the improvement of the state is noted on the background of conventional therapy: the moderate reducing the arterial pressure value in its elevation, improved in the state of health, enhanced working capacity, reduced retrosternal pains, ear noise, vertigo, headache.

EFFECT: valuable medicinal properties of supplement.

1 ex

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