RU2236858C2 - Biologically active supplement "fitogipertonit" - Google Patents

Abstract

FIELD: medicine, pharmaceutical industry, phytotherapy.

SUBSTANCE: invention is used for prophylaxis and adjunctive therapy in hypertension, in early stage stages of heart ischemic disease. The preparation used for prophylaxis and adjunctive therapy in hypertension and early stages of heart ischemic disease comprises haw-thorn tincture dry extract, motherwort tincture dry concentrates, common balm herb infusion, rowan melanocarpus (Aronia) fruits infusion and bear berry leaves infusion, citric acid, magnesium aspartate, potassium aspartate, starch, calcium stearate, talk and sugar taken in the definite ratio. The preparation is made as tablet with mass 0.55 g. The preparation promotes to effective prophylaxis and adjunctive therapy in hypertension, in early stages of heart ischemic disease.

EFFECT: valuable medicinal properties of supplement.

1 tbl

Description

The invention relates to medicine, in particular to the parapharmaceutical industry, producing drugs for therapeutic and prophylactic purposes, and can be used for prophylaxis and adjunctive therapy of hypertension, in the early stages of coronary heart disease.

Known dietary supplement “Co Q ₁₀ ” / Pilate T.L. and other Kazakhstani register of biologically active food additives. Almaty, Leovit, 2000, p.139 / - a drug that is a complex that activates the energy processes in the cell, strengthens the heart muscle, has antioxidant properties, normalizes blood coagulation, positively affects the heart rhythm, improves microcirculation. It is used for vegetative-vascular dystonia, hypertension, coronary heart disease. The preparation contains hawthorn berries, cayenne pepper, hawthorn extract, coenzyme Q ₁₀ , peppermint, green mint.

Known dietary supplement “Cardio Health” / Pilate T.L. and other Kazakhstani register of biologically active food additives. Almaty, Leosit, 2000, p.138 / - a drug for the prevention of cardiovascular diseases that improves heart function, lowers blood pressure, improves microcirculation in blood vessels, provides vitamin and mineral support for the heart muscle and nerve fibers, lowers blood cholesterol, anti-atherosclerotic means. Antioxidant and antihypoxant (promotes activation of cellular respiration). It is indicated for coronary heart disease, strokes, myocardial infarction, for the elderly. The preparation contains vitamins A, C, E, B ₁₂ , niacin, folic acid, magnesium, zinc, selenium, potassium, garlic, white willow bark, a concentrate of hawthorn berries, an extract from the leaves of ginkgo biloba, coenzyme Q ₁₀ .

The objective of the invention is the development of a new affordable drug - biologically active additives in tablet form, convenient for use, as well as having hypotensive, vasodilating, cardiotonic effect.

The invention is aimed at expanding the arsenal of drugs for the prevention and treatment of hypertension and the early stages of coronary heart disease.

The proposed preparation contains a dry concentrate of tincture of hawthorn, dry concentrate of tincture of motherwort, infusion of lemon balm herb, infusion of aronia chokeberry and extract of bearberry leaves, citric acid, magnesium asparaginate, potassium asparaginate, as well as starch, calcium stearate, talc and sugar in the following ratio of components, g per tablet weighing 0.55 g:

dry concentrate

tincture of hawthorn 0.000175-0,000525

dry concentrate

motherwort tinctures 0.000175-0,000525

dry infusion concentrate

lemon balm herbs 0.0000075-0.0000225

dry infusion concentrate

chokeberry aronia 0.0000225-0.0000375

dry infusion concentrate

bearberry leaves 0.0000075-0.0000225

citric acid 0.0045-0.0055

potassium asparaginate 0.0045-0.0055

magnesium asparaginate 0.0045-0.0055

starch 0.06-0.08

calcium stearate 0.005-0.006

talcum powder 0.005-0.015

sugar rest

The drug is called - Dietary supplement "FitoHypertonitis."

The pharmacological activity of dietary supplements “FitoHypertonitis” is manifested in hypotensive, vasodilating, cardiotonic, sedative, diuretic action; regulates the rhythm of heart contractions, vascular tone, improves general and organ hemodynamics.

Supplements are used for the prevention and adjunctive therapy of hypertension, neurocirculatory dystonia of the hypertonic type, in the early stages of coronary heart disease.

The dietary supplement “FitoGipertonit” in the form of tablets is prepared as follows.

Sugar in the amount of 81.4 is ground in a mill.

The yield of crushed sugar is 80.8 kg.

Next, the fruits of chokeberry aronia in the amount of 0.37 kg and crushed bearberry leaves in the amount of 0.185 kg are poured into 9 kg of purified room temperature water, insisted on a boiling water bath with frequent stirring for 15 minutes.

Pre-crushed lemon balm herb, in the amount of 0.185 kg, is placed in an enameled container of 10 liters containing infusion of chokeberry fruits and bearberry leaves and insist on a boiling water bath for another 15 minutes. Cool at room temperature for 45 minutes, after which the infusion with a decoction is filtered, squeezing the plant material. If necessary, add water to the desired volume. Then filtered through four layers of gauze.

The yield of infusion with a decoction (1.5% dry) of 7.4 kg.

0.93 kg of citric acid are loaded into a 5-liter container, 1 kg of combined broth and infusion are added, mixed with a wooden spatula until the acid is completely dissolved; if necessary, heat (mixture 1).

The output is 1.93 kg.

In an enameled 20-liter container, 5.0 kg of ready-made infusion of herbs, 10 kg of sugar are weighed on a scale, brought to a boil, stirring with a wooden spatula (syrup).

Separately, starch in an amount of 1.0 kg (in terms of 100% of the preparation) is placed in an enameled container of 3 l, 1.4 kg of combined infusion with broth are added. The prepared suspension of starch is introduced into boiling syrup with constant stirring, brought to a boil. The yield of starch paste is 17.2 kg.

The crushed sugar, starch, potassium asparaginate, magnesium asparaginate are sieved on a vibrating unit through a sieve with a hole diameter of 1 mm, calcium stearate and talc are sieved through a sieve with a hole diameter of 0.5 mm.

Tinctures (3.5% dry) of hawthorn and motherwort are filtered through four layers of gauze.

In the mixer with the lid open, load 70.8 kg of ground sugar; 14.4 kg of starch (in terms of 100% of the drug), and mixed for 5 minutes. Separately, 0.93 kg of potassium asparaginate, 0.93 kg of magnesium asparaginate and 10 kg of a mixture of sugar and starch are mixed, mixed thoroughly and added to the mixer. Mix again for 5 minutes. Then add tincture of hawthorn in an amount of 1.85 kg and tincture of motherwort in an amount of 1.85 kg, mix for 3 minutes and add mixture 1 in an amount of 1.93 kg, mix for 3 minutes and add starch paste in syrup in an amount of 17.2 kg, mix for 5 minutes.

The yield of the product is 109.89 kg.

The wet mass in the amount of 109.89 kg is loaded in portions into the installation to obtain granulate from wet tablets. Wet granulate is collected in a receiver. Wet granulate is transferred from the receiver to the dryer.

The yield of wet tablet mass is 109.34 kg.

Moistened tablet mass in the amount of 109.34 kg is laid out on paper in trays with a layer thickness of 1.5-2 cm and dried at a temperature of 40-45 ° C, with an increase in which the flow of hot air is automatically turned off. The drying process is carried out for 8-10 hours to constant weight, with periodic stirring (at least 3 times). Product humidity - no more than 2%. The dry tablet mass is sent to dry granulation.

The yield of dry tablet mass is 98.43 kg.

The dried mixture in the amount of 98.43 kg is loaded in portions into the installation to obtain granulate from dry tablets.

The yield of dry granulate is 97.94 kg.

To the dry granular tablet mixture, sifted talc in an amount of 2.04 kg and sieved calcium stearate in an amount of 1.02 kg are added to the mixers and mixed for 10 minutes. The finished granulate is transferred to tableting.

The yield of finished granulate is 101.00 kg.

From the mixer, the dry granulate is sent for tabletting to the loading hopper of the tabletting machine.

The diameter of the tablet is 12.0 ± 0.2 mm,

tablet height 3.8 ± 0.2 mm,

the average tablet weight is 0.55 g ± 0.02.

Finished tablets are sieved on a vibrating screen through a hole with a diameter of 8 mm, weighed on an 8 kg scale and loaded into clean, dry plastic buckets.

Samples of the finished tablets are transferred to the control and analytical laboratory for analysis.

If the tablets comply with the technical documentation standards, the finished tablets are transferred to the packaging stage. The output of the finished tablets is 100 kg.

The sequence of operations is the same regardless of the number of prepared composition.

The dietary supplement "PhytoHypertonitis" contains well-known medicinal products that are approved for use in medical practice, which, in the indicated combination (see table, examples 1-3), have hypotensive, vasodilating, cardiotonic effects.

Calcium stearate and talc are used as auxiliary components to ensure the reliability of maintaining the shape of pressed tablets in a dry form and their short disintegration time in a humid environment, and sugar, starch and water are used to improve the flowability of granules and increase the compressive strength.

Available in the form of tablets, which is convenient for use, has a long shelf life (2 years).

Clinical trials were conducted on volunteers.

Supplements "FitoHypertonitis" were included in the complex therapy of patients aged 49-75 years with a diagnosis of grade II-III hypertension in patients with IHD of varying severity. In 70% of patients, a stable nature of hypertension was noted, in 30% - a crisis course.

Against the background of basic therapy with the inclusion of dietary supplement in 72% of patients, it was possible to cancel potassium-sparing diuretics (hypothiazide), the rest of the patients reduced the dose of the diuretic by 2 times. The dynamics of blood pressure in 54% of patients on the background of the intake of dietary supplements made it possible to reduce the dosage of ACE inhibitors (enaloprim) by 50% (to 5 mg × 2) and in 36% of patients by 25% (to 7.5 mg × 2). None of the 6 patients with a critical course of hypertension during the observation period (within 21 days) showed hypertensive crises, despite a decrease in basic therapy.

The data obtained made it possible to use the dietary supplement "PhytoHypertonitis" as monotherapy in the treatment of patients aged 17-34 years with a diagnosis of grade I hypertension and hypertensive neurocirculatory dystonia.

All patients from the first days had a satisfactory diuretic effect. On days 3-7, normalization of blood pressure and positive dynamics of neuro-vegetative symptoms were observed. The quality of sleep improved, fatigue decreased, the emotional state stabilized, and the pulse returned to normal. During the observation period (14 days), vascular crises were not observed in patients.

Claims (1)

A drug for the prevention and adjunctive therapy for hypertension and the early stages of coronary heart disease, characterized in that it contains a dry concentrate of tincture of hawthorn, dry concentrates of tincture of motherwort, infusion of lemon balm herb, tincture of chokeberry fruit and tincture of bearberry leaves, citric acid, magnesium asparaginate potassium aspartate, as well as starch, calcium stearate, talc and sugar in the following ratio of components, g per tablet weighing 0.55 g: Dry concentrate of tincture of hawthorn 0.000175-0,000525 Dry concentrate tinctures motherwort 0,000175-0,000525 Dry concentrate of lemon balm herb infusion 0.0000075-0.0000225 Aronia infusion dry concentrate aronia 0.0000225-0.0000375 Dry leaf infusion concentrate bearberry 0.0000075-0.0000225 Citric acid 0.0045-0.0055 Potassium Asparaginate 0.0045-0.0055 Magnesium Asparaginate 0.0045-0.0055 Starch 0.06-0.08 Calcium Stearate 0.005-0.006 Talcum powder 0.005-0.015 Sugar Else