RU2236864C1 - Preparation for compensation of calcium and iodine insufficiency - Google Patents

Abstract

FIELD: medicine, phytotherapy, pharmacy.

SUBSTANCE: invention relates to a preparation used for compensation of calcium and iodine insufficiency. Preparation comprises the following components, wt.-%: calcium carbonate, 80.0-90.0; potassium iodide, 0.008-0.02; alcoholic-oily or aqueous-alcoholic extracts prepared from perforated Saint-John's-wort herb, dandelion roots, sandy common immortelle flowers, peppermint leaves, elecampane rhizomes and roots, and sweet flag rhizomes taken in the ratio = (1-2):(1-2):(1-2):(1-2):(1-2):(1-2):(1-2), respectively, or 0.09-0.19 wt.-% of dry aqueous-alcoholic extract of indicated herbs taken in the indicated ratio, and vehicle, up to 100. Preparation contains magnesium oxide, or sodium thiosulfate, or their mixture taken in any ratios, or mixture of sodium thiosulfate, magnesium basic carbonate, magnesium sulfate, calcium state and talk taken in any ratios as a vehicle. Preparation compensates calcium and iodine insufficiency in human body and normalizes the content of free radicals in lower iodine content and retained efficiency with respect to normalization of thyroid gland function in its hypofunction.

EFFECT: enhanced effectiveness and valuable medicinal properties of preparation.

6 cl, 2 ex

Description

The present invention relates to medicine, in particular to preparations intended to replenish calcium and iodine deficiency.

According to the Ministry of Health of the Russian Federation, food containing all the necessary vitamins and minerals is consumed by no more than 3% of Russian citizens (Emelyanova TP Vitamins and minerals: Complete Encyclopedia. - SPB: ID ″ VES ″, 2001). It is also widely known that calcium deficiency in the body leads to osteoporosis. Calcium, in addition, is necessary for the normal activity of the cardiovascular system, transmission of nerve impulses, growth and normal activity of muscle tissue. Iodine deficiency leads to thyroid disease and dementia in children.

Therefore, the task is to develop drugs that are effective enough and affordable for the general public (i.e., fairly cheap) to replenish calcium and iodine deficiency.

Known drug (AS SU 394046), containing in wt.% Potassium iodide 2.7-3.3 and as a filler sodium thiosulfate 0.09-011, basic magnesium carbonate 48.4-59.2, magnesium sulfate 36.0-44.0, calcium stearate 0.09-0.11 and talc 2.7-3.3, designed to compensate for iodine deficiency, since calcium stearate is a salt, calcium from which is practically not absorbed in the human body and enters in the composition of the drug as a sliding agent necessary in the formation of tablets.

A number of drugs are known to compensate for calcium deficiency, for example, calcium gluconate (Radar Drug Encyclopedia, annual collection, issue 9, 2002, p. 390), calcium carbonate (Radar Drug Encyclopedia, annual collection, issue 9, 2002, p. 390) and calcium lactate (Radar Encyclopedia of Medicines, annual collection, issue 9, 2002, p. 390), which do not contain iodine compounds.

A number of compositions are known that contain mixtures of vitamins and minerals taken in different ratios, including calcium and iodine, described in US patents US 6562378, US 6572903, US 6565891, Germany - DE 10109798, European patent - EP 1214893.

However, all these compositions contain either synthetic vitamins or “pure” vitamins and antioxidants isolated from natural sources, which is not physiological, since the isolation of pure (single) antioxidants requires the use of organic solvents, trace amounts of which are always present. In addition, pure vitamins and antioxidants are deprived of their natural environment, which affects their effect and the preservation of their activity.

The main task, the solution of which the invention is directed, is to expand the range of funds designed to replenish calcium and iodine deficiency.

Another task is to increase the effectiveness of the effect of drugs on the content of free radicals in the body and, in particular, to normalize the content of free radicals in the body.

The tasks are solved by the fact that the proposed drug to compensate for calcium and iodine deficiency, including potassium iodide and a filler, which, according to the invention, additionally contains calcium carbonate and alcohol-oil or liquid or dried water-alcohol extract from St. John's wort perforated, dandelion root, sandy immortelle flowers, peppermint leaves, rhizomes and roots of elecampane and calamus rhizomes in the following ratio of components, wt.%:

Calcium Carbonate 80.0-90.0

Potassium iodide 0.008-0.015

Alcohol oil

or liquid water-alcohol

herb extract

Hypericum perforatum,

dandelion root flowers

immortelle sand,

peppermint leaves

Rhizomes and Roots of Elecampane

and rhizomes of calamus 9.0-19.0

or

Dried water-alcohol

extract from these herbs 0.09-0.19

Filler Up to 100

As a filler, the preparation may contain magnesium oxide or sodium thiosulfate, or a mixture thereof in any ratio.

As a filler, the preparation may also contain a mixture of sodium thiosulfate, basic magnesium carbonate, magnesium sulfate, calcium stearate and talc in any proportions.

As an alcohol-oil or water-alcohol extract, the preparation contains an extract prepared from plants taken in the following ratio, parts by weight:

Hypericum perforatum 1.0-2.0

Dandelion Root 1.0-2.0

Sandy Helichrysum flowers 1.0-2.0

Peppermint leaves 1.0-2.0

Rhizomes and roots of elecampane 1.0-2.0

Rhizomes of calamus 1.0-2.0

The drug is prepared in the form of capsules or tablets.

The drug, packaged in gelatin capsules, contains a dried water-alcohol extract of these plants in the following ratio, wt.%:

Calcium Carbonate 80.0-90.0

Potassium iodide 0.008-0.015

Dried water-alcohol

hypericum herb extract

perforated, dandelion root,

sand immortelle flowers

peppermint leaves

Rhizomes and Roots of Elecampane

and rhizomes of calamus 0.09-0.19

Filler Up to 100

The drug is prepared in the form of capsules or tablets at a dose of 500 mg per capsule.

The technical result of the invention lies in the fact that the composition and ratio of components are selected, allowing to replenish calcium and iodine deficiency in the human body, on the one hand, and normalize the content of free radicals in the body, on the other hand. In addition, the claimed composition of the drug allowed to reduce the amount of iodine in the drug while maintaining its effectiveness in relation to the normalization of thyroid function with its hypofunction.

For the preparation of the drug take well-known medicinal plants:

St. John's wort - Hypericum perforatum, herb which contains tannin derivatives, pyrocatechol, essential oils, flavonoids (hyperoside, rutin, quercetin, izokvertsetin, kvertsetrin), azulene, colorants: hypericin, psevdogiperetsin, giperikodegidrodiantron, psevdogiperikodegidrodiantron, franguloemodinantrokol, carotene, ceryl alcohol , choline, vitamins C, PP, anthocyanins, saponins, resinous substances. The active substances of St. John's wort have an astringent, bactericidal, anti-inflammatory, biostimulating and pronounced choleretic effect.

Sandy immortelle flowers - Helichrysum arenarium (L.) Moench., Which contain flavonoids, tannins (tannin), coumarins, saponin, resin, beta-phytosterol and others.

Immortelle preparations accelerate blood coagulation, have choleretic and anthelmintic effects.

Dandelion root (dandelion officinalis) - Taraxaciim officinale, containing flavonoids, inulin, bitter glycoside taraxacin, organic acids, sugars, fatty oil, triterpene alcohols. Preparations from dandelion root have a blood-purifying, diuretic, choleretic effect. They are used for constipation, diabetes, renal colic and gout.

Rhizomes and roots of elecampane (elecampane high) - Inula helenium containing allanctolactone, proazulene and other levorotatory polysaccharides (up to 44%).

Elecampane is used in collections and galenic preparations for coughing, gastric ulcer and duodenal ulcer.

Calamus rhizomes - Acorus calamus, containing an essential oil rich in sesquiterpenes and terpenoids, and acorin. Calamus rhizomes are used for increased acidity and gastric and duodenal ulcers.

Peppermint - Mentha piperita, the leaves of which contain an essential oil that contains menthol.

An infusion of leaves is used internally against nausea and as a choleretic.

Also take:

Calcium carbonate according to GOST 8253-79, GOST 4530-86.

Potassium iodide according to GFH, art. 364.

Magnesium oxide according to GFH, art. 380.

Sodium thiosulfate according to GOST 27068-86.

Edible vegetable oil - olive, rapeseed, sunflower, linseed.

The invention is illustrated by the following examples of specific performance.

EXAMPLE 1

To obtain 100.0 kg of the drug, 0.012 kg of potassium iodide, 88.0 kg of calcium carbonate, 0.2 kg of magnesium oxide, 0.018 kg of sodium thiosulfate and 11.77 kg of vegetable oil extract were taken.

To obtain 20.0 kg of alcohol-oil extract, 0.2 kg of dandelion root, perforated St. John's wort, sandwort flowers, peppermint leaves, rhizomes and roots of elecampane and calamus rhizomes, 1.2 kg of rectified ethyl alcohol were taken (in terms of 100%), 3.0 kg of olive oil and 18.0 kg of flaxseed oil. All components were mixed, kept at a temperature of 50 ° C for 6 hours, the insoluble part was filtered. 0.012 kg of potassium iodide, 0.1 kg of calcium carbonate, 0.2 kg of magnesium oxide and 0.018 kg of sodium thiosulfate were mixed in a laboratory mixer. To the resulting mixture was added 0.6 kg of calcium carbonate and mixed again. The remaining amount (87.3 kg) of calcium carbonate was loaded into the mixer, where the resulting mixture of salts and 11.77 kg of an alcohol-oil extract of plant material were gradually introduced with stirring. The resulting mixture was packaged in 0.5 g in gelatin capsules. 1 gelatin capsule contains 0.44 g of calcium carbonate, 0.00006 g of potassium iodide (contains iodine 45.9 μg) and 0.05885 g of an oil extract of the specified plant material.

EXAMPLE 2

To obtain 100.0 kg of the drug, 0.01 kg of potassium iodide, 87.0 kg of calcium carbonate, 12.84 kg of magnesium oxide, 0.02 kg of sodium thiosulfate and 0.13 kg of dried aqueous-alcoholic extract from plant material were taken.

To obtain 20.0 kg of an aqueous-alcoholic extract, 0.25 kg of dandelion root, perforated St. John's wort grass, sandwort flowers, peppermint leaves, rhizomes and roots of elecampane and calamus rhizomes were taken, 9.0 kg of rectified ethyl alcohol (in terms of 100%), purified water to 21.0 kg.

All components were mixed, kept at room temperature for 24 hours, the insoluble part was filtered off. The resulting water-alcohol extract was dried. In this case, 200 g of dry weight was obtained. 0.01 kg of potassium iodide, 0.1 kg of calcium carbonate, 0.2 kg of magnesium oxide and 0.02 kg of sodium thiosulfate were mixed in a laboratory mixer. To the resulting mixture was added 0.6 kg of calcium carbonate, 0.13 g of a dried aqueous-alcoholic extract of plant material and was mixed again. The remaining amount (86.3 kg) of calcium carbonate was loaded into the mixer, where the resulting mixture of salts with dried aqueous-alcoholic extract of plant material and the remaining part of magnesium oxide were introduced up to 100 kg with stirring. The resulting mixture was packaged in 0.5 g in gelatin capsules. 1 gelatin capsule contains 0.435 g of calcium carbonate, 0.00005 g of potassium iodide (contains iodine 38.25 μg) and 0.065 g of an aqueous-alcoholic extract of the indicated plant material.

This drug can be prepared without first drying the aqueous-alcoholic extract of plant materials. To do this, 0.01 kg of potassium iodide, 0.1 kg of calcium carbonate, 0.2 kg of magnesium oxide and 0.02 kg of sodium thiosulfate are mixed in a laboratory mixer. 0.6 kg of calcium carbonate was added to the resulting mixture and mixed again. The remaining amount (86.3 kg) of calcium carbonate is loaded into the mixer, where the resulting mixture of salts and 13.0 kg of an aqueous-alcoholic extract of plant materials obtained as described above are gradually introduced with stirring. The resulting mixture was granulated and dried. Then, magnesium oxide is introduced into it with stirring, bringing the weight of the total mass to 100 kg, and 0.5 g are packaged in gelatin capsules.

Tests of the drug were carried out on the basis of the Russian Research Center. N.N. Blokhina RAMS.

Five people (women aged 30-50 years old) suffering from various thyroid diseases without nodular pathology, or after undergoing operations on the thyroid gland with partial violation of the parathyroid structures and signs of hypothyroidism of varying severity and hypoparathyroidism, received depending on the severity of the condition from 1 to 3 capsules containing 0.5 g of the proposed drug, obtained as described in example 1, for 30 days.

Before and after treatment, all patients underwent blood tests to determine thyroid hormones (T3, FT4, TG, At-TG, At-TPO), pituitary gland (TSH), as well as parathyroid hormone and osteocalcin.

In all patients who took the drug for 30 days, a positive trend was clearly observed with normalization:

- Improving overall well-being (the disappearance of weakness, apathy);

- the disappearance of swelling of the face and limbs;

- increase in heart rate from 55-60 to 66-72 beats per minute;

- slight weight loss;

- normalization of the thyroid gland and pituitary gland (T3, FT4, TSH) to euthyroid state in patients with mild hypothyroidism;

- a positive trend towards normalization in patients with pronounced hypothyroidism.

As a result of the examination, indications for the use of the proposed drug were developed:

- prevention of the development of diffuse goiter with a lack of iodine intake;

- prevention of re-development of diffuse goiter upon completion of treatment with thyroid hormones or in parallel with hormonal treatment of the thyroid gland for hypothyroidism;

- regarding hypothyroidism and hypoparathyroidism caused by surgical interventions on the thyroid gland, when a part of the parathyroid glands is removed along with subtotal resection.

In addition to these studies, studies were conducted of the concentration of free radicals in the blood of people who received the proposed drug, and in the control groups, one of which received the same dose as described in example 1, potassium iodide and calcium carbonate (i.e. 0.44 g calcium carbonate, 0.00006 g of potassium iodide) 2 times a day, and the other is an extract from plant materials obtained as described in example 1, i.e. alcohol-oil extract from St. John's wort perforated grass, dandelion root, sandwortweed flowers, peppermint leaves, rhizomes and roots of elecampane and calamus rhizomes, 0.2 g also 2 times a day.

Blood tests were carried out using a FRAS3 photometer to determine the concentration of free radicals in whole blood (Free Radical Analytical System - FRAS), which (free radical concentration) is determined in arbitrary units of "Carr". One Carr corresponds to a concentration of hydrogen peroxide of 0.08 mg%. The normal concentration of free radicals in human blood corresponds to a value not exceeding 250 Carr, the borderline state is 250-300 Carr, a value of more than 300 Carr characterizes a strong, and more than 400 Carr - a very strong oxidative stress.

It was found that the content of free radicals in the whole blood of patients who had an initial level of free radical concentration of 350-400 Carr and received only potassium iodide and calcium carbonate decreased to 300-320 Carr after a 2-week course of taking potassium iodide and calcium carbonate in the dose corresponding to their concentration in the preparation obtained as described in example 1.

The content of free radicals in the whole blood of patients who received only alcohol-oil extract from plants also decreased from the level of 350-400 Carr (before taking the extract) to the level of 300-320 Carr after a 2-week course of taking the extract from plants.

The content of free radicals in the whole blood of patients receiving the proposed drug decreased from 350-400 Carr before treatment to 220-240 Carr after a 2-week course of taking the proposed drug.

Thus, as follows from the above results of clinical and laboratory studies of the consequences of the use of the proposed drug, it is quite effective in preventing the development of diffuse goiter with a lack of iodine intake, while reducing the amount of iodine in the proposed drug (0.000060 g of potassium iodide contains 46 μg iodine) in 1.5-2 times in comparison with analogues (patents DE 10109798, EP 1214893), and also helps to normalize the content of free radicals in human blood.

For the prevention of osteoporosis, the proposed drug is sufficient to take in an amount of 1 to 3 capsules per day (1 capsule contains 0.5 g of the drug and, accordingly, 0.44 g of calcium carbonate), i.e. the maximum daily dose does not exceed 1500 mg. At the same time, precipitated calcium carbonate (Calcii carbonas praecipitatus) in 0.5 g tablets is prescribed to prevent calcium deficiency, 2 tablets 3 times a day, i.e. in a total dose of 3000 mg, although it is already known about the danger of excessive saturation of the body with calcium.

Claims (6)

1. A preparation for the replacement of calcium and iodine deficiency, including potassium iodide and an excipient, characterized in that it additionally contains calcium carbonate and alcohol-oil or liquid or dried water-alcohol extract from St. John's wort perforated, dandelion root, sandwort flowers, leaves peppermint, rhizomes and roots of elecampane, and calamus rhizomes, in the following ratio of components, wt.%: Calcium Carbonate 80.0-90.0 Potassium iodide 0.008-0.015 Oil or liquid water-alcohol extract 9.0-19.0 Or dried extract plants 0.09-0.19 Filler Up to 100 2. The drug according to claim 1, characterized in that the filler contains magnesium oxide, or sodium thiosulfate, or a mixture thereof in any ratio. 3. The drug according to claim 1, characterized in that the filler contains a mixture of sodium thiosulfate, basic magnesium carbonate, magnesium sulfate, calcium stearate and talc in any ratio. 4. The drug according to claim 1, characterized in that as the alcohol-oil and water-alcohol extract contains an extract prepared from plants taken in the following ratio, wt. hours: Hypericum perforatum 1.0-2.0 Dandelion Root 1.0-2.0 Sandy Helichrysum flowers 1.0-2.0 Peppermint leaves 1.0-2.0 Rhizome and Roots of Elecampane 1.0-2.0 Calamus rhizome 1.0-2.0 5. The drug according to claim 1, characterized in that it is prepared in the form of capsules or tablets. 6. The drug according to claim 5, characterized in that it is packaged in gelatin capsules and at the same time contains dried aqueous-alcoholic extract of plants in the following ratio of components, wt.%: Calcium Carbonate 80.0-90.0 Potassium iodide 0.008-0.015 Dried water-alcohol plant extract 0.09-0.19 Filler Up to 100