Composition containing dietary supplements (options)

 

(57) Abstract:

The composition includes a salt of calcium, vitamin D and at least one mineral substance. The calcium salt selected from calcium carbonate, calcium gluconate, calcium lactate, secondary acidic calcium phosphate and calcium nitrate. Mineral substance selected from salt, boron, copper, magnesium, manganese and zinc. The composition according to the second variant includes a salt of calcium, vitamin D, boron salt. The composition according to the third variant includes, mg salt of calcium - 1000-2500; vitamin D - 50-8000 IU; salt of boron - 50-3000 mcg; salt of copper, 0.1 to 5.0; salt magnesium - 10-150; salt of manganese - 3-10; salt zinc - 3-25. The compositions are used as dietary supplements and are designed to protect the bones from depression. The technical result consists in realization of the specified destination. 3 C. and 15 C.p. f-crystals, 1 table.

Mineral and vitamin composition are commonly used as dietary supplements used either as therapeutic drugs for specific medical purposes, or as General nutritional supplements.

Add in food calcium and trace elements necessary for both adults and children. Adults calcium supplements are necessary to prevent clericism period of life need more calcium because of changes in their hormonal status, which may contribute to the acceleration of the speed of the rarefaction of the bones and lead to osteoporosis.

Osteoporosis is a common disease that, for example, in the United States is subject to 15-20 million people. In osteoporosis the bone mass decreases, causing bones to become more fragile and more susceptible to fractures. According to experts in the U.S., at least 1.3 million fractures due to this disease (national Foundation for the study of osteoporosis, Stand UP Osteoporosis, Your Guide to Staving Heathy and Independent Through Prevention and Treatment, Washington, D. C. 1992). Many scientists believe that one of the most important factors contributing to the development of osteoporosis is a chronic deficiency of calcium in the body. Optimal calcium intake by the adult (1000 mg - 1500 mg) may be provided by the diet; food enriched with calcium, calcium supplements; or a combination of both. Studies have shown that the calcium intake of adult women in the United States is 450-500 mg / day (Ministry of health and US social security, health Service, national institutes of health; Osteoporosis, Cause, Treatment, Prevention, Maryland, national Institute of health, 1987), which was subscales, that in addition to calcium an important role in osteogenesis are also minerals such as boron, copper, magnesium, manganese and zinc. (L. Strause , et al, The Role of Trace Elements in Bone Metabolism, Nutritional - Aspects of Osteoporosis, New York, Raven Press, pp. 223-233, 1992, and F. Nielsen : Facts and Fallacies about Boron, Nutrition Today 27 (3): 6-12, May/Iune 1992). In addition, it is known that a crucial role in the absorption of calcium by the human body plays vitamin D. the Recommended daily dose of vitamin D is in the range of 400 International units (hereinafter referred to ME) to ME 800 for the elderly.

The present invention relates to compositions containing dietary supplements of calcium, vitamin D and minerals. Such minerals can be salts of boron, copper, magnesium, manganese and zinc. This composition may also contain pharmaceutically acceptable carriers and excipients.

The present invention relates to compositions containing dietary supplements of calcium, vitamin D and minerals, designed to protect against dilution of the bone.

It is known that not all sources of calcium equivalent in its biological digestibility and absorption. The preferred source of calcium is calcium carbonate, which contains NIBCO available drug which can be easily compressed into tablets having a high content of calcium. Due to the high content of calcium tablets calcium carbonate can have a smaller size and contain a higher concentration of digestible calcium. A small sized tablets easier swallowing, especially for the elderly.

Other sources of calcium that are used as additives are calcium gluconate, calcium lactate, secondary acidic calcium phosphate, calcium citrate, etc., Elemental calcium is supplied in the range of about 400-1000 mg

Vitamin D, which plays an important role in the absorption of calcium, is added in an amount of from 50 IU to 800 IU. While the preferred range is 200-400 IU.

As mineral substances use boron, copper, magnesium, manganese and zinc. Anions for these mineral elements can serve as phosphate, chloride, sulfate, nitrate, etc.

Copper, zinc and magnesium is essential for bone formation and metabolism. These elements are the main cofactor of some enzymes involved in the synthesis of organic extracellular bone matrix. Data obtained from studies of ceII healthy human skeleton (Strause, - L., et al: The Role of Trace Elements in Bone Metobolism, Nutritional Aspests of Osteoporosis, New York, Raven Press, p. 223-233, 1992). Magnesium deficiency is manifested in slower growth and degenerative changes in the bones. In addition, magnesium is a major component of all soft tissues and bones. Most of the magnesium present in the body, is present in the bones along with calcium and salts phosphorus (Avioli, L.: Calcium and Osteoporosis - Ann. Rev. Nutr. 4: 471-491, 1984). Boron deficiency affects the composition, structure and strength of bone. Influence of boron on bone metabolism may be due to its known effects on the metabolism of macronutrients. The results obtained in the study of the human body, gives grounds to assume that boron has a positive effect on the metabolism of calcium and its absorption (Nielsen, F.: Facts and Fallacies about Boron, Nutrition Taday, 27 (3): 6-12, May/Iune, 1992).

The preferred amount of mineral additives are: salt of boron - 50 - 3000 mcg; salt of copper - 0.10 to 5.0 mg; salt magnesium - 10 - 150 mg; manganese salt of 3 - 10 mg and zinc salts - 3 - 25 mg.

The overall assessment total weight of the single form is approximately less than 3, In a preferred embodiment of the present invention, the mass of a single form is about 2 g or less.

Comparatively hydroxyanisol, bottled hydroxytoluene, sulfur dioxide, etc., food emulsifiers, such as lecithin, mono - and diglycerides of fatty acids with long chain esters of propylene glycol; and pharmaceutically acceptable carriers and excipients are well known to the specialists.

Used in the present description, the term "pharmaceutically acceptable" refers to a component that is suitable for administration to humans and do not have undesirable side effects such as irritation, toxicity, and allergic reaction.

The composition of the present invention can be manufactured in the form of a solid single form for oral administration, such as tablets, capsules, lozenges, chewable tablets, or loose powder. Pill, capsule or toffee may contain appropriate binders, oil, thinners, dezintegriruetsja agents, additives that increase the fluidity, and the agent, reducing the melting point; moreover, all of these additives are well known to specialists.

The composition of the present invention can also be manufactured in the form of liquid disposable form an emulsion or suspension. Specified single liquid form may contain, asiausa substances; the agent, reducing the melting point; dyes and fragrances, all of these additives are well known to specialists.

This is preferred if the composition of the present invention is administered in tablet form, but can be used in any other form for oral administration.

To protect the ingredients of the composition of the present invention from exposure to moisture, oxygen or light and to mask the undesirable taste or appearance of a solid single form can have a film coating. Suitable agents for coating are cellulose, hypromellose, cellulose phthalate, methacrylic acid copolymer, and shellac. This can be used intersolubility floor, as well as dyes for identification; and, if necessary, the solid form may be covered with a polishing composition, for example a wax, such as Carnauba wax.

The following example is provided for illustrative purposes and should not be construed as a limitation of the invention. In this example, unless specifically indicated, all parts are given by weight.

Example 1. As shown schematically below, a mixture of carbonate CSW (soluble in cold water, 100000 IU/g); copper oxide; magnesium oxide; manganese sulfate; sodium borate 10H2O and sodium lauryl stirred for 5 minutes (Mixture A).

The mixture was placed between layers of zinc oxide and the balance of calcium carbonate (like a sandwich), and stirred for 10 minutes (Final mix).

Suspension for coatings containing 15% solids, was prepared by mixing the premix for film coating pink (dusty pink), mineral oil, and sodium lauryl (Drug solution to cover).

The final mixture was compressed into the desired single form.

The obtained solid single form was applied to the drug solution to cover.

The following table shows the composition containing dietary supplements of calcium, vitamin D and minerals, preferred amounts of ingredients.

In the example in the end of the description of the scheme of obtaining the composition of the figures correspond to the numbers above the original components.

1. A composition comprising a dietary Supplement designed to protect against dilution of the bone, including calcium salt selected from calcium carbonate, calcium gluconate, lactate to esto, selected from the group comprising salts of boron, copper, magnesium, manganese and zinc.

2. The composition according to p. 1, characterized in that the specified calcium salt is calcium carbonate.

3. The composition according to p. 1, characterized in that the salt content of calcium is 1000 - 2500 mg.

4. The composition according to p. 3, characterized in that the salt content of calcium is 1500 - 2000 mg.

5. The composition according to p. 1, characterized in that the content of vitamin D is 50 to 800 IU.

6. The composition according to p. 5, characterized in that the content of vitamin D is 100 to 300 IU.

7. The composition according to p. 1, characterized in that the salt of boron, copper, magnesium and zinc has an anion selected from the group consisting of phosphate, chloride, sulfate, nitrate and mixtures thereof.

8. The composition according to p. 7, characterized in that the salt content of boron is 50 to 3000 μg.

9. The composition according to p. 7, characterized in that the salt content of copper is 0.1 to 0.3 mg.

10. The composition according to p. 7, characterized in that the salt content of magnesium is from 10 to 150 mg.

11. The composition according to p. 7, characterized in that the salt content of manganese is 3 to 10 mg.

12. The composition according to p. 7, characterized in that the content of the second single form for oral administration.

14. A composition comprising a dietary Supplement designed to protect against dilution of the bone, including calcium salt selected from calcium carbonate, calcium gluconate, calcium lactate, secondary acidic calcium phosphate and nitrate calcium, vitamin D and at least one mineral substance, which represents a salt of boron.

15. The composition according to p. 14, characterized in that the specified calcium salt is calcium carbonate.

16. The composition according to p. 15, characterized in that the salt content of calcium is 1500 - 2000 mg.

17. Composition for protection from the rarefaction of the bone, including the following dietary supplements, mg: calcium salt selected from calcium carbonate, calcium gluconate, calcium lactate, secondary acidic calcium phosphate and calcium nitrate - 1000 - 2500; vitamin D - 50 to 800 IU; salt of boron - 50 - 3000, g; salt of copper, 0.1 to 5.0; salt magnesium - 10 - 150; salt of manganese from 3 to 10; zinc salts - 3 - 25.

18. The composition according to p. 17, wherein represents a single oral form selected from tablets, capsules, lozenges, chewable tablets and loose powder.

 

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