Novel falecalcitriol tablet and preparation method thereof

The technology of fluorocalcitriol tablets and fluorocalcitriol is applied in the directions of bone diseases, pharmaceutical formulations, medical preparations with inactive ingredients, etc., and can solve the problems such as difficult storage of fluorocalcitriol, drug deterioration, and influence on treatment effects. , to achieve the effect of maintaining stability, rapid decomposition and good therapeutic effect

Inactive Publication Date: 2020-07-10
CP PHARMA QINGDAO CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] It has been found through research that fluorocalciotriol has a far stronger therapeutic effect on osteoporosis than calcitriol, and the dosage is less than that of calcitriol, which is more suitable for the drug treatment of osteoporosis. There are few studies on fluocautotriol, and because flucitriol is not easy to store, it will cause deterioration of the drug due to improper storage during the storage process of the drug, thus affecting the normal therapeutic effect

Method used

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  • Novel falecalcitriol tablet and preparation method thereof
  • Novel falecalcitriol tablet and preparation method thereof
  • Novel falecalcitriol tablet and preparation method thereof

Examples

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Embodiment 1

[0029] The invention provides a novel fluocautotriol tablet, comprising a tablet core and a sugar-coated tablet, wherein the tablet core includes the following raw materials in parts by weight: 0.01-0.06 parts of fluocautotriol, 12-18 parts of light calcium carbonate, 6-9 parts of calcium gluconate, 8-12 parts of manganese gluconate, 4-6 parts of anhydrous citric acid, 4072-3.5 parts of poloxamer, 0.8-1.2 parts of fat replenishing agent, the sugar-coated tablet is by weight The count includes: 4-6 parts of dextrin, 6-8 parts of medicinal gelatin, 0.5-1.5 parts of sodium carboxymethyl starch, 0.3-0.7 parts of polysorbate 80, 8-12 parts of talcum powder, and the balance is distilled water;

[0030] Specifically in this embodiment, the tablet core includes the following raw materials in parts by weight: 0.06 parts of fluocautotriol, 12 parts of light calcium carbonate, 6 parts of calcium gluconate, 8 parts of manganese gluconate, anhydrous citron 4 parts of acid, 2 parts of polox...

Embodiment 2

[0045] The invention provides a novel fluocautotriol tablet, comprising a tablet core and a sugar-coated tablet, wherein the tablet core includes the following raw materials in parts by weight: 0.01-0.06 parts of fluocautotriol, 12-18 parts of light calcium carbonate, 6-9 parts of calcium gluconate, 8-12 parts of manganese gluconate, 4-6 parts of anhydrous citric acid, 4072-3.5 parts of poloxamer, 0.8-1.2 parts of fat replenishing agent, the sugar-coated tablet is by weight The count includes: 4-6 parts of dextrin, 6-8 parts of medicinal gelatin, 0.5-1.5 parts of sodium carboxymethyl starch, 0.3-0.7 parts of polysorbate 80, 8-12 parts of talcum powder, and the balance is distilled water;

[0046] And specifically in this embodiment, wherein the tablet core includes the following raw materials in parts by weight: 0.03 parts of fluocautotriol, 15 parts of light calcium carbonate, 7.5 parts of calcium gluconate, 10 parts of manganese gluconate, anhydrous citron 5 parts of acid, 3...

Embodiment 3

[0061] The invention provides a novel fluocautotriol tablet, comprising a tablet core and a sugar-coated tablet, wherein the tablet core includes the following raw materials in parts by weight: 0.01-0.06 parts of fluocautotriol, 12-18 parts of light calcium carbonate, 6-9 parts of calcium gluconate, 8-12 parts of manganese gluconate, 4-6 parts of anhydrous citric acid, 4072-3.5 parts of poloxamer, 0.8-1.2 parts of fat replenishing agent, the sugar-coated tablet is by weight The count includes: 4-6 parts of dextrin, 6-8 parts of medicinal gelatin, 0.5-1.5 parts of sodium carboxymethyl starch, 0.3-0.7 parts of polysorbate 80, 8-12 parts of talcum powder, and the balance is distilled water;

[0062] Specifically in this embodiment, the tablet core includes the following raw materials in parts by weight: 0.01 part of fluocautotriol, 18 parts of light calcium carbonate, 9 parts of calcium gluconate, 12 parts of manganese gluconate, anhydrous citron 6 parts of acid, 3.5 parts of pol...

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Abstract

The invention discloses a novel falecalcitriol tablet and a preparation method thereof, and specifically relates to the field of pharmaceutical preparations. The novel falecalcitriol tablet includes atablet core and a sugar-coated tablet, the tablet core includes the following raw materials in parts by weight: 0.01-0.06 part of falecalcitriol, 12-18 parts of light calcium carbonate, 6-9 parts ofcalcium gluconate, 8-12 parts of manganese gluconate, and 4-6 parts of anhydrous citric acid. According to the novel falecalcitriol tablet, in the sugar-coated tablet arranged outside the falecalcitriol tablet, sodium carboxymethyl starch and dextrin are added, so that the protective effect of a traditional sugar-coated tablet on the inner tablet core can be ensured, and the sugar-coated tablet protects against light, moisture and air, and can prevent the deterioration of the tablet core, thereby prolonging the shelf life of the tablet; and the added dextrin and sodium carboxymethyl starch canhave a thickening effect during the preparation of the sugar-coated tablet, and the sugar-coated tablet can be decomposed and dissolved more quickly under the gastric juice acidic environment after consumption, can be quickly decomposed after consumption to achieve the effect of drug supply, and can take effect quickly.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, and more specifically, the invention relates to a novel flucitriol tablet and a preparation method thereof. Background technique [0002] Osteoporosis, or osteoporosis, is a group of bone diseases caused by a variety of reasons. Bone tissue has normal calcification, and the ratio of calcium salt to matrix is ​​normal. It is a metabolic bone lesion characterized by a decrease in the amount of bone tissue per unit volume. . Osteoporosis can occur in different genders and at any age. Symptoms are often manifested as low back pain, shortened body length, hunchback, and easy fractures. Etiology: ① endocrine factors due to estrogen deficiency after menopause, can lead to osteoporosis. Decreased calcium intake due to endocrine reasons is also an important cause of osteoporosis. Parathyroid hormone can directly act on osteoclasts to increase bone resorption and decrease bone mass. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/191A61K31/37A61K31/593A61K33/10A61K33/32A61K47/36A61K47/02A61K47/10A61K47/12A61P3/02A61P19/10
CPCA61K9/2009A61K9/2013A61K9/2031A61K9/286A61K31/191A61K31/37A61K31/593A61K33/10A61K33/32A61P3/02A61P19/10A61K2300/00
Inventor 陈阳生孙桂玉刘晓霞杜昌余王清亭刘振玉李洁张丽敏刘昭嵘
Owner CP PHARMA QINGDAO CO LTD
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