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Eldecalcitol soft capsule and preparation method thereof

A technology of edicalcidol and soft capsules, which is applied in the directions of capsule delivery, microcapsules, bone diseases, etc., can solve the problems of monotonous drug action point and the inability to fully exert the effect of edicalcidol soft capsules, and achieve a mixed effect. Better, better treatment effect, reduced calcium loss

Inactive Publication Date: 2020-06-19
CP PHARMA QINGDAO CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Among the existing idecalcitol soft capsules, only idecalcitol is the main active substance of osteoporosis, and the drug action point is relatively monotonous, but osteoporosis is caused by a variety of reasons, which leads to AIDS The efficacy of decalcidol soft capsules cannot be fully exerted

Method used

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  • Eldecalcitol soft capsule and preparation method thereof
  • Eldecalcitol soft capsule and preparation method thereof
  • Eldecalcitol soft capsule and preparation method thereof

Examples

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Effect test

Embodiment 1

[0023] The invention provides an idecalcitol soft capsule, which includes contents and a capsule shell, and the contents include the following raw materials in parts by weight: 0.05 part of idecalcitol, 0.1 part of glucosamine, and 0.5 part of threonine , 0.02 parts of monofluorophosphate, 100 parts of refined camellia oil, the capsule shell includes the following raw materials in parts by weight: 200 parts of gelatin, 200 parts of glycerin, 20 parts of microcrystalline cellulose, 5 parts of malic acid, and 5 parts of tartrazine;

[0024] Among the raw materials of the content, the refined camellia oil is a camellia oil obtained through physical purification according to the pharmaceutical production process standard, and the camellia oil has higher quality and less impurities.

[0025] Among the raw materials of the content, the monofluorophosphate is glutamine monofluorophosphate, which has a better stimulating effect on bone formation.

[0026] Among the raw materials of th...

Embodiment 2

[0036] The difference from Example 1 is that the content includes the following raw materials in parts by weight: 0.5 parts of idecalcitol, 0.8 parts of glucosamine, 1 part of threonine, 0.08 parts of monofluorophosphate, 200 parts of refined camellia oil , the capsule shell includes the following raw materials in parts by weight: 300 parts of gelatin, 500 parts of glycerin, 50 parts of microcrystalline cellulose, 10 parts of malic acid, and 40 parts of tartrazine.

Embodiment 3

[0038]Different from Examples 1-2, the content includes the following raw materials in parts by weight: 0.3 parts of idecalcitol, 0.45 parts of glucosamine, 0.75 parts of threonine, 0.05 parts of monofluorophosphate, refined camellia 150 parts of oil, and the capsule shell includes the following raw materials in parts by weight: 250 parts of gelatin, 350 parts of glycerin, 35 parts of microcrystalline cellulose, 7.5 parts of malic acid, and 22 parts of tartrazine.

[0039] Take the idecalcitol soft capsules prepared in the above-mentioned embodiments 1-3 and give them orally to ovariectomized osteoporosis rats, each 20 as a group, and divide into three groups to try out the idecalcitol soft capsules prepared in the three embodiments respectively. Decalcidol soft capsule, once a day, after one month of continuous administration, the bone density, bone content, cartilage tissue and collagen content of ovariectomized osteoporosis rats were detected, and the following data were obt...

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Abstract

The invention discloses an eldecalcitol soft capsule, and specifically relates to the technical field of pharmaceutical preparations. The eldecalcitol soft capsule includes a content and a capsule shell; the content includes the following raw materials: eldecalcitol, glucosamine, threonine, monofluorophosphate, and refined camellia oil; the capsule shell includes the following raw materials: gelatin, glycerin, microcrystalline cellulose, malic acid and lemon yellow; and a preparation method of the soft capsule includes the following preparation steps: capsule shell preparation, content preparation, pelleting, two-stage vacuum drying, inspection and packaging. The eldecalcitol soft capsule prepared by the raw material formula of the invention can reach a maximize drug utilization rate, enhance the synthetic effect on cartilage matrix protein, promote generation of collagen, reduce calcium loss and have a better treatment effect on osteoporosis; and a special stirring manner is adopted in the preparation process of the capsule shell and the content, so that the multiple variable-speed stirring mixing of the raw materials can be realized, and the content deviation of effective substances in each soft capsule is smaller to ensure the drug effect.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, more specifically, the invention relates to an idecalcitol soft capsule and a preparation method thereof. Background technique [0002] Idecalcitol Soft Capsules, the active substance idecalcitol is another new active vitamin D3 derivative used to treat osteoporosis after alfacalcidol. Alfacalcidol has a better curative effect than alfacalcidol, and its safety is similar to that of alfacalcidol, so it has a good application prospect. [0003] Among the existing idecalcitol soft capsules, only idecalcitol is the main active substance of osteoporosis, and the drug action point is relatively monotonous, but osteoporosis is caused by a variety of reasons, which leads to AIDS The efficacy of decalcidol soft capsules cannot be fully exerted. Contents of the invention [0004] In order to overcome the above-mentioned defects of the prior art, the embodiments of the present invent...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K47/42A61K47/44A61K47/18A61K47/26A61K47/24A61K31/593A61P19/10
CPCA61K9/4825A61K9/5015A61K31/593A61P19/10
Inventor 陈阳生孙桂玉刘晓霞王清亭刘振玉臧云龙杜昌余张怀征李秀秀
Owner CP PHARMA QINGDAO CO LTD
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