Method for preparing tablet drug composition containing Rosuvastatin calcium

A technology of rosuvastatin calcium and its composition is applied in the field of preparation of rosuvastatin calcium pharmaceutical composition, which achieves the effects of mature technology, simple operation and improved in vitro dissolution rate
CN102008477BInactive Publication Date: 2012-11-07TIANJIN HANRUI PHARMA
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
TIANJIN HANRUI PHARMA
Publication Date
2012-11-07
Estimated Expiration
Not applicable · inactive patent

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Abstract

The invention relates to a method for preparing a tablet drug composition containing Rosuvastatin calcium. The preparation forms of the drug composition can be administered to the patients safely and the stability of Rosuvastatin calcium and the absorbability in gastrointestinal tract can be improved. Specifically, the invention relates to a method for preparing the drug composition containing amorphous Rosuvastatin calcium and beta-cyclodextrin. The method is characterized by grinding Rosuvastatin calcium and beta-cyclodextrin under alkaline condition, drying and crashing to obtain (80-100)-mesh fine powder, mixing the fine powder with appropriate auxiliary materials, preparing granules, carrying out tabletting and carrying out coating, thus preparing the drug composition. The in vitro release of the composition is improved to a greater degree, thus improving the bioavailability; and the composition can effectively treat hyperlipidemia, is convenient to take orally, covers the bad taste and is fast to disintegrate and absorb and convenient to carry.
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Description

technical field

[0001] The invention relates to a preparation method of a rosuvastatin calcium pharmaceutical composition. Dispersing rosuvastatin calcium in beta cyclodextrin can greatly increase the release rate in vitro, thereby improving the bioavailability. Background technique

[0002] Rosuvastatin Calcium (Rosuvastatin Calcium), chemical name: bis-[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl) )amino]-pyrimidin-5-yl](3R,5R)-3,5-dihydroxyhept-6-enoic acid] calcium salt (2:1).

[0003] Its structural formula is:

[0004]

[0005] Molecular formula: (C 22 h 27 FN 3 o 6 S) 2 Ca

[0006] Molecular weight: 1001.13

[0007] Pharmacological type: Rosuvastatin is a 3-hydroxy-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor, so it can reduce the cholesterol level in plasma.

[0008] Mechanism of action: Rosuvastatin can selectively inhibit the rate-limiting enzyme HMG-CoA reductase in the synthesis of cholesterol in the liver, reducing liv...

Claims

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