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Stable rosuvastatin calcium pharmaceutical composition and preparation method thereof

A technology for rosuvastatin calcium and a composition is applied in the field of stable pharmaceutical composition and its preparation, and can solve the problems of product quality influence, large amount of lactone impurities, and inability to apply drug production, etc.

Inactive Publication Date: 2014-08-06
SHENZHEN SALUBRIS PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, controlling the pH value of the composition alone is not enough to solve the problem, and the stability of the rosuvastatin calcium composition is also closely related to the specific stabilizer type
[0007] Chinese patent CN200710024860.9 discloses a stable pharmaceutical composition containing rosuvastatin calcium. The composition has added micropowder silica gel as a stabilizer. However, the inventor prepared the product according to its prescription and performed several accelerated stability tests It was found that when micropowdered silica gel was used as a stabilizer, the amount of lactone impurities produced was large, and the stability of the composition was not good, so it could not be used in pharmaceutical production
Moreover, the wet granulation process is complicated. During the production process, the drug will come into contact with the solvent in the binder and be dried at high temperature, which will definitely affect the product quality.

Method used

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  • Stable rosuvastatin calcium pharmaceutical composition and preparation method thereof
  • Stable rosuvastatin calcium pharmaceutical composition and preparation method thereof
  • Stable rosuvastatin calcium pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Name of raw material Dosage (g) Rosuvastatin Calcium 10 Calcium Citrate 20 lactose monohydrate 60 microcrystalline cellulose 45 Sodium carboxymethyl starch 15 Magnesium stearate 2 Opadry Film Coating Premix Appropriate amount

[0036] Pass the prescribed amount of rosuvastatin calcium and calcium citrate through a 80-mesh sieve, and mix the two thoroughly; , fully mixed uniformly; add the prescribed amount of magnesium stearate, fully mixed uniformly; the uniform mixed powder obtained was pressed into 1000 tablets; the tablets were coated with Opadry® 295K640007 PINK coating powder provided by Clorcon, Coating weight gain is 2~3% (w / w).

Embodiment 2

[0038] Name of raw material Dosage (g) Rosuvastatin Calcium 10 Calcium Citrate 20 pregelatinized starch 60 Mannitol 45 Low-substituted hydroxypropyl cellulose 15 Magnesium stearate 2 Opadry Film Coating Premix Appropriate amount

[0039]Pass the prescribed amount of rosuvastatin calcium and calcium citrate through a 80-mesh sieve, and mix the two thoroughly; add the prescribed amount of pregelatinized starch, mannitol, and low-substituted hydroxypropyl cellulose , fully mixed uniformly; add the prescribed amount of magnesium stearate, fully mixed uniformly; the uniform mixed powder obtained was pressed into 1000 tablets; the tablets were coated with Opadry® 295K640007 PINK coating powder provided by Clorcon, Coating weight gain is 2~3% (w / w).

Embodiment 3

[0041] Name of raw material Dosage (g) Rosuvastatin Calcium 10 Calcium Citrate 20 microcrystalline cellulose 60 Mannitol 45 Crospovidone 15 Magnesium stearate 2 Opadry Film Coating Premix Appropriate amount

[0042] The prescription amount of rosuvastatin calcium and calcium citrate are passed through 80 mesh sieve respectively, and the two are fully mixed evenly; Mix well; add the prescribed amount of magnesium stearate, mix well; press the obtained uniform mixed powder into 1000 tablets; use Opadry? 295K640007 PINK coating powder provided by Clorcon to coat the tablets, The weight gain is 2~3% (w / w).

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Abstract

The invention provides a stable rosuvastatin calcium pharmaceutical composition. The composition has high stability. A tablet containing the pharmaceutical composition has total impurity content of lower than 1.0% after accelerated testing, wherein lactone individual impurity content is lower than 0.10%.

Description

technical field [0001] The invention relates to a stable pharmaceutical composition and a preparation method thereof, in particular, the present invention relates to a stable rosuvastatin calcium pharmaceutical composition and a preparation method thereof. Background technique [0002] Rosuvastatin Calcium (Rosuvastatin Calcium), molecular formula: (C 22 h 27 FN 3 o 6 S) 2 Ca, CAS: 147098-20-2, chemical name: bis-[E-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino ]-pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt (2:1), its structural formula is [0003] [0004] Rosuvastatin Calcium is an effective 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor, developed by Shionogi Co., Ltd. in Japan, and released in April 2001 It was first listed in Japan by AstraZeneca, and its Chinese product name is "Crestor". Rosuvastatin calcium is mainly used for the treatment of primary and familial hypercholesterolemia and mixed d...

Claims

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Application Information

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IPC IPC(8): A61K31/505A61K47/12A61K9/28A61P3/06A61P3/00A61P9/10
Inventor 陈金脱张宣崔樱琪
Owner SHENZHEN SALUBRIS PHARMA CO LTD
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