Atorvastatin calcium composition, preparation and preparation method thereof

The invention relates to a stable atorvastatin calcium composition, a preparation and the preparation method thereof. The atorvastatin calcium preparation is prepared by micronizing active componentsand alkaline auxiliary materials in a prescription, suspending or dissolving into a mixed solvent of...

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Bibliographische Detailangaben
Hauptverfasser: CAO XIANGLIN, SHANG DANDAN, ZHANG ZHONGLING, LI PING, GAO WANFENG
Format: Patent
Sprache:chi ; eng
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Zusammenfassung:The invention relates to a stable atorvastatin calcium composition, a preparation and the preparation method thereof. The atorvastatin calcium preparation is prepared by micronizing active componentsand alkaline auxiliary materials in a prescription, suspending or dissolving into a mixed solvent of methanol and purified water and adopting a spray drying mode; compared with the original research product, the obtained preparation has higher stability, reduces adverse effect and improves the medicine compliance of patients; moreover, the dissolution uniformity is higher, and the bioequivalence test indicates that the product is bioequivalent to the original research product. 本发明涉及种稳定的阿托伐他汀钙组合物、制剂及其制备方法,本发明采用将处方中活性成分和碱性辅料微粉化后混悬于或溶于甲醇与纯化水的混合溶剂中采用喷雾干燥的方式制备阿托伐他汀钙制剂,得到的制剂相比原研品具有更好的稳定性,降低了不良反应,提高患者用药顺应性;同时,溶出均性更好,生物等效性试验表明,本品与原研品生物等效。