奥拉西坦胶囊的制备及其稳定性考察
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[摘要] 目的：设计奥拉西坦胶囊处方并制备奥拉西坦胶囊。方法：以溶出度、装量差异为指标，通过多处方筛选，确定奥拉西坦胶囊的处方组成，并进行稳定性考察。结果：按确定的处方制备的奥拉西坦胶囊，各项质量指标均符合国家标准要求。结论：确定的奥拉西坦胶囊工艺达到国家食品药品监督管理局标准(试行)YBH06622003的要求。
[关键词] 奥拉西坦胶囊；装量差异；溶出度；稳定性
[中图分类号]R944.5 [文献标识码]A [文章编号]1673-7210(2008)06(b)-032-02
Preparation and stability study of Oxiracetam Capsules
CUI Yue, ZHANG Min-yue,WANG Hong-lei
(Shijiazhuang Ouyi Pharmaceutical Co. Ltd., Shijiazhuang 050051, China)
[Abstract] Objective: To design the formula of Oxiracetam Capsules and to manufacture Oxiracetam Capsules according to the formula.Methods: Dissolution and weight deviation were taken as the target to screen Oxiracetam Capsules formula andthe stability study was carried out.Results: The quality of Oxiracetam Capsules manufactured according to the formula met the requirements.Conclusion:The screened process of Oxiracetam Capsulesmeets the SFDA's requirements YBH06622003 ......
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