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。
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 and the 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 Capsules meets the SFDA＇s requirements YBH06622003.
出处
《中国医药导报》
CAS
2008年第17期32-33,共2页
China Medical Herald
关键词
奥拉西坦胶囊
装量差异
溶出度
稳定性
Oxiracetam Capsules
Weight deviation
Dissolution
Stability
