楤木总皂苷胶囊的稳定性考察  

Study on the Stability of Aralia Saponin Capsules

作　　者：崔佳[1,2] 贾娜 奚苗苗 宋小妹[1] 文爱东 

机构地区：[1]陕西中医学院药学院,陕西咸阳712083 [2]第四军医大学第一附属医院药学部,西安710032

出　　处：《中国药房》2012年第39期3689-3693,共5页China Pharmacy

基　　金：国家自然科学基金资助项目(81001673);陕西省"13115"科技创新工程重大科技专项项目(2010ZDKG-62);陕西省自然科学基础研究计划项目(2010JQ4018)

摘　　要：目的:考察楤木总皂苷胶囊的稳定性。方法:以齐墩果酸为指标,观察及测定楤木总皂苷胶囊在影响因素试验、加速试验和长期试验的不同条件下的外观性状、pH值、崩解时限、水分、微生物限度和装量差异,并采用高效液相色谱法测定胶囊中齐墩果酸的含量。结果:外观性状、pH值、崩解时限、水分、装量差异及含量均无明显改变,微生物数量不超过规定限度。结论:楤木总皂苷胶囊在2年有效期内质量稳定。OBJECTIVE：To investigate the stability of Aralia saponin capsules.METHODS：Using oleanolic acid as index,the appearance,pH value,disintegration time,water content,microbial limit and content uniformity of Aralia saponin capsules were observed and determined in influential factor test,accelerated test and long-term test under different conditions.The contents of oleanolic acid were determined by HPLC.RESULTS：No obvious changes were observed in the appearance,pH value,disintegration time,water content,content uniformity and contents.The number of microorganisms did not exceed the prescribed limits.CONCLUSION：The quality of Aralia saponin capsules is stable in 2 years validity duration.

关 键 词：楤木总皂苷胶囊 稳定性 齐墩果酸 

分 类 号：R283.65[医药卫生—中药学] R927.2[医药卫生—中医学]