莲菊感冒胶囊的质量控制及稳定性考察  

Study on the quality control and stability of Lianju-ganmao capsules

作　　者：张治蓉[1] 黄勇[1] 郑林[1] 王爱民[1] 王永林[1] 

机构地区：[1]贵阳医学院药学院,贵州贵阳550004

出　　处：《中国医院药学杂志》2013年第8期604-607,共4页Chinese Journal of Hospital Pharmacy

基　　金：贵州省科技计划项目[黔科合计工字(2009)4001];贵阳市科技计划项目[(2009)筑科计合同字第9-3-04号]

摘　　要：目的:建立莲菊感冒胶囊的质量控制方法并考察其在加速和室温条件下的稳定性。方法:采用薄层色谱法鉴别莲菊感冒胶囊中的主要药味羊耳菊和穿心莲;采用高效液相色谱法测定制剂中3,5-二咖啡酰基奎宁酸、穿心莲内酯和脱水穿心莲内酯的含量。结果:3批莲菊感冒胶囊中试样品经加速试验6个月和长期试验18个月考察,各项指标均符合质量标准要求。结论:莲菊感冒胶囊稳定性良好。ABSTRACT：OBJECTIVE To establish the quality control method and study the stability of Lianju-ganmao capsules at accelerated testing and room temperature. METHODS Inula cappa DC,Andrographis paniculata Nees in the capsules were identified by TLC. The content of 3,5-dicaffeoylquinic acid, andrographolide and 14-deoxy 1 1, 12-didehydroandgrapholide were determined by HPLC. RESULTS In the accelerated testing and the iong-term testing, various indexes of 3 pilot test samples accorded with the quality standard of Lianju-ganmao capsules. CONCLUSION The present study showed that Lianju-ganmao capsules had excellent stability.

关 键 词：莲菊感冒胶囊 稳定性 薄层色谱法 高效液相色谱法 

分 类 号：R943[医药卫生—药剂学]