半夏泻心结肠靶向片的稳定性考察  

Stability Investigation of Banxia Xiexin Colon Targeted Tablets(半夏泻心结肠靶向片)

作　　者：余巧 李大炜 冯白茹 申茹 徐英辉 祁银德 YU Qiao;LI Da-wei;FENG Bai-ru;SHEN Ru;XU Ying-hui;QI Yin-de(Huizhou Health Sciences Polytechnic,Huizhou Guangdong 516025,China)

机构地区：[1]惠州卫生职业技术学院,广东惠州516025

出　　处：《中医药导报》2020年第10期42-45,共4页Guiding Journal of Traditional Chinese Medicine and Pharmacy

基　　金：2016年度惠州市科技专项资金资助项目(2016X0401016)。

摘　　要：目的:考察半夏泻心结肠靶向片的稳定性,初步确定其贮存条件和有效期限。方法:采用HPLC法测定半夏泻心结肠靶向片中盐酸小檗碱和黄芩苷的含量,以多成分为指标,采用经典恒温法预测制剂的有效期;采用高温、高湿、强光照射试验考察制剂的稳定性。结果:盐酸小檗碱、黄芩苷的含量随时间变化属一级降解反应,在25℃时的分解速度常数K分别为:4.6539×10-6、3.5140×10-6,以有效期时间最短的盐酸小檗碱为指标,制剂有效期为2.50年。制剂经高温、高湿、强光照射,盐酸小檗碱和黄芩苷的含量有所下降,制剂性状和释药行为有一定变化。结论:半夏泻心结肠靶向片在室温(25℃)条件下,有效期为2.50年,为该制剂的包装、贮存条件的制定提供了依据。Objective:To investigate the stability of Banxia Xiexin colon targeted tablets,and to initially determine its storage conditions and validity period.Methods:The contents of berberine hydrochloride and baicalin in Banxia Xiexin colon targeted tablets were determined by HPLC,the validity period of the preparation was predicted by classical constant temperature method,and the stability of the preparation was investigated by high temperature,high humidity and strong light irradiation tests.Results:The content of berberine hydrochloride and baicalin changes with time is a first-order degradation reaction.The decomposition rate constants K at 25℃are:4.6539×10-6 and 3.5140×10-6,respectively.Taking berberine hydrochloride with the shortest validity period as the index,and the validity of the preparation is 2.50 years.The content of berberine hydrochloride and baicalin in the preparation decreased after high temperature,high humidity and strong light irradiation.There are some changes in the properties of the preparation and the release behavior.Conclusion:The validity period of Banxia Xiexin colon targeted tablets was 2.50 years at room temperature(25℃).

关 键 词：半夏泻心结肠靶向片 稳定性 盐酸小檗碱 黄芩苷 经典恒温法 

分 类 号：R284.1[医药卫生—中药学]