多指标经典恒温法预测戊己胃漂浮缓释片有效期  

Prediction of the validity period of Wuji Gastric Floating Sustained Release Tablets with multi-index by classic constant-temperature method

作　　者：王群[1] 刘文[1] 陈中芬[1] 杨颂[1] 施晓伟[1] 

机构地区：[1]贵阳中医学院,贵阳550002

出　　处：《中华中医药杂志》2014年第7期2370-2373,共4页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：贵州省中药现代化科技产业研究开发专项(No.黔科合中药[2010]5016号)~~

摘　　要：目的:进行戊己胃漂浮缓释片有效期研究。方法:采用HPLC法同时测定戊己胃漂浮缓释片中盐酸小檗碱、吴茱萸碱、吴茱萸次碱及芍药苷的含量,并以多个有效成分为指标,运用经典恒温法预测其有效期。结果:盐酸小檗碱、吴茱萸碱、吴茱萸次碱及芍药苷的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:4.22×10-6、3.13×10-6、4.80×10-6、4.14×10-6,以有效期时间最短的吴茱萸次碱为指标,制剂有效期为2.50年。结论:戊己胃漂浮缓释片的有效期暂定为2.50年。Objective： To study the validity period of Wuji Gastric Floating Sustained Release Tablets. Methods： The contents of berberine hydrochloride, evodiamine, rutaecarpine, paeonil orin in Wuji Gastric Floating Sustained Release Tablets were detected by HPLC method, and the validity period with multi-index of tablets was predicted by classic constant-temperature method. Results： The data showed that the time change of four ingredients met thefirst order degradation. At 25℃, the K of decomposition rate constant included 4.22×10-6, 3.13×10-6, 4.80×10-6 and 4.14×10-6. By using the validity period for the shortest time of rutaecarpine as index, the validity period of Wuji Gastric Floating Sustained Release Tablets was 2.5 years. Conclusion： The validity period of Wuji Gastric Floating Sustained Release Tablets is 2.50 years temporarily.

关 键 词：戊己胃漂浮缓释片 经典恒温法 有效期 吴茱萸碱 盐酸小檗碱 吴茱萸次碱 芍药苷 

分 类 号：R284.2[医药卫生—中药学] O657.72[医药卫生—中医学]