摘要
目的建立康胃胶囊中质量评价指标的测定方法,考察质量指标延胡乙素的变化,推测该药有效期。方法采用HPLC测定康胃胶囊中延胡乙素的含量;在温度(25±2)℃、相对湿度(60±10)%的条件下,不同时期该药延胡乙素含量的变化为主要考察指标,用有效期统计分析方法推算药物的有效期。结果有效期为27.7个月。结论有效期暂定为24个月。
Objective To Establish the assay method of quality guideline of Kangwei capsule and presume its validity duration by inspecting the content of tetrahydropalmatine.Methods Tetrahydropalmatine in Kangwei capsule was determined by HPLC.The validity duration of Kangwei capsule was calculated by statistical analysis method in the condition of temperature（25±2）℃,RH（60±10）%.Results The validity duration is 27.7 months.Conclusion The validity duration of Kangwei capsule is tentatively setted on 24 months.
出处
《中国实用医药》
2008年第14期3-4,共2页
China Practical Medicine
关键词
康胃胶囊
延胡乙素
稳定性
有效期
Kangwei capsule
Tetrahydropalmatine
Stability
Validity duration
