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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 a method for the determination of quality evaluation indexes in Kangwei capsules, investigate changes in the quality index of tetrahydropalmatine, and speculate the validity of the drug. Methods HPLC method was used to determine the content of faberline B in Kangwei capsules. Under the conditions of temperature (25±2)°C and relative humidity (60±10)%, the change of the content of faberlin in the drug at different time was the main inspection index. The analytical method calculates the validity of the drug. The result is valid for 27.7 months. The validity of the conclusion is tentatively set at 24 months.