【摘要】 目的 :用化学动力学方法预测中药复方注射剂的有效期 ,为评价其质量提供依据。方法 :采用初均速温度加速实验法预测有效期 ,复方中有效成分葛根素和丹参素的含量测定采用HPLC法。结果 :注射剂中有效成分的降解 ,葛根素符合一级反应规律 ,丹参素则难以确定 ;分别以两成分为指标 ,t0 .9,2 5℃ 分别为 3 .4 9a和 1.69a。结论 :中药复方注射剂的有效期宜以其中t0 .9较短者为准 ,本注射剂可暂定为 1.5a。更多还原

【Abstract】 Objective: To predict the stable life for a complex injection of Chinese meteria medica. Method: The prediction was carried out by initial average rate stability tests, and the contents of puerarin and danshensu (major active components of the injection) were assayed by HPLC. Result: The degradation of puerarin followed the first order action,while danshensu was hard to determine; the t 0.9,25℃ was 3.49 years and 1.69 years respectively. Conclusion: The stable life of the injection has been determined as 1.5 years. [更多还原