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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。
Objective: To predict the validity period of compound injections of traditional Chinese medicine by chemical kinetics, and to provide basis for evaluating the quality of traditional Chinese medicine injections. Methods : The initial average velocity accelerated experimental method was used to predict the effective period. The contents of puerarin and danshensu were determined by HPLC. RESULTS: The degradation of the active ingredients in the injections showed that puerarin met the first-order reaction rule, and that Danshensu was difficult to determine. The two components were used as indicators, and the t 0 .9, 25 °C were 3.49a and 1.69a, respectively. Conclusion: The effective period of Chinese herbal compound injection should be based on the shorter t9. The injection can be tentatively set to 1.5a.