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目的:考察补肾温肺合剂的稳定性。方法:采用经典恒温加速试验法和留样观察法,以淫羊藿苷的含量作为考察指标,采用高效液相色谱法测定其含量的变化。结果:补肾温肺合剂中淫羊藿苷的含量变化符合一级动力学过程,2种考察方法的结果基本一致。在室温(25℃)条件下,补肾温肺合剂的有效期为1.25年。结论:建议补肾温肺合剂质量标准中有效期订为室温保存1年。
Objective: To investigate the stability of Bushen Wenfei Mixture. Methods: The classical constant temperature accelerated test method and sample retention observation method were adopted. The content of icariin was taken as the index of investigation, and the content of icariin was determined by high performance liquid chromatography. Results: The content of icariin in Bushen Wenfei Mixture conformed to the first-order kinetic process, and the results of the two methods were basically the same. Under the conditions of room temperature (25 ℃), Bushen Wenfei Mixture is valid for 1.25 years. Conclusion: It is suggested that the validity period of Kidney-Warming-Lung Mixture Quality Standard be reserved for 1 year at room temperature.