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目的:对固肾合剂含量测定的方法进行验证,以证明药品标准中含量测定的方法符合要求。方法:参照药品标准分析方法验证指导原则,进行试药含量测定的线性关系、精密度、重现性、稳定性和回收率试验。结果:淫羊藿苷在浓度33.6～672μg/mL范围内线性关系良好,分析方法的阴性对照无干扰,精密度、重现性、稳定性符合要求,平均回收率为97.2%,RSD为1.6%。结论:固肾合剂中淫羊藿苷含量测定准确、可靠,方法符合药品检验要求。
Objective: To verify the method of determining the content of Gushen mixture in order to prove that the method of content determination in the standard of medicine meets the requirements. Methods: With reference to the guidelines for the validation of standard analytical methods for pharmaceuticals, the linearity, precision, reproducibility, stability and recovery of the tested drug contents were tested. Results: Icariin had a good linearity in the concentration range of 33.6-672μg / mL. The negative control of the method had no interference and the precision, reproducibility and stability were satisfactory. The average recovery was 97.2% and the RSD was 1.6% . Conclusion: The determination of icariin in Gushen mixture is accurate and reliable, and the method accords with the requirement of drug inspection.