摘要
目的建立清肺胶囊质量控制方法。方法采用薄层色谱法对制剂中黄连、黄芩进行定性鉴别;对组方中有效成分黄芪甲苷用RP-HPLC法进行定量分析。结果薄层色谱中斑点清晰,易于识别;RP-HPLC法精密度、重现性良好,黄芪甲苷在0.5006～4.0048μg内均较好的线性关系,平均加样回收率为99.19%,RSD为0.95%。结论在本研究基础上制定的质量标准可以控制本品的内在质量,其方法是可行的。
Objective To establish the control method for Qingfei Capsule, Methods Qualitation discrimination of Coptis chinensis and Radix Scutellariae in this formula are identified by TLC. Quantitive analysis of Astragaloside A which is the effective element of the formula is adopted by RP HPLC. Result The specks in TLC are clear and easy to discriminate.The precision and reproducibility of the RP HPLC method are fine .In 0.521-4.036μg the contents of Paeoniflorin have good linear relationship. The average recovery rate for application of sample experiment is 99.19,and RSD is 0.95%. Conclusion On this study the foundation establishment that quantity standard that can control inside quantity, its method is viable.
