孕妇金花片的质量标准研究

Study on Quality Standard for Yunfujinhua Tablet

目的建立孕妇金花片的质量控制方法。方法采用薄层色谱法鉴别金银花、白芍、黄柏、黄连;高效液相色谱法测定栀子苷、黄芩苷的含量。结果本品定性鉴别薄层色谱特征明显,专属性强;栀子苷浓度在0.010～0.060mg.L-1范围内,与峰面积呈良好的线性关系(r=0.999 6),平均回收率为99.22%,RSD=1.29%。黄芩苷浓度在0.02～0.10mg.L-1范围内,与峰面积呈良好的线性关系(r=0.999 8),平均回收率为98.93%,RSD=0.96%。结论该方法方便、准确、重现性好,可用于孕妇金花片的质量控制。

Objective To establish the quality stangdard for Yunfujinhua tablet.Methods TLC was performed to identify Lonicerae Japonicae Flos,Paeoniae Radix Alba,Coptidis Rhizoma,Phellodendri Chinensis Cortex.HPLC was used to determine the content of geniposide and baicalin.Results The study on the quality control showed that the characteristic of identification by TLC was distinct and hightly specific.The geniposide quantification method had the linear range of 0.010～0.060mg·L-1.The average recovery was99.22% and RSD was1.29%.The baicalin quantification method had the linear range of 0.02～0.10mg·L-1.The average recovery was 98.93% and RSD was0.96%.Conclusion The method for idetification and quantification was simple,realizable and reproducible.It can be used effectively for the quality control of Yunfujinhua Tablet.