助孕丸的质量标准研究

Study on the quality standard of Zhuyun Pills

目的建立助孕丸的质量标准。方法采用显微镜观察方中党参、白术和续断3味药以进行显微鉴别;采用TLC法对方中黄芪进行定性鉴别;采用HPLC法测定助孕丸中特女贞苷的含量。结果党参、白术和续断的显微鉴别图谱清晰且易观察;黄芪薄层色谱斑点清晰,阴性对照无干扰;特女贞苷进样量在0.264 0~2.640μg范围内呈良好的线性关系(r=0.999 8),平均回收率为98.1%,RSD值为1.56%(n=6)。结论所建立的定性、定量方法简便易行、重复性好,为助孕丸提供了质量控制方法。

Objective To establish the quality standard for Zhuyun Pills.Methods Radix Codonopsis,Rhizoma Atractylodis macrocephalae and Radix Dipsaci were observed under microscopy for microscopic identification.Radix Astragali was identified by TLC for qualitative identification.The content of specnuezhenide in Zhuyun Pills was determined by HPLC.Results Microscopic identification of Radix Codonopsis,Rhizoma Atractylodis macrocephalae and Radix Dipsaci were clear and were easy for discrimination.The spots of TLC were distinct without any interference from the negative references.There was a good linear relationship（r=0.999 8）between the peak area and the contents of specnuezhenide in the range of 0.264 0-2.640μg.The average recovery was98.1% with RSD of 1.56%（n=6）.Conclusion The established qualitative and quantitative methods are simple,rapid,accurate and repeatable,which provide the effective methods for the quality control of Zhuyun Pills.