补肾调周合剂的制备及质量控制研究

目的：建立补肾调周合剂质量控制方法。方法：采用薄层色谱法对当归、川芎、白芍进行定性鉴别,采用高效液相色谱法测定淫羊藿中淫羊藿苷含量。结果：薄层色谱对当归、川芎及白芍特征斑点定性鉴别清晰,供试品色谱中在与对照药材和对照品色谱相应的位置上显相同颜色的斑点;HPLC法以甲醇-水（55∶45）为流动相,检测波长270nm,淫羊藿苷含量在0.196μg-2.94μg范围内线性关系良好（r=0.9999）,平均回收率为99.21%（RSD=1.41%,n=6）。结论：所建立的定性、定量方法准确、重现性好,可以作为该制剂的质量控制方法。

Study on Preparation and Quality Control of Bu Shen Tiao Zhou Mixture

Objective：To establish methods of quality control of Bu Shen Tiao Zhou Mixture.Methods：The thin-layer chromatography was used for qualitative identification of Dangui,Chuanxiong and Baishao and high performance liquid chromatography was used to determine the content of icariin in Epimedium.Results：The thin-layer chromatography had clear qualitative identification of characteristics and spots of Dangui,Chuanxiong and Baishao.The color spectrum of the test materials has the same spot color in the corresponding position of the control medicinal materials and control articles;HPLC method used methanol-water（55∶45）as mobile phase with detection wavelength 270nm,the icariin content ranged in 0.196 μg-2.94 μg with good linear relationship（r=0.9999）and the average recovery rate was 99.21%（RSD=1.41%,n=6）.Conclusion：The qualitative and quantitative method is accurate and reproducible and can serve as the quality control methods of preparation of Bu Shen Tiao Zhou He Ji.