五子衍宗丸质量标准研究

目的建立五子衍宗丸的质量标准。方法采用薄层色谱法(thin-layer chromatography,TLC)对五子衍宗丸中的枸杞子、菟丝子和五味子进行定性鉴别;采用薄层扫描法测定五味子酯甲的含量。结果枸杞子、菟丝子和五味子的TLC特征斑点清晰,分离度好,阴性无干扰;五味子酯甲在0.250～1.004μg(r=0.999)范围内与峰面积积分值呈良好线性关系,平均加样回收率为100.96%,相对标准偏差为0.51%(n=6)。结论所建立的标准可用于五子衍宗丸的质量控制。

Study on Quality Standards for Wuzi Yanzong Pills

Objective To establish quality standards for Wuzi Yanzong Pills,a patent traditional Chinese medicine for male infertility.Methods Fructus Lycii,Custuta chinensis Lam.and Schisandra sphenanthera Rehd.et Wils.were qualitatively identified by thin-layer chromatography(TLC).The content of Schisantherin A was determined by TLC scanning.Results The characteristic spots of Fructus Lycii,Custuta chinensis Lam.,and Schisandra sphenanthera Rehd.et Wils.were clear without interference in the negative sample,showing a good resolving power.The concentration of Schisantherin A was linearly correlated with the scores of peak area within the range of 0.250 to 1.004 μg(r=0.999).The average recovery was 100.96% with relative standard deviation being 0.51%(n=6).Conclusion The established method can be used for the quality control of Wuzi Yanzong Pills.