椎间盘丸质量标准的研究探讨

Study on the quality standard of Zhuijianpan Pills

目的:建立椎间盘丸的质量标准。方法:采用薄层色谱法对方中主药黄芪进行薄层定性鉴别,并以RP-HPLC测定芍药苷的含量。采用Hypersil ODS C18(4.6 mm×200 mm,5μm)色谱柱,检测波长为230 nm,流动相为乙腈-0.1%磷酸溶液(14∶86),流速为1.0 ml/min;柱温为30℃。结果:薄层色谱法可对该制剂中黄芪的主要成分黄芪甲苷进行鉴别。芍药苷在8～80μg/ml范围内线性关系良好,r=0.999 8,平均加样回收率为98.97%,RSD值为1.08%(n=6)。结论:该方法专属性强,重现性好,结果准确可靠,可有效控制椎间盘丸的质量。

Objective： To develop a quality standard for Zhuijianpan Pills. Methods： TLC was used for qualitative identi- fication to identify the ingredients of astragli radix. Meanwhile, the content of paeoniflorin in Zhuijianpan pills was deter mined by RP-HPLC with Hypersil ODS C18 （4.6 mm×200 mm, 5 μm）. The detection wavelength was 230 nm, methyl cyanide - 0.1% phosphoiic acid （14：86） was used as mobile phase, the flow rate was 1.0 ml/min and the column temperature was 30℃.Results： Astragaloside in astragli radix could be identified by TLC. The calibration curve of paeoniflorin was linear within the range of 8-80μg/ml, r=0.999 8. The average recovery of paeoniflorin was 98.97%, RSD=-1.08% （n=6）. Conclusion： The method is specific, reliable and accurate. It can be used for quality control of Zhuijianpan Pills.