清金散质量标准研究

Study on Quality Control of Qingjin Pulvis

目的提高并完善清金散的质量标准。方法采用TLC法对清金散中的紫苑、陈皮进行定性鉴别;采用HPLC测定制剂中甘草苷的含量。Wonda Sil C_(18)-WR(4.6 mm×250 mm,5μm)色谱柱;流动相为乙腈-0.1%磷酸溶液系统,梯度洗脱;流速:1.0 ml·min^(-1);检测波长:237 nm;柱温:25℃;进样量:10μl。结果 TLC中,供试品在与对照药材相应位置上出现相同颜色的斑点,阴性对照无干扰;甘草苷进样量在0.041~0.453μg范围内与峰面积线性关系良好(r=1.00)。平均加样回收率为99.37%,RSD为1.27%(n=9)。结论本方法简便、准确、可靠、重复性好,可作为该制剂的质量控制。

Objective To improve the quality standards of Qingjin pulvis. Methods Asteris radix et rhizoma and citri reticulatae pericarpium were qualitatively identified by TLC. The content of liquiritin in the preparation was determined by HPLC. The separation was performed on Wonda Sil C18-WR（ 4. 6 mm × 250 mm,5 μm） column with a mobile phase consisting of acetonitrile-0. 1% phosphoric acid solution and gradient elution at the detection wavelength of 237 nm. The column temperature was 25 ℃,the flow rate was 1. 0 ml·min-1and the sample volume was 10 μl. Results In the TLC,the test sample appeared in the same position and was of the same color as the reference crude herb. The negative control was free of interference. The linearity of liquiritin was good within the range of0. 041- 0. 453 μg（ r = 1. 0000）. The average recovery was 99. 37%,while RSD was 1. 27%. Conclusion This method is simple,accurate,reliable and reproducible. It can be used for quality control of Qingjin pulvis.