顽癣净质量标准的研究

Studies on quality standard of Wanxuanjing

目的:提高顽癣净的质量标准。方法:采用TLC法对制剂中的紫荆皮进行鉴别;采用HPLC法代替原用于测定苯甲酸和水杨酸总量的酸碱滴定法,来对制剂中的这两种成分进行含量测定,色谱条件:色谱柱为Shim-packCLC-ODSC18柱(6.0mm×150mm,5μm);流动相为甲醇-0.02mol/L磷酸二氢钾溶液(用磷酸调pH至3.1)(50∶50);检测波长为230nm;流速为0.8ml/min。结果:紫荆皮TLC鉴别专属性强;HPLC法测定苯甲酸的回归方程为Y=586238.6X+5780,r=0.9999,线性范围为0.249～2.490μg,平均回收率为99.6%(n=9,RSD=0.38%);水杨酸的回归方程为Y=460688.3X+694.6,r=1.0000,线性范围为0.123～1.230μg,平均回收率为99.5%(n=9,RSD=0.70%)。结论:本文建立的鉴别和含量测定方法简便、准确、重现性好,能更准确、有效地控制顽癣净的质量。

Objective：To improve the method for quality control of Wanxuanjing. Methods：TLC was used to identify Cortex Kadsurae Radicis; the content of benzoic acid and salicylic acid in Wanxuanjing was determined by HPLC, the sample was separated by Shim-pack CLC-ODS C^8 column（6.0 mm×l50 mm,5 μm） using a mixture of MeOH-KH2PO4（50：50） as the mobile phase, which was adjusted to pH 3.1 by phosphoric acid, the detective wavelength was set at 230 nm and the flow rate was 0.8 ml/min. Results：Cortex Kadsurae Radicis could be identified by TLC; the regression equation of benzoic acid was Y=586 238.6X＋5 780,r=0.999 9,which was linear over the range of 0.249-2.490 μg, the average recovery was 99. 6%（n=9, RSD=0.38%）; the regression equation of salicylic acid was Y=460 688.3X＋694.6, r=l.000 0, which was linear over the range of 0.123-1.230 μg, the average recovery was 99.5%（n=9, RSD=0.70%）. Conclusion：The method is sensitive, rapid, accurate, and can be used to control the quality of Wanxuanjing.