顽癣净质量标准研究.docVIP

顽癣净质量标准研究 　　[摘要] 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-pack CLC-ODS C18柱(6.0 mm×150 mm，5 μm)；流动相为甲醇-0.02 mol/L磷酸二氢钾溶液（用磷酸调pH至3.1）（50∶50）；检测波长为230 nm；流速为0.8 ml/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=586 238.6X+5 780，r=0.999 9，线性范围为0.249～2.490 μg，平均回收率为99.6%（n=9, RSD=0.38%）；水杨酸的回归方程为Y=460 688.3X+694.6，r=1.000 0，线性范围为0.123～1.230 μg，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。 　　[关键词] 顽癣净；紫荆皮；苯甲酸；水杨酸；TLC；HPLC；质量控制 　　[中图分类号]R927.11 [文献标识码]B [文章编号]1673-7210（2009）03（b）-054-03 　　 　　Studies on quality standard of Wanxuanjing 　　QIAN Mushui1, HAN Peng2, YE Xingfa2 　　(1.Shaoxing Huatong Medicine Co.,Ltd, Shaoxing 312030, China; 2.Shaoxing Huatong Pharmaceutical Co.,Ltd, Shaoxing312025,China) 　　[Abstract] Objective:To improve the method for quality control of Wanxuanjing. Methods:TLC was used to identify Cortex Kadsurae Radicis; the content ofbenzoic acid and salicylic acid in Wanxuanjing was determined by HPLC, the sample was separated by Shim-pack CLC-ODS C18 column(6.0 mm×150 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=1.000 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. 　　[Key words] Wanxuanjing; Cortex Kadsurae Radicis; Benzoic acid; Salicylic acid; TLC; HPLC; Quality control 　　 　　顽癣净由苯甲酸、水杨酸和紫荆皮酊复方组成，收载于中药成方制剂第19册，具有祛风止痒、保湿杀虫等作用，常用于手癣、脚癣、股癣、体癣等各种皮肤癣症的治疗。原标准中只采用酸碱滴定法测定苯甲酸和水杨