冬凌草片溶出度测定方法的建立

Stuy on Dissonlution Test of Donglingcao Pian

目的研究并建立冬凌草片溶出度测定方法。方法按中国药典2010年版附录中溶出度测定第三法,分别以5%乙醇溶液、0.1mol.L-1盐酸溶液、水、磷酸盐缓冲液(pH6.8)500mL为溶出介质,转速为75r.min-1,采用HPLC法测定冬凌草片中冬凌草甲素在溶出介质中的浓度。结果冬凌草甲素在0.4～1.2μg.mL-1范围内呈良好的线性关系(r=0.9997),平均回收率为99.2%,RSD=0.72%。结论本法测定冬凌草片的溶出度科学、准确、简便,可用于冬凌草片的质量控制。

Objective To study and establish a method for the determining the dissolution Donglingcao Pian.Methods According to Chinese pharmacopoeia（2010） dissolution method III.The dissolution tests of Donglingcao Pian_were performed with phosphate 5% alchohol solution, 0.1mol.L-1 hydrochloric acid solution,wate, buffer（pH6.8） as dissolution mediators respectively with a speed,of 75 r＇min-1,The concentration of Oridonin in Donglingcao Pian in dissolution mediatos were determined by HPLC.Results Oridonin_presented a good linear correlation within the range of （0.4--1.2）μg.m1-1 （r=0.9997）.The average recovery was 99.2%,with RSD of 0.72%.Conclusion This method is scientific,accurate and simple.This study provides the reference to establish quality standard for Donglingcao Pian.