痔疮外洗散质量标准研究

Studies on the Quality Standard of the External Used Washing Powder for Hemorrhoid

目的建立痔疮外洗散的质量标准。方法采用TLC法对处方中防风、甘草、花椒进行定性鉴别;并采用HPLC测定黄连中盐酸小檗碱的含量。结果薄层色谱均检出防风、甘草、花椒;盐酸小檗碱在0.0524～2.0960μg内呈良好的线性关系,r=0.9997;平均回收率为99.4%,RSD=1.36%。结论该方法简便易行,重复性好,可作为该制剂质量控制标准。

OBJECTIVE To establish a quality standard of the external used washing powder for Hemorrhoid. METHODS The Radix Saposhnikoviae, Radix Et Rhizoma Glycyrrhizae and Pericarpium Zanthoxyli were identified by TLC and the content of berberine hydrochloride in Rhizoma Coptidis was determined by HPLC. RESULTS Radix Saposhnikoviae, Radix Glycytthizae and Pericarpium Zanthoxyli were found in TLC ; The linear range of berberine hydrochloride in Rhizoma Coptidis was 0. 052 4 - 2. 096 0ug （ r = 0. 999 7） ,the average recovery was 99.4% with RSD of 1.36%. CONCLUSION The method is simple and reproducible. It can be used to control the quality of the external used washing powder for Hemorrhoid.