排石利胆片质量标准的研究  

Study on Quality Standard of Paishi Lidan Tablets

作　　者：李瑞莲[1] 雷玉萍[1] 

机构地区：[1]湖南省药品检验所,长沙410001

出　　处：《中国药品标准》2006年第6期49-51,共3页Drug Standards of China

摘　　要：目的:制订排石利胆片质量控制方法。方法:采用薄层色谱法对方中龙胆苦苷、芍药苷进行定性研究,采用高效液相色谱法,以乙腈-0.4%磷酸溶液(8∶92)为流动相,检测波长为327nm,采用C18(Hypersil BDS5.0×200mm,5μm)柱,测定方中茵陈中绿原酸的含量。结果:龙胆与赤芍可用薄层色谱鉴别;绿原酸在0.02176～0.19584μg范围内线性关系良好,相关系数为0.9999,加样回收率为97.9%,RSD为0.90%(n=5)。结论:所建立的方法能控制排石利胆片质量,且含量测定方法简便、快速、准确。Objective：To establish the method for quality control of Paishi Lidan Tablets. Methods：Gentiopicrin and Paeoniflorin in Paishi Lidan Tablets were identified by TLC,the ehlorogenie acid was determined by HPLC. The condition of HPLC was Hypersil BDS C18 eolumn,acetonitrile-0. 4% phosphoric acid （8：92） as mobile phase tthe detective wavelength was 327nm. Results：Gentiopierin and Paeoniflorin can be identified by TLC;The calibration cure was linear in the range of 0. 02176-0. 19584μg of chlorogenie acid （r=0. 9999）. The average recovery and RSD of puerarin were 97.9% and 0. 9%,respectively. Conclusion：The method established in this paper can be adopted for the quality control of Paishi Lidan Tablets and the determination method of ehlorogenie acid is simple,relatively rapid and accurate.

关 键 词：排石利胆片 龙胆苦苷 芍药苷 绿原酸 高效液相色谱法 

分 类 号：R657.405[医药卫生—外科学]