不同厂家龙胆泻肝丸中龙胆苦苷、栀子苷、黄芩苷的溶出度测定和比较  

Determination and comparison of dissolution rates of gentiopicroside,geniposide and baicalin in Longdan Xiegan Pills from different manufacturers

作　　者：玄敏 程雪梅[1,2] 王峥涛[1,2] 王长虹[1,2] 

机构地区：[1]上海中医药大学中药研究所,中药标准化教育部重点实验室,上海201203 [2]上海中药标准化研究中心,上海201203

出　　处：《中成药》2016年第4期790-795,共6页Chinese Traditional Patent Medicine

基　　金：国家药品标准提高暨2015版药典科研任务资助(2012)

摘　　要：目的建立龙胆泻肝丸(龙胆、栀子、黄芩等)中龙胆苦苷、栀子苷、黄芩苷溶出度的检测方法,并比较7个生产厂家8批样品的溶出度情况。方法 HPLC法测定龙胆泻肝丸中龙胆苦苷、栀子苷、黄芩苷的含有量。以0.1mol/L盐酸为溶出介质进行溶出度试验,测定不同厂家该药物中3种成分的体外溶出度,绘制累积溶出曲线。然后,通过相似因子(f2)法对累积溶出度进行比较。结果龙胆苦苷、栀子苷的溶出参数(T_(50)和T_d)无显著性差异(P>0.05)。与龙胆苦苷和栀子苷相比,黄芩苷的溶出参数(T_(50)和T_d)有显著性差异(P<0.05)。8批样品中,龙胆苦苷和栀子苷的相似因子(f2)值均大于50,而黄芩苷小于50。结论有必要对龙胆泻肝丸中这3种成分进行溶出度测试。AIM To establish a method for determing the dissolution rates of gentiopicroside,geniposide and baicalin in Longdan Xiegan Pills（ Gentiana scabra,Gardenia jasminoides,Scutellaria baicalensis,etc.） and to compare the dissolution behaviors of eight samples from seven manufacturers. METHODS HPLC was applied to determining the contents of gentiopicroside,geniposide and baicalin in Longdan Xiegan Pills. The dissolution test was carried out with 0. 1 mol/L hydrochloric acid as dissolution medium,and the cumulative dissolution curves of these three constituents were drawn. Then similarity factor（ f2） method was used for comparing the cumulative dissolution rates. RESULTS There were no significant differences in the dissolution parameters of gentiopicroside and geniposide（ T（50） and Td）（ P〈0. 05）. Compared with geniposide and baicalin,there were significant differences in the dissolution parameters of gentiopicroside（ T（50） and Td）（ P〈0. 05）. The similarity factor（ f2） values of gentiopicroside and geniposide were more than 50,while that of baicalin was less than 50. CONCLUSION It is necessary to conduct dissolution tests for these three constituents in Longdan Xiegan Pills.

关 键 词：龙胆泻肝丸 龙胆苦苷 栀子苷 黄芩苷 溶出度 HPLC 

分 类 号：R927.11[医药卫生—药学]