摘要
目的 :筛选岩白菜素片最佳处方组成及制备工艺 ,并建立其含量测定方法。方法 :以辅料中低取代羟丙基纤维素 (Ls -HPC)、吐温 -80和淀粉为3因素 ,每因素取3水平 ,选用L9(34)正交表 ,以岩白菜素片的体外溶出参数(Td)为指标进行正交实验 ,筛选最佳处方组成和制备工艺 ;用双波长紫外分光光度法测定片剂中岩白菜素的含量。结果 :辅料中影响片剂溶出度的因素是Ls -HPC和吐温 -80(P<0 01)。最佳处方组成为每片含岩白菜素0 125g、Ls-HPC0 0186g、吐温 -800 0248g、淀粉0 1354g、硬脂酸镁0 0032g。双波长紫外分光光度法测定片剂中岩白菜素的含量 ,平均回收率为 (100 92±0 87) %(n=8)。结论 :本处方具有辅料价廉易得 ,有效成分溶出快 ,制备工艺简单 ,质量稳定及测定方法简便。
OBJECTIVE:To screen the optimum formulation of bergenin tablet and to establish an analysis method for measuring the content of bergenin in the tablets METHODS:The L3(34) orthogonal table and the parameter of in vitro dissolubility(Td) was employed to select the optimum formulation by taking LS-HPC,tween-80-starch,and starch as the three main factors,and three levels were adopted for each-factor The dual-wavelength spectrophotography was employed to determine the content of bergenin in the tablets RESULTS:The experimental results indicated that LS-HPC and tween-80-starch were the chief factors of influencing dissolution of tablet(P<0 01),and starch had no statistic significance(P>0 05) The optimum formulation was composed of bergenin:0 125g,Ls-HPC:0 0 186g,tween 80-starch:0 0 248g,starch:0 1 354g,magnesium stearate:0 0 032g The dual-wavelength spectrophotography was convenient and accurate The average recovery rate of bergenin was (100 92±0 87)%(n=8) CONCLUSION:The formulation has merits of low price of supplementary materials,rapid release of effective component,simple manufacture technique,and stability in quality
出处
《中国药房》
CAS
CSCD
2002年第7期398-399,共2页
China Pharmacy
关键词
岩白菜素
处方
正交实验
双波长紫外分光光度法
含量测定
bergenin
formulation
orthogonal experiment
dual-wavelength spectrophotogrophy
determination of content
