不同厂家/批次黄藤素片及分散片的溶出曲线测定  

Determination of the Dissolution Curves of Different Brand/Batch of Fibraurea Tablets and Dispersible Tablets

作　　者：祝宇龙 余飞 卫星红 彭灿[1,2,3] 阚家义 ZHU Yulong;YU Fei;WEI Xinghong;PENG Can;KAN Jiayi(Anhui University of Chinese Medicine,Hefei 230012;Anhui Province Key Laboratory of Chinese Medicinal Formula,Hefei 230012;Institute of Pharmaceutics,Anhui Academy of Chinese Medicine,Hefei 230012;Anhui Institutes for Food and Drug Control,Hefei 230051)

机构地区：[1]安徽中医药大学,安徽合肥230012 [2]中药复方安徽省重点实验室,安徽合肥230012 [3]安徽省中医药科学院药物制剂研究所,安徽合肥230012 [4]安徽省食品药品检验研究所,安徽合肥230051

出　　处：《中国医药工业杂志》2020年第5期626-631,共6页Chinese Journal of Pharmaceuticals

基　　金：国家“重大新药创制”科技重大专项(2017ZX09101001)。

摘　　要：本研究考察了不同厂家黄藤素片和分散片在4种溶出介质中的体外溶出行为。采用高效液相色谱法测定溶出液的含量,色谱柱为Unitary C18柱,流动相为乙腈-水(含0.4%磷酸和0.01%三乙胺),流速1.0 ml/min,检测波长345 nm,柱温40℃,进样量10μl。采用相似因子(f2)评价该制剂各厂家/批次溶出曲线的相似性,结果表明不同厂家产品的溶出曲线存在明显差异,提示其质量应该进一步研究。This study investigated the in vitro dissolution behavior in four dissolution media of fibraurea tablet and dispersible tablet from different manufacturers. The determination was performed by HPLC with column Unitary C18, and acetonitrile-water(including 0.4% phosphoric acid and 0.7% trimethylamine)as the mobile phase with the flow rate of 1.0 ml/min. The detection wavelength was set at 345 nm and the column temperature was 40 ℃, and injection volume was 10 μl. The similarity of dissolution curve was evaluated by similar factor(f2). The results showed that there were significant differences in the dissolution profiles of different manufacturers. It was suggested that the quality of these products should be re-evaluated.

关 键 词：黄藤素 片剂 高效液相色谱 溶出曲线 一致性评价 

分 类 号：R286.0[医药卫生—中药学] O657.72[医药卫生—中医学]