阿苯达唑片多条溶出曲线的研究和测定  

Determination of the Dissolution Curves of Albendazole Tablets

作　　者：马玲 王曼泽 朱捷 陈欢 黄钰馨 沈晓华 撖志明 刘瑞 MA Ling;WANG Man-ze;ZHU Jie;CHEN Huan;HUANG Yu-xin;SHEN Xiao-hua;HAN Zhi-ming;LIU Rui(Ningxia Institute of Drug Control,Yinchuan 750001,China;Ningxia Institute of Food Control,Yinchuan 750001,China)

机构地区：[1]宁夏回族自治区药品检验研究院,银川750001 [2]宁夏回族自治区食品检测研究院,银川750001

出　　处：《中国药学杂志》2018年第24期2123-2126,共4页Chinese Pharmaceutical Journal

摘　　要：目的建立阿苯达唑片有区分能力的溶出曲线测定方法,并考察参比制剂与仿制制剂体外溶出曲线的一致性。方法采用浆法,转速为50 r·min^(-1),以p H 1. 2的盐酸溶液和水各900 m L为溶出介质,并采用相似因子(f_2)法评价相似性。结果建立的3条溶出曲线均具有较好的区分能力,由仿制制剂与参比制剂在2种介质中溶出曲线的f_2可知,A厂家相似,B、C厂家不相似。结论本实验为阿苯达唑片体外溶出曲线一致性评价提供了试验依据。OBJECTIVE To establish a determination method of the dissolution curves of albendazole tablets with differentiation ability and investigate the similarity of dissolution curves in vitro between reference preparation and generic preparations. METHODS Paddle method was adopted with rotation speed of 50 r·min-1 and the dissolution medium volume was 900 m L. The dissolution media were p H 1. 2 hydrochloric acid solution and water. The similarity factor( f2) method was used to evaluate the comparability of dissolution curves. RESULTS The three established dissolution curves had good distinguishing ability. As shown by the similarity factor( f2),the generic preparation from manufacture A was similar to the reference preparation,while those from the manufacture B and C were not similar. CONCLUSION The study provides the experimental basis for the consistency evaluation of the dissolution curves of abendazole tablets.

关 键 词：仿制药 阿苯达唑片 溶出曲线 一致性评价 高效液相色谱法 相似因子 

分 类 号：R917[医药卫生—药物分析学]