摘要
目的:建立雷贝拉唑钠肠溶片往复筒溶出试验方法,并考察不同厂家产品的溶出行为。方法:通过对往复频率、筛网孔径等关键试验条件的筛选考察,建立往复筒试验。方法:温度37℃,往复频率10 dip·min^(-1),浸入时间10 s,滴水时间20 s,上筛网20目,下筛网40目,介质分别为pH 8.0三羟基甲基氨基甲烷缓冲液、pH 7.4磷酸盐缓冲液和pH 6.8磷酸盐缓冲液,介质体积250 mL。采用新建立的往复筒溶出条件和《中华人民共和国药典》中规定的桨法溶出条件考察了原研制剂和4个仿制制剂的溶出行为,并以相似因子比较溶出行为的相似性。结果:采用桨法条件进行溶出行为评价时,有2个仿制制剂与原研制剂的溶出行为相似(f_(2)>50),采用往复筒法溶出条件,这2个仿制制剂仅1个在pH 8.0和pH 7.4介质条件下的溶出行为相似,其余条件均不相似。结论:新建立的往复筒法溶出试验方法具有一定的区分力,可为雷贝拉唑钠肠溶片处方工艺优化和仿制药一致性评价提供支持。本研究亦为其他主药易降解制剂体外溶出度研究提供了思路。
Objective:To establish a reciprocating cylinder method for the dissolution test of rabeprazole sodium enteric-coated tables and compare the dissolution behaviors of rabeprazole sodium enteric-coated tables from different manufacturers.Methods:Through the screening and investigation of the key test conditions such as reciprocating frequency and screen aperture,the reciprocating cylinder apparatus test method was established.The temperature was 37℃,the frequency of repetition was 10 dip·min^(-1),the immersion time was 10 s,the drip time was 20 s,the upper screen was 20 mesh,the lower screen was 40 mesh,and with 250 mL pH 8.0 tris hydrochloride buffer,pH 7.4 phosphate buffer and pH 6.8 phosphate buffer as the dissolution medium.The dissolution profiles of rabeprazole sodium enteric-coated tables from different pharmaceutical manufacturers were determined by using the newly established reciprocating cylinder method and the dissolution conditions of paddle method specified in Chinese Pharmacopoeia and the dissolution curves of consistency were evaluated by calculating the similarity factor.Results:While using paddle method the dissolution profiles of the two domestic pharmaceutical manufacturers were similar to those of the reference listed drug(f_(2)>50).While using reciprocating cylinder method the dissolution profiles of the two domestic pharmaceutical manufacturers were similar only under the conditions of pH 8.0 and pH 7.4,and the other conditions were not similar.Conclusion:This method can be used to determine the dissolution of rabeprazole sodium enteric-coated tablets with a certain resolution.It can provides assistance for further optimizing manufacturing process and evaluating the consistency of generic drugs.This study also provides an idea for the in vitro dissolution study of other active pharmaceutical ingredients readily degradable preparations.
作者
庾莉菊
陈天伊
李伊娜
齐衍超
宁保明
YU Li-ju;CHEN Tian-yi;LI Yi-na;QI Yan-chao;NING Bao-ming(National Institutes for Food and Drug Control,Key Laboratory of National Medical Products Administration-Key Laboratory of Research and Evaluation of Chemical Drug Quality,Beijing 102629,China;China Resources Double-Crane Pharmaceutical Co.,Ltd.,Beijing 100111,China;Jinan Second People’s Hospital,Jinan 250021,China;Weifang Inspection and Testing Center,Weifang 261200,China)
出处
《药物分析杂志》
北大核心
2025年第4期654-662,共9页
Chinese Journal of Pharmaceutical Analysis
基金
国家局药品监管科学体系建设重点项目(RS2024H001)。
关键词
往复筒法
体外
溶出行为
相似因子
雷贝拉唑钠
肠溶片
质量评价
reciprocating cylinder method
in vitro
drug dissolution
similarity factor
rabeprazole sodium
entericcoated tablets
quality evaluating
