国内外药物溶出度仪机械参数验证的考察研究  

Investigation and Research on Mechanical Parameter Validation of Drug Dissolution Meters at Home and Abroad

作　　者：苏峰 刘为中 鲁胜男 胡晓静 何广卫 SU Feng;LIU Weizhong;LU Shengnan;HU Xiaojing;HE Guangwei

机构地区：[1]合肥医工医药股份有限公司 [2]安徽省药物一致性评价及高端制剂重点实验室 [3]中国药科大学

出　　处：《计量与测试技术》2024年第7期125-129,共5页Metrology & Measurement Technique

摘　　要：根据溶出度仪机械验证标准要求,本文以美国安捷伦Agilent708-DS、瑞士SOTAX AT-Xtend、美国Hanson Vision-Elite8、日本岛津SNTR-8600AST、上海富科思FADT-1202的自动取样溶出仪为研究对象,对机械验证参数进行汇总分析。结果表明:各自动取样溶出仪机械验证参数均符合要求,可用于口服固体制剂体外溶出的实验方法研究,为新药处方研发探索与仿制药质量一致性评价等工作提供实验室技术支持。According to the mecharical verification standard requirements of dissolution meter,In this paper,the n tomatic sampling dissolution instrument of Agilent 708-DS in the United States,SOTAX AT-Xtend in Switzer-Land,Hanson Vision-Elite&in thc United States,Shimadsu SNTR-8600AST in Japan,and Fukos FADT-1202 in Shanghai are taken as the rescarch object.Summarize and analyze the mechanical verification parameters.The re-sults showed that the mchanical verification parameters of each automatic sampling dissolution instrument met the requirements,and it could be used for the experimental method rescarch of in vitro dissolution af oral solid prepaгa-tions,prowviding laboratory technical support for the rescarch and development of new drug presription and the qual-ity consistency cvaluation of generic drugs。

关 键 词：溶出度 溶出度仪机械验证 一致性评价 生物等效性试验 

分 类 号：R927[医药卫生—药学]