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

苏峰 ¹刘为中 ²鲁胜男 ²胡晓静 ²何广卫²

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作者信息

1. 合肥医工医药股份有限公司;安徽省药物一致性评价及高端制剂重点实验室;中国药科大学
2. 合肥医工医药股份有限公司;安徽省药物一致性评价及高端制剂重点实验室
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摘要

根据溶出度仪机械验证标准要求,本文以美国安捷伦Agilent 708-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.

Abstract

According to the mechanical verification standard requirements of dissolution meter,In this paper,the automatic sampling dissolution instrument of Agilent 708-DS in the United States,SOT AX AT-Xtend in Switzer-land,Hanson Vision-Elite8 in the United States,Shimadsu SNTR-8600AST in Japan,and Fukos FADT-1202 in Shanghai are taken as the research object.Summarize and analyze the mechanical verification parameters.The re-sults showed that the mechanical verification parameters of each automatic sampling dissolution instrument met the requirements,and it could be used for the experimental method research of in vitro dissolution of oral solid prepara-tions,providing laboratory technical support for the research and development of new drug prescription and the qual-ity consistency evaluation 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

Key words

dissolution/mechanical verification of dissolution meter/consistency evaluation/bioequivalence test

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出版年

2024

计量与测试技术

成都市计量监督检定测试所

计量与测试技术

影响因子：0.175

ISSN：1004-6941

参考文献量11

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