综述专论

往复筒法在药物溶出度研究中的应用进展*

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  • 1.烟台大学,烟台 264005;
    2.中国食品药品检定研究院,国家药品监督管理局重点实验室-化学药品质量研究与评价重点实验室,北京 102629;
    3.安捷伦科技(中国)有限公司,北京 100102;
    4.Logan 公司,美国新泽西州 08873;
    5.ERWEKA GmbH,德国兰根 63225
第一作者 Tel:18953744218;E-mail:lyn960722@163.com
** 宁保明 Tel:(010)53851575;E-mail:ningbm@nifdc.org.cn
庾莉菊 Tel:(010)53851601;E-mail:yuliju@nifdc.org.cn

收稿日期: 2020-09-01

  网络出版日期: 2024-05-31

基金资助

* 药品医疗器械审评审批制度改革相关药品标准研究课题——溶出度与释放度测定法往复筒法的建立研究(编号:ZG2018-4-2)

Progress in applications of the reciprocating cylinder apparatus in dissolution testing of drug formulations*

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  • 1. Yantai University, Yantai 264005, China;
    2. 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;
    3. Agilent Technologies Co., Ltd. Beijing 100102, China;
    4. Logan Instruments Corp., New Jersey 08873, USA;
    5. ERWEKA GmbH, Langen 63225, Germany

Received date: 2020-09-01

  Online published: 2024-05-31

摘要

探讨往复筒溶出度测定方法的研究进展与应用现状。在查阅国内外往复筒法文献的基础上,对往复筒法的历史、发展历程、装置、工作原理、主要特点及其在药物制剂中的应用进行了回顾和阐述。往复筒法可以更好地满足复杂或新型制剂处方、工艺筛选及体外质量研究的需要,在药物制剂的研发与质量控制领域有着非常广阔的应用前景,对于开展体内外相关性研究也有重要的参考价值。

本文引用格式

李伊娜, 张娜, 刘万卉, 袁松, 黄海伟, 李婕, 王晓波, 李明豪, Thorsten BOETTCHER, 庾莉菊, 宁保明 . 往复筒法在药物溶出度研究中的应用进展*[J]. 药物分析杂志, 2021 , 41(2) : 185 -194 . DOI: 10.16155/j.0254-1793.2021.02.01

Abstract

To introduce the research progress and application status of reciprocating cylinder dissolution method in drug products development. Based on the published reports,a brief historical background,device characteristics and advancement, and applicable dosage forms are presented in this review. Reciprocating cylinder method could better meet the regular requirements for complex or new formulation,process screening and in vitro development study. As a biorelevant apparatus, it has a very broad prospect for formulation development and quality control,and provides practical references for the in vitro-in vivo correlation(IVIVC) research.

参考文献

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