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相容性研究中几个关键阈值的简介及转换

高用华,蔡弘   

  1. 中国医药包装协会,中国医药包装协会
  • 收稿日期:2013-12-18 修回日期:2014-01-23 出版日期:2014-02-25 发布日期:2014-01-25

Introduction and Converting of Several Key Threshold in Compatibility Study

  1. China National Pharmaceutical Packaging Association,Beijing,100082,China National Pharmaceutical Packaging Association,Beijing,100082
  • Received:2013-12-18 Revised:2014-01-23 Online:2014-02-25 Published:2014-01-25

摘要: 目的:通过相容性研究中可提取物与浸出物评估方法研究和评估阈值的转换,将化学物质的毒理学数据转换为化学物质的分析数据,从而实现药品与包装材料相容性研究中对浸出物的控制。方法:文献查阅,汇总美国产品质量研究学会( PQRI)毒理学家和化学家们确定的几个重要概念、关键阈值,并举例说明。意义:为在药品研发及生产过程中对药品及包装系统的可提取物与浸出物进行研究和控制提供明确的思路和方法。

Abstract: Objective: By developing the evaluation methods and the conversion from SCT to AET of the extractable and leachable in the compatibility, the toxicological data can be converted to analysis data of chemicals, so we can control the leachables in compatibility studies. Methods: literature review, and the summary of several important concepts and key threshold identified by the toxicologists and chemists from PQRI, and make examples. Meaning: to provide clear ideas and methods for the research and control of extractables and leachables in the process of drug development and production.