黏合剂功能性指标对制剂的影响

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摘 要 药用辅料是药品的重要组成部分，不仅影响药品质量和疗效，对药品生产的工艺也有影响。同一辅料在不同的制剂中使用，会表现出不同的功能，对于这些功能性指标，需要根据质量源于设计（QbD）原则来确认。本文综述黏合剂功能性指标对制剂的影响，希望对制剂研发中黏合剂的功能性指标选择提供一些参考。

关键词 药用辅料 黏合剂 功能性指标 质量标准

中图分类号：R943 文献标志码：A 文章编号：1006-1533（2022）01-0075-05

Effect of binder’s functionality-related characteristics on drug preparation

WANG Ruyi， LIU Yi

（Shanghai Ashland Chemical Technology Development Co.， Ltd.， Shanghai 200233， China）

ABSTRACT Pharmaceutical excipients are important components for drug preparations， and can affect not only the quality and efficacy of drugs， but also the production process of drugs. The same excipient with different dosage or its application in different preparations will show different functions. Therefore， in addition to the specified quality items in pharmacopoeia or other quality standard， some other functionality-related characteristics are crucial and need to be confirmed according to the principle of quality by design （QbD）. The selection and function of binder’s functionality-related characteristics are reviewed so as to provide some references for the selection of binder quality items in drug preparation development.

KEy wORDS pharmaceutical excipients； binder； functionality-related characteristics； quality standard

藥用辅料是药品重要组成部分，是制剂实现其功能的载体，不仅影响到药品质量和稳定性，也影响到药品生产的工艺。（剩余10107字）