预混与共处理药用辅料应用进展及其质量控制要点探讨

    Application Progress and Quality Control Points of Pre-mixed and Co-processed Pharmaceutical Excipients

    • 摘要: 目的 对预混与共处理药用辅料的生产工艺、应用进展和质量控制要点作最新概述和分析。方法 结合近年来国内外相关文献和药典标准进行介绍、评述和展望。结果 不同工艺制备的预混与共处理辅料性质不同,在药物制剂中的应用不同,从而使其质量控制要点也不尽相同。结论 预混与共处理辅料对于药物制剂的质量与疗效有着重要意义,需根据辅料特性完善能反映产品安全性、功能性与质量均一性的相关质量指标。

       

      Abstract: OBJECTIVE To summarize and analyze the production technology, application progress and quality control points of pre-mixed and co-processed pharmaceutical excipients. METHODS Domestic and foreign related literatures and pharmacopoeia standards in recent years were reviewed to introduce, comment and prospect the excipients. RESULTS Pre-mixed and co-processed excipients prepared by different processes were various in their properties and applications in pharmaceutical preparations. Therefore, the key points of quality control of those excipients were also different. CONCLUSION Pre-mixed and co-processed excipients play an important role in quality and efficacy of pharmaceutical preparations. Related quality indicators that reflect product safety, functionality and quality uniformity should be improved according to the characteristics of excipients.

       

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