| 引用本文: | 孙逍,谢升谷,陶巧凤.预混与共处理药用辅料应用进展及其质量控制要点探讨[J].中国现代应用药学,2021,38(11):1397-1403. |
| SUN Xiao,XIE Shenggu,TAO Qiaofeng.Application Progress and Quality Control Points of Pre-mixed and Co-processed Pharmaceutical Excipients[J].Chin J Mod Appl Pharm(中国现代应用药学),2021,38(11):1397-1403. |
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| 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。 |
| 关键词: 预混辅料 共处理辅料 应用进展 质量控制 |
| DOI：10.13748/j.cnki.issn1007-7693.2021.11.021 |
| 分类号:R942 |
| 基金项目:浙江省药品监督管理局科技计划项目（2021005） |
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| Application Progress and Quality Control Points of Pre-mixed and Co-processed Pharmaceutical Excipients |
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SUN Xiao, XIE Shenggu, TAO Qiaofeng
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Zhejiang Institute for Food and Drug Control, National Medical Products Administration Key Laboratory for Core Technology of Generic Drug Evaluation, Hangzhou 310052, China
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| 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. |
| Key words: pre-mixed excipients co-processed excipients application progress quality control |
