| 中药制剂关键质量属性确认的思考 |
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| 引用本文： | 赵晓霞,赵巍,张永文. 中药制剂关键质量属性确认的思考[J]. 中草药, 2019, 50(17): 4008-4012 |
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| 作者姓名： | 赵晓霞 赵巍 张永文 |
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| 作者单位： | 国家药品监督管理局 药品审评中心, 北京 100022,国家药品监督管理局 药品审评中心, 北京 100022,国家药品监督管理局 药品审评中心, 北京 100022 |
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| 摘 要： | 通过对中药制剂关键质量属性确认中应重点考虑的问题分析,提出药品关键质量属性的确定应全面考虑药物的有效性、安全性、药用物质本身的性质等方面的因素,同时还应关注中药制剂成型的要求,体现药物质量控制的整体性要求,以提取完整的能表征药品性质的质量控制指标,为企业生产过程控制和药品质量标准建立提供依据。
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| 关 键 词： | 中药制剂 关键质量属性 生产质量控制 质量标准 药用物质 药用组分 |
| 收稿时间： | 2019-08-02 |
Consideration on critical quality attributes determination of Chinese materia medica preparations |
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| ZHAO Xiao-xi,ZHAO Wei and ZHANG Yong-wen. Consideration on critical quality attributes determination of Chinese materia medica preparations[J]. Chinese Traditional and Herbal Drugs, 2019, 50(17): 4008-4012 |
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| Authors: | ZHAO Xiao-xi ZHAO Wei ZHANG Yong-wen |
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| Affiliation: | Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China,Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China and Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China |
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| Abstract: | In this paper, through the analysis of the key issues in the confirmation of the critical quality attributes (CQAs) of traditional Chinese medicine preparations, it is proposed that the determination of the CQAs should fully consider factors such as the efficacy, safety, nature of the drug substance, requirements of formulation and overall requirements of drug quality control. Complete quality control items that can characterize the properties of drugs should be extracted to provide a basis for the establishment of process control and drug quality standards. |
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| Keywords: | Chinese materia medica preparation critical quality attributes (CQAs) production quality control quality standards medicinal substances medicinal components |
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