| 引用本文: | 孙健,季申,胡青.《中国药典》2025年版指导原则9303“色素检测法建立指导原则”修订概况[J].中国现代应用药学,2025,42(20):6-12. |
| Sun Jian,Ji Shen,Hu Qing.Overview of the Revision to the Guideline 9303: Guideline for the Establishment of Pigment Detection Methods in Chinese Pharmacopoeia 2025 Edition[J].Chin J Mod Appl Pharm(中国现代应用药学),2025,42(20):6-12. |
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| 摘要: |
| 《中国药典》2025年版指导原则9303“色素检测法建立指导原则”为药品中作为辅料合规使用色素的检测和可能出现的非法使用色素的检测提供方法指导。本文系统梳理色素分类及命名编号系统,介绍国内外对药用色素的监管情况,解读本次修订的理念与内容,并提出监管和药典编制进一步发展完善的思考与建议。 |
| 关键词: 中国药典 色素 辅料 非法染色 指导原则 |
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| Overview of the Revision to the Guideline 9303: Guideline for the Establishment of Pigment Detection Methods in Chinese Pharmacopoeia 2025 Edition |
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Sun Jian, Ji Shen, Hu Qing
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Shanghai Institute for Drug Control
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| Abstract: |
| The "Guideline for the Establishment of Pigment Detection Methods" in the 2025 edition of the Chinese Pharmacopoeia provides methodological guidance for the detection of compliant pigment use as excipients in pharmaceuticals and the detection of potential illegal use. This article comprehensively reviews the classification and nomenclature systems of pigments, introduces domestic and international regulatory frameworks for pharmaceutical colorants, interprets the rationale and specific content of the current revisions, and offers insights and recommendations for further improvements in regulatory oversight and pharmacopoeia compilation. |
| Key words: Chinese Pharmacopoeia Pigments Excipients Illegal dyeing Guideline |
