| 引用本文: | 陈超,王妍,訾晓伟,章蔼静,戴寿沣,张传杰,史沛,陈雪帆.起草人视角技术阐述《中国药典》2025年版扫描电子显微镜法[J].中国现代应用药学,2025,42(20):1-0. |
| chenchao,wangyan,zixiaowei,zhangaijing,daishoufeng,zhangchuanjie,shipei,chenxuefan.Drafting Perspective Technical Elaboration on Scanning Electron Microscopy Method in the 2025 Edition of the Chinese Pharmacopoeia[J].Chin J Mod Appl Pharm(中国现代应用药学),2025,42(20):1-0. |
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| 起草人视角技术阐述《中国药典》2025年版扫描电子显微镜法 |
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陈超1, 王妍2, 訾晓伟1, 章蔼静1, 戴寿沣2, 张传杰3, 史沛4, 陈雪帆5
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1.浙江省食品药品检验研究院;2.浙江和泽医药科技股份有限公司;3.复纳科学仪器（上海）有限公司;4.安徽省食品药品检验研究院;5.浙江工业大学
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| 摘要: |
| 目的 本文旨在解读《中国药典》2025年版中新增的“扫描电子显微镜法”（以下简称扫描电镜法），为标准的实施提供帮助，为药品检测提供科学依据。方法 通过对不同国家药典标准的比较，介绍ChP扫描电镜法增订概况，系统阐述了该方法的制定背景、技术特点和实施要点。同时结合药品检测的实际案例，探讨了方法的具体应用。结果 《中国药典》2025年版中新增的扫描电镜法，为药品检测提供了更为精确、高效的技术手段。该方法能够直观展现药品表面的微观形貌，准确分析药品的成分和元素组成，以及进行结晶学分析，从而有效提升了药品检测的准确性和科学性。结论 《中国药典》2025年版新增的“扫描电镜法”具有重要的应用价值，不仅为药品质量控制提供了有力的技术支撑，还为药品研发的创新发展注入了新的活力，助力我国药品质量与疗效的提升。 |
| 关键词: 扫描电镜 中国药典 二次电子 背散射电子 X射线能谱 美国药典 欧洲药典 |
| DOI： |
| 分类号:R284.1；R917.101?????? |
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| Drafting Perspective Technical Elaboration on Scanning Electron Microscopy Method in the 2025 Edition of the Chinese Pharmacopoeia |
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chenchao1, wangyan2, zixiaowei1, zhangaijing1, daishoufeng2, zhangchuanjie3, shipei4, chenxuefan5
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1.Zhejiang Insititute for Food and Drug Control;2.Zhejiang Heze Medical Technology Co., LTD;3.Compound Scientific Instrument (Shanghai) Co., LTD;4.Anhui Insititute for Food and Drug Control;5.Zhejiang University of Technology
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| Abstract: |
| OBJECTIVE This paper aims to interpret the new "scanning electron microscopy method" (hereinafter referred to as SEM method) added in the 2025 edition of the Chinese Pharmacopoeia, so as to help the implementation of the standard and provide a scientific basis for drug testing. METHODS By comparing the standards of pharmacopoeias from different countries, this paper introduces the revision overview of the ChP scanning electron microscopy method, systematically expounds the background of the method""s establishment, its technical features, and key points of implementation. At the same time, it discusses the specific application of the method through practical cases of drug testing. RESULTS The newly added scanning electron microscopy method in the 2025 edition of the Chinese Pharmacopoeia provides a more accurate and efficient technical means for drug testing. This method can visually display the micro-morphology of the drug surface, accurately analyze the composition and elemental composition of the drug, and conduct crystallographic analysis, thereby effectively improving the accuracy and scientific nature of drug testing. CONCLUSION The newly added "Scanning Electron Microscopy Method" in the 2025 edition of the "Chinese Pharmacopoeia" has significant application value. It not only provides strong technical support for pharmaceutical quality control but also injects new vitality into the innovative development of pharmaceutical research and development, aiding in the enhancement of the quality and efficacy of drugs in our country. |
| Key words: SEM ChP secondary electrons backscattered electron X-ray energy spectrum USP EP |
