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    中国药典2025年版扫描电子显微镜法技术解读

    Interpretation of Scanning Electron Microscopy Method in Chinese Pharmacopoeia 2025 Edition

      摘要
    • 摘要:
      目的 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进行比较，介绍中国药典中扫描电镜法的增订概况，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，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“扫描电子显微镜法”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。

       

      Abstract:
      OBJECTIVE To interpret the new “scanning electron microscopy method” added in the Chinese Pharmacopoeia(ChP) 2025 Edition, 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, the overview of the addition and revision of the scanning electron microscopy method in ChP was introduced. The background, technical features, and key points of implementation of this method were systematically expounded. At the same time, specific applications of the method were discussed through practical cases of drug testing.
      RESULTS The newly added scanning electron microscopy method in the ChP 2025 Edition provided a more accurate and efficient technical means for drug testing. This method could 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 ChP 2025 Edition 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.

       

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