| 冯艳春,王晨,肖亭,尹利辉,许明哲.美国药典43版近红外通则内容最新变化分析[J].中国药事,2021,35(5):565-568 |
| 美国药典43版近红外通则内容最新变化分析 |
| Review on the Latest Update and Revision of the Near-infrared Spectroscopy Chapter in the United States Pharmacopeia (43rd version) |
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| DOI：10.16153/j.1002-7777.2021.05.011 |
| 中文关键词: 美国药典43版 通则 近红外光谱分析技术 修订 |
| 英文关键词: United States Pharmacopeia (43rd version) general chapter near-infrared spectroscopy revision |
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| 摘要点击次数: 969 |
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| 中文摘要: |
| 目的：跟踪美国药典检验检测技术最新发展和动态，为国内近红外光谱技术在制药领域的监管和应用提供借鉴和参考。方法：通过文献检索和新旧版美国药典比对，归纳总结美国药典43版中近红外光谱技术通则有关章节的增修订情况。结果：与42版相比，美国药典43版近红外通则内容进行了较大规模的修订和更新。新增了通则＜856＞，同时将原有的通则＜1119＞修订并重命名为＜1856＞近红外光谱技术的理论和应用实践。通则＜856＞侧重近红外光谱仪器的确认和方法的验证，通则＜1856＞侧重近红外光谱技术的基础理论和实践经验。结论：美国药典43版近红外通则内容的修订，不仅为使用近红外光谱技术的制药企业和药品检验机构在满足ISO17025关于仪器确认和方法验证相关要求方面提供了最新的技术指南和依据，还明确了该技术作为替代方法应用于各论时需要满足的最低标准，进一步提高了通则内容的实用性和可操作性，为药品生产和监管领域对近红外光谱技术的应用和相应的质量管理体系建设提供了很好的依据和参考，同时对各国药典相关内容的增修订也有很高的借鉴作用。 |
| 英文摘要: |
| Objective: To track the latest development and dynamics of the U.S. Pharmacopoeia inspection and testing technology, and to provide references for the supervision and application of near-infrared spectroscopy (NIRS) in the domestic pharmaceutical field. Methods: Through literature search and comparison with the old and new U.S. Pharmacopoeia, the changes on the general chapter Near-Infrared Spectroscopy in the USP (43 version) were highlighted and summarized. Results: Compared with the 42nd version, fairly comprehensive updates and revisions were adopted in the 43rd version in terms of NIRS General Chapters. A new general chapter titled ＜856＞ Near-Infrared Spectroscopy was included, and the general chapter ＜1119＞ was revised and renamed as ＜1856＞ Near-Infrared Spectroscopy——theory and practice in the 43rd version. The chapter ＜856＞ focuses on qualification criteria for instrument as well as the acceptable procedure validation criteria. The chapter ＜1856＞ provides the theory and practices of NIRS. Conclusion: The updated chapters on NIRS in the USP (43rd version) not only provide the latest reference and guidance for the regulatory authorities and quality laboratories using NIR spectroscopy to meet the ISO 17025 requirements for the instrument qualification and analytical methodvalidation, but also explicitly defines the minimum standard to be met with when an NIRS spectroscopic procedure is applied as an alternative to the monograph procedure, further improving the practicality and operability of the general rules. It provides a good basis and reference for the application of NIR spectroscopy and the construction of the corresponding quality management system in the field of drug production and supervision, and also has a high reference effect on the increase and revision of the relevant contents of national pharmacopoeias. |
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