| 引用本文: | 钟辉,汪立冬,程奇蕾,岳志华.洛铂和注射用洛铂药典标准制定研究概述[J].中国现代应用药学,2025,42(20):23-27. |
| zhong hui,wang li dong,cheng qi lei,yue zhi hua.Establishment of Chinese pharmacopoeia standards for lobaplatin and lobaplatin for injection[J].Chin J Mod Appl Pharm(中国现代应用药学),2025,42(20):23-27. |
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| 摘要: |
| 洛铂和注射用洛铂为《中国药典》2025年版二部新增收载品种,其药典标准的制定对于保障药品质量和临床用药安全具有较大意义。本文重点针对洛铂有关物质项的标准起草过程进行详细分析,同时系统阐述了洛铂原料药及注射剂药典标准制定的思路和过程,为其他药品标准的提升及药典标准制定提供了参考。 |
| 关键词: 洛铂 注射用洛铂 国家药品标准提高 药典标准建立 质量控制 |
| DOI： |
| 分类号:R284.1；R917.101?????? |
| 基金项目: |
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| Establishment of Chinese pharmacopoeia standards for lobaplatin and lobaplatin for injection |
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zhong hui1, wang li dong, cheng qi lei, yue zhi hua2
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1.Hainan Changan International Pharmaceutical Co.,Ltd;2.Chinese Pharmacopoeia Commission
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| Abstract: |
| Lobaplatin and lobaplatin for injection have been included in the 2025 version of Chinese Pharmacopoeia(Volume II). The establishment of pharmacopoeia standards is of significant importance for ensuring drug quality and clinical medication safety. This article focuses on a detailed analysis of the drafting process of the related substances item for lobaplatin，and systematically expounds the ideas and establishment process of pharmacopoeia standards for Lobaplatin active pharmaceutical ingredient (API) and its injection formulation, and also provides a reference for improvement of national drug standards and establishment of the pharmacopoeia standards. |
| Key words: lobaplatin lobaplatin for injection improvement of national drug standards establishment of the pharmacopoeia standerds quality control |
