| 岳志华,李丹,岳瑞齐,乐健,李慧义.卡培他滨药典标准制定概述[J].中国药事,2021,35(3):329-336 |
| 卡培他滨药典标准制定概述 |
| An Overview of the Development of Pharmacopoeia Standards for Capecitabine |
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| DOI：10.16153/j.1002-7777.2021.03.013 |
| 中文关键词: 卡培他滨 国家药品标准提高 药典标准建立 质量控制 |
| 英文关键词: capecitabine Improvement of national drug standards elaboration of the pharmacopoeia monograph quality control |
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| 摘要点击次数: 731 |
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| 中文摘要: |
| 目的：卡培他滨为抗肿瘤药，是《中华人民共和国药典》2020年版二部新增品种，对其药典标准制定的思路和过程进行介绍，以利于卡培他滨药典标准的理解和执行。方法：有关物质是卡培他滨原料药的关键质量属性，此项药典标准的制定对于药品质量控制起到重要作用。通过案例分析方法，对卡培他滨药典标准的起草、复核、公示、审核及确定过程进行了详细阐述。结果：建立的卡培他滨药典标准可有效控制药品质量。结论：通过对卡培他滨药典标准制定过程的全面分析，为其他药品标准提高及药典标准制定提供了参考。 |
| 英文摘要: |
| Objective: Capecitabine is an antineoplastic drug and its monograph has been adopted by the 2020 edition of Chinese Pharmacopoeia (Volume Ⅱ). The strategy and processes of its pharmacopoeia standard elaboration were introduced to facilitate the understanding and implementation of capecitabine pharmacopoeia standard. Methods: The relevant substances are key quality attributes of capecitabine active pharmaceutical ingredients (API), and the establishment of this pharmacopoeia standard plays an important role in the quality control. The processes of drafting, verification, publicity, review and approval for capecitabine was elaborated through a case study approach. Results: The pharmacopoeia monograph for capecitabine could effectively control the quality of drugs. Conclusion: According to the detailed description of monograph elaboration for capecitabine, this paper provides scientific references for the improvement of other drug standards and the development and revision of the pharmacopoeia standard. |
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