| 引用本文: | 岳志华,程奇蕾,王志军,王建.阿那曲唑及其片剂标准提高与中国药典标准制定思路分析[J].中国现代应用药学,2021,38(6):646-650. |
| YUE Zhihua,CHENG Qilei,WANG Zhijun,WANG Jian.Analysis on Improvement of Standards and Thoughts on Establishment of Chinese Pharmacopoeia Standards for Anastrozole and Anastrozole Tablets[J].Chin J Mod Appl Pharm(中国现代应用药学),2021,38(6):646-650. |
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| 摘要: |
| 目的 介绍中国药典2020年版（二部）阿那曲唑及阿那曲唑片标准制修订的思路和过程。方法 对阿那曲唑及片剂药典标准起草、审核、公示及确定过程进行详细分析。结果 建立的阿那曲唑与阿那曲唑片药典标准可有效控制药品质量。结论 阿那曲唑原料药和片剂标准建立过程体现了药典标准的科学和严谨性，同时也为其他药品标准提高及药典标准制定提供了参考。 |
| 关键词: 阿那曲唑 阿那曲唑片 国家药品标准提高 药典标准建立 质量控制 |
| DOI：10.13748/j.cnki.issn1007-7693.2021.06.002 |
| 分类号:R914 |
| 基金项目: |
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| Analysis on Improvement of Standards and Thoughts on Establishment of Chinese Pharmacopoeia Standards for Anastrozole and Anastrozole Tablets |
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YUE Zhihua1, CHENG Qilei1, WANG Zhijun1, WANG Jian2
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1.Chinese Pharmacopoeia Commission, Beijing 100061, China;2.Zhejiang Institute for Food and Drug Control, Hangzhou 310052, China
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| Abstract: |
| OBJECTIVE To introduce the ideas and processes of standard formulation for anastrozole and anastrozole tablets in Chinese Pharmacopoeia 2020 Edition(Volume Ⅱ). METHODS To introduce the drafting, review, publicity and determination of pharmacopoeia standards for anastrozole and anastrozole tablets. RESULTS The pharmacopoeia standards for anastrozole and anastrozole tablets can effectively control the quality of drugs. CONCLUSION The pharmacopoeia standards for anastrozole and anastrozole tablets are scientific and rigorous, and also provide reference for the improvement of national drug standards and establishment of Chinese Pharmacopoeia standards of other drugs. |
| Key words: anastrozole anastrozole tablets improvement of national drug standards establishment of the pharmacopoeia standards quality control |
