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

Analysis on Improvement of Standards and Thoughts on Establishment of Chinese Pharmacopoeia Standards for Anastrozole and Anastrozole Tablets

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。

OBJECTIVE To introduce the ideas and processes of standard formulation for anastrozole and anastrozole tablets in Chinese Pharmacopoeia 2020 Edition(VolumeⅡ).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.