首页|《中国药典》四部制剂通则洗剂修订的探讨

《中国药典》四部制剂通则洗剂修订的探讨

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目的:梳理分析《中国药典》2020年版四部0127洗剂通则,探讨如何完善《中国药典》洗剂通则的通用技术要求。方法:通过比较国内外药典关于洗剂通则的收载情况,从收载的定义、分类、工艺、贮藏及相应的检查项要求等方面进行比较分析。结果与结论:《中国药典》0127洗剂通则应进行修订,建议完善定义,增加制剂形态,扩大收录品种,以促进药品科学监管,切实发挥《中国药典》对药品检验的指导作用。
Discussion on the revision of the general chapter for lotions in the Chinese Pharmacopoeia 2020 Volume Ⅳ
Objective:To analyze the general chapter for lotions 0127 of the Chinese Pharmacopoeia 2020 Vol-ume Ⅳ,and discuss how to improve the general technical requirements of lotions 0127 in the Chinese Pharma-copoeia.Methods:By comparing the general chapter for lotions in domestic and international pharmacopoe-ias,the definition,classification,process,storage and corresponding inspection requirements were analyzed.Results and Conclusions:The general chapter for lotions 0127 of the Chinese Pharmacopoeia should be revised,including improvement of the definition,increasement of forms of preparations,and expansion of included varieties,so as to promote scientific regulation for drugs and exhibit a guiding role of the Chinese pharmacopoeia in drug control.

Chinese Pharmacopoeiageneral chapterlotionsappendixdefinitionrevision

欧嘉娜、李淑娟、杨梅、伍良涌、李玮玲、曾文雪、王金钱、王跃生

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广州市药品检验所,广州 510160

江西中医药大学,南昌 330004

景德镇学院,江西景德镇 333000

中国中医科学院中药研究所,北京 100700

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中国药典 附录 洗剂 通则 定义 修订

2024

中国药品标准
国家药典委员会

中国药品标准

影响因子:0.372
ISSN:1009-3656
年,卷(期):2024.25(5)