中国药房2017，Vol.28Issue(6)：831-834,4.DOI:10.6039/j.issn.1001-0408.2017.06.30
我国与国外药典中苯扎氯铵的质量控制标准及相关方法比较
Comparison of Standards and Related Methods of the Quality Control of Benzalkonium Chloride in Phar-macopoeias of China and Foreign
栾爽 1韩春晖 1窦佳 1宫珊珊1
作者信息
- 1. 大连市药品检验所,辽宁大连 116021
- 折叠
摘要
Abstract
OBJECTIVE:To provide ideas for revise and improve the standard and related method of the quality control of ben-zalkonium chloride in Chinese Pharmacopoeia (2015 edition,Ⅱ). METHODS:The standards and related methods of the quality control of benzalkonium chloride in Chinese Pharmacopoeia(2015 edition,Ⅱ),British Pharmacopoeia(2013 edition),European Pharmacopoeia (7.0 edition) and United States Pharmacopoeia (36 edition) were comprehensively compared. RESULTS:Com-pared with Chinese Pharmacopoeia(2015 edition,Ⅱ),the standards abroad provided the component and the ratio of the benzalko-nium chloride substituted homolog,the method for ammonia compound test had higher sensibility,it also added the test for benzyl alcohol,benzaldehyde and benzyl chloride impurity,as well as the component ratio test and average relative molecular mass calcu-lation. CONCLUSIONS:The standard and related method of the quality control of benzalkonium chloride in Chinese Pharmacopoe-ia(2015 edition,Ⅱ)still need to be further improved.关键词
中国药典/英国药典/欧洲药典/美国药典/苯扎氯铵/质量控制标准/方法Key words
Chinese Pharmacopoeia/British Pharmacopoeia/European Pharmacopoeia/United States Pharmacopoeia/Benzal-konium chloride/Standard of the quality control/Method分类
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栾爽,韩春晖,窦佳,宫珊珊..我国与国外药典中苯扎氯铵的质量控制标准及相关方法比较[J].中国药房,2017,28(6):831-834,4.
