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 Pharmacopoeias of China and Foreign

目的:为修订和提高2015年版《中国药典》(二部)中苯扎氯铵的质量控制标准及相关方法提供思路。方法:全面比较2015年版《中国药典》(二部)、2013年版《英国药典》、《欧洲药典》(7.0版)和《美国药典》(36版)中苯扎氯铵的质量控制标准及相关方法。结果:与2015年版《中国药典》(二部)相比,国外药典规定了苯扎氯铵各取代同系物组成及比例,氨化合物检查采用的方法灵敏度更高,并且增加了苯甲醇、苯甲醛和苄基氯杂质检查,同系物组成比例检查以及平均相对分子量计算。结论:2015年版《中国药典》(二部)中苯扎氯铵的质量控制标准及相关方法仍有提高和完善的必要。

OBJECTIVE：To provide ideas for revise and improve the standard and related method of the quality control of benzalkonium 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：Compared with Chinese Pharmacopoeia（2015 edition,Ⅱ）,the standards abroad provided the component and the ratio of the benzalkonium 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 calculation. CONCLUSIONS：The standard and related method of the quality control of benzalkonium chloride in Chinese Pharmacopoeia（2015 edition,Ⅱ）still need to be further improved.