论文部分内容阅读
目的:比较国内外苯扎氯铵的质量差异,为我国苯扎氯铵质量标准的修订提供参考。方法:采用《美国药典》2015年版(USP 38)中苯扎氯铵项下HPLC法测定国内外样品的烷基组成比率。分别照《中国药典》2015年版、USP 38中苯扎氯铵项下化学滴定法测定总含量。结果:烷基组成比率结果表明,国产与进口样品的不合格率分别为100%和50%。按两国药典方法计算含量的差值显示,国产与进口样品的总含量变化分别为3.86%~4.15%和1.15%~3.90%。结论:国内外苯扎氯铵的质量存在较大差异,建议我国药典参照USP 38增订烷基组成比率的测定,修正苯扎氯铵总含量的计算公式,提高该品种的质量标准。
OBJECTIVE: To compare the quality differences of benzalkonium chloride at home and abroad, and to provide a reference for the revision of the quality standards of benzalkonium chloride in our country. METHODS: The alkyl composition ratios of domestic and foreign samples were determined by HPLC with benzalkonium chloride in the United States Pharmacopeia 2015 edition (USP 38). According to the “Chinese Pharmacopoeia” 2015 edition, USP 38 benzalkonium chloride under the chemical titration total content. Results: The results of alkyl compositional ratios showed that the failure rates of domestic and imported samples were 100% and 50% respectively. The difference between the calculated contents of the two Chinese Pharmacopoeia methods shows that the total contents of domestic and imported samples vary from 3.86% to 4.15% and from 1.15% to 3.90%, respectively. Conclusion: The quality of benzalkonium chloride in our country is quite different. It is suggested that the calculation formula of the total alkylbenzalium content should be revised according to the determination of the alkyl composition ratio increased by USP 38 according to the Chinese Pharmacopoeia to improve the quality standard of the varieties.