盐酸萘甲唑啉滴鼻液质量评价

Quality Evaluation of Naphazoline Hydrochloride Nasal Drops

目的考察盐酸萘甲唑啉滴鼻液的质量现状。方法对10家企业生产的262批盐酸萘甲唑啉滴鼻液按法定质量标准进行检验,同时进行有关物质等探索性研究;对法定检验及探索性研究结果进行统计分析,综合评价盐酸萘甲唑啉滴鼻液质量情况。结果262批样品法定检验合格率95.4%,不合格样品12批;探索性研究结果显示,12批样品有关物质含量较高,54批样品抑菌剂含量偏高。结论盐酸萘甲唑啉滴鼻液整体质量状况不容乐观。

Objective To research the quality status and problems of naphazoline hydrochloride nasal drops.Methods A total of 262 batches of naphazoline hydrochloride nasal drops produced by 10 manufactures were analyzed according to the legal quality standard.At the same time,some exploratory researches are also carried out.The results of legal inspection and exploratory study were statistically analyzed to evaluate the quality of naphazoline hydrochloride nasal drops.Results The legal qualified rate of 262 batches of samples was 95.4%,and 12 batches of samples were unqualified.The results of exploratory study showed that the contents of related substances in 12 batches of samples were high,while the contents of bacteriostatic agents in 54 batches were high.Conclusion The overall quality of naphazoline hydrochloride nasal drops was not optimistic.