目的 评价国产加替沙星滴眼液的质量现状并分析存在问题.方法 按照2016年国家评价性抽验计划总体要求,采用法定检验方法进行样品检验,并结合探索性研究进行统计分析,对国产加替沙星滴眼液的质量现状进行评价.结果 法定检验显示60批样品均符合规定;探索性研究显示个别生产企业渗透压偏低较多,部分企业处方抑菌效力不达标,个别企业涉嫌防腐剂滥用.结论 加替沙星滴眼液按各法定标准检验合格率较好,但仍存在一些问题,建议企业调整处方,加强工艺控制,建议进一步完善和统一标准,加强监管.%Objective To evaluate the quality status of the domestic gatifloxacin ophthalmic solution and to analyze the existing problems.Methods According to the general requirements of national assessment programs in 2016,statutory testing methods combined with the exploratory research were used to evaluate the quality of domestic gatifloxacin ophthalmic solution,and the results were analyzed statistically.Results All 60 batches of the gatifloxacin ophthalmic solution samples met the requirements of current specifications.Exploratory studies showed that the osmotic pressure of the samples from some companies was obviously low.The antimicrobial preservative effectiveness test showed that several companies chose and used the preservative inappropriatly.Conclusions At present,most of the quality of the domestic gatifloxacin injection can meet the current standards,but there are still some problems.Companies need to adjust their recipe and strengthen process control.In addition,the current specifications have deficiencies,need to be improved and unified.
展开▼
