2009年国产加替沙星注射剂评价性抽验结果及质量评价

Sampling results and assessment quality of domestic gatifloxacin injection in 2009

目的:评价国产加替沙星注射剂的质量现状及存在问题。方法:按照2009年度国家评价性抽验计划总体要求,采用法定检验方法结合探索性研究进行样品检验,统计分析检验结果对国产加替沙星注射剂的质量现状进行评价。结果:法定检验显示70批样品中69批合格,有1批因可见异物不合格;探索性研究显示部分生产企业产品的渗透压测定结果明显低于各国药典规定的限度规定,而采用HPLC法分析了加替沙星注射剂和原料中杂质的分布情况,结果表明注射液中的杂质主要源于原料;对不同生产工艺的加替沙星注射液的光照稳定性进行了比较,结果表明如生产中以稀盐酸代替乳酸助溶,加替沙星注射剂的光稳定性更好。结论:加替沙星注射剂按各执行标准检验,总体合格率较好。但是还存在一些问题,如细菌内毒素限度需要规范统一、100℃30 min灭菌工艺能否保障无菌等。通过探索性研究还建议生产企业改进生产工艺,提高产品质量;同时改进并统一现行质量标准,进一步加强对加替沙星注射剂的监管。

Objective：To evaluate the quality status of domestic gatifloxacin injection and exsisting problems.Methods：According to the general requirements of national assessment programs in 2009,use statutory testing methods and combine with the exploratory research to evaluate the quality of domestic gatifloxacin injection by statistical analysis of the results.Results：In 70 batches of gatifloxacin injection samples,69 batches meet the requirements of current specifications,one batch failed,visible foreign matter of solution as the main causes of failure.Exploratory studies have shown that osmotic pressure of the samples from partial company have been obviously belower than the requirements of pharmacopeia.The results by comparing the HPLC impurity profile of gatifloxacin injection and raw materials reveal that the impurity profiles of injection originate from raw material.Comparing light radiation stability of gatifloxacin injection of different manufacture process,the result revealed gatifloxacin injection manufactured by process that gatifloxacin is dissolved with diluted chloride acid would be stabler than that with diluted lactic acid.Conclusions：At present the most products quality of domestic gatifloxacin injection can meet the current specifications,there are still in some problems in few enterprises,such as the limit of bacterial endotoxin should be unified and whether the sterilization process of 100 ℃ lasting 30 minutes will be disable to assure the sterility of products.And exploratory research suggests that existing standards is in deficiencies,and need to improve standard immediately,using more proprietary methods such as HPLC to control and check the quality of drugs.