2009年国产注射用阿奇霉素评价性抽验结果与质量评价

目的: 评价国产注射用阿奇霉素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注射用阿奇霉素的质量现状进行评价。 结果: 法定检验显示217批样品中190批合格(87.6%),27批(12.4%)不合格,不合格项主要为溶液的澄清度;探索性研究显示若采用HPLC法替代原方法检查含量和有关物质,则样品的不合格率显著增加。 结论: 目前绝大部分国产注射用阿奇霉素的产品质量能符合现行标准要求,少部分企业产品仍存在澄清度与可见异物超标,装量不均匀及含量测定偏低等问题;而探索性研究提示现行标准存在缺陷,急需提高标准,采用更专属方法如HPLC法检查控制药品质量。

Objective: To evaluate the quality status of domestic azithromycin for 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 examine sample,evaluate the quality status of domestic azithromycin for injection by statistical analysis of the results. Rseults: In 217 batchs of samples,190 batch of qualified(87.6%),27 groups (12.4%) failed,clarity of solution as the main causes of failure,exploratory studies have shown that if using HPLC method to replace the original method of checking content and related substances,then the sample failure rate increased significantly. Conclusions: At present the most products quality of domestic azithromycin for injection can meet the current standards,there are still in some problems in few enterprises,such as clarity and visible foreign matter exceeded,weight uniform uneven and content assayed lowly and so on.But 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.