克林霉素系列注射剂质量和标准现状分析

Analysis of Current Standard and Quality of Clindamycin Injection Series

目的：了解克林霉素注射剂系列的质量状况,分析现行标准存在的问题,为质量标准提高提供参考.方法：采用现行标准和拟修订标准进行样品检验,重点考察有关物质和苯甲醇,统计分析检验结果,进行质量和标准现状分析.结果：按现行标准检验,合格率为98.5％,1批不合格样品为注射用克林霉素磷酸酯;按拟修订标准,对已知单个杂质：林可霉素、克林霉素B、7-差向克林霉素和其他单个杂质以及各杂质总和进行测定,发现7-差向克林霉素量在0.4％～0.6％之间,在拟定限度（0.5％）附近,对辅料苯甲醇进行分析检验,发现各厂家之间差异明显.结论：目前克林霉素注射剂系列的产品质量基本能符合现行标准要求,但各标准之间项目设置、项目的检验方法和限度均不尽相同,检验结果的可比性不是很强,同一品种甚至同一规格存在太多标准,该品种标准亟待统一;现行标准有关物质限度宽松,且未对单个杂质进行控制,辅料存在随意添加现象,现行标准不能有效地控制产品质量,该品种标准亟待提高.

Objective：To investigate the quality of clindamycin injection series and analyze the major problems existing in the current standard in order to provide reference information for improving the quality standard.Methods：The experiments were carried out using the methods in both the current standard and the revised protocol,which mainly focused on the terms of related substances and benzyl alcohol.The experimental results were statistically recorded to analyze the drug quality and the current situation of standard.Results：Totally 98.5％ of the samples passed the tests according to the current standard and only one batch （clindamycin phosphate for injection） was failed.According to the revised standard,the content of known single impurities,such as lincomycin,clindamycin B,7-epi clindamycin and the others,and total impurity were tested.It can be found that the content of 7-epi clindamyein was within the range of 0.4％ ～0.6％,which was close to the set limit （0.5％）.On the other hand,the content of benzyl alcohol in the preparations from different manufacturers was variable.Conclusion：The quality of clindamycin injection products meets the standard requirements,while the terms setting,analytical methods and limits in the standards are different,thus the comparability of the results obtained from different standards is weak.In some cases,different dosage forms and even specifications exist several various standards.Hence,it is essential to unify the standards for clindamycin injection series.Moreover,the limit range of the related substance in the current standard is broad,and there is no requirement on the single impurity control.Excipients are also found to be added casually.Overall,The current standard can not effectively control the quality of the products and therefore is necessary to be improved.