阿奇霉素分散片质量评价研究  

Quality Evaluation of Azithromycin Dispersible Tablets

作　　者：苑思坤 刘亚 陈维一 郭宏[1] 刘惠军[1] 杨飞 邹佳洁 梁倩立 YUAN Sikun;LIU Ya;CHEN Weiyi;GUO Hong;LIU Huijun;YANG Fei;ZOU Jiajie;LIANG Qianli(Baoding Institute for Food and Drug Control,Baoding,Hebei,China 071000;Baoding Sports School,Baoding,Hebei,China 071000)

机构地区：[1]河北省保定市食品药品检验所,河北保定071000 [2]保定市体育运动学校,河北保定071000

出　　处：《中国药业》2022年第13期78-83,共6页China Pharmaceuticals

基　　金：河北省市场监督管理局科研计划项目[2020ZC40];河北省保定市科技计划项目[1951ZF089]。

摘　　要：目的考察阿奇霉素分散片的质量现状及存在问题。方法抽取阿奇霉素分散片43批次,依据2010年版《中国药典(二部)》(法定标准)检验,并对检验结果进行分析;针对法定标准有关物质项对杂质阿奇霉素B易造成漏判的情况,建立新的有关物质测定方法,并对43批次样品进行测定与分析。结果43批次阿奇霉素分散片按法定标准检验的合格率为100.00%;仅有2批次样品检出阿奇霉素B,检出率仅为4.65%。按照新建立的方法进行检验,43批次全部检出阿奇霉素B,检出率为100.00%,但均在限度内,仅有2批次样品的检测结果接近限值2.0%。结论阿奇霉素分散片整体质量较好,但仍有提升空间,生产企业应加强基础研究及生产管理。所建立的新的有关物质检验方法专属性强,不易造成阿奇霉素B的漏判,线性关系考察、重复性试验结果及检测限确定结果均满足规定要求,可作为阿奇霉素分散片的有关物质检验及其质量评价方法。Objective To investigate the quality status and existing problems of Azithromycin Dispersible Tablets.Methods Forty-three batches of Azithromycin Dispersible Tablets were selected and tested according to the statutory standards in the Chinese Pharmacopoeia(2010 Edition,VolumeⅡ),then test results were analyzed.Due to the impurity azithromycin B was not easy to be detected according to the detection methods of relevant substances in statutory standards,a new detection method for relevant substances was established to detect and analyze 43 batches of samples.Results The qualified rate of 43 batches of Azithromycin Dispersible Tablets detected by the statutory standards was 100.00%,and azithromycin B was detected in only two batches of samples with a detection rate of 4.65%.When Azithromycin Dispersible Tablets were detected by the established new method,azithromycin B was detected in all batches of samples with a detection rate was 100.00%,which was within the limit,and the detection rate in two batches of samples was close to the limit of 2.0%.Conclusion The overall quality of Azithromycin Dispersible Tablets is good,but there is still some room for improvement.Manufacturers should strengthen the basic research and production management.The established new method for determination of relavant substances has strong specificity,and is not easy to cause missed detection of azithromycin impurity B.Results of the linear relation test,repeatability test and limit of detection(LOD)meet the requirements.Therefore,this method can be used for the detection of relavent substances in Azithromycin Dispersible Tablets and the quality evaluation.

关 键 词：阿奇霉素分散片 质量评价 有关物质 阿奇霉素B 

分 类 号：R917[医药卫生—药物分析学] R978.1[医药卫生—药学]