2011年军队评价性抽验克拉霉素片质量分析  

Quality Analysis of Clarithromycin Tablets in Legionary Selective Examination in 2011

作　　者：苗爱东[1] 李永申[1] 杨静[1] 李晓翠[1] 王彦宗[1] 

机构地区：[1]北京军区联勤部药品仪器检验所,北京100071

出　　处：《解放军医药杂志》2012年第9期51-55,共5页Medical & Pharmaceutical Journal of Chinese People’s Liberation Army

摘　　要：目的对2011年军队评价性抽验克拉霉素片的质量现状进行分析。方法对抽验的31批次克拉霉素按《中华人民共和国药典》2005年版二部和2010年版二部进行全项检验,并对检验结果进行统计分析。结果 31批次克拉霉素片样品的质量均符合标准规定。结论目前国内克拉霉素片的生产工艺较为稳定,克拉霉素片质量总体较好,但仍有个别生产厂家的产品需加强监督,其质量标准还需进一步充实和完善。Objective To explore the molar condition of the legionary evaluation testing of Clarithromycin tablets. Methods The quality of 31 batches of Clarithromycin tablets were detected according to the Chinese Pharmacopoeia （2005 edition, second volume; 2010 edition, second volume） and the results were statistically analyzed. Results The quality of 31 batches of Clarithromycin tablets met a criterion. Conclusion At present the process and quality of production of Clarithromycin tablets is relatively stable in China and the total quality is fine. But some manufacturers need to strengthen the supervision and management, and the quality standards of Clarithromycin tablets need to be further improved.

关 键 词：克拉霉素 片剂 质量控制 

分 类 号：R927.11[医药卫生—药学]