片材类药包材微生物限度检查法中供试液制备方法的研究  

Study on sample pretreatment of microbial limit test of drug packaging materials

作　　者：方良艳 王文庆 栾同青 李翠 国宪虎 马恒 FANG Liang-yan;WANG Wen-qing;LUAN Tong-qing;LI Cui;GUO Xian-hu;MA Heng(Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection,NMPA Key Laboratory for Quality Evaluation of Medical Materials and Biological Protective Devices,NMPA Key Laboratory for Quality Control of Pharmaceutical Packaging Materials,Jinan 250101,China)

机构地区：[1]山东省医疗器械和药品包装检验研究院、国家药品监督管理局医用卫生材料及生物防护器械质量评价重点实验室、国家药品监督管理局药品包装材料质量控制重点实验室,济南250101

出　　处：《药物分析杂志》2023年第2期355-358,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立片材类药包材适用的微生物限度检查供试液制备方法。方法:用萎缩芽孢杆菌(ATCC9372)芽孢,接种膜、硬片和铝箔这3种药包材,制作人工污染样品,分别采用手动振摇法、机械振摇法和袋蠕动法进行样品前处理制备供试液,并采用薄膜过滤法收集供试液中的微生物,培养计数,比较3种供试液制备方法的采集效率。进一步对手动振摇法进行了人员比对研究。采用单因素方差分析和t检验进行统计学分析。结果:3种供试液制备方法中,手动振摇法的微生物采集效率最高,且三组的结果比较具有统计学差异(P<0.0001);对手动振摇法进行了人员比对研究,结果发现该方法在3种药包材中人员差异较小(P>0.05)。结论:综合考虑微生物采集效率、可操作性、重复性等因素,认为手动振摇法更适合用于药包材的供试液制备。Objective:To establish a suitable method to prepare samples in microbial limit test of drug packaging materials.Methods:Bacillus astrophaeus(ATCC9372)spore was inoculated on the surface of drug packaging films materials,sheet materials and aluminium foil to make artificial pollution samples.Samples were prepared using manual shaking method,mechanical shaking method and stomacher processing method.Microorganisms were collected by membrane filtration.Personnel comparison was performed in manual shaking method group.Data was analyzed by one way analysis of variance(ANOVA)or t-test.Results:Among the three methods,the highest microorganism recovery efficiency(P<0.0001)was obtained from manual shaking method.For manual shaking method,personnel comparison was conducted during these three kinds of drug packaging materials,and showed a little difference(P>0.05).Conclusion:Manual shaking method is considered as the best method to prepare samples ofdrug packaging materials under the consideration of recovery efficiency,operability and repeatability.

关 键 词：片材类药包材 微生物限度检查 供试液制备 手动振摇法 人员比对 薄膜过滤法 

分 类 号：R917[医药卫生—药物分析学]