4种方法检测片材类药包材微生物计数回收率对比研究  

Comparative study of four methods for detecting microbial count recovery rate on sheet drug packaging materials

作　　者：佘凡 周瑞 焦明欢 刘刚 高翔 SHE Fan;ZHOU Rui;JIAO Ming-huan;LIU Gang;GAO Xing(Drug Testing Monitoring and Evaluation Center,Yangling Agricultural High-Tech Industrial Demonstration Zone,Yangling 712100,China;Xi'an Wanlong Pharmaceutical Co.,Ltd.,Yangling 712100,China;Shaanxi Institute for Food and Drug Control,Xi’an 710065,China)

机构地区：[1]杨凌示范区药品检验监测评价中心,杨凌712100 [2]西安万隆制药有限责任公司,杨凌712100 [3]陕西省食品药品检验研究院,西安710065

出　　处：《药物分析杂志》2024年第6期1040-1045,共6页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:通过4种采样方法检测片材类药包材表面微生物的结果对比,建立适合片材类药包材简便实用的微生物计数方法。方法:用标准菌株加标方法制备片材类药包材人工污染样品,采用国家药品包装容器(材料)标准规定的擦拭法,以及自行设计的淋洗法、直接接种法和接触碟法,分别进行表面微生物采集,计算对应回收率。采用单因素方差对4种采样方法的结果进行统计学分析。结果:回收率由高到低依次为,接触碟法>直接接种法>擦拭法>淋洗法,接触碟法回收率最高。接触碟法和擦拭法、淋洗法回收率比较有显著差异(P<0.05);接触碟法回收率略高于直接接种法,但二者无显著差异(P>0.05);4种方法在药用膜、药用铝箔、药用硬片回收率无显著差异(P>0.05)。结论:接触碟法简便、灵敏、准确,可用于片材类药包材微生物限度计数方法的检查。Objective:To establish a simple and practical microbiological counting method suitable for sheet drug packaging materials by comparing the results of four sampling methods.Methods:The samples of artificial contamination of sheet drug packaging materials were prepared by standard strain adding method.The surface microorganisms were collected by wiping method prescribed by national drug packaging container(material)standard,as well as by self-designed washing method,direct inoculation method and contact dish method.The corresponding recovery rate was calculated.The results of 4 sampling methods were analyzed by one way analysis of variance(ANOVA).Results:From high to low,the recovery rate was as follows:contact dish method,direct inoculation method,wiping method and washing method.There were significant differences in the recovery rates of contact dish method,wiping method and washing method(P<0.05).The recovery rate of contact dish method was slightly higher than that of direct inoculation method,but there was no significant difference between them(P>0.05).There was no significant difference in the recoveries of medicinal film,aluminum foil and hard sheet among the four methods(P>0.05).Conclusion:The contact dish method is simple,sensitive and accurate,and can be used for the examination of the microbial limit counting method of sheet drug packaging materials.

关 键 词：接触碟法 片材类药包材 微生物计数 回收率 直接接种法 擦拭法 淋洗法 

分 类 号：R917[医药卫生—药物分析学]