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
佘凡 1周瑞 1焦明欢 2刘刚 1高翔3
作者信息
- 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
- 折叠
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.
Abstract
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 con-tamination of sheet drug packaging materials were prepared by standard strain adding method.The surface micro-organisms 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 correspond-ing 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Key words
contact dish method/sheet drug packaging materials/microbial count/recovery rate/direct inocula-tion method/Wiping method/Washing method引用本文复制引用
出版年
2024
NETL
NSTL
万方数据