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胰酪大豆胨琼脂培养基比对研究

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目的 研究 5 个不同品牌胰酪大豆胨琼脂培养基产品信息标识差异,分析适用性检查结果,为提高检验检测效率,规范培养基生产和管理提供研究依据.方法 比对 5 个不同品牌,各 3 个批号的胰酪大豆胨琼脂培养基内外包装信息标识和自检项目,并按照《中华人民共和国药典》2020 版四部和《食品安全国家标准食品微生物学检验培养基和试剂的质量要求》(GB 4789.28-2013),对培养基适用性进行研究分析.结果 5 个品牌胰酪大豆胨琼脂培养基内外包装标识信息存在较大差异,自检报告使用的检验依据和具体检测项目以及适用性判定标准都不相同,5 个品牌胰酪大豆胨琼脂培养基适用性检查结果均符合相关标准要求,但相同品牌不同批号间的检查结果均一性存在差异.结论 培养基质量控制标准有待规范和完善,有利于培养基生产和使用.
Comparative study on the tryptose soya agar
Objective To study the differences in product information labeling among 5 different brands of tryptose soya agar,analyze the suitability test results,and provide a research basis for improving inspection and detection efficiency,and standardizing culture media production and management.Methods The exterior and interior packaging information labeling and self-inspection items of tryptose soya agar of 5 different brands and 3 batches were compared,and research and analysis were conducted on the suitability of the culture media following the VolumeⅣof Pharmacopoeia of the People's Republic of China(2020 Edition),and the National Food Safety Standard-Food Microbiological Examination-Quality Requirements of Culture Media and Reagents(GB 4789.28-2013).Results There were significant differences in the labeling information of the exterior and interior packaging of the 5 brands of tryptose soya agar.The inspection basis,specific testing items,and suitability judgment standards used in the self-inspection report were different.The suitability test results of the 5 brands of tryptose soya agar met the relevant standard requirements,but there were differences in the uniformity of the test results between different batches of the same brand.Conclusion The quality control standards for culture media need to be standardized and improved,which is beneficial for the production and use of culture media.

Tryptose soya agarQuality controlSuitability testComparative study

梁谋、庞逸辉、刘欢、王霞、宣泽、江志杰

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北京市药品检验研究院 国家药品监督管理局中成药质量评价重点实验室中药成分分析与生物评价北京市重点实验室,北京 102206

胰酪大豆胨琼脂培养基 质量控制 适用性试验 比对研究

2024

中国医药科学
海峡两岸医药卫生交流协会 二十一世纪联合创新(北京)医药科学研究院

中国医药科学

影响因子:1.083
ISSN:2095-0616
年,卷(期):2024.14(5)
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