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商品化的预制TSA培养基有效期确定方法的探讨

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目的:通过对商品化的预制胰酪大豆胨琼脂培养基(tryptone soya agar,TSA),在2~25℃避光条件下贮存不同时间质量稳定性的考察,为该类培养基有效期的确定方法进行探讨。方法:选取2个厂家各连续3个批次商品化的预制TSA培养基,分别置2~25 ℃避光条件下贮存30、90和180 d,对其进行外观性状检测、pH检测、培养基适用性检查、无菌性检查。结果:2个厂家TSA培养基每批、每个贮存时间点,外观性状检测、pH检测、培养基适用性检查、无菌性检查结果均符合《中国药典》2020年版四部对培养基质量控制的要求。结论:2个厂家生产的TSA培养基在2~25℃避光条件下贮存180 d质量均符合要求,说明两个厂家生产的TSA培养基的有效期均可达到180d。
Discussion on the validity period determination method of commercial ready-to-use TSA medium
Objective:To study the quality and stability of commercial ready-to-use tryptone soya agar(TSA)after storing at 2-25 ℃ for different storage duration under dark condition in order to discuss a determination method of validity period for medium.Methods:Three consecutive batches of ready-to-use TSA medium from two manufac-turers were selected and stored at 2-25 ℃ under dark conditions for 30,90 and 180 days,respectively.The appearance,pH,medium suitability and sterility of the medium were tested.Results:The results of appearance,pH,suitability and sterility of TSA medium from two manufacturers for each batch under different storage duration all met the requirements of the Chinese Pharmacopoeia 2020 Volume IV on the quality control of medium.Conclusion:The TSA medium from two manufacturers all met the requirements when stored for 180 days at 2-25 ℃ under dark condition,indicating that the validity period of TSA medium from two manufacturers can reach 180 days.

commercialTSA mediumappearancepHmedium suitabilitysterility

寇文月、江雨茹、郝璐瑶、唐宇毅、周雪云、朱秀娟、钱臻、金歌、王娇娇

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北京生物制品研究所有限责任公司,北京 100176

商品化 TSA培养基 外观性状 pH 培养基适用性 无菌性检查

2024

中国药品标准
国家药典委员会

中国药品标准

影响因子:0.372
ISSN:1009-3656
年,卷(期):2024.25(3)