技术方法

支原体检测用培养基的质量稳定性考察

  • 敖嘉 蒲蕾东 邓雪莲 陈超 钱莉 宗健 唐倩 陈晓燕
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  • 1成都生物制品研究所有限责任公司培养基室、四川省疫苗工程技术研究中心,成都6100232成都生物制品研究所有限责任公司质量运营部、四川省疫苗工程技术研究中心,成都610023

网络出版日期: 2025-08-16

Quality stability of mycoplasma culture mediums 

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  • 1Culture Medium Department, Chengdu Institute of Biological Products Co., Ltd., Vaccine Engineering Research Center of Sichuan Province, Chengdu 610023, China; 2Quality Compliance Management Department , Chengdu Institute of Biological Products Co., Ltd., Vaccine Engineering Research Center of Sichuan Province, Chengdu 610023, China

Online published: 2025-08-16

摘要

目的  考察支原体检测用培养基存放在15~25 ℃不同时间的质量稳定性及其影响因素。方法  支原体肉汤、支原体半流体、精氨酸支原体肉汤、精氨酸支原体半流体培养基灭菌后在15~25 ℃存放021354970d,检测各时段4种培养基的外观、pH值和灵敏度,综合分析3个质量指标的变化规律,以及引起变化的因素。结果  4种支原体检测用培养基的3个质量指标相互作用,均随存放时间延长而变化:存放21 d内,支原体肉汤和半流体培养基内环境变化最剧烈,颜色变化明显,pH下降较快;存放35 d内,4种培养基质量符合中国药典标准,不同稀释度的对应支原体生长管数均达到接种管数的2/3或以上。结论  4种支原体检测用培养基在15~25 ℃存放35 d,质量符合标准;存放过程中,分装容器的密封性决定溶于培养基的空气总量,进而影响培养基的质量稳定性。

本文引用格式

敖嘉 蒲蕾东 邓雪莲 陈超 钱莉 宗健 唐倩 陈晓燕 . 支原体检测用培养基的质量稳定性考察[J]. 国际生物制品学杂志, 2022 , 45(4) : 205 -209 . DOI: 10.3760/cma.j.cn311962-20211201-00082

Abstract

Objective To investigate the quality stability and influencing factors of mycoplasma detection media stored at 15-25 ℃ for different time. Methods Four kinds of mycoplasma detection media (mycoplasma broth. mycoplasma semifluid, arginine mycoplasma broth and arginine mycoplasma semifluid) were stored at 15-25 ℃ for 0, 21, 35, 49 and 70 days after sterilization. The appearance, pH and sensitivity of four media were detected at different storage time and the factors causing the change were analyzed. Results Three quality indexes of 4 mycoplasma detection media affected each other and changed with the increasing of storage time. During the first 21 days storage period, the internal environmental changes in mycoplasma broth and semiliquid media were the most severe with the most obvious change of color and fast decrease of pH. Three quality indexes of the four mycoplasma media all conformed to the pharmacopoeia standard during the first 35 days storage period, as growing-tube number of corresponding mycoplasma reached at least 2/3 of inoculating-tube number at different dilutions. Conclusions At 15-25 ℃, the quality of mycoplasma detection media is qualified during the first 35 days storage period. During the storage period, the sealing of the container determines the amount of air dissolved in the media, and affects the quality stability of media.
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