肺炎链球菌无动物源冻干保护剂的筛选

廖淡宜; 唐利; 程可欣; 王博; 黄显省; 赵静

doi:10.3760/cma.j.cn311962-20230109-00005

国际生物制品学杂志 >

2023 , Vol. 46 >Issue 6: 338 - 342

DOI: https://doi.org/10.3760/cma.j.cn311962-20230109-00005

工艺研发

肺炎链球菌无动物源冻干保护剂的筛选

廖淡宜 ,
唐利 ,
程可欣 ,
王博 ,
黄显省 ,
赵静

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成都生物制品研究所有限责任公司细菌疫苗研究室，成都 610023

网络出版日期: 2025-08-16

基金资助

国家科技重大专项“重大新药创制”（2018ZX0973806）

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Screening of animal-free lyophilized protective agent for Streptococcus pneumoniae

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Laboratory of Bacterial Vaccines, Chengdu Institute of Biological Products Co., Ltd., Chengdu 610023, China

Online published: 2025-08-16

Supported by

National Science and Technology Major Project of China for "Major New Drug Innovation and Development" (2018ZX0973806)

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摘要

目的制备无动物源成分的肺炎链球菌冻干菌种，并保重菌种活力和菌种保藏时间。方法采用单因素筛选、多因素复配及正交试验，观察肺炎链球菌在不同温度存放不同时间的稳定性，从冻干物外观，菌种活力方面进行评价。结果确定保护剂配方为海藻糖20 g/L、大豆胨20 g/L、甘露醇60 g/L、甘油6 ml/L。制备的冻干菌种外观良好，菌种活力可达10⁹ CFU/支，在2～8 ℃放置2年活菌数无显著下降。结论开发的保护剂无动物源成分保护剂适用于冻干菌种制备。

关键词： 无动物源；冻干保护剂；肺炎链球菌；真空冷冻干燥；稳定性

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廖淡宜 , 唐利 , 程可欣 , 王博 , 黄显省 , 赵静 . 肺炎链球菌无动物源冻干保护剂的筛选[J]. 国际生物制品学杂志, 2023 , 46(6) : 338 -342 . DOI: 10.3760/cma.j.cn311962-20230109-00005

Abstract

Objective To prepare freeze-dried Streptococcus pneumoniae strains using protective agent without animal-derived components, and ensure the viability and the preservation time of strains. Methods Using single-factor screening, multi-factor compounding with orthogonal experimental design, the stability of Streptococcus pneumoniae stored at different temperatures for various durations was evaluated , and the appearance of the freeze-dried product and the viability of the strains were observed. ResultsThe formula of the protective agents was determined to be trehalose 20 g/L, soy peptone 20 g/L, mannitol 60 g/L, glycerol 6 ml/L. The prepared freeze-dried strains had good appearance. The total bacteria count reached 10⁹ CFU per bottle. The viable counts of the strains kept at 2-8 °C for 2 years did not decrease significantly.Conclusion The developed protective agents that do not contain animal-derived components are suitale for freeza-dry preparation.

Key words： Free of animal origin, Lyophilized protective agent; Streptococcus pneumoniae; Vacuum freeze-drying; Stability

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