三七药材中芽孢杆菌的热激活研究  

Study on Thermal Activation of Bacillus in Panax Notoginseng

作　　者：白雯静 石晓峰[2] 徐雪梅 李志俊 BAI Wen-jing;SHI Xiao-feng;XU Xue-mei;LI Zhi-jun(Lanzhou Institute for Food and Drug Control;Gansu Academy of Medical Sciences)

机构地区：[1]兰州市食品药品检验检测研究院 [2]甘肃省医学科学研究院

出　　处：《中国食品药品监管》2023年第7期80-85,共6页China Food & Drug Administration Magazine

基　　金：2022年甘肃省陇原青年创新创业人才项目(甘组通字〔2022〕77号);甘肃省药品产业技术扶持项目(2019KF006);2022年度兰州市科技发展指导性计划项目(2022-5-9)。

摘　　要：目的:探讨三七药材在常规灭菌工艺中可能会出现芽孢杆菌的热激活现象,为下一步三七药材灭菌工艺的研究奠定理论基础。方法:参照2020年版《中国药典》四部通则1105的方法,结合传统生化法和基质辅助激光解析电离飞行时间质谱法(MALDI-TOF-MS)对三七药材中的污染菌进行分型和鉴定;参照2020年版《中国药典》四部通则9208的相关热激活参数对三七药材进行处理,并对需氧菌总数进行计数,考察是否存在热激活现象。结果:三七药材中污染菌多为芽孢杆菌属,如枯草芽孢杆菌、地衣芽孢杆菌等。与阴性对照组相比,三七药材经90℃、30min热激活处理后的需氧菌总数增幅达147倍之多。结论:芽孢杆菌在三七药材污染菌中占比较大,且存在芽孢热激活现象。制药企业在制定灭菌工艺时,应综合考虑,制定行之有效的灭菌方案。Objective:To explore the possibility of thermal activation of Bacillus in the conventional sterilization process of Panax notoginseng,in order to lay a theoretical foundation for further research on the sterilization process of Panax notoginseng.Methods:Following General Rule 1105 of The Fourth Part of Chinese Pharmacopoeia(2020 edition),the contaminating bacteria in Panax notoginseng were classified and identified by combining traditional biochemical methods and matrix-assisted laser desorption ionization time of flight mass spectrometry(MALDI-TOF-MS).Based on the relevant thermal activation parameters in General Rule 9208 of The Fourth Part of Chinese Pharmacopoeia(2020 edition),Panax notoginseng was treated,and the total number of aerobic bacteria was counted to investigate the existence of thermal activation.Results:Most of the contaminated bacteria in Panax notoginseng are Bacillus species,such as Bacillus subtilis and Bacillus licheniformis.Compared with the negative control group,the total count of aerobic bacteria increased by up to 147 times after thermal activation treatment at 90℃for 30 min.Conclusion:Bacillus accounted for a significant proportion of the contaminated bacteria in Panax notoginseng,and there is a phenomenon of spore thermal activation.Pharmaceutical enterprises should comprehensively consider and develop effective sterilization plans when formulating sterilization processes.

关 键 词：三七 芽孢杆菌 热激活 

分 类 号：R282[医药卫生—中药学]