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作 者:余萌 王似锦[1] 曹蕊 马仕洪[1] Yu Meng;Wang Sijin;Cao Rui;Ma Shihong(National Institutes for Food and Drug Control,NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs,Beijing 100050,China;Yantai University,Yantai 264000,China)
机构地区:[1]中国食品药品检定研究院,国家药品监督管理局化学药品质量研究与评价重点实验室,北京100050 [2]烟台大学,烟台264000
出 处:《中国药事》2022年第7期746-757,共12页Chinese Pharmaceutical Affairs
摘 要:目的:对现有洋葱伯克霍尔德菌群(Bcc)选择性培养基配方进行优化和调整,以获得更优的选择和分离培养效果,提高Bcc的检出效率,形成《中国药典》拟收载Bcc检查法中的选择和分离培养基。方法:调整选择性培养基营养成分和指示剂组分,使用分离自制药环境及产品的Bcc菌株,通过计数回收、表型观察和生长曲线试验等方法,从选择性培养基的促生长能力、指示特性、抑制能力几方面评估其配方优化后的结果。结果:优化获得的Bcc选择性培养基(BCCSA),对Bcc菌株的回收优于其他选择性培养基,生长曲线试验结果也表明Bcc菌株在BCCSA中的生长速率更快并更早到达生长稳定期;BCCSA对Bcc生长的指示特性相较于其他培养基更好,表现为培养基颜色变化更为明显,菌落颜色更易观察;对于美国药典中要求的抑制特性试验菌株,BCCSA可满足其抑制能力要求。结论:综合而言,BCCSA表现出更优的促生长能力和指示特性,可作为《中国药典》拟收载Bcc检查法中的选择和分离培养基。Objective:To optimize and adjust the present selective medium formula of Burkholderia cepacia Complex(Bcc),so as to obtain a better selection and subculture agar,improve the detection efficiency of Bcc,and form the selectition and subculture agar in the examination of Bcc to be included in Chinese Pharmacopoeia.Methods:Selective medium nutrient composition and indicator composition were adjusted,Bcc strains isolated from pharmaceutical environment and products were used to evaluate the optimized formula from the aspects of growth promoting,indication properties and inhibitory ability by counting recovery,phenotype observation and growth curve test.Results:The selective agar BCCSA,which optimized from existing formula,shows better recovery results for Bcc than other selective agars.Growth curves experiment of Bcc strains also exhibits faster growth rate in BCCSA and reaches the stationary phase earlier.BCCSA has better indication characteristics for Bcc growth than other media,which shows that the color change of agar is more obvious and the color of the colony was easier to observe.For the inhibitory property test strains required by USP43-NF38<60>,BCCSA is able to meet the requirement of inhibitory ability.Conclusion:In general,BCCSA shows better growth promoting and indicative property,and could be used as the selection and subculture agar in the examination of Bcc to be included in Chinese Pharmacopoeia.
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