手持拉曼光谱技术在乙型脑炎减毒活疫苗生产用辅料检定中的应用  

Application of handheld Raman spectrometry in control tests on excipients for production of live attenuated Japanese encephalitis vaccine

作　　者：谢姗姗[1] 李欣 朱晓艳 张杜鹃[1] 赵青 汪伟[1] XIE Shan-shan;LI Xin;ZHU Xiao-yan;ZHANG Du-juan;ZHAO Qing;WANG Wei(Quality Control Department,Chengdu Institute of Biological Products Co.,Ltd.,Chengdu 610023,Sichuan Province,China)

机构地区：[1]成都生物制品研究所有限责任公司质量检定室,四川成都610023

出　　处：《中国生物制品学杂志》2020年第12期1431-1435,共5页Chinese Journal of Biologicals

摘　　要：目的分析采用拉曼光谱技术对乙型脑炎减毒活疫苗生产用辅料进行快速鉴别的可行性。方法使用拉曼光谱仪对乙型脑炎减毒活疫苗不同批次、不同规格生产用关键辅料(蔗糖、乳糖、尿素、磷酸二氢钾、十二水磷酸氢二钠)进行扫描。对同一辅料不同部位多次采集,建立相应拉曼光谱方法和图谱库,并用以上辅料进行性能确认。选择与乙型脑炎减毒活疫苗生产用辅料化学结构类似的物质(葡萄糖和二水合磷酸二氢钠)进行专属性验证。结果用手持式拉曼光谱仪对乙型脑炎减毒活疫苗生产用关键辅料进行检测,在分析中未发现偏差,采集的样品图谱与标准图谱一致,与《中国药典》四部(2015版)鉴别结果一致。检测与乙型脑炎减毒活疫苗生产用辅料化学结构类似、性状相近的物质则显示失败,表明拉曼光谱仪建立的方法准确,专属性强,仪器性能可靠。结论拉曼光谱鉴别方法符合相关法规要求,可用于乙型脑炎减毒活疫苗生产用辅料的快速鉴别检测。Objective To analyze the feasibility of rapid identification of excipients for the production of live attenuated Japanese encephalitis vaccine(JEV)by Raman spectroscopy.Methods Raman spectrometer was used for scanning the excipients(sucrose,lactose,urea,potassium dihydrogen phosphate and disodium hydrogen phosphate dodecahydrate)for production of live attenuated JEV.According to the multiple acquisition of different parts of the excipients,the corresponding Raman spectrum method and the library were established.The excipients were used for verification test.The materials with similar chemical structure to that of excipients for production of live attenuated JEV,such as glucose and disodium hydrogen phosphate dehydrate,were selected for verification of specificity.Results No deviation was found in identification of the excipients for production of live attenuated JEV by using handheld Raman spectrometer.The spectrum of test sample was consistent with that in standard spectrum library,while the identity test result was consistent with that of chemical identification in Chinese Pharmacopoeia(VolⅣ,2015 edition).However,when the materials with similar chemical structure to that of the excipients were tested,the system presented the message"Failed",indicating high accuracy,specificity and reliability of the method developed based on Raman spectrometer.Conclusion Raman spectroscopy meets the relevant requirements,which may be used for the rapid identification of excipients for production of live attenuated JEV.

关 键 词：拉曼光谱仪 乙型脑炎减毒活疫苗 辅料 鉴别 

分 类 号：Q657.37[生物学—生物物理学]