气相色谱法检测灭活狂犬病毒浓缩液中残留的β-丙内酯  

Determination of Residual β-propiolactone in Inactivated Rabies Virus Concentrate by Gas Chromatography

作　　者：山广志[1,2] 马迅[2,3] 纪宏[2] 余立[2] 

机构地区：[1]中国医学科学院医药生物技术研究所,北京100050 [2]北京市药品检验所,北京100035 [3]中国食品药品检定研究院,北京100050

出　　处：《中国药房》2014年第25期2357-2359,共3页China Pharmacy

摘　　要：目的：建立检测灭活狂犬病毒浓缩液中残留的β-丙内酯的方法。方法：采用直接进样的气相色谱法。色谱柱为HP—DB624毛细管柱，程序升温；采用氢火焰离子化检测器（FID），载气为氮气，流速为1．0ml／min；氢火焰离子化检测器温度为250℃，进样口温度为150℃。以乙腈为对照品稀释溶剂，样品溶液经离心后直接进样。结果：乙腈和样品中其他成分对β-丙内酯的测定无干扰。β-丙内酯的检测质量浓度线性范围为1．082-1082．0μg／ml（r=0．9994）；检测限和定量限分别为0．2、1．0ng：方法精密度和耐用性良好。在4批样品中未检出残留的β-丙内酯。结论：建立的方法操作简便、通用性强，可满足灭活狂犬病毒浓缩液中残留的伊丙内酯监控的需要。OBJECTIVE： To develop a method for the determination of residual β-propiolactone in inactivated rabies virus concentrate. METHODS： Gas chromatography with direct injection was adopted. HP-DB624 capillary column was used with nitrogen as cartier gas at flow rate of 1.0 ml/min; column temperature was programmed temperature, and FID was used as detector. The detector temperature was 250 ℃, and the injector temperature was 150 ℃. β-propiolactone was dissolved in acetonitrile as reference solution, and inactivated rabies virus concentrate was direct injected for determination after centrifugation. RESULTS： There was no interference from acetonitrile and inactivated rabies virus concentrate. The linear range of β-propiolactone were 1.082-1 082.0 μg/ml （r=0.999 4）. The limits of detection and quantification were 0.2 and 1.0 ng. The established method was accurate and durable. β-propiolactone was not found in 4 batches of inactivated rabies virus concentrate. CONCLUSIONS： The method is simple and universal, and can be used for the determination of residual β-propiolactone in inactivated rabies virus concentrate.

关 键 词：β-丙内酯 灭活狂犬病毒浓缩液 气相色谱法 

分 类 号：R927.2[医药卫生—药学]