红外吸收法检测西林瓶包装冻干制品中的氧含量

Development of an infrared absorption method in determination of oxygen content in cylindroids vials packaged freeze-dried biological products

目的应用HSA-P型激光检漏仪建立西林瓶包装冻干制品中氧气含量的测定方法。方法考察冻干制品中氧含量测定的操作条件:标准样瓶对仪器的校准;氮气吹扫前后样品中氧含量值的比较;不同纯度氮气吹扫标准样瓶后的氧含量值的变化。深化红外吸收法在测定西林瓶包装冻干疫苗中氧含量的应用。结果将该方法用于检测A群C群脑膜炎球菌多糖疫苗400批、麻疹减毒活疫苗86批、乙型脑炎减毒活疫苗46批,氧含量分别为1.64%±1.99%、1.36%±1.64%和0.99%±1.58%。结论该法测定冻干疫苗中的氧含量具有灵敏度高、速度快和易操作的优点,为冻干制品真空度的测定提供了定量检测方法。

Objective To establish a method in determination of oxygen content inside cylindroids vials dispensed freeze- dried biological products by applying a Leak Tester. Methods It was carried out investigation of operating conditions in determination of oxygen content in cylindroids vials by dispensed freeze-dried products so as to enhance the application of established method in this aspect as followings ： the three standard vials were used in calibration of accuracy for instrument ; comparison changes of oxygen contents in sample vials were performed with LASER radiation before and after nitrogen gas （ N2 } sweeping; same way was carried out in test for oxygen contents in the standard vials with LASER radiation by using different purity of N2. Results The method was used in test for 400 batches of group A, C Meningococcal polysaccharide vaccine, 86 batches of Measles Vaccine, Live and 46 batches Japanese Encephalitis Attenuated Vaccine, Live. The oxygen content is 1.64%±1.99%, 1.36%±1.64% and 0.99%±1.58%, respectively. Conclusion The determination re- suits showed that the method has several advantages, such as with a high sensitivity, quick and easy to operation. It pro- vides a basis in quantitative determination of oxygen content for freeze-dried biological products.