CAJ | 학술논문

以鸡新城疫活疫苗为例,介绍了泡沫冷冻干燥的工艺过程,并对用泡沫冷冻干燥法制得的样品进行热分析及鸡胚半数感染量(50% egg infectious dose , EID50)测试,然后与用传统冷冻干燥法生产的低毒疫苗和耐热疫苗进行对比.结果表明:经泡沫冷冻干燥工艺处理的疫苗与低毒疫苗、耐热疫苗的玻璃化转变温度分别为33.9℃、30.2℃和40.1℃;泡沫冷冻干燥疫苗和耐热疫苗的耐老化试验下降滴度分别为1.1和0.8.表明用泡沫冷冻干燥法制得的疫苗在耐热性能上有其优越性,值得进一步深入研究.
이계신성역활역묘위례,개소료포말냉동간조적공예과정,병대용포말냉동간조법제득적양품진행열분석급계배반수감염량(50% egg infectious dose , EID50)측시,연후여용전통냉동간조법생산적저독역묘화내열역묘진행대비.결과표명:경포말냉동간조공예처리적역묘여저독역묘、내열역묘적파리화전변온도분별위33.9℃、30.2℃화40.1℃;포말냉동간조역묘화내열역묘적내노화시험하강적도분별위1.1화0.8.표명용포말냉동간조법제득적역묘재내열성능상유기우월성,치득진일보심입연구.
Freeze‐drying has been widely used in the production of pharmaceuticals , vaccines and high‐valued foods . Foam freeze‐drying is a new type of drying technology , in which the sample is foamed and frozen before drying . Compared with traditional freeze‐drying method , the new method can reduce operation time and cost significantly . Some foreign researchers have used this method to produce heat‐resistant vaccines which can endure higher temperature and remain effective after a longer storage in refrigerator . Up to now , little research about foam freeze‐drying has been reported domestically . In this study , newcastle disease vaccine was used as an example to illustrate the procedure of foam freeze‐drying method and to test its capability of producing heat‐resistant vaccine . The ingredient of the foam freeze drying ( FFD ) sample included w ( trehalose) = 10% , w ( hydrolyzed gelatin) = 5% , w( pluronic F‐108) = 3% , w( arginine) = 2% , 25 mmol/L phosphate buffer ( pH = 7 .2) . The sample was prepared through the following procedure:1) One milliliter sample was placed on the plate of the freeze dryer and cooled to 15 ℃ ;2) then the pressure was lowered to 5 Pa and foaming began;3) after one hour the plate temperature was increased up to 31 ℃ at a velocity of 0 .7 ℃ /min and kept for another 48 hours . The samples made by foam freeze drying were analyzed with thermal analysis and aging test , and were compared with live attenuated samples and heat‐resistant samples prepared by traditional freeze drying . The latter two kinds of sample were bought from market ( Tianbang Biotechnology Corporation , Nanjing , China) . Thermal analysis was done with a differential scanning calorimetry (DSC 200 F3 Maia , NETZSCH , Germany) . The procedure was as follows:1) the sample was cooled to -20 ℃ at a rate of 10 ℃ /min and held for 3 minutes;2) the sample was heated to 80 ℃ at the rate of 10 ℃/min and held for 3 minutes;3) the sample was cooled to room temperature at the rate of 10 ℃ /min . Aging test was carried out by placing the sample at 37 ℃ for 10 days and thereafter measuring its EID50 . EID50 was determined by vaccination with chick embryo and Reed‐Muench calculation method . @@@@The appearance of the FFD sample was like sponge , totally different from the flat biscuit‐like sample made by traditional freeze drying method . The average glass transition temperature of FFD vaccine was 33 .9 ℃ , higher than 30 .2 ℃ of live attenuated vaccine , but lower than 40 .1 ℃ of heat‐resistant vaccine . This means that the heat resistance ability of FFD vaccine is physically better than that of live attenuated vaccine . After aging test the titers decreased for FFD vaccine was 1 .1 , which was a little higher than 0 .8 for heat‐resistant vaccine . The latter result was in consistent with the former result . @@@@It is clear that FFD vaccine has its own superiority on heat resistance ability , although the formula and operation parameters still need to be improved . Considering its obvious economic prospect , it is worth to carry out further work on the study of FFD vaccine .