CAJ | 학술논문

目的研制不同成分不含明胶及人血白蛋白的甲型肝炎(甲肝)减毒活疫苗冷冻干燥保护剂.方法通过对不同保护剂组合的系列试验,筛选一组较好的配方,在适宜条件下制备成冻干甲肝疫苗,并与传统配方进行比较.结果使用不含明胶及人血白蛋白冷冻干燥保护剂的疫苗,冻干后疫苗病毒滴度仅下降0.21lg CCID50/mL,37℃放置7d病毒滴度下降0.21lg～ 0.34lg CCID50/mL,冻干保护效果良好；成品的内毒素含量与注射用水相同,均低于0.25 EU/mL,明显低于传统配方.制备的3批试验疫苗,各项检测指标均符合冻干甲肝减毒活疫苗的质量标准.结论以海藻糖、甘露醇、氯化镁、甘氨酸等成分为主,不含明胶及人血白蛋白的保护剂是一种安全性较高、冻干保护效果好、适合疫苗生产的有效保护剂.
목적 연제불동성분불함명효급인혈백단백적갑형간염(갑간)감독활역묘냉동간조보호제.방법 통과대불동보호제조합적계렬시험,사선일조교호적배방,재괄의조건하제비성동간갑간역묘,병여전통배방진행비교.결과 사용불함명효급인혈백단백냉동간조보호제적역묘,동간후역묘병독적도부하강0.21lg CCID50/mL,37℃방치7d병독적도하강0.21lg～ 0.34lg CCID50/mL,동간보호효과량호；성품적내독소함량여주사용수상동,균저우0.25 EU/mL,명현저우전통배방.제비적3비시험역묘,각항검측지표균부합동간갑간감독활역묘적질량표준.결론 이해조당、감로순、록화미、감안산등성분위주,불함명효급인혈백단백적보호제시일충안전성교고、동간보호효과호、괄합역묘생산적유효보호제.
Objective To prepare a protective additive of freeze-dried live attenuated hepatitis A vaccine without gelatin and human albumin,but containing different ingredients.Methods By testing the different combination of protective additive and sifting out a group of better ingredients,make the freeze-dried hepatitis A vaccine to compare with the traditional ingredients.Results The infectivity titer of the vaccine decreased by 0.21lg CCID50/mL after lyophilization,titers decreased by 0.21lg-0.34lg CCID50/mL in 37 ℃ after 7 days,which used the better protective additive with no gelation and no human albumin,showing an effective result of protection.The endotoxin content of final product! was less than 0.25 EU/mL,apparently lower than traditional ingredients and same as water for injection.Three batches of vaccine made from the harvests were all qualified and complied with the standard of freeze-dried live attenuated hepatitis A vaccine.Conclusions The protective additive without gelatin and human albumin but containing terhalose,mannitol,magnesium chloride and glycine is safe,effective and suitable for vaccine production.