CAJ | 학술논문

目的通过研究冷酚与粗糖的混合比例、粗糖提纯时的质量浓度和乳糖保护剂的用量来制备符合规定的ACYW135群脑膜炎球菌多糖疫苗.方法发酵细菌,提取A、C、W135、Y群脑膜炎球菌多糖粗制品,以不同的纯化工艺纯化A、C、W135、Y群脑膜炎球菌多糖.将4种纯化的多糖原液按一定比例混合,加入乳糖作为保护剂,冷冻干燥制成ACYW135群脑膜炎球菌多糖疫苗.结果通过比较不同纯化工艺制备的多糖,确定最佳提纯条件为多糖与冷酚的体积比为1∶1,粗糖提纯时的质量浓度为6 g/L.检测按此纯化条件制备的ACYW135群脑膜炎球菌多糖疫苗显示,3批疫苗的水分含量分别为1.7％、2.0％和2.1％,疫苗的A、C、W135、Y群脑膜炎球菌多糖含量和回收率分别都≥50 μg/剂和80％,符合相关规定的要求.结论按确定的工艺成功制备ACYW135群脑膜炎球菌多糖疫苗.
목적 통과연구랭분여조당적혼합비례、조당제순시적질량농도화유당보호제적용량래제비부합규정적ACYW135군뇌막염구균다당역묘.방법 발효세균,제취A、C、W135、Y군뇌막염구균다당조제품,이불동적순화공예순화A、C、W135、Y군뇌막염구균다당.장4충순화적다당원액안일정비례혼합,가입유당작위보호제,냉동간조제성ACYW135군뇌막염구균다당역묘.결과 통과비교불동순화공예제비적다당,학정최가제순조건위다당여랭분적체적비위1∶1,조당제순시적질량농도위6 g/L.검측안차순화조건제비적ACYW135군뇌막염구균다당역묘현시,3비역묘적수분함량분별위1.7％、2.0％화2.1％,역묘적A、C、W135、Y군뇌막염구균다당함량화회수솔분별도≥50 μg/제화80％,부합상관규정적요구.결론 안학정적공예성공제비ACYW135군뇌막염구균다당역묘.
Objective To development qualified groups A,C,Y,W135 meningococcal polysaccharide vaccine (ACYW135-PS) by studying mixing ratio of phenol and crude polysaccharide,mass concentration of crude saccharide in purifying and dosage of lactose.Methods Bacteria were fermented,and crude saccharides of groups A,C,W135,Y meningococcus were extracted and purified by different purification processes.Groups A,C,W135 and Y meningococcal polysaccharide were mixed at a certain ratio,then lactose was added into mixture as stabilizer and ACYW135-PS was prepared by freeze-drying.Results The optimum conditions for crude saccharides purification were as follows:volume ratio of crude polysaccharide to phenol was 1 ∶ 1 and mass concentration of crude saccharide in purifying was 6 g/L.The results showed that moisture contents of 3 bathes of ACYW135-PS prepared according to these conditions were 1.7％,2.0％ and 2.1％,respectively,and polysaccharide contents and recovery rates of groups A,C,W135 and Y meningococcal polysaccharide in ACYW135-PS were all ≥50 μg/dose and 80％,respectively,complying with the relevant requirements.Conclusion ACYW135-PS is successfully prepared under confirmed conditions.