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作 者:何长民[1] 杨晓明[1] 陈平纡[1] 陈爱荣[1] 张蓉[1] 程夷[1] 边淑娟[1] 吕桂荣
出 处:《上海免疫学杂志》1991年第5期289-293,共5页Shanghai Journal of Immunology
摘 要:采用百日咳杆菌C.S中国株经培养、盐析、浸提、组分分离以及脱毒等工艺,制备出含有LPF和FHA两种主要免疫原的无细胞百日咳菌苗。SDS-PAGE的结果表明,菌苗的LPF和FHA组分和参考品的相同,测得的分子量与文献报道的结果相一致。小鼠体重减轻、白细胞增多、组织胺敏感以及热原质等试验证明,菌苗中无内毒素;菌苗的免疫原性经我国和日本的国家检定部门检定,其效价为14.5~44.3IPU/ml,说明菌苗是安全有效的,An acellular pertussis vaccine manufactured by us was investigated for purity, antigenicity and immunogenicity. The vaccine contains two main protective antigens, leucocytosis promoting factor (LPF) and filamentous haemagglutinin (FHA) that are purified from culture supernatant of the Chinese Strain (G. S) of phase 1B. pertussis. The steps in the preparation include cultivation, salting-out, extraction, fractionation, detoxification and addition of adjuvant and preservative. The results of SDS-PAGE of the preparations showed the same bands of LPF and FHA as compared with the reference standard. The five subunits of LPF molecular weights were S-1:27000; S-2: 23000;S-3:22000;S-4:18000,8-5:16500 and the bands of FHA were 9500,126000,160000 respectively. The vaccine was free of endotoxin as judged by BWD,LP,HS and pyrogen tests. The potency of the vaccines were 14.5-44.3 IPU/ml as tested by Chinese and Japanese institutes. This acellular pertussis vaccine is not only safe but also effective.
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