基于中英两国药典对比分析我国儿童免疫规划疫苗质量标准综述

通过对比中英两国药典关于儿童免疫规划疫苗质量标准的规定，可看出国内当下儿童免疫规划疫苗质量标准有领先之处亦有不足，中国在重组乙肝和甲肝灭活疫苗游离的甲醛标准、A群流脑多糖与A群C群流脑多糖疫苗抗原、蛋白质及核酸的含量标准、百白破疫苗中的破伤风原液的抗原纯度标准、重组乙肝和吸附百白破联合疫苗的铝含量标准规定上要严于英国。而英国在A群流脑多糖以及A群C群流脑多糖疫苗的热原规定、脊髓灰质炎减毒活疫苗的病毒滴度标准规定上严于中国。我们应当取长补短，参考英国药典提升我国儿童免疫规划疫苗质量标准，以促进我国疫苗质量和国际接轨。

Quality standards of Chinese childhood immunization plan vaccines based upon a comparison of Chinese and British pharmacopoeias

By comparing the Chinese and British Pharmacopoeias on the quality standards of childhood immunization program,current domestic childhood immunization program quality standards have some strength and yet a few shortcomings.The examples included domestic regulations on free formaldehyde in recombinant hepatitis B vaccine and hepatitis A inactivated vaccines;antigen content,protein content and nucleic acid content of group A meningococcal polysaccharide vaccine and group C meningococcal polysaccharide vaccine;purity of tetanus stock solution in DPT vaccine;differences existed in recombinant hepatitis B vaccine and combined DPT vaccine.The regulations of aluminum content were stricter than those in UK.In United Kingdom,pyrogen regulations of group A meningococcal polysaccharide vaccine and group A/C meningococcal polysaccharide vaccine;virus titer of live attenuated polio vaccine was stricter than that of China.We should recognize each other’s strengths and learn from British Pharmacopoeia to improve the quality standards of vaccines in Chinese childhood immunization program so as to ensure domestic vaccine quality and uphold international standards.