伤寒甲型副伤寒结合疫苗质量标准的建立

Establishment of quality standards for typhoid and paratyphoid A conjugate vaccine

目的建立国产伤寒甲型副伤寒结合疫苗的质量控制标准。方法参照《中国药典》三、四部(2015版)、《预防用疫苗临床前研究技术指导原则》、《结合疫苗质量控制和临床研究技术指导原则》及《世界卫生组织生物制品规程续编Ⅱ》(1995年版)等中的相关原则及方法,对4批国产伤寒甲型副伤寒结合疫苗的各项质量指标进行检测。结果 4批国产伤寒甲型副伤寒结合疫苗的各项质量检测指标均符合国家拟定的质量标准。结论建立的国产伤寒甲型副伤寒结合疫苗的质量控制标准适用于该疫苗工艺的质量控制。

Objective To establish the quality control standard for domestic typhoid and paratyphoid A conjugate vaccine. Methods The quality indicators of four batches of typhoid and paratyphoid A conjugate vaccine were tested according to the relevant principles and methods in the Chinese Pharmacopoeia（Volumes Ⅲ and Ⅳ,2015 Edition）,the Guiding Principles for Preclinical Research Techniques for Preventive Vaccines,the Guidelines for the Quality Control and Clinical Research of Combined Vaccines and the WHO Requirement for BiologicalsⅡ（1995 edition）. Results All the quality indexes of the four batches of domestic met the relevant national requirements for typhoid and paratyphoid A conjugate vaccine. Conclusion The developed standard was suitable for the quality control of production procedure for domestic typhoid and paratyphoid A conjugate vaccine.