中国标准百日咳菌苗效价的标定

Calibration of the Potency of Chinese Standard Pertussis Vaccine

中国标准百日咳菌苗#1#2系于1978年用百日咳I相菌CMCC 58004(型1、2、3)、CMCC 58031(型1、2)制备。该两批标准品曾用WHO标准百日咳菌苗#1、日本标准百日咳菌苗#28及英国百日咳菌苗参考制品#2为标准,对其效价进行了标化。1980～1981年又送至日本-N.I.H、美国F.D.A实验室核检,标化的结果经统计学分析,其效价每安瓶分别为16及21国际单位。反馈的信息证明,该标准品的质量及稳定性令人满意。

The No. 1 and No. 2 Chinese Standard Pertussis Vaccines (CSPV) were prepared from the strains of B. pertussis CMCC 58004 (factor 1, 2, 3) and CMCC 58031 (factor 1, 2) in 1978. The potency of the two preparations were calibrated in term of the No. 1 International Standard Pertussis Vaccine, No. 28 Japanese Standard Pertussis Vaccine and No. 2 British Reference Preparation Pertussis Vaccine, and the CSPV had been checked by laboratories of Japan-N. I. H and F. D. A-U. S. A. in 1980～1981. Based upon the statistical analysis results, the potency of the No. 1 CSPV and No. 2 CSPV were defined as 16IU and 21IU per ampoule respectively. According to the feedback information, the quality and stability of CSPV were satisfactory.