Jansen D L, Meade B D
Food and Drug Administration, Rockville, MD 20852-1448, USA.
Biologicals. 1996 Dec;24(4):363-70. doi: 10.1006/biol.1996.0051.
The Center for Biologics Evaluation and Research within the U.S. Food and Drug Administration has prepared a new U.S. Standard Pertussis Vaccine. Whole cell pertussis vaccine concentrate was diluted in 5% (w/v) lactose and lyophilized. The preparation was tested for toxicity, sterility, heterogeneity and residual moisture. Based on data from an international collaborative study involving 11 laboratories, the potency was estimated in relation to the U.S. Master Standard Pertussis Vaccine, Lot 4 and the International Standard for Pertussis Vaccine, Lot 2. The potency of the preparation was defined to be 90 units per ampoule. When reconstituted and stored according to instructions, no significant change in potency was observed in the 14 days following reconstitution. This material was shown to be suitable for a pertussis vaccine standard and accordingly it was designated as U.S. Standard Pertussis Vaccine, Lot 11 on March 22, 1994.
美国食品药品监督管理局生物制品评估和研究中心制备了一种新的美国标准百日咳疫苗。将全细胞百日咳疫苗浓缩物用5%（w/v）乳糖稀释并冻干。对该制剂进行了毒性、无菌性、均一性和残留水分检测。基于一项涉及11个实验室的国际协作研究数据，相对于美国主标准百日咳疫苗4号批次和国际百日咳疫苗标准2号批次评估了效力。该制剂的效力定义为每安瓿90单位。按照说明复溶并储存后，复溶后14天内未观察到效力有显著变化。该材料被证明适用于百日咳疫苗标准，因此于1994年3月22日被指定为美国标准百日咳疫苗11号批次。
