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以灭菌效力Ｆ０值和破损率为灭菌主要参数，对塑料袋装血液抗凝液的灭菌方法可靠性进行验证。结果表明：１１２～１１５℃３０ｍｉｎ蒸汽灭菌，Ｆ０＞８，破损率低，符合中国《药品生产管理规范》有关规定，灭菌效果可靠，并对质量控制作了讨论。
The sterilization efficiency F0 value and the damage rate were the main parameters of sterilization, and the reliability of sterilization method of anticoagulant solution in plastic bag was verified. The results showed that steam sterilization at 112 ~ 115 ℃ for 30min, F0> 8, the damage rate was low, which accorded with the relevant regulations of “Code of Drug Production Management” in China. The sterilization effect was reliable and the quality control was discussed.