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目的:杀灭心脏停搏液中可能存在的细菌的繁殖体和芽孢,并保持主药盐酸普鲁卡因含量,达到临床使用要求。方法:采用热压灭菌法。结果:灭茵过程中保持了软袋内外压平衡,多次生产的平均破损率为1.254%,盐酸普鲁卡因平均标示含量为0.0986%,无菌检查全部合格。结论:本方法既可使盐酸普鲁卡因含量保持在标示量的95%-105%范围,又达到了灭菌要求。
OBJECTIVE: To kill the propagules and spores of bacteria that may exist in cardioplegic solution and to maintain the procaine hydrochloride content of main drug to meet the clinical requirements. Methods: Autoclaving method. Results: During the process of extinction, the pressure balance inside and outside the soft bag was maintained. The average breakage rate of multiple production was 1.254%. The average content of procaine hydrochloride was 0.0986%. All the sterile tests were qualified. Conclusion: The method can not only maintain the content of procaine hydrochloride in the range of 95% -105% of the labeled amount, but also meet the sterilization requirements.