热压式蒸馏水机和多效蒸馏水机制备注射用水的质量比较  

Quality comparison of water for injection generated by thermocompression distillation machine and multi-effect distilled machine

作　　者：赵书艺 韩祥东 赵小洁 祁军 徐永浩 张齐明 勾洋梅 刘晓 ZHAO Shu-yi;HAN Xiang-dong;ZHAO Xiao-jie;QI Jun;XU Yong-hao;ZHANG Qi-ming;GOU Yang-mei;LIU Xiao(Lanzhou Lansheng Plasma-derived Biotherapies Co.,Ltd.,Lanzhou 730046,China)

机构地区：[1]兰州兰生血液制品有限公司,兰州730046

出　　处：《医疗卫生装备》2022年第2期51-55,共5页Chinese Medical Equipment Journal

摘　　要：目的:比较热压式蒸馏水机和多效蒸馏水机制备的注射用水的质量。方法:选取多效蒸馏水机和热压式蒸馏水机的总出水口和总回水口共4个取样点,每周取样1次,连续取样28周,按照《中华人民共和国药典》(2020年版)的注射用水质量标准,对热压式蒸馏水机和多效蒸馏水机制备的注射用水的性状、pH值、氨、硝酸盐、亚硝酸盐、电导率、总有机碳、不挥发物、重金属、细菌内毒素和微生物限度进行评价。结果:多效蒸馏水机和热压式蒸馏水机制备的注射用水的质量均符合《中华人民共和国药典》(2020年版)的要求,且热压式蒸馏水机制备的注射用水的电导率比多效蒸馏水机更低。结论:相比多效蒸馏水机,热压式蒸馏水机制备的注射用水纯度更高、质量更好,更符合制药用水的要求。Objective To compare the quality of water for injection(WFI)generated by the thermocompression distillation(TD)machine and multi-effect distilled(MD)machine.Methods Samples were taken once a week for 28 weeks from a total of 4 sampling points at the main outlets and returns of the TD and MD machines.The WFI prepared by the TD and MD machines was evaluated for properties,pH,ammonia,azotate,nitrite,conductivity,total organic carbon,non-volatile matter,heavy metals,bacterial endotoxin and microbiological limits according to the Pharmacopeia of the People's Republic of China(2020)quality standards for WFI.Results The quality of WFI prepared by the TD and MD machines both met the requirements of the Pharmacopeia of the People's Republic of China(2020),and the conductivity of WFI generated by the TD machine was lower than that of the MD machine.Conclusion The TD machine gains advantages over the MD machine in purity and quality of WFI when used for pharmaceutical requirements.

关 键 词：热压式蒸馏水机 多效蒸馏水机 注射用水 《中华人民共和国药典》 制药用水 

分 类 号：R318.6[医药卫生—生物医学工程] TH788.5[医药卫生—基础医学]