不同包装材料的注射用水总有机碳含量的长期稳定性研究  

Long-term stability research of total organic carbon in different packaging materials

作　　者：孙悦[1] 唐素芳[1] 

机构地区：[1]天津市药品检验所,天津300070

出　　处：《药物分析杂志》2012年第11期2031-2033,2050,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:考察不同包装材料对注射用水中总有机碳含量的影响。方法:采用薄膜电导法测定不同包装材料包装的注射用水在12个月内电导率及总有机碳含量的变化,对结果进行相关性分析及偏相关性分析。结果:采用不同包装材料的包装的注射用水的总有机碳在12个月内变化非常明显,不同包装之间总有机碳的变化存在明显差异,总有机碳与电导率值不存在相关性(p>0.05)。结论:包装材料对注射用水中总有机碳含量的增加有非常显著的影响。Objective： To study the impact of different packaging materials on total organic carbon （TOC） of water for injection. Methods： Membrane conductometric analysis was employed to determine TOC and conductivity of wa- ter for injection in different packaging materials and their changes in twelve months were recorded. The result was disposed by correlate and partial correlate analysis. Results： There was a significant change of TOC of water for in- jection in different packaging materials in twelve months. Significant differences for TOC also existed between the different packaging materials. There was no significant correlation between the conductivity and TOC （p 〉 O. 05 ）. Conclusion： There was a significant effect of packaging materials on increasing TOC of water for injection.

关 键 词：不同包装材料 注射用水 电导率含量变化 总有机碳含量变化 化学需氧量 生化需氧量 高锰酸盐指数 长期稳定性的研究分析 

分 类 号：R917[医药卫生—药物分析学]