张剑峰项峥窦德强血塞通注射液溶血检测方法-中国试验动物学报.DOCVIP

不同水质水对体外溶血试验的影响 高梅，朱春花，曲保恩 (山东省医药工业研究所，山东省化学药物重点实验室，山东 济南 250101) 【摘要 目的 通过比较饮用水、去离子水、纯水、双蒸水、纯净水及灭菌注射用水等不同水质水在体外溶血试验中的溶血度，为体外溶血试验提供较好的阳性对照。方法 采用常规体外试管法（肉眼观察法）和改进的体外溶血性试验法（分光光度法）测定不同水质水对兔血红细胞的溶血度。结果 这几种水质水在体外均有溶血作用，灭菌注射用水最大，饮用水溶血最小，其它几种水质溶血差异不大，肉眼观察法和分光光度法结果一致。结论 在本试验条件下，几种水质水对兔血红细胞的为灭菌注射用水纯净水双蒸水纯水去离子水饮用水，溶血试验阳性对照推荐使用灭菌注射用水。 关键词 溶血试验；灭菌注射用水；肉眼观察法；分光光度法中图分类号 【文献标识码A Experimental study on hemocytolysis test of various character water GAO Mei, ZHU Chun-hua, QU Bao-en （Shangdong Institute of Pharmaceutical Industry, Shandong Provincial Key Laboratory of Chemical Drug, Jinan250101） Abstract】 Objective Through comparing the drinking water, deionized water, pure water, double steamed water, purified water and sterilized water for injection and so on the various character water in vitro hemolysis test of hemolysis degree, we hope to provide the better positive control. Methods The hemocytolysis of various character water was observed by means of the routine test tube method in vivo (macroscopic observation methods) and modified hemolytic test method in vitro (spectrophotometry). Results Hemolytic crisis occur between the six character water, the hemolysis degree of sterilized water for injection is the largest, drinking water is minimum, the difference of several other character water is small, macroscopic observation method and spectrophotometry results are consistent. Conclusions In this test conditions, several character water to the rabbit red blood cells of hemolysis degree is sterilization water for injection purified water double steamed water pure water deionized water drinking water, we recommended sterilized water for injection for hemolysis test positive control. 【Key words】 Hemocytolysis; Sterilized water for injection; Macroscopic observation; Spectrophotometry 水质指的是水体的物理（如色度、浊度、臭味等）、化学（无机物和有机物的含量）和生物（细菌、微生物、浮游生物、底栖生物）的特性及其组成的状况。饮用水饮用水（rinking water）为天然水经净化处理所得的水；纯化水（Purified ater）为原水经蒸馏法、离子交换法、反渗透法或其他适宜的方法制得的制药用的水，不含任何附加剂；注射用水（Water for njection）是以纯化