目的 补充和完善《中国药典》2010年版中溶血与凝聚实验方法，排除有色注射剂和乳状注射液对溶血检查的干扰。方法 方法一是增加显微镜观察和血球计数仪检测，与现有肉眼观察方法进行。方法二是将温育的血细胞离心后取上清液在紫外分光光度计上，波长545 nm处比色，计算溶血阳性率。结果 利用血球计数仪计数红细胞得出的溶血阳性率结果与肉眼观察存在一定的差异，镜下观察红细胞数量和形态与肉眼观察具有一致性和相关性。有色供试品溶液溶血检查比色法所得结果的溶血阳性率明显高于传统的肉眼观察法。结论 利用显微镜下观察红细胞数量和形态的方法有助于进一步准确判断溶血与否，可以考虑纳入药典作为一些特殊品种溶血的检测方法，以排除有色注射剂和乳状注射液品种对溶血检查的干扰。比色法还需要进一步研究。

OBJECTIVE To supplement and improve the method of haemolysis and agglomeration test of Pharmacopoeia of the People′s Republic of China (2010 edition) thus to exclude the interference of colored injections and emulsion injections on haemolysis test. METHODS The results of microscope observation and blood analyzer test were compared with that of existing visual inspection method. In addition, the supernatant obtained by centrifugation of incubated blood cells was assayed with UV spectrophotometer at 545 nm, and the results were used to calculate haemolysis positive rate. RESULTS There were some differences in the haemolysis positive rate between hematology analysis and visual inspection. The results of microscope observation and visual inspection had consistency and relevance. The haemolysis positive rates of colored injection assayed by colorimetric method were significantly higher than those by the traditional visual inspection. CONCLUSION Microscope observation of the number and morphology of red blood cells helps further accurately determine haemolysis, which can be considered as a supplement test of pharmacopoeia method to exclude the interference of emulsion injections and colored injections. Further research of colorimetric method is warranted.