中文摘要：

目的探讨半数溶血量（HD50）在中药注射剂致溶血不良反应预警中的作用，分析其导致异常溶血的原因。方法家兔耳缘静脉取血，加入生理盐水，制备体积分数为1．1％的红细胞悬液，加入不同厂家不同批号不同浓度的血塞通注射液，采用分光光度法测定其溶血度，采用Sigmaplot10．0软件做浓度溶血度关系曲线，计算半数溶血量。对加入血塞通注射液、鞣酸和没食子酸的兔红细胞溶液分别进行血红蛋白全波长扫描，分析最大吸收波长变化。按照《中国药典》方法对血塞通注射液中酚类及鞣质成分进行检测。结果肉眼观察血塞通注射液可引起正常溶血（红细胞破裂，上层溶液为红色）和异常溶血（上清液颜色由鲜红色变为棕褐色或棕红色）。不同厂家生产的注射液之间HD50有明显差异，同一厂家生产的不同批号注射液HD50也有较大差别，最高与最低HD50之间可相差4-60倍。加入没食子酸、鞣酸和部分加入血塞通注射液的兔红细胞溶液血红蛋白波长扫描图谱显示血红蛋白特征吸收峰消失，提示血塞通注射液产生的异常溶血现象与鞣质类成分引起的相似。溶血活性明显增强的注射液中酚类及鞣质含量相对较高。结论HD50测定可以反映中药注射剂的溶血活性，可用于对其引起的异常溶血进行预警。中药注射剂所致异常溶血现象可能与酚类及鞣质成分含量较高有关。

英文摘要：

Objective To explore the function of half hemolytic dose （ HDs0 ） detection in alerting hemolytic adverse drug reactions caused by Xuesaitong injections and analyze the cause of abnormal hemolysis. Methods The red cell suspension （ volume fraction 1.1% ） was prepared with blood taken from the ear edge vein of rabbits and physiological saline solution. The red cell suspension was added into the different concentrations of Xuesaitong injections produced by different pharmaceutical factories and their hemolytic degrees were detected using spectrophotometry. Curve relationship between concentrations and hemolytic degrees were performed using Sigmaplot 10.0 software and half hemolytic dosage was calculated. Full wavelength scanning for hemoglobin in the red cell suspension of rabbit which had been added Xuesaitong injections, gallic acid or tannic acid was conducted and the changes of maximum absorbance wavelength were analyzed. The contents of phenols and tannin in the Xuesaitong injections were measured according to the method described in Chinese pharmacopeia. Results Normal （red blood cells ruptured and the supernatant changed into red） and abnormal hemolysis （ the supernatant changed from red to brown or reddish brown） caused bv Xuesaitong injections could be observed hv naked eyes. The differences of HD50 were marked among injections produced in the different pharmaceutical factories and even among different batch numbers of the same pharmaceutical factory. The highest HD50 value was about 60 times of the lowest one. The characteristic absorption peak of hemoglobin disappeared in the scan spectra after the red cells suspension of rabbit were added into gallic acid, tannic acid or some Xuesaitong injections, suggesting that the abnormal hemolysis induced by some Xuesaitong injections were similar to that induced by tannin. The contents of phenols and tannin were higher relatively in the Xuesaitong injections with stronger hemolytic ability. Conclusion HD50 detecting could reflect the hemolytic act