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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Sigmaplot 10.0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。
Objective To investigate the role of half-value hemolysis (HD50) in early warning of hemolysis-induced adverse reactions induced by traditional Chinese medicine injection and analyze the causes of abnormal hemolysis. Methods Rabbit ear vein blood was taken and physiological saline was added to prepare a suspension of erythrocytes with a volume fraction of 1.1%. Xuesaitong injection with different batches of different batches was added into the rabbits and the hemolytic degree was measured by spectrophotometry. Sigmaplot 10.0 Software concentration hemolytic relationship curve, calculate the amount of hemolytic half. The hemoglobin full-wavelength scanning was performed on the Xelyseed injection, tannic acid and gallic acid in rabbit erythrocyte solution, respectively, and the maximum absorption wavelength was analyzed. According to “Chinese Pharmacopoeia” method of Xuesaitong injection of phenols and tannins were detected. Results Xuesaitong injection can cause normal hemolysis (ruptured erythrocytes, red solution in the upper layer) and abnormal hemolysis (the color of the supernatant changes from bright red to brown or reddish brown). Different manufacturers have significant differences between the injection of HD50, the same manufacturer of different lot injection HD50 also have a greater difference between the highest and lowest HD50 can be a difference of 4 to 60 times. The addition of gallic acid, tannic acid and partial addition of Xuesaitong injection of rabbit erythrocyte solution hemoglobin wavelength scans showed disappearance of the characteristic absorption peak of hemoglobin, suggesting that Xuesaitong injection of abnormal hemolytic phenomenon and tannin composition caused by similar. The hemolytic activity was significantly enhanced injection of phenols and tannins content is relatively high. Conclusion HD50 can reflect the hemolytic activity of traditional Chinese medicine injection and can be used for early warning of abnormal hemolysis. Abnormal hemolysis caused by injection may be related to the higher content of phenols and tannins.