中文摘要：

目的探讨半数溶血量（HD50）在含皂苷类中药复方注射剂致溶血反应预警中的作用。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%的兔红细胞悬液,将红细胞悬液加入产自不同厂家的不同批号和不同浓度的含皂苷类中药复方注射剂（参麦注射液或生脉注射液）,采用分光光度法测定溶血度,用Sigmaplot 10.0软件制作浓度-溶血度关系曲线,计算HD50。按照《中国药典》的方法测定2种注射液中酚类及鞣质含量。采用SPSS19.0统计软件对参麦注射液所含总酚、鞣质含量与HD50的相关性进行分析。结果河北神威药业生产的6个批号参麦注射液HD50有较大差异,其中2个批号注射液在最大浓度时未达半数溶血;余4个批号注射液的HD50分别为0.116、0.147、0.182、0.236 ml/ml,低于四川升和制药生产的2个批号注射液（分别为0.333、0.363 ml/ml）。HD50较低的参麦注射液鞣质含量较高。山西太行药业生产的生脉注射液溶血活性、总酚及鞣质含量均明显高于四川宜宾制药生产的生脉注射液（前者分别为0.066 ml/ml、1.298 mg/ml、0.361 mg/ml,后者分别为0.079ml/ml、0.221 mg/ml、0.029 mg/ml）。参麦注射液HD50与总酚含量呈显著负相关（r=-0.936,P=0.009）。结论 HD50测定可以反映含皂苷类中药复方注射剂的溶血活性,可用于该类药物所致溶血的预警。

英文摘要：

Objective To explore the effects of half hemolytic degree （ HDs0 ） detection on alerting hemolytic reactions caused by saponin-containing traditional Chinese medicine compound injection. 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 saponin-containing traditional Chinese medicine compound injection （Shenmai injection or Shengmai injection） with different batch numbers and different concentrations produced by different pharmaceutical factories. The HDs0 was detected using spectrophotometry, the concentration-hemolytic degree curve was performed by Sigmaplot 10.0 software and HDs0 was calculated. The contents of total phenols and tannins in the two kinds of above-mentioned injections were measured according to the method in Chinese Pharmacopoeia. The correlation between contents of total phenols, tannins and HDs0 was analyzed using SPSS 19.0 software. Results The differences in HDs0 were significant among six batches of Shenmai injection produced by Hebei Shenwei pharmaceutical factory. Among them, two batches of injection failed to reach the half hemolysis at the highest concentration, and the HDs0 of other four batches of injection （0. 116, 0. 147, 0. 182 and 0. 236 nd/ml ） were lower than those of two batches of injection （0. 333, 0. 363 ml/ml） produced by SichuanShenghe pharmaceutical factory. The Shenmai injections with lower HDs0 had higher content of tannins. The hemolytic activity, the contents of total phenols and tannins in Shengmai injection produced by Shanxi Taihang pharmaceutical factory were higher than those in Shengmai injection produced by Sichuan Yibin pharmaceutical factory（the former were 0.066 ml/ml, 1. 298 mg/ml and 0.361 mg/ml, the latter were 0. 079 ml/ml, 0.221 mg/ml, and 0.029 mg/ml, respectively）. HDs0 and content of total phenols in Shenmai injection showed a significant negative correlation （r=- 0.936, P = 0.00