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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。
Objective To investigate the role of HD50 in the early warning of hemolytic reaction induced by compound saponin injection. Methods Rabbit ear vein blood was taken and physiological saline was added to prepare a suspension of rabbit erythrocytes with a volume fraction of 1.1%. The suspension of erythrocytes was added to different batches of different batches and different concentrations of saponin-containing compound injections from different manufacturers Injection or Shengmai injection), determination of hemolysis by spectrophotometry, concentration - hemolysis curve using Sigmaplot 10.0 software to calculate the HD50. According to “Chinese Pharmacopoeia” method of determination of 2 kinds of injection of phenols and tannin content. SPSS19.0 statistical software was used to analyze the correlation between the content of total phenols and tannin contained in Shenmai injection and HD50. Results Hebei Shenwei Pharmacopoeia produced six batch Shenmai HD50 injection there is a big difference, of which two batches injection at the maximum concentration less than half the hemolysis; the remaining four batches injection HD50 were 0.116,0.147,0.182 , 0.236 ml / ml, which was lower than that of Sichuan Lotion and two batches of injection (0.333 and 0.333 ml / ml, respectively) produced by the pharmaceutical industry. The lower HD50 Shenmai injection tannin content is higher. The Shengmai injection hemolytic activity, total phenols and tannin content produced by Shanxi Taihang Pharmaceutical Group were significantly higher than those of Shengmai Injection produced by Sichuan Yibin Pharmaceutical Factory (the former were 0.066 ml / ml, 1.298 mg / ml and 0.361 mg / ml, respectively) , The latter 0.079 ml / ml, 0.221 mg / ml, 0.029 mg / ml, respectively). Shenmai injection HD50 and total phenol content was significantly negatively correlated (r = -0.936, P = 0.009). Conclusion The HD50 assay can reflect the hemolytic activity of the saponin-containing compound injection and can be used for the early warning of hemolysis caused by these drugs.