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目的:对检测葛根素注射液溶血反应的改良溶血检查法进行评价。方法:取Beagle犬24只(体重6～8kg,雌雄各半),制备50%和2%新鲜Beagle犬红细胞悬液。应用中国药典2005年版记载的标准溶血检查法和本实验室建立的改良溶血检查法(其特点为增加葛根素浓度和延长孵育时间),观察Beagle犬红细胞在体外经不同浓度葛根素注射液和(或)丙二醇作用后的溶血反应,分别以生理盐水和蒸馏水为阴性和阳性对照计算溶血发生率并对结果进行统计学分析。结果:用药典标准方法,丙二醇浓度为3.3～16.7ml/L、葛根素浓度为0.33～1.67mg/ml,观察3h,Beagle犬红细胞未出现溶血;而采用改良方法,丙二醇浓度为100ml/L时发现4只犬红细胞溶血,溶血发生率为16.6%,与阴性对照组比较差异有统计学意义(P<0.05);丙二醇浓度为100ml/L、葛根素浓度为10mg/ml时,16只犬红细胞出现溶血,溶血发生率为66.7%,与阴性对照管比较差异有统计学意义(P<0.01)。相关性分析显示,溶血发生率与丙二醇浓度不存在相关性(r=0.571,P>0.05);与葛根素浓度存在显著相关性(r=0.952,P<0.01)。结论:改良溶血检查法似比常规溶血检查法能更有效地检测葛根素注射液所致的溶血反应。
OBJECTIVE: To evaluate the modified hemolysis test for detecting hemolysis of puerarin injection. Methods: Twenty-four Beagle dogs (weighing 6 ~ 8kg, male and female) were used to prepare 50% and 2% fresh Beagle dog erythrocytes suspension. Application of Chinese Pharmacopoeia 2005 edition of the standard hemolysis test method and the laboratory established improved hemolysis test (which is characterized by increased concentrations of puerarin and prolonged incubation time), observed Beagle dog red blood cells in vitro by different concentrations of puerarin injection and ( Or) propanediol after hemolysis reaction, saline and distilled water were negative and positive control hemolysis incidence and the results were statistically analyzed. Results: The pharmacopoeia standard method, propanediol concentration of 3.3 ~ 16.7ml / L, puerarin concentration of 0.33 ~ 1.67mg / ml, observed 3h, Beagle dog erythrocyte did not hemolysis; and using improved methods, the concentration of propylene glycol 100ml / L The hemolysis rate of 4 dogs was found to be 16.6%, which was significantly different from that of the negative control group (P <0.05). When the concentration of propylene glycol was 100ml / L and the concentration of puerarin was 10mg / ml, 16 dogs’ red blood cells Hemolysis occurred, the incidence of hemolysis was 66.7%, compared with the negative control tube was statistically significant (P <0.01). Correlation analysis showed that there was no correlation between the incidence of hemolysis and the concentration of propylene glycol (r = 0.571, P> 0.05), but significant correlation with the concentration of puerarin (r = 0.952, P <0.01). Conclusion: The modified hemolytic test may be more effective than the conventional hemolysis test puerarin injection induced hemolytic reaction.