目的 盐酸多柔比星溶液为红色澄明液体，不适宜采用常规的肉眼观察法进行溶血性评价，需采用多种方法综合评价有色注射液盐酸多柔比星的体外溶血作用，为临床用药安全性提供参考。方法 采用常规家兔红细胞为实验对象，盐酸多柔比星溶液高、低质量浓度为4.0、2.0 mg/mL，分别采用血球计数法、酶标仪直接比色法和间接比色法综合评价注射用盐酸多柔比星的体外溶血作用。结果 3种不同测定方法的评价结果一致：盐酸多柔比星溶液4.0 mg/mL质量浓度下各管溶血率均远远大于5%，即发生严重溶血；2.0 mg/mL质量浓度下仅加样0.1 mL管（按试管中药物浓度折算该管相当于0.4 mg/mL药物浓度下加样0.5 mL）无溶血发生，其他各管溶血率均远远大于5%，即发生严重溶血。结论 临床直接将2.0 mg/mL的盐酸多柔比星溶液进行静脉推注发生溶血的可能性较大，建议将盐酸多柔比星溶液适当稀释后（终质量浓度不超过0.4 mg/mL）静脉给药安全性更好。

Objective The visual inspection method were not appropriate to perform a hemolysis evaluation for colored injection like doxorubicin hydrochloride, this article adopted three methods to evaluate the hemolysis test of doxorubicin hydrochloride in vitro and provide reference for clinical drug safety. Methods Using rabbit erythrocytes as experimental object, the durg concentration 4.0 and 2.0 mg/mL was chosen which range of clinical concentration and preclinical safety evaluation concentration, to evaluate the hemolysis test of doxorubicin hydrochloride injection with blood analyzer test, direct colorimetric assay, and indirect colorimetric assay. Results The evaluation results of three different methods were very consistent. The tube's hemolysis rate of 4.0 mg/mL dose was far greater than 5%, which means serious hemolysis; Only 0.1 mL tube of 2.0 mg/mL dose (according to the drug concentration equal to 0.5 mL tube of 0.4 mg/mL drug concentration) without hemolysis occurring, the other tubes' hemolysis rates were far greater than 5%, which means serious hemolysis. Conclusion The hemolysis phenomenon may occur when 2.0 mg/mL dose of doxorubicin hydrochloride solution for iv injection is used in clinic and dilution (final concentration not more than 0.4 mg/mL) is recommended.