目的 鹽酸多柔比星溶液為紅色澄明液體，不適宜采用常規(guī)的肉眼觀察法進行溶血性評價，需采用多種方法綜合評價有色注射液鹽酸多柔比星的體外溶血作用，為臨床用藥安全性提供參考。方法 采用常規(guī)家兔紅細(xì)胞為實驗對象，鹽酸多柔比星溶液高、低質(zhì)量濃度為4.0、2.0 mg/mL，分別采用血球計數(shù)法、酶標(biāo)儀直接比色法和間接比色法綜合評價注射用鹽酸多柔比星的體外溶血作用。結(jié)果 3種不同測定方法的評價結(jié)果一致：鹽酸多柔比星溶液4.0 mg/mL質(zhì)量濃度下各管溶血率均遠(yuǎn)遠(yuǎn)大于5%，即發(fā)生嚴(yán)重溶血；2.0 mg/mL質(zhì)量濃度下僅加樣0.1 mL管（按試管中藥物濃度折算該管相當(dāng)于0.4 mg/mL藥物濃度下加樣0.5 mL）無溶血發(fā)生，其他各管溶血率均遠(yuǎn)遠(yuǎn)大于5%，即發(fā)生嚴(yán)重溶血。結(jié)論 臨床直接將2.0 mg/mL的鹽酸多柔比星溶液進行靜脈推注發(fā)生溶血的可能性較大，建議將鹽酸多柔比星溶液適當(dāng)稀釋后（終質(zhì)量濃度不超過0.4 mg/mL）靜脈給藥安全性更好。

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.