不同浓度注射用盐酸米托蒽醌的体外溶血性试验研究

Study on the Hemolysis of Different Concentrations of Mitoxantrone Hydrochloride for Injection in vitro

目的:研究不同浓度注射用盐酸米托蒽醌在家兔红细胞悬液中的体外溶血性。方法:选用家兔红细胞作为受试物,加入注射用盐酸米托蒽醌临床推荐用量0.23mg/ml及其系列稀释质量浓度0.115、0.058、0.029mg/ml,肉眼和显微镜下观察3h内的溶血和红细胞凝聚情况,545nm波长处检测3h时吸光度来验证溶血情况。另设阴性对照(氯化钠注射液)组和阳性对照(纯化水)组进行比较。结果:3h内肉眼、显微镜下观察和吸光度检测结果表明,阴性对照组未见溶血和红细胞凝聚;阳性对照组发生明显溶血,无红细胞凝聚;注射用盐酸米托蒽醌质量浓度为0.23～0.058mg/ml时均发生溶血,但未见明显红细胞凝聚,0.029mg/ml时未见溶血和红细胞凝聚。结论:注射用盐酸米托蒽醌临床推荐用量较高,在使用中可能发生溶血,建议降低临床用量。

OBJECTIVE：To study the hemolysis of different concentrations of Mitoxantrone hydrochloride for injection in red blood cells of rabbits in vitro.METHODS：Red blood cells of rabbit were chosen as the subject.Clinical recommended dosage of Mitoxantrone hydrochloride for injection was 0.23 mg/ml and diluted to 0.115,0.058 and 0.029 mg/ml.The hemolysis and condensation reaction were observed by naked-eye and microscope within 3 h,and the absorbance was detected at 545 nm in 3 h.They were compared with negative control group（Sodium chloride injection）and positive control group（purified water）.RESULTS：Results of naked-eye and microscope observation and absorbance determination in 3 h showed that no hemolysis and condensation reaction were found in negative control group;significant hemolysis was found in positive control group without condensation reaction;hemolysis occurred but no significant condensation reaction was found when the concentrations of Mitoxantrone hydrochloride for injection were 0.23-0.058 mg/ml.When the concentration of Mitoxantrone hydrochloride for injection was 0.029 mg/ml,above reation were not found.CONCLUSIONS：It is suggested to decrease clinical recommended dosage of Mitoxantrone hydrochloride for injection,because the high dosage of the injection may result in hemolysis.