论文部分内容阅读
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/m L,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/m L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/m L质量浓度下仅加样0.1 m L管(按试管中药物浓度折算该管相当于0.4 mg/m L药物浓度下加样0.5 m L)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/m L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0.4mg/m L)静脉给药安全性更好。
The purpose of the doxorubicin hydrochloride solution is red clear liquid, it is not suitable for conventional hemolytic evaluation with the naked eye observation method, a variety of methods need comprehensive evaluation of colored injection of doxorubicin hydrochloride in vitro hemolysis, for clinical drug safety for reference. Methods Routine rabbit erythrocytes were used as experimental subjects. The high and low concentration of doxorubicin hydrochloride solution were 4.0 and 2.0 mg / mL, respectively. The blood count, microplate reader and indirect colorimetric method In vitro hemolysis of doxorubicin hydrochloride for injection. Results The results of three different assays were consistent: the hemolysis rates of each tube were much greater than 5% at the concentration of 4.0 mg / mL in the doxorubicin hydrochloride solution, which resulted in severe hemolysis; at the concentration of 2.0 mg / mL Pipette 0.1 ml tube (calculated according to the concentration of the test tube in the tube equivalent to 0.4 mg / m L drug concentration 0.5 ml) without hemolysis occurred, the other tube hemolysis rates were much greater than 5%, that is serious Hemolysis. CONCLUSION: It is highly probable that intravenous injection of 2.0 mg / m L doxorubicin will result in hemolysis. Clinically, it is recommended that doxorubicin hydrochloride solution be properly diluted (the final concentration should not exceed 0.4 mg / m L ) Intravenous administration of safety better.