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目的:观察多西他赛注射液是否具有血管刺激性、溶血反应。方法:家兔耳缘静脉注射多西他赛注射液高、低剂量组,每日一次,连续5次,每天给药前及最后给药后48h、96h对动物和注射部位进行肉眼观察耳局部血管刺激情况,停药96h后对注射部位做病理组织学检查;体外不同浓度的多西他赛注射液0.1～0.5ml在2%兔红细胞混悬液中放置15min～4h,观察对兔红细胞悬液的溶血作用及有无红细胞凝聚作用。结果:多西他赛注射液对家兔血管内皮没有损伤和刺激作用;对兔红细胞没有致溶血作用和凝聚作用。结论:多西他赛注射液用药血管没有刺激性反应,无溶血及红细胞凝聚现象。制剂有关安全性检测结果符合新药申报要求。
Objective: To observe whether docetaxel injection has vascular irritation and hemolysis. Methods: The rabbits were injected intravenously with high and low doses of docetaxel injection once daily for 5 consecutive days. The animals were given the macroscopic observation at the 48h and 96h after the last administration, Vascular stimulation, stopping 96h after the injection site histopathological examination; different concentrations of docetaxel 0.1-0.5ml injection in 2% rabbit erythrocyte suspension for 15min ~ 4h, observe the rabbit erythrocyte suspension Hemolysis and the role of red blood cells without coagulation. RESULTS: Docetaxel injection had no damage and irritation on rabbit vascular endothelium; it did not cause hemolysis and agglutination on rabbit erythrocytes. Conclusion: Docetaxel injection did not stimulate blood vessels with irritating reaction, no hemolysis and erythrocyte aggregation phenomenon. Preparation of the relevant safety test results in line with new drug requirements.