多西他赛注射液对血管刺激性与溶血性试验研究

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。

Study of Docetaxel Injection on Vascular Irritation and Hemolysis Test

Objective： To observe whether docetaxel injection has vascular stimulation, hemolyzation and agglutination. Methods：The vascular stimulation assay of docetaxel injection on rabbit at the dose of high and low group, qd for 5days. Before injection and after administration of 48h and 96h, animals and the ear local vascular stimulation of injection site was the naked eye observation, drug withdrawal after 96h histologic examination for the injection site. In vitro effects of dif ferent concentration of docetaxel in 0. 1 - 0. 5 ml in 2% rabbit red cells suspension placed 15rain ~ 4 h,observed on rabbit erythrocyte suspensions of hemolysis and red cell aggregation without. Results：It was showed that the docetaxel injection had no vascular irritation and injury effect on rabbit vascular endothelial cell. No evidences of hemolyzation and aggregation on rab- bit erythrocyte in vitro. Conclusion：The test results of docetaxel injection show there are no vascular stimulation on rabbit vas cular endothelial cell and no hemolyzation or agglutination on rabbit red blood cells in vitro. These results of preparation safety will just fit the new drugs application reguirements.