以斑马鱼为模型评价酒石酸长春瑞滨注射用乳剂与水针剂的毒性

发布时间：2018-04-26 23:02

本文选题：斑马鱼 + 长春瑞滨　；参考：《中国新药杂志》2016年24期

【摘要】：目的:以斑马鱼为模型,评价并比较酒石酸长春瑞滨注射用乳剂与市售长春瑞滨水针剂(诺维本)的骨髓毒性、肠道毒性的变化情况。方法:以不同浓度酒石酸长春瑞滨注射用乳剂与水针剂静脉注射给药,观察对斑马鱼红细胞和中性粒细胞数量的影响以及对肠蠕动的影响,比较2种剂型的毒性情况。结果:长春瑞滨乳剂和水针剂均抑制红细胞和中性粒细胞的形成,并呈现明显的剂量效应;相同剂量的乳剂对中性粒细胞形成的抑制作用显著低于水针剂(P0.001,P0.01);2种制剂对红细胞形成的抑制作用无统计学差异;与5%葡萄糖注射液组相比,长春瑞滨水针剂显著抑制肠蠕动(P0.01),并呈明显的剂量效应;相同剂量乳剂组对肠蠕动仅产生轻微的抑制作用(抑制率:4%~7%),与5%葡萄糖注射液组相比无明显差异。结论:与酒石酸长春瑞滨注射用水针剂相比,乳剂的骨髓抑制毒性和肠道毒性较低,提示乳剂具有降低长春瑞滨临床不良反应的优势。
[Abstract]:Objective: to evaluate and compare the changes of bone marrow toxicity and intestinal toxicity between vinorelbine tartrate emulsion and vinorelbine injection (Novibene). Methods: the effects of different concentrations of vinorelbine tartrate emulsion and water injection on the number of erythrocytes and neutrophils in zebrafish and the intestinal peristalsis were observed and the toxicity of the two formulations was compared. Results: both vinorelbine emulsion and water injection inhibited the formation of erythrocytes and neutrophils in a dose-dependent manner. The inhibitory effect of the same dose of emulsion on neutrophil formation was significantly lower than that of water injection P0.001, P0.01P0.01P0. 01, and compared with the 5% glucose injection group. Vinorelbine water injection significantly inhibited intestinal peristalsis (P0.01), and the same dose emulsion group had only slight inhibition (inhibition rate: 4% and 7%), and there was no significant difference compared with 5% glucose injection group. Conclusion: compared with vinorelbine tartrate injection, the bone marrow inhibition toxicity and intestinal toxicity of the emulsion are lower, suggesting that the emulsion has the advantage of reducing the clinical adverse reaction of vinorelbine.
【作者单位】：浙江省药品化妆品审评中心;杭州环特生物科技股份有限公司;民生(天津)药物研究有限公司;
【基金】：国家“重大新药创制”科技重大专项资助项目(2014ZX09201003-004) 天津市抗癌重大专项资助项目(12ZCDZSY00700) 浙江省科技重大专项资助项目(2014C03009)
【分类号】：R965

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