摘要
目的:研究中药制剂怡欣乐口服液(YXL)的安全性评价和升高外周白细胞的作用机理。方法:按照新药审批办法有关规定,分别运用小鼠和大鼠进行了YXL急性和长期毒性实验;分别采用环磷酰胺、苯中毒及60Co-γ辐射等因素诱发小鼠外周血白细胞总数低下运动模型,观察YXL对模型小鼠外周血白细胞数的影响。结果:以最大浓度、最大体积的YXL给小鼠口服灌胃,一天1次,最大耐受量为35.6 g/kg。大鼠给药60 d后,高剂量组白蛋白,高、中剂量组总胆红素明显下降,与对照组比较有显著性差异;高、中剂量组的总胆固醇有下降趋势,但与对照组比较无显著性差异;停止给药15 d,各项指标均在正常值范围内与对照组比较无差异;给予YXL3g/kg、2g/kg和1g/kg 3个剂量的药物干预后,3个给药剂量均能提高以上3种诱因所致小鼠外周血白细胞总数低下。结论:YXL以灌胃给药测得最大耐受量为35.6 g.kg-1,接近临床剂量的200倍;长期毒性的各项指标均在正常值范围内与对照组比较无差异;YXL具有明显升高血白细胞作用。本实验YXL临床运用提供了安全性评价依据和药效学方面的实验依据。
Objective：To evaluate the safety of YXL Oral Liquid and to study its mechanism in increasing the in peripheral blood.Methods：According to the regulation for New Drug application,mice and rats were applied for the acute and long term toxic experiment;dynamic low peripheral blood WBC mouse and rat model were build up by toxic treatment of Cyclophosphamide,benzene,and the 60Co-γray irradiation,then the effect on WBC in peripheral blood were observed.Results：YXL Oral Liquid was feed to the mice by gastric perfusion with the maximum concentration and volume,once per day,maximally tolerated dose is 35.6 g/kg.The albumin in the high dosage group and the total Bilirubin in the high and medium dosage decreased obviously in rat after the drug was feed for 60 days,which had obvious difference with the control group.The total cholesterol in the high and medium had the trend of decrease,but didn＇t have obvious difference with the control group.The treatment of all three different dosage,YXL3g/kg、2g/kg and 1g/kg could improve the low WBC in Peripheral Blood of the 3 mouse models.Conclusion：The maximum tolerance dosage of YXL Oral Liquid by gastric perfusion is 35.6 g·kg^-1,which was about 200 times than the clinical dosage.All the indexes for the long term toxicity are in the normal range which had no difference compared with the control group.YXL has an obvious effect in increasing the amount of WBC.This research provided experimental evidence for the safety evaluation and pharmacodynamics in the clinical application of YXL.
出处
《黑龙江医药》
CAS
2011年第1期61-63,共3页
Heilongjiang Medicine journal
