摘要
目的:预测扶正抗毒胶囊可能引起的临床不良反应,包括不良反应的性质、程度、剂量-反应和时间-反应关系等;推测扶正抗毒胶囊反复给药的临床毒性靶器官或靶组织;预测临床试验用药的安全剂量范围,提示临床试验中需重点监测的指标。方法:扶正抗毒胶囊大鼠连续灌胃给药6个月,观察药物对大鼠体重、血液学指标、血清生物化学指标以及主要脏器指数和病理组织学的影响。结果:扶正抗毒胶囊高、中、低剂量连续灌胃给药6个月未发现明显毒性反应。给药组高剂量大鼠体重增长有所减慢;少量血清生化和血液学指标与对照组比较差异有显著性意义,提示临床试验时应关注患者的相关功能及实验室指标检查。结论:试验结果表明扶正抗毒胶囊高、中、低剂量连续灌胃给药6个月对大鼠无明显毒性作用。
Objective: To predict the clinical adverse reactions of Fuzheng Antitoxic Capsule,including its cause,nature,extent and relationship between dose - response and time - response and infer the clinical toxicity target organ or tissue of repeated administration of the drug and conduct clinical trials with safe dose range and propose key monitoring indicators in clinical trials. Methods: Rats by intragastric administration of the drug for 6 months were observed for their weight,hematological parameters,serum biochemical indices and organ index and histopathological effects. Results: The rats given by high,medium and low dose intragastric administration of the drug for 6 continuous months showed no obvious toxic reaction. The rats given the high dose of the drug put on weight. The comparative difference of a small amount of serum biochemical and hematological indices with that of the control group had significance,and suggested that the clinical trials should focus on the correlation function of patients and the index of laboratory examination. Conclusion: The results show that the high,medium and low dose intragastric administration of Fuzheng Antitoxic Capsule for continuous 6 months show no obvious toxicity on the rats.
出处
《云南中医中药杂志》
2013年第4期50-51,89,共2页
Yunnan Journal of Traditional Chinese Medicine and Materia Medica
关键词
扶正抗毒胶囊
长期毒性
试验
Fuzheng Antitoxic Capsule,long - term toxicity,test
