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目的观察和解方颗粒剂对大鼠的长期毒性反应,评价该药物临床应用的安全性。方法将80只Wistar大鼠随机分为和解方高、中、低剂量组和对照组,每组20只,分别给予50、25、12.5g/kg和解方颗粒剂和等容积蒸馏水,给药体积为20ml/(kg·d),每日2次灌服,连续灌服12周。期间测量大鼠体重,观察一般状况。用药12周末,各组处死10只大鼠,检测血常规、血液生化,计算脏器系数并行脏器组织病理学检查。停药2周后,处死各组剩余大鼠,进行上述检测。结果各组大鼠体重增长正常,一般状况良好,实验组与对照组比较,实验组间比较脏器系数、血常规和血液生化学指标均无显著性差异(P﹥0.05),脏器组织未发现因药物导致的病理学改变。结论长期应用和解方颗粒剂对大鼠无明显毒性作用,可安全用于临床。
OBJECTIVE To observe the long-term toxicological response of Hefang Granule to rats and to evaluate the safety of the drug in clinical application. Methods 80 Wistar rats were randomly divided into high, medium and low dose groups and control group, with 20 rats in each group. The rats were treated with 50, 25, 12.5g / 20ml / (kg · d), 2 times a day orally, continuous infusion of 12 weeks. During the measurement of body weight, observe the general situation. At the end of the 12th week, 10 rats in each group were sacrificed, blood routine and blood biochemistry were measured, and histopathological examination of organs was performed. Two weeks after discontinuation, the remaining rats in each group were killed and the above tests were performed. Results The weight gain of rats in each group was normal and the general condition was good. There was no significant difference between the experimental group and the control group in organ coefficient, blood routine and blood biochemical indexes (P> 0.05) Found by the pathological changes caused by the drug. Conclusion Long-term use of reconciliation Fang Granules no significant toxic effects on rats, safe for clinical use.