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目的观察抗柯萨奇B病毒性心肌炎胶囊(KCoxBJN)复方新制剂长期给药对大鼠的肝、肾功能是否产生影响,为临床安全用药提供实验依据。方法将Wistar大鼠随机分高、中、低3个剂量组和对照组,每组雌雄各20只,分别为KCoxBJN复方新制剂1.36,0.68,0.34 g/(kg·d)灌胃给药[相当于生药量13.6,6.8,3.4 g/(kg·d)],为人用有效剂量的40倍、20倍和10倍;对照组每天灌胃蒸馏水。连续灌胃给药90天及停药2周后,各组分别随机取雌雄各10只,尾静脉取血,测定血生化指标:包括总蛋白、白蛋白、球蛋白、白/球比例、总胆红素、谷丙转氨酶、谷草转氨酶、肌酐、尿素氮、尿酸、葡萄糖等。结果复方新制剂连续给药90天及停药2周后对大鼠血生化指标均未见异常,给药组各指标与对照组比较,均无明显差异。结论 KCoxBJN复方新制剂长期给药及停药恢复期对大鼠肝、肾功能没有造成明显的影响。
Objective To observe whether long-term administration of compound new KCoxBJN anti-CoxBJN can affect the liver and kidney function of rats and provide experimental evidence for clinical safety. Methods Wistar rats were randomly divided into high, middle and low dose groups and control group, 20 in each group, with KCoxBJN compound preparations of 1.36, 0.68 and 0.34 g / (kg · d), respectively. Equivalent to 13.6,6.8,3.4 g / (kg · d) of crude drug), 40 times, 20 times and 10 times of the effective dose for human. The control group was given distilled water daily. After continuous oral administration for 90 days and withdrawal for 2 weeks, 10 female and 10 female rats were randomly selected from each group. Blood was collected from tail vein to determine blood biochemical parameters including total protein, albumin, globulin, white / Bilirubin, alanine aminotransferase, aspartate aminotransferase, creatinine, urea nitrogen, uric acid, glucose and so on. Results The new prescription of compound was administered continuously for 90 days and stopped for 2 weeks. No abnormal blood biochemical indexes were observed in rats. There was no significant difference between the two groups in the indexes of the administration group and the control group. Conclusions The long-term administration of KCoxBJN compound new drug and the recovery period of drug withdrawal have no obvious effect on the liver and renal function in rats.