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华泰八宝丹在10只NIH小鼠,以143.2g(成药)/kg·d的剂量(相当成人临床有效量的858倍)灌胃,观察9天,未见不良反应,全部存活,表明本品符合纯中药制剂的急性毒性试验的安全要求。长期毒性试验表明,华泰八宝丹按30、12和6倍;临床有效量,每天分别给三组SD大鼠(每组20只)灌胃,连续90天,对照组灌同容积的水。结果各组大鼠活动正常,体重增加,血常规、肝肾功能与对照组比较,无明显差异;主要脏器(心、肝、肾、肺和肾上腺)切片镜检均未发现与用药有关的病理异常变化。
Huatai Babao Dan gavages in 10 NIH mice at a dose of 143.2 g / kg · d (858 times the clinically effective dose of a comparable adult) for 9 days without adverse reactions and all survived This product is in line with the safety requirements of acute toxicity test of pure Chinese medicine preparation. Long-term toxicity tests showed that Huatai Babao Dan was administered 30, 12 and 6 times daily in a clinically effective dose. Three groups of SD rats (20 in each group) were given gavage daily for 90 consecutive days. The control group was filled with the same volume of water. Results The activities of rats in each group were normal, the body weight was increased, blood routine, liver and kidney function were not significantly different from those in the control group. No significant correlation was found with the biopsies of the major organs (heart, liver, kidney, lung and adrenal gland) Pathological changes.