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目的观察Beagle犬连续口服曼陀罗子提取物(MTL)的长期毒性反应。方法 Beagle犬24只,随机分为空白对照组及低、中、高剂量药物组,每组6只。低、中、高剂量药物组分别给予MTL 40,80,160 mg.kg-1.d-1,po,qd,连续3个月,空白对照组给予羧甲基纤维素钠。末次给药24 h每组处死4只犬,停药后恢复2周每组再处死2只犬,分别检测血液学、血液生化学等指标,测定脏器系数,进行系统尸检、脏器组织病理学检查。结果中、高剂量药物组犬给药后出现活动先增多后减少、扩瞳、口干、呕吐等症状;与空白对照组比较,中、高剂量药物组犬体质量明显降低,血小板计数、淋巴细胞数目、肌酸磷酸激酶明显升高,粒细胞数目明显降低;组织病理学检查无明显变化。结论 MTL连续口服给予Beagle犬3个月,对犬中枢神经系统、消化系统、血液系统、心脏有一定毒性。MTL对Beagle犬安全剂量不高于40 mg.kg-1.d-1(相当于生药388 mg.kg-1.d-1)。
Objective To observe the long-term toxicities of continuous oral administration of Mandrara extract (MTL) in Beagle dogs. Methods Twenty-four Beagle dogs were randomly divided into blank control group and low, medium and high dose groups of 6 rats in each group. The low, medium and high dose groups were given MTL 40,80,160 mg.kg-1.d-1, po, qd for 3 consecutive months. The blank control group was given sodium carboxymethylcellulose. Four dogs in each group were sacrificed 24 h after the last administration, and two dogs were sacrificed for 2 weeks after stopping the treatment. Two dogs were sacrificed and their hematology and blood biochemistry indexes were measured. The organ coefficient was measured, and autopsy, Physical examination. Results, high-dose drug group after administration of the first increase in activity and reduce, dilation, dry mouth, vomiting and other symptoms; compared with the blank control group, medium and high dose of drug group was significantly lower body weight, platelet count, lymph Cell number, creatine phosphokinase increased significantly, the number of granulocytes decreased significantly; histopathological examination showed no significant change. Conclusions MTL can be given to beagle dogs for 3 months orally. It has certain toxicity to the central nervous system, digestive system, hematological system and heart in dogs. MTL Beagle dogs safe dose of not more than 40 mg.kg-1.d-1 (equivalent to crude drug 388 mg.kg-1.d-1).