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目的:观察金克痤胶囊浸膏粉连续的反复给药后对大鼠的长期毒性反应及其性质、程度、发展和恢复情况;确定毒性作用的靶器官及其损害的可逆性;预测其可能的对人体产生的不良反应;初步估计供试品不出现毒副反应的剂量水平。方法:将160只SD大鼠,随机分为溶剂对照组及供试品高、中、低3个剂量组,每组40只,雌雄各半,分别给予0.5%羧甲基纤维素钠溶液、金克痤胶囊浸膏粉2.5,1.25和0.44 g·kg-1(相当于临床拟用剂量的113.6倍,56.8倍和20倍),连续灌胃给药3个月,观察动物的一般状况、体质量、摄食量;给药中期、末期和恢复期后分别采血测定血常规、凝血酶原时间和血清生化指标,并对每只大鼠进行系统解剖,进行脏器称重,计算脏器系数及主要脏器的组织病理学检查。结果:试验过程中,各组动物行为活动、外观体征、粪便颜色、性状等一般状况均正常,均未见与供试品有关的中毒症状及死亡。供试品组与对照组相比,大鼠的体质量、摄食量、血常规、血清生化、主要脏器重量、脏器系数等及组织病理学检查指标均未见与供试品相关的改变。结论:本实验室条件下,大鼠经口灌胃给予金克痤胶囊浸膏粉,未观察到与供试品相关的毒性反应,供试品对大鼠的无可见有害作用剂量(NOAEL)为2.5 g·kg-1剂量(相当于临床拟用剂量的113.6倍,临床等效剂量的18.4倍)。
OBJECTIVE: To observe the long-term toxicity and its nature, extent, development and recovery of Jinke Capsule extract powder after repeated repeated administration in rats. To determine the target organ of toxic effect and the reversibility of its damage, and to predict its possible Of the adverse reactions to the human body; preliminary estimates for the test dose does not appear toxic side effects. Methods: 160 SD rats were randomly divided into solvent control group and high, medium and low doses of the test group of 40, each male and female, respectively, were given 0.5% sodium carboxymethyl cellulose solution, Jinke acne capsule extract powder 2.5,1.25 and 0.44 g · kg-1 (equivalent to the clinical dose of 113.6 times, 56.8 times and 20 times), continuous gavage for 3 months to observe the general condition of animals, Body weight and food intake were measured. Blood samples, prothrombin time, and serum biochemical parameters were determined by blood sampling in the middle, the end of the administration and the recovery period respectively. Systematic anatomy was performed on each rat to weigh organ and calculate organ coefficient Histopathological examination of major organs. Results: During the experiment, the general behavior of animal behavior, appearance and appearance, stool color and traits in all groups were normal. No symptoms and death related to the test substance were found. Compared with the control group, there was no change in the body weight, food intake, blood routine, serum biochemical, major organ weight, organ coefficient and histopathological examination in the test group and the control group . Conclusions: Under the laboratory conditions, rats were orally gavaged with Jinke acne capsule extract powder, no toxic reaction was observed with the test sample, and no visible adverse effect dose (NOAEL) 2.5 g · kg-1 dose (equivalent to 113.6 times the clinical quasi-dose, equivalent to 18.4 times the clinical dose).