【摘要】 目的:观察珍黄养颜胶囊对大鼠的长期毒性反应,确定本品安全用药剂量。方法:将大鼠按性别和体重随机分成高、中、低剂量组(分别为2.93、1.47、0.74 g生药·kg-1)及对照组,连续灌胃给药6个月及停药观察1个月,分期检查大鼠体重、进食量、血常规、血液生化学、重要脏器指数及组织病理学变化。结果:与对照组比较,给药3个月后,高剂量组大鼠进食量降低;高、中剂量组体重增长缓慢;高剂量雌性组肌酸激酶(CK)略升高,肾脏指数略升高,肺脏、胸腺指数稍降低。给药6个月后,高、中剂量组血小板(PLT)、天门冬氨酸氨基转移酶(AST)、碱性磷酸酶(ALP)升高,平均红细胞体积(MCV)降低。停药1个月后,上述部分指标可恢复正常;高、中剂量组MCV值降低,高剂量组PLT值升高。结论:珍黄养颜胶囊0.74 g·kg-1剂量组大鼠各项检查均未见明显毒性反应。1.47 g·kg-1剂量组出现轻微毒性反应。开始出现明显毒性剂量为2.93 g·kg-1,主要表现为轻微可逆性肝毒性及血小板升高、平均红细胞体积降低。此试验提示本品长期用药安全剂量应低于0.74 g·kg-1。更多还原

【Abstract】 Objective: To study the chronic toxic reaction of Zhenhuangyangyan Capsulesls( 珍黄养颜胶囊, ZYC) in rats and define the safe dose for its clinical usage. Methods: Rats were randomly divided into four groups, high, medium, low dose(re-spectively 2.93, 1.47 and 0.74 g·kg-1) and the control group. The drug groups were orally ravaged continuously with ZYC for 6months and withdrawal restorative observation 1 month. The changes of the rats’ common condition, body weight, hematology blood biochemistry, coefficient of important organs and histological were detected during the dosing and recovery period. Results:Compared with normal control group, Dosing after 3 months, ZYC of high dose decreased the food intake. The body weights of rats grew slowly in high and medium dose. The high dose increased creatine kinase(CK) and kidney index and decreased lung index and thymus index of female rats. 6 months later, the values of platelets(PLT), aspartate aminotransferase(AST) and alka-line phosphates(ALP) increased and the mean corpuscular volume(MCV) decreased of high and medium dose. Drug withdrawal 1month later, some of the index mentioned above has no difference, but the MCV of high、medium dose decreased and the PLT increased of high dose. Conclusions: There was no obvious toxic reaction in 0.74 g·kg-1of ZYC; 1.47 g·kg-1group have slight toxic reaction; obvious toxic began to appear dose at 2.93 g·kg-1, mainly cause slight reversible hepatotoxicity and platelet increased and the mean corpuscular volume irreversible decreased. This test indicates that the safe dose of ZYC’ long-term medi-cation should lower than 0.74 g·kg-1daily.更多还原