灯银脑通胶囊在大鼠长期毒性试验中的安全性评价  

Safety evaluation of Dengyin Naotong capsule in long-term toxicity test in rats

作　　者：肖震心[1] 李洪梅[2] XIAO Zhen-xin;LI Hong-mei(Department of Acupuncture and Encephalopathy,Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300151,China)

机构地区：[1]天津中医药大学第二附属医院脑病针灸科,300151 [2]中国中医科学院中药研究所中药新药研发中心,100029

出　　处：《中国实用医药》2023年第14期166-171,共6页China Practical Medicine

摘　　要：目的探究灯银脑通胶囊在大鼠长期毒性试验中的毒性反应,对其安全性进行评价。方法将160只大鼠随机分为四组,分别为灯银脑通胶囊提取物高剂量组(10.2 g生药/kg)、中剂量组(5.1 g生药/kg)、低剂量组(2.55 g生药/kg)和对照组(等容积的蒸馏水),每组40只,雌雄各半,自由取食及摄水。给药26周及恢复期,观察大鼠的一般状况、血液学指标、血液生化指标及主要脏器病理组织学情况。结果给药26周,低剂量组淋巴细胞百分比(LYM%)低于对照组、中性粒细胞百分比(NEUT%)高于对照组,差异具有统计学意义(P<0.05)。恢复期,低剂量组红细胞平均血红蛋白浓度(MCHC)含量低于对照组(仅具有统计学意义,不具有生物学意义),中剂量组嗜酸性粒细胞百分比(EOS%)低于对照组,高、低剂量组嗜碱性粒细胞百分比(BASO%)低于对照组,差异具有统计学意义(P<0.05)。给药26周,低剂量组天门冬氨酸氨基转换酶(AST)水平低于对照组,高、中剂量组尿素氮(BUN)水平低于对照组,高、中、低剂量组总胆红素(TBIL)水平低于对照组,高、中、低剂量组钠离子(Na^(+))浓度高于对照组(仅具有统计学意义,不具有生物学意义),中剂量组钾离子(K^(+))浓度低于对照组,中、低剂量组氯离子(Cl-)浓度高于对照组(仅具有统计学意义,不具有生物学意义),低剂量组肌酸激酶(CK)水平低于对照组,差异具有统计学意义(P<0.05或<0.01)。恢复期,高、中剂量组BUN水平低于对照组,中剂量组肌酐(CRE)水平低于对照组,中剂量组葡萄糖(GLU)水平低于对照组,中剂量组甘油三酯(TG)水平高于对照组,高剂量组Na^(+)浓度高于对照组,中、低剂量组CK水平低于对照组,差异具有统计学意义(P<0.05或<0.01)。给药26周,低剂量组脾重量指数高于对照组,差异具有统计学意义(P<0.05),脾脏在镜下未发现病理形态学改变。病理组织学检查未发现由于药物所引起的病理形态学方Objective To investigate the toxicity of Dengyin Naotong capsule in long-term toxicity test in rats and evaluate its safety.Methods 160 rats were randomly divided into four groups:Dengyin Naotong capsule extract high-dose group(10.2 g crude drug/kg),medium-dose group(5.1 g crude drug/kg),low-dose group(2.55 g crude drug/kg)and control group(equal volume of distilled water),with 40 rats in each group,half male and half female,free to eat and drink.The general condition,hematological indexes,blood biochemical indexes and pathological histology of the main organs of the rats were observed during 26 weeks of administration and recovery period.Results After 26 weeks of administration,the percentage of lymphocyte(LYM%)in lowdose group was lower than that in control group,and the percentage of neutrophil(NEUT%)was higher than that in control group.The differences were statistically significant(P<0.05).During the recovery period,the mean corpuscular hemoglobin concentration(MCHC)content in the low-dose group was lower than that in the control group(statistical significance only,not biological significance);the percentage of eosinophil(EOS%)in the medium-dose group was lower than that in the control group;the percentage of BASO%in the high-dose group and low-dose group was lower than that in the control group;the differences were statistically significant(P<0.05).After 26 weeks of administration,the level of aspartate aminotransferase(AST)in low-dose group was lower than that in control group;blood urea nitrogen(BUN)level in high-dose and medium-dose groups was lower than that in control group;the level of total bilirubin(TBIL)in high-,medium-and low-dose groups was lower than that in control group;the concentration of sodium ion(Na^(+))in high-,medium-and low-groups was higher than that in control group(only statistically significant,but not biologically significant);the concentration of potassium ion(K^(+))in medium-dose group was lower than that in control group;the concentration of chloride ion(Cl-)in medium-and low-d

关 键 词：灯银脑通胶囊 大鼠 毒性试验 毒性反应 安全性 

分 类 号：R285.5[医药卫生—中药学]