| 安神补脑液对大鼠长期毒性的观察 |
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| 引用本文： | 张海晶,孙桂波,陈荣昌,王健,陈大忠,王永彬,王永宽,解钧秀,孙晓波.安神补脑液对大鼠长期毒性的观察[J].实验动物与比较医学,2015,23(2):147-152. |
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| 作者姓名： | 张海晶 孙桂波 陈荣昌 王健 陈大忠 王永彬 王永宽 解钧秀 孙晓波 |
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| 作者单位： | 黑龙江中医药大学中医药研究院, 哈尔滨 150040;中国医学科学院北京协和医学院药用植物研究所, 北京 100193;中国医学科学院北京协和医学院药用植物研究所, 北京 100193;中国医学科学院北京协和医学院药用植物研究所, 北京 100193;黑龙江中医药大学中医药研究院, 哈尔滨 150040;吉林敖东延边药业股份有限公司, 吉林 延吉 133700;吉林敖东延边药业股份有限公司, 吉林 延吉 133700;吉林敖东延边药业股份有限公司, 吉林 延吉 133700;中国医学科学院北京协和医学院药用植物研究所, 北京 100193 |
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| 基金项目： | 国家科技重大专项课题,重大新药创制基金项目(编号:2012ZX09501001-004)。 |
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| 摘 要： | 目的 观察安神补脑液长期灌胃给药对大鼠所产生的毒性反应及严重程度, 提供毒副反应的靶器官及其损害的可逆程度, 确定无毒反应剂量, 以评价安神补脑液长期用药的安全性, 为拟定临床试验剂量及观察指标提供参考。方法 Wistar大鼠随机分为安神补脑液低、中、高剂量组(2.5、5、10 mL/kg)和溶剂对照组(灌服同容积蒸馏水 2 mL/100 g), 每组60只, 雌雄各半, 每天给药1 次, 每周给药6 d, 连续26周。观察大鼠的外观行为、体重、摄食量, 并分别于给药第13、26周末及四周恢复期结束进行血液学及血液生化学等各项指标检测及脏器系数、病理组织学检查。结果 长期连续灌胃给予安神补脑液, 对动物一般状态、行为活动和外观体征无明显不良影响;各剂量组的摄食量、体重、血液学及血液生化学指标与对照组比较无明显差别;给药3个月、6个月对动物各脏器组织位置、重量和脏器系数无不良影响, 但部分脏器重量有所增加, 各组动物脏器系数在正常范围内;病理结果显示对照组和安神补脑液高剂量组动物未见明显与给药相关的异常病理改变和毒性改变, 恢复期停药后未见延迟性毒性, 因此, 中、低剂量组动物各脏器组织无需进行组织病理形态学检查。结论 安神补脑液长期用药对大鼠未见明确的毒性反应, 停药后亦无延迟性毒性反应, 预期拟定的临床用药量为安全剂量。
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| 关 键 词： | 安神补脑液 长期毒性 大鼠 |
| 收稿时间： | 2014/10/9 0:00:00 |
Evaluation of the chronic toxicity of Anshen Bunao liquid in rats |
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| ZHANG Hai-jing,SUN Gui-bo,CHEN Rong-chang,WANG Jian,CHEN Da-zhong,WANG Yong-bin,WANG Yong-kuan,XIE Jun-xiu and SUN Xiao-bo.Evaluation of the chronic toxicity of Anshen Bunao liquid in rats[J].Laboratory Animal and Comparative Medicine,2015,23(2):147-152. |
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| Authors: | ZHANG Hai-jing SUN Gui-bo CHEN Rong-chang WANG Jian CHEN Da-zhong WANG Yong-bin WANG Yong-kuan XIE Jun-xiu and SUN Xiao-bo |
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| Affiliation: | Research Institute of Traditional Chinese Medicine, Heilongjiang University of Chinese Medicine, Harbin 150040, China;Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100193;Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100193;Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100193;Research Institute of Traditional Chinese Medicine, Heilongjiang University of Chinese Medicine, Harbin 150040, China;Jilin Ao Dong Yanbian Pharmaceutical Co., Ltd., Yanji 133700;Jilin Ao Dong Yanbian Pharmaceutical Co., Ltd., Yanji 133700;Jilin Ao Dong Yanbian Pharmaceutical Co., Ltd., Yanji 133700;Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100193 |
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| Abstract: | Objective To study the chronic toxicity and its severity of a Chinese medicine, Anshen Bunao Liquid (ABL), in rats, provide the target organs and extent of reversibility of their adverse effects, determine its non-toxic dose, and to evaluate the safety of medication and provide reference for clinical trial dose and observation indexes. Methods Two hundred and forty healthy 6-week old Wistar rats (male:female=1:1) were divided into low, middle, and high dose Anshen Bunao liquid groups (2.5, 5, 10 mL/kg), and solvent control group (distilled water 2 mL/100 g), with 60 rats in each group. The drug was orally administered to rats once a day and 6 days per week for 26 weeks. The general state, body mass and food intake were measured.By the end of 13 weeks, 26 weeks of experiment and 4-week recovery period after drug withdrawal, hematological and biochemical indexes were assayed, organ coefficients were determined, and histopathological observation was performed. Results Long-term continuous oral administration of Anshen Bunao liquid, the general state, behavior and gross appearance showed no significant abnormal changes. Compared with the control group, no significant differences in all checked items were found in the treatment groups.During 3 and 6 months, the size and location of organs, organ weight and organ coefficient had no obvious changes, with only non-significant increase of weight of some organs. All the organ coefficients of the animals in different groups were within normal range. Histopathology showed no obvious pathological and toxicological changes even in the high-dose drug treatment group, and no delayed toxicity occurred after withdrawal of drug administration. Conclusions The Chinese drug, Anshen Bunao liquid has no obvious toxicity and no delayed toxicity after withdrawal of the drug in rats. It is expected that the planned dose in clinical use is a safe dose. |
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| Keywords: | Anshen Bunao liquid Chronic Toxicity Rats |
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