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1 6 2 Vol. 6 No Journal of Food Safety and Quality Feb., 2015 赵 岩 1, 妙志岩 1, 郜玉钢 1*, 刘双利 1, 杨鹤 1, 张连学 1*, 王士杰 2 (1., ; 2., ) 摘要 : 目的, 方法, 60, 12 h, (2.2 g ml 1 ), (40 ml kg 1 ),, 14 d 14 d, 结果 1,,, (LD 50 ), (MTD) 88 g kg 1 结论, 关键词 : ; (LD50); (MTD) Acute toxicity test of Renshen Rongzhi capsules ZHAO Yan 1, MIAO Zhi-yan 1, GAO Yu-Gang 1*, LIU Shuang-Li 1, YANG He 1, ZHANG Lian-Xue 1*, WANG Shi-Jie 2 (1. Chinese Medicine Material College of Jilin Agricultural University, Changchun , China; 2. College of Chinese Medicine, Jilin Academy of Agricultural Science and Technology, Jilin , China) ABSTRACT: Objective To investigate the acute toxicity and evaluate the safety of Renshen Rongzhi capsule. Methods According to the technical guidelines for the acute toxicity experiment on traditional Chinese medicine and natural medicine, 60 mice were randomly divided into treatment group and control group. After fasting but not restraining water for 12 h, Renshen Rongzhi capsule at a maximum concentration (2.2 g ml 1 ) and maximum capacity (40 ml kg 1 ) were given ig in the treatment group, while distilled water to the control group. After administration, mice were free to forage and water for 14 d and the body weight and behavioral events and circumstances of the death were recorded, after 14 d, all animals were killed and autopsied. Then the internal organs were observed, which included heart, liver, kidney, and brain. Results The mortality was 0 in the treatment group. Compared with the treatment group, the changes of the food intake and the body weight were not significantly different in the treatment group. The general conditions of animals 基金项目 : (2011BAI03B01) ( )(2009GJB10031) ( , YY, YYZX201258, YY) Fund: Supported by the National Science and Technology Support Program (2011BAI03B01), the National nonprofit industry research and special ( ), the Ministry of Science and Technology personnel services business project (2009GJB10031) and the Jilin Province Science and Technology Development Programme ( , YY, YYZX201258, YY) * 通讯作者 :,,, gaoyugang_2006@163.com,,, zlx863@163.com *Corresponding author: GAO Yu-Gang, Professor, Chinese Medicine Material College of Jilin Agricultural University, No.2888, Xincheng Street, Nanguan District, Changchun , China. gaoyugang_2006@163.com ZHANG Lian-Xue, Professor, Chinese Medicine Material College of Jilin Agricultural University, No.2888, Xincheng Street, Nanguan District, Changchun , China. zlx863@163.com

2 2, : 615 were not abnormal in the treatment group. After the gross anatomy, the appearance of organ showed no abnormality. The LD 50 of mice Renshen Rongzhi capsule could not be measured, the maximum tolerance dosage (MTD) was 88 g kg -1, respectively. Conclusion Based on the medicinal toxic experimental results, Renshen Rongzhi capsule is a kind of safe form. KEY WORDS: Renshen Rongzhi capsule; median lethal doses; maximum tolerance dosage 1 引言,, [1], [2], [3], [4] [5],, [6-9], 2 材料与方法 2.1 实验材料, 80,, KM SPF, 5~7,, 18~22 g,, : SCXK( ) ;, (22±2), (70±5)%,, 2.2 实验方法 预实验 (LD 50 ) [10-12], 18~22 g 20,,,, 3 d, 12 h, (2.2 g ml -1 ), (40 ml kg -1 ), ( ),,, 7 d,, 1,, (), [13,14] 最大耐受量测定 KM SPF 40,,, 12 h, (2.2 g ml -1 ), (40 ml kg -1 ), 1 d, 24 h 3 ( ), 4 h,, 4 h,, 2, 14 d, 观察指标,,,,,,, 统计方法 SPSS13.0, x s t, P 结果与分析 3.1 预实验测定结果,,, 20 min,,,,, 2 ( 9:00, 18:00),

3 616 6,, 7 d,,, 1 2 3,, 1 Fig. 1 Weight changes of mice after the treatment :, 7 d,,,, LD 50, 3.2 最大耐受量测定结果, 2 h 1 d, 14 d,,,,, 1 4 5, 2,,, Fig. 2 2 Food intake quantity changes of pre-test mice 表 2 各组小鼠给药后肝脏和脾脏与体重的比值 Table 2 Liver and spleen of mice with the ratio of weight after the treatment ( ) 0.053± ±0.001 ( ) 0.052± ±0.001 ( ) 0.050± ±0.005 ( ) 0.047± ±0.002 Fig. 3 3 Drinking water quantity changes of pre-test mice Fig 4 4 MTD Food intake quantity changes of MTD measured mice 表 1 人参茸芝胶囊混悬液对小鼠体质量的影响 (g, x s) Table 1 Effect of Renshen Rongzhi capsule suspension on body weight of mice (g, x s) 1 d 7 d 14 d ( ) 21.48± ± ± ±2.45 ( ) 21.29± ± ± ±1.99 ( ) 20.99± ± ± ±1.18 ( ) 21.72± ± ± ±1.47

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