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1 7 10 Vol. 7 No Journal of Food Safety and Quality Oct., 2016 蔡绮君, 罗雪婷, 赵 * 博, 陈伟民, 张晓文 (, ) 摘要 : 目的方法, KM 10 g/kg BW, 14, (LD 50 ) 30 d, 2670 mg/kg BW 1330 mg/kg BW 670 mg/kg BW), SD 30 d, SD 结果, ; 30 d 30 d,, (), 30 d 结论关键词 : ; ; Safety evaluation on Dongliyuan capsule CAI Qi-Jun, LUO Xue-Ting, ZHAO Bo, CHEN Wei-Min, ZHANG Xiao-Wen * (Laboratory of Sports Nutrition, Guangzhou Institute of Sports Science, Guangzhou , China) ABSTRACT: Objective To evaluate the safety of anti fatigue functional food of Dongliyuan capsule by toxicology study. Methods The acute toxicity tests were determined by limit method, KM mice were given the maximum dose of 10 g/kg BW and observed the death within 14 days, and the median lethal dose (LD 50 ) were calculated. SD rats 30 days feeding test: 2670 mg/kg BW, 1330 mg/kg BW, 670 mg/kg BW dose group were administrated for 30 days by intragastric respectively and distilled water as control group, then the growth of SD rats and the perturbation of appetite, food utilization rate, blood serum, blood biochemical indexes and pathological examinations were observed and recorded. Results During the observation period of acute toxicity test, there was no abnormal expression and death of the tested animals, so the samples showed no toxicity. After 30 d feeding test, the blood chemical examination, body weighting results showed that the difference of each test item of experiment group and control group was not significant. Histopathological examination showed that the liver, spleen, kidney, stomach, intestine and testis (ovary) of the control group and the high dose group were not related to the pathological changes of the experimental factors, so 30 days feeding test showed no toxicity to the tested animals. Conclusion Dongliyuan capsule is safety for use by the safety evaluation study. 基金项目 : (2011J ) Fund: Supported by Science Project Foundation Supported by Science and Information Technology Bureau of Guangzhou (2011J ) * 通讯作者 :,, gzstkskyzxw@163.com *Corresponding author: ZHANG Xiao-Wen, Researcher, Guangzhou Institute of Sports Sciences, No 299, Tianhe Road, Tianhe District, Guangzhou , China. gzstkskyzxw@163.com

2 10, : 3919 KEY WORDS: Dongliyuan capsule; toxicology; safety evaluation 1 引言,,,,,,,, [1,2],,, [3-8] 30 d, GB [9-11], 2 材料与方法 2.1 样品,, 400 mg/,, 1600 mg/60 kg BW/d, 2, 实验动物 SPF (KM) SD, : SCXK( ) , SPF, : SYXK( ) : 20~26, 40%~70% 2.3 主要检测仪器与试剂 Triolgy ( DREW()); SYSMEX XS-1000i (); TP1020 (); RM2126RT (); TB-718E TB-718L TK-218 ( ); ( DREW ) 2.4 剂量选择与检测指标 : 18~22 g 10 SPF KM, ( 16 h, ),, 0.2 ml/10 g BW 14 d 30 d : 3~4 70~100 g SD 80, [3-5],, 2670 mg/kg BW 1330 mg/kg BW 670 mg/kg BW (, ),, 1, 1 2, ( 100 g ),, 30 d,,,,, : (1) : ; (2): (ALT)(AST)(BUN) (Cr) (Glu)(Alb)(TP) (TCH) (TG); (3), / 2.5 试验数据统计 ± ( X ±s), SPSS17.0 t,, P< 结果与分析 3.1 动力源胶囊急性毒性试验结果,, GB [10], LD mg/kg BW, 3.2 动力源胶囊 30 d 喂养试验结果动力源胶囊 30 d 喂养试验对大鼠体重的影响 30 d,,,, (P>0.05)

3 动力源胶囊 30 d 喂养试验对大鼠周食物摄入量的影响 30 d, 1 (91.50±8.93)~(102.21±9.69) g,, 4 (136.00±13.33)~(169.88±7.23) g,, (P>0.05) 动力源胶囊 30 d 喂养试验对大鼠周食物利用率的影响 30 d, 1 (39.05±12.21)%~(50.65±8.14)%,,,, (P>0.05) 动力源胶囊 30 d 喂养试验对大鼠周体重增长的影响 30 d,, (P>0.05) 动力源胶囊 30 d 喂养试验大鼠体重增加进食量总食物利用率结果 30 d,, (P>0.05) 血液学检查动力源胶囊 30 d 喂养试验临床血液学检查结果 30 d,, ( P>0.05) 动力源胶囊 30 d 喂养试验血液生化学检测结果 2 3, 30 d,, (P>0.05) 动力源胶囊 30 d 喂养试验脏器绝对重量 4, 30 d,, (P>0.05) 动力源胶囊 30 d 喂养试验对大鼠脏体比的影响 5, 30 d,, (P>0.05) Table 1 表 1 动力源胶囊 30 d 喂养试验大鼠体重增加进食量总食物利用率结果 ( X ±s) Effect on body weight growth, food intake and total food utilization rate of Dongliyuan capsule in rats 30 d feeding test ( X ±s) ( ) (g) (g) (%) (F/H) (P) ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ±3.06 F= F= Table 2 表 2 动力源胶囊 30 d 喂养试验血液生化学检测结果 ( X ±s) Effect on Blood biochemistry examination of Dongliyuan capsule in rats 30 d feeding test ( X ±s) ( ) (U/L) (U/L) (g/l) (g/l) ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ±1.2 :, P 0.05

4 10, : 3921 Table 3 表 3 动力源胶囊 30 d 喂养试验血液生化学检测结果 ( X ±s) Effect on Blood biochemistry examination of Dongliyuan capsule in rats 30 d feeding test ( X ±s) ( ) (mmol/l) (μmol/l) (mmol/l) (mmol/l) (mmol/l) ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ±0.31 :, P 0.05 Table 4 表 4 动力源胶囊 30 d 喂养试验对脏器绝对重量的影响 ( X ±s) Effect on absolute organ weight of Dongliyuan capsule in rats 30 d feeding test ( X ±s) ( ) (g) (g) (g) (g) ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± :, P 0.05 Table 5 表 5 动力源胶囊 30 d 喂养试验对大鼠脏体比的影响 ( X ±s) Effect on absolute organ/weight ratio of Dongliyuan capsule in rats 30 d feeding test ( X ±s) ( ) (g) / ( ) / ( ) / ( ) / ( ) ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± :, P 0.05

5 组织病理学检查结果大体检查 80,, 镜下检查 20, / :,, ; :,, ; :,, ; :,,, ; :, () 4 结论 KM,,, GB LD mg/kg BW, 30 d, 2670 mg/kg BW 1330 mg/kg BW 670 mg/kg BW, () GB d 90 d, 30 d,,, [12] ;,,, [13],, [14],,, [15,16],, 参考文献 [1] Fukuda K, Straus SE, Hickie I, et al. The chronic fatigue syndrome: a comprehensive approach to its definition and study [J]. Ann Intern Med, 1994, 121: [2],,,. [J]., 2008, 14(10): Li XL, Zhao GC, Xu YL, et al. Advance in Research of Sub-health (review) [J]. Chin J Rehabil Theory Pract, 2008, 14(10): [3],. [J]., 2006, 9(5): Liu HY, Zhao GC. Effects of anti-fatigue functional components in sports drinks [J]. Beverage Ind, 2006, 9(5): [4]. [J]., 2014, 36(3): YU JH. Research on biological effects and exercise ability of Taurine [J]. Amino Acids Biotic Res, 2014, 36(3): [5],,,. [J]., 2016, 22(1): Zhu TT, Li F, Chen B, et al. Studies on the saponins from the leaves of Panax ginseng [J]. Chin J Appl Environ Biol, 2016, 22(1): [6],,,. [J]., 2014, 39(3): Bai M, Mao Q, Xu JD, et al. Advance in saponins of aerial parts of Panax ginseng [J]. China J Chin Mater Med, 2014, 39(3): [7],. [J]., 2015, 46(17): Ma LY, Yang XW. Chemical constituents in acid hydrolysates of total saponins from stems and leaves of Panax ginseng [J]. Chin Herbal Med, 2015, 46(17): [8],. [J]., 2010, 31(5): Zhang HF, Yang XH. Application of Herba Epimedii in food industry: current status and prospect [J]. Food Sci Technol, 2010, 31(5): [9]. (2003)[M]. :, 2003: Ministry of Health. Health food inspection and evaluation technical specification [M]. Beijing: Ministry of Health, 2003: [10] GB [S]. GB National Standardization of food safety-acuteoral toxicity test [S]. [11] GB [S]. GB days and 90 days feeding test [S]. [12],,,. [J]., 2005, 15(8): Xia ZL, Gong T, Chen H, et al. Study on the joint toxicity and mutagenicity of twenty-eight alkyl alcohols and taurine [J]. Chin J Health Lab Technol, 2005, 15(8): [13],,. [J]. 2014, 5(7): Zhang S, Guo JX, Chen W. Research progress of effect of taurine on cholesterol metabolism [J]. J Food Saf Qual, 2014, 5(7): [14],,. [M]. :, 2008.

6 10, : 3923 Xie MH, Feng W, Yan Y, et al. The endocrinology of sports [M]. Beijing: Beijing Sport University Press, [15],,,. [J]., 2011, 32(5): Guo YC, Di J; Hu SH, et al. Sub-chronic toxicity test of ginseng leaf oral liquid in rats [J]. Progress Vet Med, 2011, 32(5): [16],,,. [J]., 2011, 27(22): Sun L, Gao F, Wu XG, et al. Study for security and genetic toxicity of Ginseng powder [J]. Occup Health, 2011, 27 (22): ( 责任编辑 : 白洪健 ) 作者简介蔡绮君, 实验师, 主要研究方向为运动保健食品的功能学与安全性评价研究 gzstkskycqj@163.com 张晓文, 研究员, 主要研究方向为保健食品的研究开发及其功能学与安全性检测研究 gzstkskyzxw@163.com

中草药 Chinese Traditional and Herbal Drugs 第 46 卷第 9 期 2015 年 5 月 1339 非酒精性脂肪性肝病 (nonalcoholic fatty liver disease,nafld) 是一种与胰岛素抵抗遗

中草药 Chinese Traditional and Herbal Drugs 第 46 卷第 9 期 2015 年 5 月 1339 非酒精性脂肪性肝病 (nonalcoholic fatty liver disease,nafld) 是一种与胰岛素抵抗遗 1338 中草药 Chinese Traditional and Herbal Drugs 第 46 卷第 9 期 2015 年 5 月九味肝泰胶囊对高脂饮食诱导大鼠非酒精性脂肪肝的治疗作用陈菲 1 2,, 艾国 3, 盛柳青 1, 麻佳蕾 1, 黄正明 1. 金华职业技术学院医学院, 浙江金华