复方芩兰口服液长期毒性试验研究
|
摘要
为了考察复方芩兰口服液的安全性,以大鼠为试验动物,分别在其饮水中连续添加20 m L/L(拟推荐剂量10倍)、40 m L/L(拟推荐剂量20倍)、80 m L/L(拟推荐剂量40倍)的复方芩兰口服液,对其长期毒性进行了为期4周的饲喂考察。结果显示,复方芩兰口服液的所有用药组大鼠,在为期28 d的试验过程中,其临床表现、增重及饲料利用、脏器指数、血液学常规、血液生化检查及组织病理学六方面均与对照组无显著差异(P>0.05),表明该药长期使用是安全的。
In order to investigate the safety of Fufang Qinlan Oral Liquid,rats were used as test animals. In clinical toxicity trials,Fufang Qinlan Oral Liquid was continuously added in drinking water with the concentration of 20 m L/L( 10 times recommended dose),40 m L/L( 20 times recommended dose),and 80 m L/L( 40 times recommended dose). This clinical trials lasted 4 weeks. The results showed that clinical manifestation,weight gain,feed utilization,organ index,hematology routine,blood biochemical examination and histopathology of the experimental group were not significantly different from the control group( P > 0.05). It is indicated that Fufang Qinlan Oral Liquid is safe and can be used in clinical trials.
In order to investigate the safety of Fufang Qinlan Oral Liquid,rats were used as test animals. In clinical toxicity trials,Fufang Qinlan Oral Liquid was continuously added in drinking water with the concentration of 20 m L/L( 10 times recommended dose),40 m L/L( 20 times recommended dose),and 80 m L/L( 40 times recommended dose). This clinical trials lasted 4 weeks. The results showed that clinical manifestation,weight gain,feed utilization,organ index,hematology routine,blood biochemical examination and histopathology of the experimental group were not significantly different from the control group( P > 0.05). It is indicated that Fufang Qinlan Oral Liquid is safe and can be used in clinical trials.
引文
[1]国家药典委员会.中国药典一部[M].北京:中国医药科技出版社,2015,1225.National Pharmacopoeia Commission. Chinese Pharmacopoeia[M].Beijing:China Medical Science Press,2015,1225.
[2]段文龙,梁先明.兽药研究技术指导原则汇编(2006—2011年)[M].北京:化学工业出版社,2013,3.Duan W L,Liang X M. A Compilation of Technical Guidelines for Veterinary Drug Research(2006-2011)[M]. Beijing:Chemical Industry Press,2013:3.
[3]于船.中兽医学(第二版)[M].北京:中国农业出版社,1999,16-22.Yu C. Chinese Veterinary Medicine(Second Edition)[M].Beijing:China Agriculture Press,1999,16-22.
[4]兽药试验技术规范汇编[Z]. 2001:5.The Office of the Veterinary Drug Review Committee of the Ministry of Agriculture[Z].2001:5.
[5]殷震,刘景华.动物病毒学(第二版)[M].北京:科学出版社,1997,1066-1073.Yin Z,Liu J H. Animal Virology(Second Edition)[M]. Beijing:Science Press,1997,1066-1073.
[6]王云峰,石星明,王玫,等.鸡传染性喉气管炎研究进展[J].兽医导刊,2008,135(11):26-29.Wang Y F,Shi X M,Wang M,et al. Research progress of avian infectious laryngotracheitis[J]. Veterinary Orientation,2008,135(11):26-29.
[7]农业部兽药评审中心.兽药研究技术指导原则汇编[M].北京:化学工业出版社,2012.Veterinary Drug Assessment of Ministry of Agriculture. Veterinary Drug Test Regulation Assemble[M]. Beijing:Chemical Industry Press,2012.
[8]杨慧,孙耀贵,孙娜,等.板芪口服液急性毒性及长期毒性实验研究[J].中国兽药杂志,2019,(3):79-85.Yang H,Sun Y G,Sun N,et al. Acute toxicity and chronic toxicity study of Banqi Oral Liquid[J]. Chinese Journal of Veterinary Drug,2019,(3):79-85.
[9]喻琴,陈玲,尹伶灵,等.鱼腥草芩兰口服液的毒理学研究[J].中国兽药杂质,2018,09:27-34.Yu Q,Chen L,Yin L L,et al. Toxicity of Yuxingcao Qinlan Oral Liquid[J]. Chinese Journal of Veterinary Drug,2018,09:27-34.
[10]李晓,郭唯,陈飞,等.连翘叶不同提取物的急性毒性实验研究[J].饲料研究,2013,01:11-12.Li X,Guo W,Chen F,et al. Experimental study on acute toxicity of different extracts of Forsythia Suspensa[J]. Feed Research,2013,01:11-12.
[2]段文龙,梁先明.兽药研究技术指导原则汇编(2006—2011年)[M].北京:化学工业出版社,2013,3.Duan W L,Liang X M. A Compilation of Technical Guidelines for Veterinary Drug Research(2006-2011)[M]. Beijing:Chemical Industry Press,2013:3.
[3]于船.中兽医学(第二版)[M].北京:中国农业出版社,1999,16-22.Yu C. Chinese Veterinary Medicine(Second Edition)[M].Beijing:China Agriculture Press,1999,16-22.
[4]兽药试验技术规范汇编[Z]. 2001:5.The Office of the Veterinary Drug Review Committee of the Ministry of Agriculture[Z].2001:5.
[5]殷震,刘景华.动物病毒学(第二版)[M].北京:科学出版社,1997,1066-1073.Yin Z,Liu J H. Animal Virology(Second Edition)[M]. Beijing:Science Press,1997,1066-1073.
[6]王云峰,石星明,王玫,等.鸡传染性喉气管炎研究进展[J].兽医导刊,2008,135(11):26-29.Wang Y F,Shi X M,Wang M,et al. Research progress of avian infectious laryngotracheitis[J]. Veterinary Orientation,2008,135(11):26-29.
[7]农业部兽药评审中心.兽药研究技术指导原则汇编[M].北京:化学工业出版社,2012.Veterinary Drug Assessment of Ministry of Agriculture. Veterinary Drug Test Regulation Assemble[M]. Beijing:Chemical Industry Press,2012.
[8]杨慧,孙耀贵,孙娜,等.板芪口服液急性毒性及长期毒性实验研究[J].中国兽药杂志,2019,(3):79-85.Yang H,Sun Y G,Sun N,et al. Acute toxicity and chronic toxicity study of Banqi Oral Liquid[J]. Chinese Journal of Veterinary Drug,2019,(3):79-85.
[9]喻琴,陈玲,尹伶灵,等.鱼腥草芩兰口服液的毒理学研究[J].中国兽药杂质,2018,09:27-34.Yu Q,Chen L,Yin L L,et al. Toxicity of Yuxingcao Qinlan Oral Liquid[J]. Chinese Journal of Veterinary Drug,2018,09:27-34.
[10]李晓,郭唯,陈飞,等.连翘叶不同提取物的急性毒性实验研究[J].饲料研究,2013,01:11-12.Li X,Guo W,Chen F,et al. Experimental study on acute toxicity of different extracts of Forsythia Suspensa[J]. Feed Research,2013,01:11-12.