加米霉素注射液的靶动物安全性试验
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摘要
为了评价加米霉素注射液对靶动物牛的安全性,选择24头健康中国荷斯坦牛犊,随机分成4组,每组6头。各组分别以对照组(生理盐水:0.2 mL/kg·bw)、推荐剂量组(6 mg/kg·bw)、3倍推荐剂量组(18 mg/kg·bw)和5倍推荐剂量组(30 mg/kg·bw)的加米霉素注射液给药。试验期间观察受试牛的临床表现和体重变化,试验结束后进行组织病理学检查,测定血液学和血清生化指标的变化。结果表明,使用推荐剂量和3倍推荐剂量的加米霉素注射液,整个试验期间受试牛精神状态、饮水、采食和粪便等均未出现异常,体温、心率、呼吸频率、增重和饲料消耗量与空白对照相比均无显著性变化。由此可以说明,加米霉素注射液按照推荐剂量应用于牛具有较好的安全性。
To evaluate the safety of gamithromycin injection on target animal calves, 24 calves were randomly divided into 4 groups, including the control group(saline injection at a dosage of 0.2 mL/kg·bw), the recommended maximum dosage group(6 mg/kg·bw), 3 times of the recommended dosage group(18 mg/kg·bw)and 5 times of the recommended dosage group(30 mg/kg·bw). During the experiment, clinical and weight changes were observed, general pathology and histopathology change were measured,and blood samples were collected for blood biochemistry. The results showed that the indicators of all cattle were within the normal range, and the indicators had no significant differences. The pathological changes of heart, liver, lung and kidney had no differences in gamithromycin treatment groups when compared with the control group. Our study suggests that gamithromycin injection is safe for calves at the recommended maximum dosage.
To evaluate the safety of gamithromycin injection on target animal calves, 24 calves were randomly divided into 4 groups, including the control group(saline injection at a dosage of 0.2 mL/kg·bw), the recommended maximum dosage group(6 mg/kg·bw), 3 times of the recommended dosage group(18 mg/kg·bw)and 5 times of the recommended dosage group(30 mg/kg·bw). During the experiment, clinical and weight changes were observed, general pathology and histopathology change were measured,and blood samples were collected for blood biochemistry. The results showed that the indicators of all cattle were within the normal range, and the indicators had no significant differences. The pathological changes of heart, liver, lung and kidney had no differences in gamithromycin treatment groups when compared with the control group. Our study suggests that gamithromycin injection is safe for calves at the recommended maximum dosage.
引文
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[9]李勇军,方玉柱,孙晨,等.磺胺氯丙嗪钠-二甲氧苄啶混悬液对鸡的靶动物安全性试验[J].中国家禽,2014,36(21):32-36.
[10]李湘鸣.SPSS软件应用指导:常用医学生物统计[M].南京:东南大学出版社,2000.
[11]EMA.European Public Assessment Report(EPAR).ZACTRAN.EPAR summary for the public[DB/OL].EMEA/V/C/129.http://www.ema.europa.eu/docs/en/GB/document library/EPAR-Summary for the public/veterinary/000129/WC500068714.pdf,2016-07-05.
[12]US Food and Drug Administration.Freedom of information summary.Original new animal drug application[J].NADA,2011,141-328.
[13]Lechtenberg K F,Scanlon Daniels C,Schieber T,et al.Field efficacy study of gamithromycin for the treatment of bovine respiratory disease associated with mycoplasma bovines in beef and non-lactating dairy cattle[J].Int J Appl Res Vet Med,2011,9(3):225-232.
[14]Huang R A,Letendre L T,Banav,et al.Pharmacokinetics of gamithromycin in cattle with comparison of plasma and lung tissue concentrations and plasma antibacterial activity[J].J VETPHARMACOL THER,2010,33(3):227-237.
[15]Zactran summary of product characteristics[EB/OL].http://www.ema.europa.eu/docs/en/GB/document library/EPAR-Prodcut Inforomation/veterinary/000129/WC500068719.pdf,2016-07-05.
[2]于丽佳.加米霉素的合成与工艺路线研究[D].上海:中国农业科学院上海兽医研究所,2012.
[3]冯克清.加米霉素注射液在治疗肉牛和非泌乳奶牛呼吸系统疾病中的应用研究进展[J].中国兽药杂志,2016,50(8):66-69.
[4]EMA.Scientific discussion[EB/OL].http://www.ema.europa.eu/docs/en/GB/document library/EPAR-Scientific Discussion/veterinary/000129/WC500068716.pdf,2008-05-04.
[5]FDA.Freedom of information summary original new animal drug application[EB/OL].http://www.fda.gov/downloads/animal veterinary/products/approved animal drug products/foia drug summaries/ucm277806.pdf,2011-01-11.
[6]萧惠来.VICH兽药靶动物安全性研究指导原则概述[J].中国兽药杂志,2009,43(12):33-37.
[7]冯忠武.兽药研究技术指导原则汇编[M].北京:化学工业出版社,2011:200-202.
[8]宗昕如,张晓辉,辛凌翔,等.磷酸替米考星可溶性粉在靶动物鸡的安全性试验[J].畜牧与兽医,2014,46(2):27-32.
[9]李勇军,方玉柱,孙晨,等.磺胺氯丙嗪钠-二甲氧苄啶混悬液对鸡的靶动物安全性试验[J].中国家禽,2014,36(21):32-36.
[10]李湘鸣.SPSS软件应用指导:常用医学生物统计[M].南京:东南大学出版社,2000.
[11]EMA.European Public Assessment Report(EPAR).ZACTRAN.EPAR summary for the public[DB/OL].EMEA/V/C/129.http://www.ema.europa.eu/docs/en/GB/document library/EPAR-Summary for the public/veterinary/000129/WC500068714.pdf,2016-07-05.
[12]US Food and Drug Administration.Freedom of information summary.Original new animal drug application[J].NADA,2011,141-328.
[13]Lechtenberg K F,Scanlon Daniels C,Schieber T,et al.Field efficacy study of gamithromycin for the treatment of bovine respiratory disease associated with mycoplasma bovines in beef and non-lactating dairy cattle[J].Int J Appl Res Vet Med,2011,9(3):225-232.
[14]Huang R A,Letendre L T,Banav,et al.Pharmacokinetics of gamithromycin in cattle with comparison of plasma and lung tissue concentrations and plasma antibacterial activity[J].J VETPHARMACOL THER,2010,33(3):227-237.
[15]Zactran summary of product characteristics[EB/OL].http://www.ema.europa.eu/docs/en/GB/document library/EPAR-Prodcut Inforomation/veterinary/000129/WC500068719.pdf,2016-07-05.