加米霉素注射液无菌检查方法的试验
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摘要
本文建立了加米霉素注射液的无菌检查方法。采用薄膜过滤法,根据《中国兽药典》2015年版一部附录要求进行试验,以0.1%无菌蛋白胨的0.1%聚山梨酯80溶液冲洗,冲洗量为500 mL/膜,验证试验结果显示,各验证菌生长良好,各供试品管均未见细菌生长。本试验成功建立了可靠、准确、可用于加米霉素注射液的无菌检查法。
To establish the sterility test for gamithromycin injection, the membrane filitration method was used and verified on the basis of the appendix to Veterinary Pharmacopoeia of the People's Republic of China(2015 edition). The results showed that the antibacterial activity of various strains could be eliminated with 500 ml 0.1% sterility peptone-0.1%polysorbate 80 solution as flushing fluid.In validation test, all the test strains grew well and bacteria were not found in the tube of test sample.The results showed that the method was reliable and accurate and could be used for sterility test of gamithromycin injection.
To establish the sterility test for gamithromycin injection, the membrane filitration method was used and verified on the basis of the appendix to Veterinary Pharmacopoeia of the People's Republic of China(2015 edition). The results showed that the antibacterial activity of various strains could be eliminated with 500 ml 0.1% sterility peptone-0.1%polysorbate 80 solution as flushing fluid.In validation test, all the test strains grew well and bacteria were not found in the tube of test sample.The results showed that the method was reliable and accurate and could be used for sterility test of gamithromycin injection.
引文
[1] EMA.Summary of product characteristics[EB/OL], [2016-03-23]http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/veterinary/000129/WC500068716.pdf.
[2] FDA.Freedom of information summary original new animal drug application[EB/OL], [2011-10-31] https://www.fda.gov/downloads/animalveterinary/products/approvedanimaldrugproducts/foiadrugsummaries/ucm277806.pdf.
[3] 罗显阳. 加米霉素及其在牛呼吸系统疾病中的应用[J].广东畜牧兽医科技, 2015 , 40 (1):12-15.
[4] Torres S, Thomson D U, Bello N M, et al. Field study of the comparative efficacy of gamithromycin and tulathromycin for the control of undifferentiated bovine respiratory disease complex in beef feedlot calves at high risk of developing respiratory tract disease[J]. American journal of veterinary research, 2013,74(6):839-846.
[5] Sifferman R L, Wolff W A, Holste J E, et al. Field efficacy evaluation of gamithromycin for treatment of bovine respiratory disease in cattle at feedlots[J]. International Journal of Applied Research in Veterinary Medicine, 2011, 9(2):166-175.
[6] Lechtenberg K, Daniels C S, Royer G C, et al. Field efficacy study of gamithromycin for the control of bovine respiratory disease in cattle at high risk of developing the disease[J]. International Journal of Applied Research in Veterinary Medicine, 2011, 9(2):184-192.
[7] 中国兽药典委员会. 中华人民共和国兽药典二〇一五年版一部[M]. 北京:中国农业出版社, 2015:附录1 101.
[8] 中国药品生物制品鉴定所.中国药品检验标准操作规范[M]. 北京:中国医药科技出版社, 2010.
[9] 李秋菲, 杨敏, 赵生奇, 等. 注射用阿奇霉素无菌检查方法学研究[J]. 中国药业, 2008, 17(20):23-24.
[10] 马丰英, 王英俊, 蒋贻海, 等. 自制美洛昔康注射液的无菌检查及局部刺激性检测[J]. 黑龙江畜牧兽医, 2017(3):204-207.
[11] 李应超, 吕涛, 王亚芳, 等. 苄星氯唑西林原料药的无菌检查方法研究[J]. 畜牧与兽医, 2015, 47(4):40-43.
[12] 刘雅华. 抗生素无菌检查法最佳冲洗条件选择的实验探索[J]. 贵州医药, 2003, 27(9):832-833.
[2] FDA.Freedom of information summary original new animal drug application[EB/OL], [2011-10-31] https://www.fda.gov/downloads/animalveterinary/products/approvedanimaldrugproducts/foiadrugsummaries/ucm277806.pdf.
[3] 罗显阳. 加米霉素及其在牛呼吸系统疾病中的应用[J].广东畜牧兽医科技, 2015 , 40 (1):12-15.
[4] Torres S, Thomson D U, Bello N M, et al. Field study of the comparative efficacy of gamithromycin and tulathromycin for the control of undifferentiated bovine respiratory disease complex in beef feedlot calves at high risk of developing respiratory tract disease[J]. American journal of veterinary research, 2013,74(6):839-846.
[5] Sifferman R L, Wolff W A, Holste J E, et al. Field efficacy evaluation of gamithromycin for treatment of bovine respiratory disease in cattle at feedlots[J]. International Journal of Applied Research in Veterinary Medicine, 2011, 9(2):166-175.
[6] Lechtenberg K, Daniels C S, Royer G C, et al. Field efficacy study of gamithromycin for the control of bovine respiratory disease in cattle at high risk of developing the disease[J]. International Journal of Applied Research in Veterinary Medicine, 2011, 9(2):184-192.
[7] 中国兽药典委员会. 中华人民共和国兽药典二〇一五年版一部[M]. 北京:中国农业出版社, 2015:附录1 101.
[8] 中国药品生物制品鉴定所.中国药品检验标准操作规范[M]. 北京:中国医药科技出版社, 2010.
[9] 李秋菲, 杨敏, 赵生奇, 等. 注射用阿奇霉素无菌检查方法学研究[J]. 中国药业, 2008, 17(20):23-24.
[10] 马丰英, 王英俊, 蒋贻海, 等. 自制美洛昔康注射液的无菌检查及局部刺激性检测[J]. 黑龙江畜牧兽医, 2017(3):204-207.
[11] 李应超, 吕涛, 王亚芳, 等. 苄星氯唑西林原料药的无菌检查方法研究[J]. 畜牧与兽医, 2015, 47(4):40-43.
[12] 刘雅华. 抗生素无菌检查法最佳冲洗条件选择的实验探索[J]. 贵州医药, 2003, 27(9):832-833.