复方庆大霉素注射液的质量控制及体外抑菌效果  

Quality control and antibacterial activity in vitro of compound gentamicin injection

作　　者：左儒楠 刘筱 王雅倩 翁启彬 侯会霞 李日飞 孟德兰 公绪同 李引乾[1] 杨鸣琦[1] ZUO Ru-nan;LIU Xiao;WANG Ya-qian;WENG Qi-bin;HOU Hui-xia;LI Ri-fei;MENG De-lan;GONG Xu-tong;LI Yin-qian;YANG Ming-qi(College of Veterinary Medicine ,Northwest A ＆F University, Yangling 712100, China)

机构地区：[1]西北农林科技大学动物医学院

出　　处：《中国兽医科学》2018年第5期649-657,共9页Chinese Veterinary Science

基　　金：西北农林科技大学省级大学生创新创业训练计划项目(2201610712011)

摘　　要：为制备复方庆大霉素注射液,对其进行质量控制方面的测定,同时进行注射液的体外抑菌试验,以便给临床应用提供理论依据。通过预实验和L9（33）正交设计优化制备处方。对复方庆大霉素注射液分别进行澄明度检查、p H值检查、热原检测试验等质量控制研究。通过对患乳房炎母猪的乳汁进行细菌分离培养和生化鉴定,采用二倍管稀释法测定复方庆大霉素注射液和庆大霉素注射液对金黄色葡萄球菌、大肠杆菌和无乳链球菌的MIC和MBC。结果,复方庆大霉素注射液的最优配方为：每50 m L注射液中硫酸庆大霉素为1 g,氟尼辛葡甲胺为0.01 g,助溶剂N,N-二甲基甲酰胺为6%,稳定剂聚乙二醇为3%,抗氧化剂无水亚硫酸钠为0.06%。质量控制结果显示,注射液澄明度检查未检出可见异物,p H在7.0~7.5,无热原出现。从患猪奶样中分离出金黄色葡萄球菌、大肠杆菌和无乳链球菌。体外抑菌试验结果表明,复方庆大霉素注射液对金黄色葡萄球菌、大肠杆菌、无乳链球菌的MIC分别是1.18、2.35、4.70 g/m L;庆大霉素注射液对金黄色葡萄球菌、大肠杆菌和无乳链球菌的MIC分别是2.35、4.70、9.39 g/m L。复方庆大霉素注射液对金黄色葡萄球菌、大肠杆菌和无乳链球菌的MBC分别是2.35、9.39、9.39 g/m L;庆大霉素注射液对金黄色葡萄球菌、大肠杆菌和无乳链球菌的MBC分别是4.70、18.78、18.78 g/m L。结论：确定了复方庆大霉素注射液配方,质量控制符合注射液要求,对常见的病原菌具有良好的抑菌效果。The study was conducted to prepare compound of gentamicin injection,and determined its mass concentration.At the same time,we need to carry out the antibacterial test in vitro of injections.Prescriptions were prepared by pre-experiments and optimization of L9（33）orthogonal design.The compound gentamycin injection was respectively studied by the aspects of quality control,p H value test and pyrogen test for clarity test.We used the milk from mastitis sows tocarry out bacterial isolation and biochemical identification.At the same time.The MIC and MBC of Staphylococcus aureus,Escherichia coli and Streptococcus agalactiae were determined by the double-tube dilution method with compound gentamicin injection and gentamicin injection.In result,the optimal formulation of compound gentamicin injection（in 50 m L volume） was composed of gentamicin sulfate about one gram,flunixin meglumine about zero point one gram,the cosolvent was called N,N-dimethylformamide（0.6%）,the stabilizer of injection was called polyethylene glycol（3%）,the antioxidants of injection was called anhydrous sodium sulfite（0.06%）,and water for injection.Results of quality control showed that the clarity of injection did not detect visible foreign body,the p H of injection was between 7.0 and 7.5,and there was no pyrogen appearing in the injection.Staphylococcus aureus,Escherichia coli and Streptococcus agalactiae were isolated from milk samples.The results in vitro antibacterial test showed that the MIC of compound gentamicin injection to Staphylococcus aureus,Escherichia coli and Streptococcus agalactiae were 1.18,2.35 and 4.70 g/m L,respectively.The MIC of gentamicin injection to Staphylococcus aureus,Escherichia coli,Streptococcus agalactiae were 2.35,4.70 and 9.39 g/m L,respectively.The MBC of the compound gentamicin injection against Staphylococcus aureus,Escherichia coli,Streptococcus agalactiae were 2.35,9.39 and 9.39 g/m L,respectively.The MBC of diclofenac to Staphylococcus aureus,Escherichia coli,Streptococcus agalactiae wer

关 键 词：硫酸庆大霉素 氟尼辛葡甲胺 正交试验 质量控制 体外抑菌试验 

分 类 号：S859.796[农业科学—临床兽医学]