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当前位置: 首页 > 文章 > 20%恩诺沙星注射液的制备及稳定性研究 西北农林科技大学学报(自然科学版) 2017,45 (5) 15-20
Position: Home > Articles > Preparation and stability of 20% enrofloxacin injection Journal of Northwest A & F University(Natural Science Edition) 2017,45 (5) 15-20

20%恩诺沙星注射液的制备及稳定性研究

作  者：
崔耀明;成建国;林莉;向瑞平;冶冬阳
单  位：
河南牧业经济学院;西北农林科技大学动物医学院;河南普尔泰动物药业有限公司
关键词：
恩诺沙星注射液;制备;稳定性;HPLC
摘  要：
【目的】用葡甲胺、聚乙二醇400作为助溶剂制备较低pH值的20%恩诺沙星注射液,并考察其稳定性,为临床应用提供理论依据。【方法】用正交试验L9(33)筛选最佳溶剂条件,按制剂通则试制备20%恩诺沙星注射液,用HPLC法测定恩诺沙星含量,并通过温度加速试验、光加速试验及长期放置试验考察其稳定性。【结果】确定恩诺沙星注射液的配制处方为:恩诺沙星100g,聚乙二醇400为100mL,葡甲胺100g,20%氢氧化钠溶液适量(调节pH 9.5~10.5),注射用水加至500mL。稳定性试验结果表明,20%恩诺沙星注射液试制品外观均为淡黄色,澄清,pH值9.5~10.5,含量98.0%~102.0%,均符合2010年版兽药典规定,产品质量稳定可控,有效期可暂定为2年。【结论】20%恩诺沙星注射液处方设计合理,制备工艺可控,质量稳定可靠。
译  名：
Preparation and stability of 20% enrofloxacin injection
作  者：
CUI Yaoming;CHENG Jianguo;LIN Li;XIANG Ruiping;YE Dongyang;Henan University of Animal Husbandry and Economy;Henan Puertai Animal Pharmaceutical co.,LTD;College of Veterinary Medicine,Northwest A&F University;
关键词：
enrofloxacin injection;;manufacturing technology;;stability;;HPLC
摘  要：
【Objective】The 20% enrofloxacin injection with low pH was prepared using meglumine,polyethylene glycol 400 as co-solvents to provide theoretical basis for its clinical application.【Method】The best solvent conditions were selected by orthogonal test L9(33).The 20%enrofloxacin injection was manufactured according to the general rules of injection.The stability of the manufacturing technology was inspected through the temperature acceleration test,the light acceleration test and the long-term test.The content of enrofloxacin was determined by HPLC method.【Result】The best solvent conditions of the enrofloxacin injection liquid were enrofloxacin 100 g,polyethylene glycol 400 100 mL,meglumine 100 g,20%sodium hydroxide solution(adjusting pH to 9.5-10.5),and injection water to 500 mL.The stability test showed that 20% enrofloxacin injection product was light yellow and clear clarity with pH of 9.5-10.5and content of 98.0%-102.0%,which met the requirements of Veterinary Pharmacopoeia 2010 edition.The product was stable and controllable with validity of 2years.【Conclusion】The 20%enrofloxacin injection had the characteristics of rational prescribing design,controllable manufacturing technology,as well as stable and reliable quality.

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