| 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100 g，聚乙二醇400为100 mL，葡甲胺100 g，20%氢氧化钠溶液适量（调节pH 9.5~10.5），注射用水加至500 mL。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。 |
| 关键词: 恩诺沙星注射液 制备 稳定性 HPLC |
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| Preparation and stability of 20% enrofloxacin injection |
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CUI Yaoming,CHENG Jianguo,LIN Li,et al
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| Abstract: |
| 【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 9.5-10.5 and content of 98.0%-102.0%,which met the requirements of Veterinary Pharmacopoeia 2010 edition.The product was stable and controllable with validity of 2 years.【Conclusion】The 20% enrofloxacin injection had the characteristics of rational prescribing design,controllable manufacturing technology,as well as stable and reliable quality. |
| Key words: enrofloxacin injection manufacturing technology stability HPLC |
