20%恩诺沙星注射液的制备及稳定性研究

发布时间：2018-04-01 11:13

本文选题：恩诺沙星注射液　切入点：制备　出处：《西北农林科技大学学报(自然科学版)》2017年05期

【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。
[Abstract]:[objective] to prepare 20% enrofloxacin injection with low pH value by using meglumine and polyethylene glycol 400 as cosolvent, and to investigate its stability and provide theoretical basis for clinical application.20% enrofloxacin injection was prepared according to the general rules of preparation. The content of enrofloxacin was determined by HPLC method.[results] the formulation of enrofloxacin injection was determined to be 100 g of enrofloxacin, 100 mL of polyethylene glycol, and 20% of sodium hydroxide solution of meglumine (adjust pH 9.510. 5%).The results of stability test showed that the appearance of 20% enrofloxacin injection was light yellow, the pH value was 9.5% and 10.5, and the content was 98.0% 102.0. The product quality was stable and controllable, and the product quality was stable and controllable according to the provisions of the 2010 Veterinary Pharmacopoeia.[conclusion] the formulation of 20% enrofloxacin injection is reasonable, the preparation process is controllable and the quality is stable and reliable.
【作者单位】：河南牧业经济学院;河南普尔泰动物药业有限公司;西北农林科技大学动物医学院;
【分类号】：S859.53

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