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。
[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 （3^3 ）. The 20% enrofloxacin injection was manu- factured according to the general rules of injection. The stability of the manufacturing technology was in- spected 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 en- rofloxacin 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 injec- tion had the characteristics of rational prescribing design, controllable manufacturing technology, as well as stable and reliable quality.
出处
《西北农林科技大学学报（自然科学版）》
CSCD
北大核心
2017年第5期15-20,共6页
Journal of Northwest A&F University(Natural Science Edition)
关键词
恩诺沙星注射液
制备
稳定性
HPLC
enrofloxacin injection
manufacturing technology
stability
HPLC
