硫酸安普霉素注射液的制备工艺及稳定性研究  

Study on preparation technology and stability of Apramycinsulfate injection

作　　者：文章 伊佳宁 纪春晓[1] 文敏 张珊珊[1] 刘进辉[1] WEN Zhang YI Jianing JI Chunxiao WEN Min ZHANG Shanshan LIU Jinhui(College of Veterinary Medicine, Hunan Agricultural University, Changsha Hunan 410128, China Hunan Lvheng Shiyuan Animal Pharmaceutical Co., LTD., Shaoshan Hunan 411300, China)

机构地区：[1]湖南农业大学动物医学院,湖南长沙410128 [2]湖南绿亨世源动物药业有限公司,湖南韶山411300

出　　处：《中兽医医药杂志》2017年第5期62-65,共4页Journal of Traditional Chinese Veterinary Medicine

基　　金：国家自然科学基金(31402258)

摘　　要：旨在制备一种稳定、高效、安全的硫酸安普霉素注射液,并为其贮藏、运输及有效期的设定提供参考依据。通过筛选辅料及正交试验确定最佳辅料及最优生产工艺条件,通过影响因素试验、加速试验、长期试验对自制硫酸安普霉素注射液的稳定性进行考察。试验结果表明,该注射液筛选后的最优辅料为亚硫酸氢钠、柠檬酸和乙二胺四乙酸二钠,最佳制备工艺为溶剂温度40℃,灭菌时间30 min,灭菌温度120℃;稳定性试验结果显示其具有较高稳定性。表明该制剂所选辅料及优化后的生产工艺合理,稳定性较好。The purpose of this study was to prepare a stable,efficient and safe Apramycin sulfate injection,and provide reference for its storage,transportation and valid setting. Through screening materials and orthogonal test,the technological conditions for the production of materials was optimized. The stability of Apramycinsulfate injection was studied by influencing factor test,accelerated test and long-term stability test. The results showed that the optimal excipient was Sodium Bisulfite,citric acid and two sodium EDTA,the best preparation process for solvent temperature was 40 ℃,30 minutes sterilization time,sterilization temperature was 120 ℃. The stability test showed that it has high stability test. The results present that the materials of the preparation and the optimization of the production process is reasonable with good stability.

关 键 词：安普霉素 硫酸安普霉素 注射液 加工工艺 稳定性 

分 类 号：S859.79[农业科学—临床兽医学]