复方新诺明注射液的制备及质量控制  

Preparation and Quality Control of Cotrimoxazole Injection

作　　者：李青云 陈胡羚 唐熙 张欣 蒋霜 侯佳琪 辛怡霖 李引乾[1] LI Qing-yun;CHEN Hu-ling;TANG Xi;ZHANG Xin;JIANG Shuang;HOU Jia-qi;XIN Yi-lin;LI Yin-qian(College of Veterinary Medicine,Northwest A&F University,Yangling,Shaanxi,712100,China;Bureau of Agriculture and Rural Affairs of Beichuan Qiang Autonomous County,Sichuan province,Beichuan,Sichuan,622750,China)

机构地区：[1]西北农林科技大学动物医学院,陕西杨陵712100 [2]四川省北川羌族自治县农业农村局,四川北川622750

出　　处：《动物医学进展》2023年第5期75-80,共6页Progress In Veterinary Medicine

基　　金：陕西省重点研发计划项目(2020NY-032);陕西省农业农村厅项目(畜牧专项资金-XN15)。

摘　　要：为探究复方新诺明注射液制备工艺及其质量标准,以药物高压前后含量的变化为评价标准,通过L9(3^(4))正交试验筛选辅料、优化处方,制备复方新诺明注射液,并对注射液的质量控制进行考察。最终确定复方新诺明注射液的最优处方为:每100 mL复方新诺明注射液含有机助溶剂45%,焦亚硫酸钠0.3 g,PEG-4003 mL,pH为8.0。质量控制结果显示,该注射液呈淡黄色,澄清,无可见异物,pH在8.0左右,无热原反应,注射液稳定性良好,用等吸收点双波长紫外分光光度法测定药物含量的方法准确可靠。In order to investigate the preparation process of cotrimoxazole injection and its quality standard,the cotrimoxazole injection was prepared by screening the excipients and optimizing the prescription through L9(3^(4))orthogonal test,using the changes in the content of the drug before and after high pressure as the evaluation criterion,and the quality control of the injection was investigated.The optimal prescription for cotrimoxazole injection was determined to be 45%organic co-solvent,0.3 g sodium metabisulphite and 3 mL PEG-400 per 100 mL of cotrimoxazole injection,pH 8.0.The quality control results showed that the injection was pale yellow,clarified,no visible foreign matter,pH around 8.0,no pyrogenic reaction,good stability of the injection and accurate and reliable method for the determination of drug content by dual wavelength UV spectrophotometry with equal absorption point.

关 键 词：磺胺甲噁唑 甲氧苄啶 等吸收点双波长紫外分光光度法 质量控制 

分 类 号：S859.79[农业科学—临床兽医学]