摘要
目的:采用逆向工程技术对呋塞米口服溶液进行处方分析。方法:采用气相色谱法测定参比制剂中丙二醇的量,分光光度法测定山梨醇的量,pH检测法测定碳酸钾的量。结果:测得规格为60 ml的呋塞米口服溶液中含呋塞米的量为0.6 g,丙二醇的量约为24.5 g,山梨醇液的量约为25.6 g,碳酸钾的用量约为0.230~0.240 g。结论:采用逆向工程技术得到的呋塞米口服溶液处方制备的样品与参比制剂比较,质量基本一致,可为后续工艺开发及生产提供参考。
Objective:To analyze the formula of furosemide oral solution by reverse engineering technique.Methods:The content of propylene glycol in reference preparation was determined by GC method,sorbitol solution by spectrophotometer method,and potassium carbonate by pH detection method.Results:The measured amount of furosemide in 60 ml oral furosemide solution was 0.6 g,the amount of propanediol was 24.5 g,the amount of sorbitol was 25.6 g,and the amount of potassium carbonate was 0.230-0.240 g.Conclusion:Compared with the reference preparation,the samples prepared by the formula of furosemide oral solution obtained by reverse engineering have basically the same quality,which can provide reference for the subsequent process development and production.
作者
凌骅
余丽花
黄志军
卢琳
明凯利
Ling Hua;Yu Lihua;Huang Zhijun;Lu Lin;Ming Kaili(College of Physiology,Wuhan University of Technology,Wuhan 430070,China;Jianmin Pharmaceutical Group Co.Ltd.)
出处
《中国药师》
CAS
2021年第10期1907-1910,共4页
China Pharmacist
基金
国家“重大新药创新”专项(编号:2018ZX09721003-008-029)。
关键词
呋塞米口服溶液
逆向工程
小试处方
Furosemide oral solution
Reverse engineering
Small trial formula
