托拉塞米注射液处方工艺研究

Study on the formulation process of Torasemide injection

目的:优选托拉塞米注射液处方工艺。方法:通过筛选托拉塞米注射液处方中的辅料种类、pH值的范围、活性炭用量的占比和灭菌条件,确定托拉塞米注射液的处方及制备工艺。结果:最佳处方为托拉塞米5 g、聚乙二醇400100 g、氨丁三醇2 g、氢氧化钠0.5 g、注射用水1000 mL;pH值的范围是9.00±0.20;活性炭的用量为0.10%;灭菌条件为121℃,15 min。工艺验证及稳定性试验研究结果表明所确定的处方工艺可行。结论:本研究确定的托拉塞米注射液处方及工艺产品质量稳定,安全性好。

Objective:The formulation process of torasemide injection was optimized.Methods:The formulation and preparation technology of torasemide injection were determined by screening the types of excipients,the range of pH value,the proportion of activated carbon dosage and sterilization conditions.Results:The best prescription is torasemide 5 g,polyethylene glycol 400100 g,tromethamine 2 g,sodium hydroxide 0.5 g,water for injection 1000 mL.The range of pH value was determined to be 9.00±0.20;the dosage of activated carbon was 0.10%;the sterilization conditions were 121℃for 15 min.The results of process verification and stability test show that the prescribed process is feasible.Conclusion:The torasemide injection product determined by this prescription and technology has stable quality and good safety.