多潘立酮注射液的研制与测定方法的建立.pdfVIP

每北雇业学报 2008，17(3)：61—63，90 Acta Agriculturae Boreali—occidentalis Sinica 多潘立酮注射液的研制与测定方法的建立 胡小艳 ，李引乾 ，李博文 ，周光辉 ，白 军 。， 周 洋 ，白东英 ，李江肃 (1．西北农林科技大学动物医学院，陕西杨凌 712100；2．南京福润德动物药业有限公司，江苏南京 210007 3．杨陵职业技术学院，陕西杨凌 712100；4．河南科技大学动物科技学院，河南洛阳 471003) 摘 要：为了给多潘立酮的临床应用提供试验依据，研制出多潘立酮注射剂，进行了性状检查，建立了测定方 法。结果表明，以多潘立酮为主药研制出的多潘立酮注射液为无色澄明的液体，pH4．4，无菌检查符合要求。 所建立的多潘立酮紫外分光光度测定法简单易行。在 1～10／~g／mL浓度范围内，标准曲线方程为：A= 0．0261C+0．0016(R =0．9984)，即在该浓度范围内回收率高，稳定性好，可用于多潘立酮注射液中多潘立酮 的测定。 关键词：多潘立酮注射液；性状检查；紫外一可见分光光度法；含量测定 中图分类号：$859．79 4 文献标识码：A 文章编号：1004—1389(2008)03—006I-03 Preparation of Domperidone Inj ection and Establishment of Method on Mensurating Content of Domperidone HU Xiao—yan ，LI Yin—qian ，LI Bo—wen ，ZHoU Guang—hui ，BAI Jun ～， ZHoU Yang ，BAI Dong—ying 一and LI Jiang—SU (1l College of Animal Science and Technology，Northwest AF University，Yangling Shaanxi 7 12 100，China 2．Nanjing Filed Animal Pharmaceutical Company Limited，Nanjing Jiangsu 210007，China 3．Yangling Vocational~Technical College，Yangling Shaanxi 712100，China：4．College of Animal Science and Technology，He’nan University of Science and Technology，Luoyang He nan 471003，China) Abstract：Domperidone injection were prepared in order to provide clinical appliance of Domperidone． Its characteristics was checked，and the method of mensurating content of Domperidone was estab— lished．The results showed that the Domperidone injection preparated is transparent and colourless， which pH was 4．4．Sterility test measure up the requirements of the injection．Method of UV—vis spectrophotometry was established to determine content of Domperidone in Domperidone injection． The standard curve equation iS A 一 0．0261C+0．0016 R。一0．9984)in the concentration range of 1～ 10 ttg／mI