多潘立酮注射液的研制与测定方法的建立

Preparation of Domperidone Injection and Establishment of Method on Mensurating Content of Domperidone

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1-10μg/mL浓度范围内,标准曲线方程为：A=0.0261C＋0.0016（R^2=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。

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 established.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 = 0.0261C ＋0.0016 R^2=0.9984） in the concentration range of 1-10 μg/mL with its recovery rate of 97.07%,and the method was extremely steady.Method of UV-vis spectrophotometry established could be used to determine Domperidone in Domperidone injection.