注射用硼替佐米澄清度的研究

Study of factors influencing Clarity of Bortezomib for Injection

采用气相色谱方法对注射用硼替佐米3.5 mg成品及中试生产过程中所涉及的非原辅料物质(如导热油、液压油、真空泵油等)进行分离检测,从而判断上述物质是否为影响本品澄清度的关键因素。结果表明:冻干机对制剂成品的澄清度影响较大,其中冻干机液压油、真空泵油等是影响本品澄清度的非关键因素,而导热油是影响本品澄清度的关键因素。

By using gas chromatography method, 3.5 mg finished product of bortezomib and some non-original auxiliary materials, such as heat transfer oil, hydraulic oil and vacuum pump used oil, were separated and inspected so as to determine the critical factors influencing the clarity of the products. It was shown from the results that refrigerating and drying machine has comparatively significant effects. There, heat transfer oil is the critical factor, but hydraulic oil and vacuum pump used oil are not.