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目的:研究采用总有机碳法测定设备表面药物残留的可行性。方法:为测定美索巴莫在制药设备不同材质上的残留,拟采用棉签擦拭取样,通过测定样品TOC来确认取样方法的回收率,从而确定用总有机碳测定设备表面药物残留的可行性。在一定大小的材质上预先涂布既定浓度的美索巴莫溶液,自然干燥后用棉签擦拭回收,所得样品中有机物在测试时被氧化成CO2,通过测定总碳(TC)和无机碳(IC),从而得到样品TOC,即TOC=TC-IC。结果:几种实验材质回收率分别为:不锈钢88%、硅胶108%、有机玻璃112%、聚四氟乙烯119%、特氟龙78%。结论:该方法具有较好重现性,可用于美索巴莫片生产设备清洁后在设备表面相应材质上的残留检测。
Objective: To study the feasibility of using total organic carbon method to determine drug residue on equipment surface. Methods: In order to determine the residue of different materials for pharmaceutical equipment, it is proposed to use cotton swab to wipe the sample and determine the recovery rate of the sampling method by measuring the sample TOC so as to determine the feasibility of using total organic carbon to determine the residual drug on the surface of the equipment. A certain amount of material is precoated with a solution of a predetermined concentration of methocarbamo, which is naturally dried and then wiped and swabbed. The resulting sample is oxidized to CO2 during the test, and the total carbon (TC) and inorganic carbon ) To give a sample TOC, ie TOC = TC-IC. Results: The recoveries of several experimental materials were 88% of stainless steel, 108% of silica gel, 112% of plexiglass, 119% of polytetrafluoroethylene and 78% of Teflon. Conclusion: The method has good reproducibility and can be used for the residual detection of the material on the surface of the device after the production equipment of methocarbamo is cleaned.