药品中生产质量检测方案(图像粒度粒形)

DKSH The Value of Flow Imaging in Quality Assurance for DrugManufacturers 流式成像技术对于药品生产企业质量保证的价值 Today's drug manufacturers are under increasing pressure to understand the particulatecomposition of their drugs， and to reduce and control particulate in their formulations. Toreduce and control particulate matter， manufacturers must first understand its source.Traditionally， particle analysis has been accomplished via light obscuration (LO] andmembrane microscopy. While having been the accepted analytical standard methods forparticulate composition as outlined by USP <788>， experts have deemed them to beinsufficient. 如今的药物制造商面临越来越大的压力，既要了解其药物的颗粒成分，又要减少和控制其配方中的颗粒。为了减少和控制颗粒物质，制造商必须首先了解其来源。传统上，通过光阻法(LO)和膜显微镜来进行颗粒分析。虽然已经被 USP <788>收录作为标准分析方法，但专家认为它们是不够的。 National Institute of Standards and Technology protein standard imaged by the FlowCam. Proteins and non-proteinaceousparticles were captured by the FlowCam. 国家标准与技术研究所使用 FlowCam对蛋白质进行成像。上图为FlowCam 捕获的蛋白质和非蛋白质颗粒。 Particle images from flow imaging microscopes enable thorough particlecharacterization， higher quality assurance and ensure greater product safety. Flowimaging microscopy captures an image of each particle in the sample. These images arerecorded and used to calculate particle measurements， such as size and concentration.Particle morphology can be used to identify the particle and its source， as well as observe any changes in protein nature that could make the therapeutic formulation ineffective orharmful. 来自流动成像显微镜的颗粒图像可以实现全面的颗粒表征，更高的质量保证并确保更高的产品安全。流式成像显微镜捕获样品中每个颗粒的图像，并记录这些图像用于计算粒子测量值，例如尺寸和浓度。颗粒形态可用于鉴定颗粒及其来源，9以及观察可能使治疗制剂产生无效性或有害性的蛋白质性质的任何变化。 选择大昌华嘉，就是选择仪器应用专家Think Asia. Think DKSH.www.dksh-instrument.cn 电话： 邮箱： ins.cn@dksh.com 如今的药物制造商面临越来越大的压力，既要了解其药物的颗粒成分，又要减少和控制其配方中的颗粒。 为了减少和控制颗粒物质，制造商必须首先了解其来源。 传统上，通过光阻法（LO）和膜显微镜来进行颗粒分析。 虽然已经被 USP <788>收录作为标准分析方法，但专家认为它们是不够的。