扫描电子显微镜在缓释微球制剂表征中的应用进展  

Progress in Characterization of Controlled Release Microspheres Using Scanning Electron Microscope

作　　者：陈超 樊海丽 蔡志威 张传杰 CHEN Chao;FAN Hai-li;CAI Zhi-wei;ZHANG Chuan-jie(Zhejiang Institute for Food and Drug Control,Hangzhou 310052,China;Phenom Scientific Instrument(Shanghai)Co.Ltd.,Shanghai 201100,China;LANBO(Suzhou)Intelligent Technology Co.Ltd.,Suzhou 215100,Jiangsu China)

机构地区：[1]浙江省食品药品检验研究院,浙江杭州310052 [2]复纳科学仪器(上海)有限公司,上海201100 [3]兰波(苏州)智能科技有限公司,江苏苏州215100

出　　处：《分析测试技术与仪器》2022年第2期132-138,共7页Analysis and Testing Technology and Instruments

基　　金：2021年度国家药品标准制修订研究课题(2021Y05)。

摘　　要：综述扫描电子显微镜在缓释微球制剂表征中的重要应用.采用扫描电子显微镜法对缓控释微球制剂进行表征,采用自动颗粒粒形、粒径图像识别法对微球进行统计学分析,对扫描电子显微镜在控释微球制剂研发过程中的4个广泛应用场景进行论证和总结.缓控释微球制剂学是高度依赖结构学的制剂类型,其性能和治疗功效很大程度上取决于微球的微观特性,如结构、孔径等.微球颗粒的尺寸及粒度分布、形状对药物释放起决定性作用.扫描电子显微镜具有所见即所得的优势,可以很直观的对微球颗粒的粒径、粒形以及表面粗糙情况进行快速评估.由于微球制剂高药物载量的特点,其批间一致性尤为重要,科学的图像识别分析方法对批间一致性的评估具有重要应用价值.结果表明,扫描电子显微镜在微球的研发与生产控制中具有广泛的应用价值,为此类型制剂的研发提供了先进的表征工具.The important applications of scanning electron microscopy(SEM)in the characterization of controlled release microspheres are reviewed.The SEM method was used to characterize the microspheres,and the SEM-based automatic particle shape and size analysis software was used to perform statistical analysis of the microspheres,and the key application scenarios of SEM in the scientific research or development of microspheres were summarized.Microspheres are a type of formulation that is highly dependent on structure,and its performance and therapeutic effects are largely determined by their microscopic features such as structure and porosity.The size,particle size distribution and shape of microspheres play a decisive role in the drug release.Due to the characteristics of high drug loading,the interbatch consistency of microspheres is particularly important.Image analysis tools are of great significance for the characterization of interbatch consistency.SEM has the advantage of what you see is what you get,and can quickly evaluate the particle size,shape and surface roughness of microspheres intuitively.The results showed that the SEM has a wide application value in the production control and development of microspheres,and provides an advanced characterization tool for research and development of this type of preparation.

关 键 词：扫描电子显微镜 微球制剂 控释 粒度分布 微观形貌 

分 类 号：TN16[电子电信—物理电子学] R284.1[医药卫生—中药学]