尺寸均一微球制剂的研究进展

Research progress of microsphere formulations with narrow size distribution

微球制剂是新型的给药系统,其粒径均一性非常重要,不仅影响产品批次间制备重复性,还会影响应用效果。因此,尺寸均一、可控的微球产品是医药制剂的关键核心。本团队成功发展了微孔膜乳化技术,20年来在粒径均一、尺寸可控微球的制备和应用方面进行了系统性研究。均一的微球制剂的优势有:绿色环保、降低成本,利于规模放大,批次间重复性好,利于研究构效关系。本团队制备的均一载药微球已成功应用于缓释制剂、疫苗递送及恶性肿瘤治疗中。

Microsphere preparation is a new type of drug delivery system, and its particle size uniformity is very important. It not only affects the repeatability of product batches, but also affects the application effect. Therefore,manufacture of microspheres with uniform and controlled size play key role in microsphere formulations. Our team has studied on membrane emulsification technology for more than 20 years and successfully prepared various polymer microspheres with uniform and controlled size, and applied them in formulation application. The uniform microsphere formulations have the advantages of green production, low cost, good batch-to-batch repeatability,beneficial to scale up. Furthermore, the uniform size of microsphere helps to study the structure – drug efficacy relationships. The drug-loaded microspheres prepared by our team have been successfully applied in sustainedrelease formulations, vaccines delivery and malignant tumor treatment.