栓塞用明胶微球的制备及其性质评价(英文)

本文目的是研究栓塞用明胶微球的制备及其质量评价。采用乳化-化学交联法制备明胶微球,以光学显微镜观察微球的形态、测定微球的粒径,并测定了微球的吸水率和溶胀率;采用质构仪测定了微球的抗压弹性,为测量微球经导管推注时的压力设计了一种新型装置。在线测定了不同粒径微球的推注压力,以毛细管顶空气相色谱法测定了明胶微球中残留的丙酮量。所得微球冻干后呈椭圆形,表面有褶皱,在生理盐水中吸水后形状圆整,表面光滑。干燥微球的粒径范围在100-1000μm,平均粒径为430.5μm;吸水后微球的粒径范围在150-1425μm,平均粒径为601.2μm,符合栓塞剂的粒径需要。微球最大平衡吸水率为590.7%,平均溶胀率为103.0%。明胶微球的弹性良好,压缩形变到50%时,对于400-700μm微球的压力为(0.771±0.064)N,对于700-850μm微球的压力为(0.814±0.153)N。三组明胶微球(湿球100-450,450-700,700-940μm)都能够以较小的压力通过导管。残余的丙酮含量低于中国药典2010版的限度。本研究制备的明胶微球体外性质良好,适于作栓塞剂使用;建立的评价明胶微球性质的方法有助于此类栓塞剂的体外评价。

Preparation and in vitro evaluation of gelatin microspheres for embolization

The objective of this research was to develop gelatin microspheres(GMSs) and study their properties for embolization.The GMSs were prepared by emulsion chemical crosslinking method.The morphology and particle size of GMSs were observed under an optical microscope.The ratio of water absorption and GMSs swelling ratio were measured.The elasticity of GMSs was studied by TMS-Pro food texture analyzer.The deliverability of GMSs through catheter was investigated with a new device designed in this study.Finally,the acetone residue was determined by headspace capillary gas chromatography.The dried GMSs were elliptic with corrugated surface and the wet GMSs were round with smooth surface.The average diameter of dried GMSs was 430.5 μm with a range of 100-1000 μm,and that of wet GMSs was 601.2 μm with a range of 150-1425 μm.The maximum ratio of water absorption was 590.7% and the average swelling ratio was 103.0%.The elasticity of GMSs was proven to be appropriate for embolization.Three subgroups of wet GMSs(100-450 μm,450-700 μm and 700-940 μm) were delivered through catheter with acceptable pressure.The content of residual acetone in GMSs was less than the minimum limit in the Chinese Pharmacopoeia 2010.Therefore,we concluded that the GMSs were suitable for embolization according to the applicable properties in vitro.And the methods for assessing the properties of GMSs in this study were going to be useful in the evaluation of embolic microspheres.