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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。
The purpose of this paper is to study the preparation of gelatin microspheres for embolization and its quality evaluation. The gelatin microspheres were prepared by emulsion-chemical cross-linking method, the morphology of the microspheres was observed under an optical microscope, the particle size of the microspheres was determined, and the water absorption and swelling rate of the microspheres were measured. The microspheres’ Pressure elasticity, a new type of device was designed to measure the pressure at the time of microsphere bolus injection. The injection pressure of microspheres with different particle sizes was measured online and the amount of acetone remaining in gelatin microspheres was determined by capillary headspace gas chromatography. The obtained microspheres were oval after lyophilization, with wrinkles on the surface. After being absorbed in saline, the microspheres were round in shape and smooth in surface. The diameter of the dried microspheres is in the range of 100-1000 μm and the average particle size is 430.5 μm. The microspheres have a particle size of 150-1425 μm and an average diameter of 601.2 μm after water uptake, which is consistent with the particle size of the embolic agent. The maximum equilibrium water absorption of the microspheres was 590.7% and the average swelling rate was 103.0%. The gelatin microspheres have good elasticity. When the compressive strain is 50%, the pressure is about 0.771 ± 0.064 N for the 400-700 μm microspheres and 0.812 ± 0.153 N for the 700-850 μm microspheres. Three sets of gelatin microspheres (wet bulb 100-450, 450-700, 700-940 μm) were able to pass through the catheter with less pressure. Residual acetone content is lower than the Chinese Pharmacopoeia 2010 edition of the limit. The gelatin microspheres prepared in this study have good in vitro properties and are suitable for use as embolic agents. The established method for evaluating the properties of gelatin microspheres is helpful for the in vitro evaluation of such embolic agents.