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目的选择不同分子量及成份的聚乳酸/羟基乙酸(PLGA)共聚物材料,考察粒径、表面形态、包封率、二氯甲烷残留量及体外释放的特点。方法以溶剂挥发法制备卡氮芥-聚乳酸/羟基乙酸(BCNU-PLGA)缓释微球,以扫描电子显微镜观察微球表面形态、测定微球直径,以高效液相色谱法测定微球包封率和体外药物释放,气相色谱法进行二氯甲烷残留量分析。结果BCNU-PLGA缓释微球粒径随分子量升高而增大,表面呈球形,包封率达90%,二氯甲烷残留量6．85‰,体外释放时间达3周。结论溶剂挥发法制备的BCNU-PLGA缓释微球释药可达3周以上,并维持较高药物浓度,为颅内缓释化疗提供新的方法。
Objective To select polylactic acid / glycolic acid (PLGA) copolymers with different molecular weight and composition, investigate the characteristics of particle size, surface morphology, entrapment efficiency, residual amount of methylene chloride and in vitro release. Methods BCNU-PLGA sustained-release microspheres were prepared by solvent evaporation method. The surface morphology of the microspheres was observed by scanning electron microscopy. The diameter of the microspheres was measured. The microspheres were determined by high performance liquid chromatography Gavage and in vitro drug release, GC analysis of methylene chloride residues. Results The particle size of BCNU-PLGA sustained-release microspheres increased with the increase of molecular weight, the surface was spherical, the entrapment efficiency was 90%, the residual amount of methylene chloride was 6.85 ‰ and the release time in vitro was up to 3 weeks. Conclusion The release of BCNU-PLGA microspheres prepared by solvent evaporation method can reach more than three weeks, and maintain a high drug concentration, providing a new method for intracranial sustained-release chemotherapy.