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目的以环孢素A为模型药,使用生物可降解材料乳酸/羟基乙酸PLGA制备微球。并评价微球的体外释放。方法使用乳化溶剂挥发法制备环孢素微球,并对微球的外观,粒径和载药量进行评价。通过衡量温度,pH值和表面活性剂等因素筛选体外释放介质。结果制得的微球外观圆整,粒径统一,平均粒径50μm左右,载药量为13%。DSC结果表明环孢素A和PLGA有结合作用。体外释放实验表明微球的释放受温度,pH值和表面活性剂的影响,加入30%的异丙醇可使微球在2周内释放完全。结论乳化溶剂挥发法可制备得到质量符合要求的环孢素微球,含30%异丙醇的释放介质是微球体外释放评价的理想介质。
OBJECTIVE To prepare cyclosporin A as a model drug and prepare the microspheres by using biodegradable material lactic acid / glycolic acid PLGA. The in vitro release of microspheres was evaluated. Methods Cyclosporin microspheres were prepared by the emulsified solvent evaporation method. The appearance, particle size and drug loading of the microspheres were evaluated. Screen media for in vitro release by measuring factors such as temperature, pH and surfactants. Results The obtained microspheres were round in appearance and uniform in particle size. The average diameter of the microspheres was about 50 μm and the drug loading was 13%. DSC results show that cyclosporine A and PLGA have a binding effect. In vitro release experiments showed that the release of microspheres by temperature, pH and surfactant effects, adding 30% isopropanol microspheres can be completely released within 2 weeks. Conclusion The cyclosporin microspheres with satisfactory quality can be prepared by emulsifying solvent evaporation method. The release medium containing 30% isopropanol is the ideal medium for in vitro release evaluation.