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目的用生物可降解材料明胶制备肺靶向异烟肼明胶微球。方法用乳化法制备异烟肼明胶微球,正交试验优化其制备的因素;用差示扫描量热法(DSC)和红外光谱法(IR)确证微球的形成;用正置荧光显微镜观察微球的形态;并对异烟肼明胶微球的粒径及其分布、载药量、包封率和稳定性等进行研究。结果最佳工艺条件,重现性好,微球形态圆整,药物确己存于微球中;粒径在5.0~25.0μm的微球占总数的90%以上,平均粒径为15.63μm,达到肺靶向要求;载药量和包封率分别为14.93%和73.30%。常温放置6个月,其外观形态、大小及含量基本不变。结论制备异烟肼明胶微球的工艺简单稳定,可用于肺靶向注射剂的研究。
Objective To prepare lung-targeted isoniazid gelatin microspheres with biodegradable gelatin. Methods The isoniazid gelatin microspheres were prepared by the emulsification method and the factors of their preparation were optimized by orthogonal test. The formation of microspheres was confirmed by differential scanning calorimetry (DSC) and infrared spectroscopy (IR) Morphology of microspheres; and particle size and distribution of isoniazid gelatin microspheres, drug loading, entrapment efficiency and stability were studied. Results The optimal conditions were good reproducibility and the shape of the microspheres was round. The drug did exist in the microspheres. The diameter of the microspheres with the diameter of 5.0 ~ 25.0μm accounted for more than 90% of the total number of microspheres with the average diameter of 15.63μm. Achieve lung targeting requirements; drug loading and encapsulation efficiency were 14.93% and 73.30%. Placed at room temperature for 6 months, the appearance of the shape, size and content of the same. Conclusion The process of preparing isoniazid gelatin microspheres is simple and stable and can be used for lung targeted injection.