喷雾干燥法制备阿奇霉素掩味肠溶缓释微球

Preparation of taste-masking enteric-coated microspheres of azithromycin by spray drying process

目的:采用喷雾干燥法制备阿奇霉素肠溶掩味微球。方法:以包封率为评价指标,对喷雾干燥工艺参数进行响应面分析法优化设计,对掩味效果进行考查。结果:最优工艺条件为雾化压力0.27 MPa,进风温度135℃,进液速度15ml/min,制得的微球外形良好,包封率可达89.8%。药物掩味效果良好;药物在人工肠液中缓慢释放,1 h释放量不超过30%,24 h不低于99%。结论:所得制备工艺可行,该方法制得的微球球形圆整,掩味效果良好,包封率较高,缓释特征良好。

Objective ： To optimize a spray drying process for preparing taste - masking enteric - coated microspheres of azithro- mycin. Methods Response surface analysis was applied to the optimization of parameters of the spray drying process, in which en- trapment ratio was measured and the taste - masking effect was investigated. Results： The optimal condition for spray drying process was as follows： temperature was 135℃ ; spray pressure was 0.27 MPa; feeding rate was 15 ml/min. Entrapment ratio could reach 89.8%, and the drug released was no more than 30% in 1 h, and not less than 99% in 24 h. Conclusion： The azithromycin microspheres prepared by the established method were round and full, with satisfying entrapment ratio, good masking effect and slow release.