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目的建立微球体外释放快速分析方法,考察其与体内相关性。方法制备生物可降解的利培酮微球,利用Box-Benhnken中心组合实验和响应面分析法,优化利培酮微球体外加速实验条件。结果体外加速释放最佳条件:温度48.4℃,磷酸盐缓冲液的pH4.62,有机溶剂浓度为24%。验证实验表明优选工艺参数较为理想。结论优选的体外加速释放与长期释放及体内相关性良好。
OBJECTIVE To establish a rapid method for the in vitro release of microspheres and study the correlation with in vivo. Methods The biodegradable Risperidone microspheres were prepared and optimized by Box-Benhnken central combination and response surface methodology. Results The optimal conditions for accelerated in vitro release were as follows: temperature 48.4 ℃, phosphate buffer pH4.62, organic solvent concentration 24%. Verification experiments show that the preferred process parameters are ideal. Conclusion The preferred accelerated in vitro release is associated with long-term release and in vivo correlation.