基于响应面法优选消炎抗菌颗粒的成型工艺

本试验旨在优选出消炎抗菌颗粒制剂最佳的成型工艺。通过采用单因素试验法，研究消炎抗菌颗粒最佳药物辅料构成及制备条件，利用综合评分筛选出最佳的辅料种类、最佳的润湿剂浓度及颗粒的最佳干燥温度，然后其制剂成型工艺通过使用响应面星点设计进行优化。结果表明:消炎抗菌颗粒最佳制剂成型工艺的条件为浸膏∶辅料质量比为1∶2.54，润湿剂为质量分数60%的乙醇，颗粒干燥温度为50℃，并且消炎抗菌颗粒制备贮存的临界相对湿度应控制在66%以下。经重复性试验可知，消炎抗菌颗粒的最佳制剂成型工艺是稳定、可行的。

Optimization of Xiaoyankangjun Granules′ Molding Process by Response Surface Methodology

The purpose of this experiment is to optimize the molding process of xiaoyankangjun granules. The composition and preparation conditions of the best excipients for xiaoyankangjun particles were studied by single factor test method. The best excipients， the best wetting agent concentration and the best drying temperature of the particles were selected by comprehensive scoring method. Then the molding process was optimized by using response surface star design. The results showed that the optimum conditions for the preparation of xiaoyankangjun granules are dry extract: excipient ratio of 1∶2.54，wetting agent of 60% ethanol， particle drying temperature of 50?℃， and the critical relative humidity of preparation and storage of xiaoyankangjun granules should be controlled below 66%. The reproducibility test showed that the optimal preparation process of xiaoyankangjun granules was stable and feasible.