消萎灵颗粒制备工艺研究

Study on preparation process of Xiaoweiling Granules

目的研究消萎灵颗粒制备工艺,确定最佳的制备工艺条件,并拟定质量标准。方法应用正交试验研究消萎灵提取工艺,运用水煎法和喷雾干燥制粒技术进行工艺制备,通过原药材鉴别、颗粒检查和微生物限度控制消萎灵质量。结果最佳制备工艺为:处方量药材加12倍量水,煎煮提取2次,每次2.0 h,喷雾干燥制粒。结论该制备工艺可行、重现性良好。

Objective To study the preparation process of Xiaoweiling Granules and find out the optimal preparation process, and to establish specification for quality control. Methods The preparation process was optimized by orthogonal experimental design. Xiaoweiling Granules were prepared by decoction method and spraying - drying method, and the quality was controlled by identification of original medicinal material, granule check and microbial limit control. Results The optimal preparation process was as follows：the prescription was extracted twice with 12 folds of water for 2.0 h, and then granulated by spraying - drying method. Conclusion The preparation process was feasible and reproducible.