皮寒感舒颗粒的制备工艺研究

Study on the preparation process of Pihan Ganshu granules

目的优选皮寒感舒颗粒的制备工艺。方法采用正交设计法,以皮寒药水提液的干膏收率、高丽槐素及芒柄花素的含量为评价指标,优化皮寒感舒颗粒原料药的水提醇沉及浓缩工艺;采用单一变量法,以成型率、溶化性及吸收率为评价指标,优化皮寒感舒颗粒的制粒工艺。结果最佳水提工艺为A3B2C1D3,即样品药材粒度为粗粉、每次加水量为12倍、分别提取2次、每次0.5 h;最佳醇沉工艺为A2B2C3,即将药液浓缩至相对密度1.10、用60%乙醇沉淀18 h;最佳浓缩工艺为：在70℃减压条件下,将药液浓缩至相对密度1.201.25;最佳制粒工艺为：以葡萄糖为辅料、浸膏与辅料比例为1∶4、采用75%乙醇为润湿剂、于60℃干燥2 h。结论所用工艺条件稳定、可控、提取率高,可为皮寒感舒颗粒的深入研究提供参考。

OBJECTIVE To optimize the preparation process of Pihan Ganshu granules. METHODS Orthogonal design method was adopted, taking the contents of maackiain and fermononetin as the evaluation indexes. The water extraction alcohol precipitation and concentration process of raw material medicine in Pihan Ganshu granules were optimized. Taking molding rate, melting rate and absorp- tion rate as evaluation indexes, the single variable method was adopted to optimize the forming process of Pihan Ganshu granules. RESULTS The best water extraction process was A3B2C1D3. The sample was coarse powder,the water was added by 12 fold each time ,extracted three times with each extracting time of 0.5 h. The best conditions for the pure precipitation process was AaB3C1. The liquor was concentrated to the relative density of 1. 10, and alcohol precipitation was for 18 hours with the ethanol concentration of 60%. The best conditions for the concentration process ： Under the condition of 70℃, concentrated the liquid to relative density of 1.20 - 1.25 ,glucose as excipient,proportion of extract and excipient was 1 ： 4,75% ethanol as wetting agent,and drying time of 2 h. CONCLUSION This technology is stable, controllable and effective. It provides a reference for the Pihan Ganshu granules preparation process.