热必清颗粒辊压干法制粒工艺研究-国际中医中药杂志.PDF

·742 · 国际中医中药杂志2018年8月第40卷第8期 Int J Trad Chin Med, August 2018, Vol. 40, No.8 ·实验与方药 · 热必清颗粒辊压干法制粒工艺研究 蔡兴航 孙安敏 侯青 韩玲 【摘要】 目的 制备热必清颗粒并优化辊压干法制粒工艺参数。方法 采用辊压干法制粒工艺制 备热必清颗粒，以加料速度、辊压压力、辊压速度为考察因素，以颗粒一次成型率和溶化性为评价指标， 采用 Box-Behnken 效应面法优化辊压干法制粒工艺参数。结果 Box-Behnken 效应面法优化得到辊压干 法制粒的最佳工艺参数为：加料速度为 8.5 Hz、辊压压力为 6.0 Mpa、辊压速度为 8.5 Hz，并经过连续生 产 3 批验证，制备的热必清颗粒成型率高、溶化性好。结论 通过 Box-Behnken 效应面法优化热必清颗 粒的辊压干法制粒工艺，可提高工艺过程的稳健性，产品质量稳定可控。 【关键词】 中药工艺改进；热必清颗粒；辊压干法制粒；Box-Behnken 效应面法 * Study on rolling drying granulation of Rebiqing granules Cai Xinghang , Sun Anmin, Hou Qing, * Han Ling. Shaanxi Collaborative Innovation Center of Chinese Medicinal Resources Industralization, Xianyang 712046, China Corresponding author: Han Ling, Department of Pediatrics, the Affiliated Hospital of Shaanxi University of Chinese Medicine, Xianyang 712000, China; Email: 【Abstract 】 Objective Rebiqing granules were prepared and the rolling drying granulation process parameters were optimized. Methods According to the previous knowledge and experience, the feed rate, pressure and speed of rolling were used as the factors for investigation, and the primary forming rate and the solubility of the Rebiqing granule were taken as the evaluation indexes, and the Box-Behnken response surface method was used to optimize the rolling drying granulation parameters. Results The optimum rolling drying granulation parameters were as follows: feed rate was 8.5 Hz, rolling pressure was 6.0 Mpa and rolling speed was 8.5 Hz. After continuous production of 3 batches of validation, the Rebiqing granules had high molding rate and good solubility. Conclus