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目的:以冠心平为模型药物,优选中药半浸膏片的制粒最佳工艺。方法:通过单因素考察,确定制粒的最佳粘合剂;采用L_9(3~4)正交试验法,以粘合剂浓度、用量及软材搅拌时间作为考察因素,通过颗粒粉体学和片芯的几个质量指标的综合评分,优选出冠心平片的最佳(湿法)制粒工艺。结果:最佳工艺条件为:采用2%浓度的羟丙甲基纤维素浆溶液,用量为浸膏粉量的26%,软材混合时间为8 min。结论:确定的制粒工序生产工艺参数适用于冠心平片的制粒。
Objective: Taking Guanxinping as a model drug, the optimal granulation process of traditional Chinese medicine semi-extract tablets was optimized. Methods: The best binder for granulation was determined by single factor test. Using L_9 (3 ~ 4) orthogonal test method, binder concentration, dosage and mixing time of soft material were taken as the investigation factors. And tablet cores several quality indicators of the overall score, the best out of coronary heart plate (wet) granulation process. Results: The optimum conditions were as follows: using 2% hydroxypropyl methylcellulose pulp solution, the dosage was 26% of the extract powder, the soft material mixing time was 8 min. Conclusion: The established process parameters of granulation process are suitable for granulation of Guanxin tablets.