湿法制粒工艺参数对颗粒成型性的影响

Effect of parameters of wet granulation process on the particle quality

目的通过对中药制粒过程中影响因素的考察为中药物料的制粒工艺设计提供参考。方法选取不同类型的中药物料,以颗粒得率和颗粒的粒径分布等为考察指标,对影响制粒结果较为显著的物料的吸湿性、润湿剂、干燥温度、辅料等因素进行试验分析。结果三七粉平衡吸湿量为12.905%,吸湿性最小,在60%的乙醇浓度下颗粒得率和20-60目的颗粒所占的比例较大,干燥温度、辅料等对其影响较小。其他含中药浸膏的粉末平衡吸湿量达到20%以上,黏性大,需要用80%的乙醇、干燥温度〉50℃的条件下才能较好地制粒,加入适宜的辅料能显著提高颗粒得率,其中祛白复方浸膏粉加入预胶化淀粉后颗粒得率〉80%。结论各类型中药粉末湿法制粒中物料性质、制备条件、辅料等过程参数对颗粒成型性有显著的影响。

Objective To investigate the factors of wet granulation and provide reference for the granulation process. Methods We selected different types of traditional Chinese medicine materials, with particle yield percentage and particle size distribution for evaluation index, and analyzed the hygroscopicity, wetting agents, drying temperature, excipient and so on, which all had a significant effect on the granulation. Results The equilibrium moisture absorption of Pseudo-ginseng powder was 12.905%, the hygroscopic was little, the particle yield percentage and the proportion in 20- 60 mesh granules were high under 60% ethanol concentration, while the drying temperature and excipient had little effect on the granulation. The equilibrium moisture absorption of other medicine extract powder was more than 20%, the hygroscopicity was good, the granulating condition was 80% ethanol concentration and more than 50 ℃ drying temperature. Materials significantly improved the particle yield percentage. After adding the pre-gelatinized starch, particle yield percentage of Qubai Fufang extract powder was more than 80%. Conclusion Parameters such as nature of the material, preparation conditions, excipients and so on have a significant effect on the particle quality of different traditional Chinese medicine powder in wet granulation.