目的采用粒径分析、粉末流动性测试和电镜扫描等分析技术,比较分析不同分离精制工艺对中药复方水提液经分离精制所得中间体的微观制剂学性质影响因素,评价预测水提液分离精制的最优工艺。方法以前期已建立生产工艺和质量标准的中药复方骨痹颗粒为例,对复方水提液分别采用95%乙醇使得含醇量达到50%、D101大孔树脂吸附并且用70%乙醇洗脱、0.2μm氧化铝陶瓷膜进行精制分离,制备3种制剂中间体,并比较流动性、粘结度、压缩性、透气性、粒子微观结构、粒径分布等微观制剂学性质。结果采用3种常用于中药复方水提液分离精制工艺(乙醇沉淀法、大孔吸附树脂法和膜分离法)制备的骨痹颗粒喷干粉,通过综合分析可知,膜分离法所得中间体的各项性质均较其他2种工艺好,易于后续的制粒、压片等工艺顺利进行,操作条件:药液质量浓度为生药0.05 g/m L,药液温度30℃,压力0.15 MPa,流速5 m/s。结论不同分离精制工艺所得喷干粉的制剂学性质差异较大,通过分析影响喷干粉吸湿性、流动性、压缩性等性质的因素,选择0.2μm氧化铝陶瓷膜分离法作为骨痹颗粒水提液分离精制的最优工艺。 OBJECTIVE To analyze the influencing factors on the microscopic properties of the intermediates obtained from the separation and purification of traditional Chinese medicine aqueous extracts by means of particle size analysis, powder fluidity test and scanning electron microscopy. The best technology. Methods The traditional Chinese medicine compound Gubi Granule with production technology and quality standard was used as an example. The content of alcohol in the compound aqueous extract was 50% with 95% ethanol, D101 macroporous resin was adsorbed and eluted with 70% ethanol, 0.2μm alumina ceramic membrane were purified and separated to prepare three kinds of preparation intermediates and to compare the micro-formulation properties such as fluidity, adhesiveness, compressibility, air permeability, particle microstructure and particle size distribution. Results Three kinds of Gubi granule spray-dried powder, which is commonly used in traditional Chinese medicine compound aqueous extract separation and purification process (ethanol precipitation method, macroporous adsorption resin method and membrane separation method) were used. Through comprehensive analysis, it can be seen that each of the intermediates obtained by membrane separation The properties were all better than those of the other two kinds of processes, and the processes such as pelletization and tabletting were easy to follow. The operating conditions were as follows: crude drug concentration of 0.05 g / m L, liquid temperature of 30 ℃, pressure of 0.15 MPa and flow rate of 5 m / s. CONCLUSION: The preparation of spray-dried powder with different separation and purification technology has quite different preparation properties. By analyzing the factors affecting the hygroscopicity, fluidity and compressibility of dried powder, 0.2 μm alumina ceramic membrane separation method was selected as the water extract of Gubi Granule Separation and purification of the best technology.