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、0.2 μm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/mL，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0.2 μm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 evaluate the optimal separation and purification processes of water extract, the analytic techniques of particle size analysis, powder fluidity testing, and scanning electronic microscope were adopted to compare the influence factor of different separation and purification techniques on microscopic preparation characteristic of intermediate product prepared from water extract of traditional Chinese medicine (TCM) formula purification. Methods Taking Gubi Granules (GG) which have established the production technology and quality standards in the previous study as an example, three common techniques used for water extract of TCM formula purification, including ethanol precipitation, column chromatogram of macroporous resin, and membrane separation, were applied to preparing the intermediate of GG. Results Through the comprehensive analysis of fluidity, adhesive property, compressibility, permeability, particle microstructure and particle size distribution, it was found that membrane separation could obtain intermediates with better performance, which was conducive to the subsequent granulation, tabletting, and other process smoothly. The operating conditions for liquid concentration were 0.05 g crude drug/mL, 30℃ liquid temperature, 0.15 MPa pressure and 5 m/s flow rate. Conclusion The different spray dried powders varied greatly. The membrane separation method of 0.2 μm Al₂O₃ ceramic was selected as the optimal process for separating and purifying of water extract of GG by analyzing the influencing factors of the pharmaceutical properties.

国家自然科学基金面上项目（81673610）；国家“十二五”重大新药创制专项（2011ZX09401-308-037）；江苏省科技厅重点研发计划-社会发展面上项目（BE2016754）；江苏省六大人才高峰项目（2014-YY-014）；江苏省“青蓝工程”资助