目的 采用混料设计的方法，对当归补血汤（Danggui Buxue Decoction，DBD）水提液进行喷雾干燥工艺研究，重点考察阿魏酸、藁本内酯等热不稳定性成分的保留率，优化喷雾干燥工艺。方法 以DBD喷干粉得率、吸湿性、流动性及指标性成分藁本内酯的含量为评价指标，对辅料进行筛选，同时基于混料设计对筛选辅料配比进行优化；在此基础上以喷干粉得率、阿魏酸、毛蕊异黄酮葡萄糖苷、藁本内酯含量及保留率，为指标进一步优化喷雾干燥工艺参数。结果 筛选辅料为羟丙基-β-环糊精、微粉硅胶和微晶纤维素，分别建立喷干粉得率、吸湿率、休止角与筛选辅料配比的回归方程，并优选辅料配比为干膏-羟丙基-β-环糊精-微粉硅胶-微晶纤维素0.500∶0.226∶0.222∶0.052；优选DBD喷干工艺参数为进风温度170 ℃，空气流速37 m³/h，雾化压力0.061 MPa，此条件下喷干粉得率为58.92%，阿魏酸保留率为50.26%，毛蕊异黄酮葡萄糖苷保留率为54.98%，藁本内酯保留率为27.74%。结论 优选的辅料及其配比能较好提高喷雾干燥产率，改善喷干粉性质，优选的工艺条件较好保留阿魏酸、藁本内酯等热不稳定性成分，可为后续DBD制剂研究打下基础，同时为其他中药复方提取液喷雾干燥研究提供参考。

Objective To study the spray drying process of the water extract of Danggui Buxue Decoction (当归补血汤, DBD) by using the method of mixture design, and optimize the spray drying process by focusing on the retention rate of ferulic acid, ligustilide and other thermally unstable ingredients. Methods The dry powder yield, hygroscopicity, fluidity and the content of index component ligustilide of DBD were used as evaluation indexes to screen the excipients, and the ratio of the screened excipients was optimized based on mixture design. On this basis, the spray drying process parameters were further optimized with the yield of spray dried powder, ferulic acid, calycosin-7-O-β-D-glucoside, ligustilide content and retention rate as indicators. Results The screened excipients were hydroxypropyl-β-cyclodextrin, micropowder silica gel and microcrystalline cellulose. The regression equations of spray-drying powder yield, moisture absorption rate, repose angle and the ratio of the screened excipients were established, and the preferred ratio of excipients was 0.500∶0.226∶0.222∶0.052 for dry paste-hydroxypropyl-β-cyclodextrin-micronized silica gel-micronized cellulose. The optimal spray-drying process parameters of DBD were air inlet temperature of 170 ℃, air flow rate of 37 m³/h, and the atomization under the pressure of 0.061 MPa. Under such conditions, the yield of spray-dried powder was 58.92%, the retention rate of ferulic acid was 50.26%, the retention rate of calycosin-7-O-β-D-glucoside was 54.98%, and the retention rate of ligustilide was 27.74%.Conclusion The optimized excipients and their proportions in this study can better improve the yield of spray drying, improve the properties of spray-dried powder. The optimized process conditions can better retain the thermally unstable components such as ferulic acid and ligustilide, which can lay the foundation for the subsequent study of DBD preparations, and provide a reference for the study of spray drying of other traditional Chinese medicine compound extracts.

R283.6

国家自然科学基金资助项目（82074004）；国家自然科学基金资助项目（81773910）；国家重点研发计划项目（2019YFC1710603）；2020年度江苏省高校“青蓝工程”资助项目