目的 优化理肺清肠颗粒的制备工艺。方法 以栀子苷、黄芩苷、阿魏酸和甘草酸的保留率为评价指 标，采用单因素结合正交实验法，考察煎煮次数、加水量、煎煮时间和浸泡时间对理肺清肠汤提取工艺的影 响，并进一步优化浓缩、干燥工艺。通过筛选矫味剂、辅料的种类和用量，开展理肺清肠颗粒的成型工艺研究 和 3 批样品中试工艺研究。结果 优选的制备工艺为除芒硝外，其他饮片加水煎煮 2 次，第一次加 8 倍量水， 第二次加 6 倍量水，每次 1 h；药液合并滤过，减压浓缩至生药量为 1.0 g·mL -1 ；加入处方量芒硝和甜菊糖苷 3.4 g，待溶解后，滤过；加糊精∶乳糖（2.5∶1.5）适量，一步制粒，分装。中试工艺验证各步骤指标成分无明显 损失，制剂特征图谱与指标成分保留率与同批饮片制得汤剂近似。结论 优选的制备工艺合理可行、重现性 好，可获得与理肺清肠汤物质基础相似的颗粒剂，为理肺清肠汤开发为颗粒剂提供了实验依据。

Objective To optimize the preparation process of Lifei Qingchang Granules. Methods Using the retention rates of geniposide，baicalin，ferulic acid，and glycyrrhizic acid as evaluation indicators，the effects of decoction number，water volume，decoction time，and soaking time on the extraction process of Lifei Qingchang Decoction were investigated by single-factor tests combined with orthogonal experimental design. The concentration and drying processes were further optimized. The formation process of the granules was studied by screening the types and amounts of flavoring agents and excipients， and a pilot-scale study of three batches of samples was conducted. Results The optimized preparation process was as follows：except for Mirabilitum，the herbal pieces were decocted twice with water，the first time with eight times the amount of water and the second time with six times the amount of water，each for one hour；the decoctions were combined and filtered，then concentrated under reduced pressure to a crude drug concentration of 1.0 g·mL -1 ； the prescribed amount of Mirabilitum and 3.4 g of stevioside were added， and after dissolution， the solution was filtered； an appropriate amount of dextrin∶lactose （2.5∶1.5） was added， followed by one-step granulation and packaging. The pilot process verification showed no significant loss of indicator components in each step， and the characteristic chromatogram and retention rates of the indicator components of the prepared granules were similar to those of the decoction prepared from the same batch of herbal pieces. Conclusion The optimized preparation process is reasonable， feasible， and reproducible， yielding granules with a material basis similar to that of Lifei Qingchang Decoction，providing an experimental basis for the development of Lifei Qingchang Decoction into granule form.

R284

广东省中医药局建设中医药强省立项资助科研课题（20251229）；广州市科技计划项目（20222A010043）。