不同干燥方法下厚朴温中汤物质基准关键质量属性的差异*

目的:对比研究厚朴温中汤煎煮液在不同干燥方法下得到的物质基准关键质量属性（指纹图、指标成分含量、干粉性状），优化干燥工艺，为厚朴温中汤颗粒制备工艺提供可靠依据。方法：采用超高压液相色谱法测定提取液及不同干燥方法所得物质基准的指纹图，采用高效液相色谱法测定不同物质基准的指标成分（厚朴酚、和厚朴酚、橙皮苷）含量，对提取液以及真空干燥、喷雾干燥、冷冻干燥制得的厚朴温中汤物质基准的UPLC指纹图、指标成分含量、干粉性状进行对比分析。结果:通过对三种干燥方法所得物质基准关键质量属性与提取液比较，发现各物质基准UPLC指纹图与提取液的相似度均大于0.9，喷雾干燥与冷冻干燥所得物质基准指标成分含量高于真空干燥，冷冻干燥所得干粉疏松多孔、流动性差、复溶性好，真空干燥、喷雾干燥所得干粉流动性较好，复溶速率较慢。结论：冷冻干燥、喷雾干燥所得物质基准化学成分轮廓与煎煮液相似度高，指标成分保留率较高，前者粉末复溶性好，适用于制备厚朴温中汤物质基准，后者粉体流动性好，利于制剂成型，适用于厚朴温中颗粒工业生产。

Differences in Key Quality Attributes of Substance Benchmark of Houpu Wenzhong Tang Decoction by Different Drying Methods

Objective: Comparative study on the key quality attributes (fingerprint, index component content, and dry powder properties) of Houpu Wenzhong Tang decoction by different drying methods, optimizing the drying process, and providing a reliable basis for the preparation process of Houpu Wenzhong granules. Methods: UPLC was used to determine the fingerprint of dry powder by different drying methods, and the content of index components (Magnolol, Honokiol, Hesperidin) of different dry powder was determined by HPLC. The UPLC fingerprint similarity, index component content, and dry powder properties of substance benchmark of Houpo WenZhong decoction prepared by vacuum drying, spray drying, and freeze drying were analyzed to optimize drying methods. Results: By comparing the key quality attributes of the substance benchmark by the three drying methods, it was found that the similarity of UPLC fingerprint was more than 0.9, the index components content of substance benchmark by spray drying and freeze drying was higher than that by vacuum drying, and the dry powder obtained by freeze drying was loose and porous, with poor fluidity and good re-solubility. The dry powder obtained by vacuum drying and spray drying had good fluidity and slow re dissolution rate. Conclusion: The chemical composition of the dry powder obtained by freeze-drying and spray drying is highly similar to that of the decoction, and the retention rate of the index composition is high. The former has good powder re-solubility, which is suitable for preparing the substance benchmark of Houpu Wenzhong Decoction. The latter has good powder liquidity, which is conducive to the formation of the preparation, and is suitable for the industrial production of Houpu Wenzhong Granules.