目的 通过分析桃红四物汤（Taohong Siwu Decoction，TSD）合煎和单煎混合冻干粉之间化学成分、核心药效的差异性，探讨TSD经典名方制剂与单味药配方颗粒临床灵活应用的合理性。方法 采用UPLC-Q-Exactive Orbitrap/MS对TSD基准样品合煎与单煎混合样品进行定性鉴定分析，同时测定合煎与单煎混合样品中9种指标成分的含量，比较单煎与合煎样品中成分的差异；并从调经止痛的核心药效建立大鼠急性痛经模型，对比评价二者药效差异。结果 通过UPLC-Q-Exactive Orbitrap/MS技术分析初步鉴定并归属TSD合煎和单煎冻干粉中共有31种化学成分，在成分种类上无明显差异；进一步测定其中9种成分的含量，结果表明，单煎混合样品比较于合煎样品，芍药苷、芍药内酯苷、羟基红花黄色素A含量相对降低，而没食子酸、绿原酸、阿魏酸、洋川芎内酯I、5-羟甲基糠醛、毛蕊花糖苷含量相对升高，且对9种成分含量进行统计学分析表明二者之间含量未有明显差异（P>0.05），说明这些成分不受合煎与单煎体系的影响；干膏得率结果表明，单煎混合样品的平均干膏得率与合煎样品差异不大。调经止痛核心药效实验结果表明，与模型组相比，合煎与单煎混合样品组均能延长大鼠扭体潜伏期、降低扭体次数，显著降低血清中前列腺素F_2α（prostaglandin F_2α，PGF_2α）、前列腺素E₂（prostaglandin E₂，PGE₂）、血管内皮生长因子（vascular endothelial growth factor，VEGF）与子宫组织中Ca²⁺、内皮素-1（endothelin 1，ET-1）、NO水平（P<0.05），改善子宫上皮细胞炎症、水肿等病理变化，具有一定的缓解痛经作用，合煎和单煎混合样品在功效上未见显著差异。结论 TSD复方合煎与单煎基准样品在化学成分种类、含量及核心药效上均未见明显差异，为其复方制剂与单味药配方颗粒制剂的临床合理应用与评价提供参考依据，也进一步为实现在古代经典名方基础上随证加减单味药配方颗粒的临床个性化用药方式提供研究基础。

Objective In order to study the differences in chemical composition and core efficacy between the combined decoction and single decoction of Taohong Siwu Decoction (TSD, 桃红四物汤), explore the rationality of the flexible application of classic prescription preparation and single prescription granules of TSD in clinic. Methods UPLC-Q-Exactive Orbitrap/MS was used to identify and analyze the composition of combined decoction and single decoction mixed samples of TSD. Further, the contents of nine index components of them were simultaneously determined to compare and analyze their difference. And the differences in core efficacy of them were evaluate when the rat model of acute dysmenorrhea was established from the core efficacy of regulating menstruation and relieving pain. Results Through UPLC-Q-Exactive Orbitrap/MS technology analysis, 31 chemical components were preliminarily identified and attributed to both TSD combined decoction and single decoction. There were no significant differences in the types of components. Further, the results of nine components contents showed that compared with the combined decoction samples, the content of albiflorin, paeoniflorin, and hydroxysafflor yellow A in the single-decocted mixed sample was relatively lower, while the content of gallic acid, chlorogenic acid, ferulic acid, senkyunolide I, 5-hydroxymethylfurfural and verbascoside were relatively increased. Then statistical analysis of the contents of nine components showed that there was no significant difference in the contents between the two samples (P > 0.05), indicating that these components were not affected by combined or single decoction system. The results of dry paste yield showed that the average dry paste yield of combined decocting and single decoction were 46.64% and 47.08%, respectively, but there was no significant difference between combined and single sample. The results of the core efficacy experiment showed that the combined decoction group and single-decocted mixed sample group can prolong the writhing latency, reduce the number of writhing, and significantly reduce PGF_2α, PGE₂, VEGF levels in the serum and ET-1, Ca²⁺ and NO levels (P < 0.05) in the uterine tissue, improve uterine epithelial cell inflammation, edema and other pathological changes, and had a certain effect on alleviating dysmenorrhea, but both combined decoction and single-decocted mixed group had little significant difference in the core efficacy of regulating menstruation and relieving pain. Conclusion TSD compounds in combined decoction and single decoction have no significant difference in the chemical composition types and content, and core drug efficacy. It provides a reference for the clinical rational application and evaluation of its compound preparation and single-decoction formula granule preparations. Moreover, this also further provides basic research for the realization of the clinical personalized medicine method of adding or subtracting single-decoction formula granule preparations according to the basis on the basis of ancient classic prescriptions.

R283.6

四川省科技计划项目（2020YFS0567）；四川省科技计划项目（2021YFS0256）