目的 探索桃红四物汤(Taohong Siwu Decoction,TSD)药材-饮片-水煎液-基准样品的全过程质量传递规律,为其经典名方制剂质量控制研究提供基础。方法 制备15批TSD水煎液、基准样品,建立水煎液、基准样品超高效液相色谱(ultraperformanceliquidchromatography,UPLC)特征图谱,并采用高效液相色谱(high performance liquid chromatography,HPLC)法测定5种指标性成分的含量,计算各成分在药材-饮片-水煎液-基准样品传递过程中的转移率。结果 15批TSD水煎液和基准样品的特征图谱,相似度均>0.9,共归属20个共有峰,经与对照品比对指认出11个色谱峰,分别为没食子酸、地黄苷D、苦杏仁苷、绿原酸、芍药苷、羟基红花黄色素A、阿魏酸、毛蕊花糖苷、槲皮素、苯甲酰芍药苷、藁本内酯。5种成分在水煎液、基准样品中的质量分数分别为地黄苷D0.26~0.46、0.11~0.30mg/g,阿魏酸0.33~0.51、0.09~0.18mg/g,芍药苷1.07~2.43、0.48~1.49mg/g,苦杏仁苷1.66~2.31、0.60~1.58mg/g,羟基红花黄色素A0.98、0.26~0.44mg/g。药材至饮片、饮片至水煎液、水煎液至基准样品的平均转移率分别为地黄苷D101.50%、55.44%、64.11%;阿魏酸94.31%(当归药材至饮片)、93.91%(川芎药材至饮片)、37.24%、35.61%;芍药苷111.55%、72.80%、63.48%;苦杏仁苷117.34%、91.78%、64.60%;羟基红花黄色素A93.64%、60.23%、34.19%。结论 采用UPLC特征图谱结合5种成分的HPLC含量测定,分析TSD药材-饮片-水煎液-基准样品的量值传递规律,为TSD经典名方制剂开发和质量控制提供科学基础。

Objective Exploring the whole process quality transmission rule of herb-herbal pieces-water decoction-benchmark sample of Taohong Siwu Decoction (TSD, 桃红四物汤), so as to provide a basis for the quality control of classic formula preparations. Methods A total of 15 batches of TSD water decoction and benchmark sample were prepared, UPLC characteristic chromatograms were established, and the contents of five components were determined by HPLC method, and the transfer rates of each component during the transmission of herb-herbal pieces-water decoction-benchmark samples were calculated. Results The similarity of 15 batches of water decoction and benchmark sample > 0.9, 20 common peaks were assigned, and 11 peaks were identified by comparison with reference substances, including gallic acid, rehmannioside D, amygdalin, chlorogenic acid, paeoniflorin, hydroxysafflor yellow A, ferulic acid, verbascoside, quercetin, benzoylpaeoniflorin, ligustilide. The mass fraction of the five components in the water decoction and benchmark samples were respectively: rehmannioside D were 0.26—0.46, 0.11—0.30 mg/g, ferulic acid were 0.33—0.51, 0.09—0.18 mg/g, paeoniflorin were 1.07—2.43, 0.48—1.49 mg/g, amygdalin were 1.66—2.31, 0.60—1.58 mg/g, hydroxysafflor yellow A were 0.98, 0.26—0.44 mg/g. The average transfer rates of herb to herbal pieces, herbal pieces to water decoction and water decoction to benchmark sample were respectively: rehmannioside D were 101.50%, 55.44%, 64.11%; ferulic acid were 94.31% [Danggui (Angelicae Sinensis Radix) to herbal pieces], 93.91% [Chuanxiong (Chuanxiong Rhizoma) to herbal pieces), 37.24% and 35.61%; paeoniflorin were 111.55%, 72.80% and 63.48%, amygdalin were 117.34%, 91.78% and 64.60%, and hydroxysafflor yellow A were 93.64%, 60.23% and 34.19%. Conclusion Using UPLC characteristic chromatogram and content determination of five components, to analyze the value transmission rule of TSD herb-herbal pieces-water decoction-benchmark sample, providing scientific basis for the development and quality control of classic formula.

R283.6

四川省科技计划项目（2021YFS0256）；四川省科技计划项目（2020YFS0567）；中药制剂过程新技术国家重点实验室开放基金资助项目（SKL2020Z0305）