目的 建立百蕊草Thesii Herba标准汤剂的UPLC特征图谱及其指标成分的含量测定方法；研究百蕊草药材与标准汤剂特征图谱的变化，并分析指标成分百蕊草素I在药材-标准汤剂的量值传递规律。方法 采用Waters Acquity UPLC BEH Shield RP₁₈色谱柱（150 mm×2.1 mm，1.7μm），流动相为乙腈-0.2%甲酸水溶液，梯度洗脱，体积流量0.4 mL/min，检测波长330、270 nm，柱温30℃，建立特征图谱与含量测定方法。以出膏率、含量及转移率、特征图谱共有峰传递数为主要评价指标，分析百蕊草标准汤剂的量值传递规律。结果 19批百蕊草药材、标准汤剂与各自的对照特征图谱相似度分别为0.986～1.000、0.989～1.000。百蕊草标准汤剂特征图谱标定6个共有峰，药材中的5个共有峰全部转移至标准汤剂并被指认，其中4个共有峰采用对照品比对确认，分别为5-O-阿魏酰奎宁酸（峰2）、4-O-阿魏酰奎宁酸（峰3）、百蕊草素I（峰5）、山柰酚-3-O-(2''-O-α-鼠李糖基-6''-O-丙二酰基)-β-葡萄糖苷（峰6）。19批标准汤剂的平均出膏率为27.45%，百蕊草素I从药材-标准汤剂的平均转移率为89.48%，出膏率与转移率均未出现离散数据。结论 建立的标准汤剂特征图谱及含量测定方法稳定可靠，百蕊草素I从药材到标准汤剂的量值传递结果表明，百蕊草标准汤剂的质量得到了较好地控制，其制备工艺具有科学性、可行性，为百蕊草配方颗粒的质量标准制定奠定基础。

Objective To establish the UPLC characteristic spectrum of the standard decoction of Bairuicao (Thesii Herba) and the content determination method of its index components, study the changes of the characteristic spectra of Thesii Herba and standard decoction, and analyze the quantity transfer law of the index component kaempferol-3-O-glucorhamnoside in the medicinal material standard decoction. Methods Analysis was performed on a Waters Acquity UPLC BEH Shield RP₁₈ (150 mm×2.1 mm, 1.7 μm) column with acetonitrile-0.2% formic acid for gradient elution. The flow rate was 0.4 mL/min, the detection wavelength was 330 nm, and the column temperature was 30 ℃. The characteristic spectrum and content determination method were established. The delivery rate, content and transfer rate, and the number of common peaks in the characteristic spectrum were used as the main evaluation indexes to analyze the quantitative transmission law of the standard decoction of Thesii Herba. Results The similarity of 19 batches of Thesii Herba and standard decoction with their respective control characteristic maps was 0.986—1.000 and 0.989—1.000, respectively. There were six common peaks in the calibration of the characteristic spectrum of the standard decoction of Bairuicao (Thesium chinense). All the five common peaks of the medicinal materials were transferred to the standard decoction and identified. Among them, four chromatographic peaks were confirmed by comparison with the reference materials, namely 5-O-ferulic quinic acid (peak 2), 4-O-ferulic quinic acid (peak 3), kaempferol-3-O-glucorhamnoside (peak 5), kaempferol-3-O-(2″-O-α-rhamnose-6″-O-malonyl)-β-glucoside (peak 6). The average extraction rate of 19 batches of standard decoction was 27.45%, and the average transfer rate of kaempferol-3-O-glucorhamnoside from Thesii Herba to standard decoction was 89.48%. There was no discrete data of extraction rate and transfer rate. Conclusion The established characteristic map and content determination method of standard decoction are stable and reliable. The results of the transmission of the quantity of kaempferol-3-O-glucorhamnoside from Thesii Herba to the standard decoction show that the quality of the standard decoction of Thesii Herba has been better controlled, and the preparation process is scientific and feasible, which lays a solid foundation for the formulation of the quality standard of the prepared granules of Thesii Herba.

R283.6

国家重点研发计划“中医药现代化研究”重点专项（2019YFC1711505）；安徽省药品监督管理局监管科学研究重点项目（AHYJ-KJ-202210）