目的 建立UHPLC-DAD同时测定开心散中西伯利亚远志糖A5、西伯利亚远志糖A6、远志（口山）酮Ⅲ、3，6'-二芥子酰基蔗糖、细叶远志苷A、人参皂苷Rg₁、人参皂苷Re、β-细辛醚、α-细辛醚的含量，并比较不同高压蒸汽灭菌温度对开心散中9种指标性成分的含量影响，为开心散灭菌工艺选择提供参考。方法 高压蒸汽灭菌法（灭菌温度111、121、131℃；保持时间60 s）灭菌处理开心散散剂；采用Acquity UPLC^® BEH C₁₈色谱柱（100 mm×2.1 mm，1.7 μm）进行检测；以乙腈-0.05%磷酸水溶液为流动相进行梯度洗脱，体积流量0.3 mL/min，进样体积2 μL，柱温30℃，检测波长203 nm。结果 9种指标性成分分离度良好，各成分均具有较宽的线性范围和良好的线性关系（r²>0.999），有良好的精密度、稳定性、重复性和加样回收率。不同的高压蒸汽灭菌温度对9种指标性成分的含量均存在一定的差异，通过对不同灭菌温度灭菌后的开心散菌检和其中9种指标性成分的含量的检测对比，高压蒸汽灭菌111℃、保留60 s，菌检符合药典要求，且各成分含量变化和灭菌前样品差异最小。结论 建立的UHPLC-DAD方法可用于同时测定开心散9种指标性成分的含量，该方法操作简便、灵敏度高、准确性好、实用可靠，开心散质量控制研究提供理论依据。

Objective To establish a UHPLC-DAD method for the simultaneous determination of sibiricose A5, sibiricose A6, polygalaxanthone Ⅲ, 3,6'-disinapoyl sucrose, tenuifoliside A, ginsenoside Rg₁, ginsenoside Re, β-asarone and α-asarone in the extract of Kaixin Powder (开心散), and compare the effect of different steam autoclaving temperatures on the content of nine index components in Kaixin Powder extract, to provide reference for the selection of sterilization process for Kaixin Powder. Methods High pressure steam sterilization method (sterilization temperature 111, 121, 131℃; holding time 60 s) was performed for the sterilization process of Kaixin Powder. The chromatographic separation was achieved on a Acquity UPLC^® BEH C₁₈ column (100 mm×2.1 mm, 1.7 μm) with acetonitrile-0.05% phosphoric acid solution as mobile phase at the flow rate of 0.3 mL/min for gradient elution. The column temperature was maintained at 30℃. The wavelength was set at 203 nm. Results The results showed that the separation of the nine index components was good, and each component had a wide linear range and a good linear relationship (r² > 0.999), with good precision, stability, repeatability and sample recovery. Through the detection and comparison of the content of the nine index components in Kaixin Powder after different sterilization conditions, the autoclave sterilization sterilization was optimized at 111℃ for 60 s. The bacterial test met the requirements of Pharmacopoeia, and the content change of each component had the smallest difference with the sample before sterilization. Conclusion The established UHPLC method can be used to simultaneously determine the contents of nine index ingredients in Kaixin Powder. The method is simple to operate, highly sensitive, accurate, practical, and reliable, which provides theoretical basis for the quality control of Kaixin Powder.

R283.6

“重大新药创制”科技重大专项（2018ZX09721005）；“重大新药创制”科技重大专项（2018ZX09201011）；天津市高等学校科技发展基金计划项目（2018KJ001）