目的 建立四神丸方（汤剂）19种成分同时定量分析的UPLC法，并对其提取工艺进行优化。方法 采用Accucore RP-MS C₁₈色谱柱（150 mm×2.1 mm，2.6 μm），乙腈-0.1%甲酸水溶液为流动相梯度洗脱，检测波长245 nm，建立19种成分的含量测定方法。以层次分析法获得的综合评分为评价指标，进行Box-Behnken设计-响应面试验，并对得到的最优提取工艺进行验证。结果 建立了四神丸方（汤剂）中19种成分的UPLC含量测定方法，方法学考察结果均符合要求。四神丸方（汤剂）最佳提取工艺为加水14倍量，浸泡30 min，提取3次，每次48 min。结论 建立的含量测定方法准确可靠，为该制剂质量控制和药效物质基础研究提供参考。优化的提取工艺合理可行，为四神丸方（汤剂）工业生产提供依据。

Objective A UPLC method for simultaneous quantitative analysis of 19 components in Sishen Pills (decoction, 四神丸方) was established, and its extraction technology was optimized. Methods The chromatography was performed on Accucore RP-MS C₁₈ column (150 mm×2.1 mm, 2.6 μm) with gradient elution of acetonitrile-0.1% formic acid aqueous solution as mobile phase at 245 nm. A method for the determination of 19 components was established. The Box-Behnken design-response surface test was carried out with the comprehensive score obtained by the analytic hierarchy process as the evaluation index, and the optimal extraction process was verified. Results A method for the determination of UPLC content of 19 components in Sishen Pills (decoction) was established. The results of methodology examination met the requirements. The optimal extraction process of Sishen Pills (decoction) was as follows: adding 14 times of water, soaking for 30 min, extracting three times, 48 min each time. Conclusion The method of content determination established in this study is accurate and reliable, which can provide reference for the quality control and the basic research of the pharmacodynamic substances of this preparation. The optimized extraction process is reasonable and feasible, which provides a basis for industrial production of Sishen Pills (decoction).

R283.6

国家自然科学基金资助项目（82204639）；河南省重点研发与推广专项（212102311090）