目的 優(yōu)選虎力散最佳提取工藝，為其制劑二次開發(fā)提供依據(jù)。方法 建立指標成分8-去乙酰滇烏堿（8-deacetyl yunaconitine，8DY）、滇烏堿、三七皂苷R₁（notoginsenoside R₁，R₁）、人參皂苷Rg₁（ginsenoside Rg₁，Rg₁）、人參皂苷Rb₁（ginsenoside Rb₁，Rb₁）、告達亭和黨參炔苷的UPLC測定方法，以指標成分含量、出膏率為關鍵質(zhì)量屬性（critical quality attributes，CQAs），采用AHP-熵權法結合化學計量學確定各指標的綜合權重系數(shù)，在單因素實驗的基礎上，采用Box-Behnken設計-響應面法（Box-Behnken design-response surface method，BBD-RSM）優(yōu)化虎力散提取工藝。結果 BBD-RSM建立的模型顯著，虎力散最佳提取工藝為加10倍量60%乙醇溶液，提取時間2.0 h，提取2次，此條件下預測綜合評分為0.659 2，3批工藝驗證結果（平均綜合評分0.659 5，RSD為0.45%）與模型預測結果相近，且各指標RSD均＜3%，表明建立的模型可用于虎力散提取工藝的分析和預測。結論 采用AHP-熵權法結合化學計量學優(yōu)選虎力散提取工藝，所建立的模型可靠，提取工藝穩(wěn)定可行，為虎力散制劑二次開發(fā)提供依據(jù)。

Objective To optimize extraction process of Hulisan (虎力散) and to provide a basis for the secondary development of its preparation. Methods A UPLC method was established for the determination of 8-deacetyl yunaconitine, yunaconitine, notoginsenoside R₁, ginsenoside Rg₁, ginsenoside Rb₁, caudatin and lobetyolin, with the content of the index components and the rate of paste as the key quality attributes, and the combined weighting coefficients of the indexes were determined by AHP-entropy weight method combined with chemometrics, and the extraction process for Hulisan was optimized by the Box-Behnken response surface method based on the one-way test. Results The model established by Box-Behnken design was significant, and the optimal extraction process of Hulisan was ten-fold volume 60% ethanol solution, extraction time of 2.0 h, and two times of extraction, and the comprehensive score was 0.659 2 under this condition, and the results of three batches process validation (the average comprehensive score is 0.659 5, with an RSD of 0.45%.) were similar to those predicted by the model with an RSD < 3%, indicating that the established model can be used for the analysis and prediction of Hulisan extraction process. Conclusion The AHP-entropy weight method combined with chemometrics was used to preferentially select the Hulisan extraction process, and the established model was reliable and the extraction process was stable and feasible, which provides a basis for the secondary development of Hulisan preparations of ethnomedicines.

R283.6

云南省科技廳社會發(fā)展專項-重點研發(fā)計劃項目（202303AC100025）；國家自然科學基金資助項目（82174065）；云南省科技廳重點研發(fā)計劃（202103AC100005）；云南省科技廳重大科技專項（202102AA310027）；云南省教育廳科學研究基金項目（2024Y379）；云南省中西醫(yī)結合慢病防治重點實驗室開放基金資助項目（YPKLG2024-016）；云南省傣醫(yī)藥與彝醫(yī)藥重點實驗室資助項目（2024SS24074）