目的 建立經(jīng)典名方黃連膏基準樣品HPLC指紋圖譜并對其指標成分（5-羥甲基糠醛、洋川芎內(nèi)酯I、鹽酸小檗堿、阿魏酸、藁本內(nèi)酯和姜黃素）進行含量測定，研究黃連膏基準樣品量值傳遞規(guī)律。方法 制備16批黃連膏基準樣品，建立HPLC指紋圖譜，明確并歸屬各特征峰；對黃連膏基準樣品中指標成分進行含量測定，分析指標成分從飲片-基準樣品的傳遞規(guī)律。結(jié)果 16批黃連膏基準樣品指紋圖譜相似度均＞0.9，標定了17個共有峰，并對各共有峰進行藥材歸屬，其中1、2（5-羥甲基糠醛）號峰歸屬于生地黃和當歸尾；3（阿魏酸）、5（洋川芎內(nèi)酯I）號峰歸屬于當歸尾；4（鹽酸小檗堿）號峰歸屬于黃連和黃柏；6、10（芝麻素）、12（芝麻林素）、13號峰歸屬于提取溶劑麻油；7（雙去甲氧基姜黃素）、8（去甲氧基姜黃素）、9（姜黃素）、14～17號峰歸屬于姜黃；11（藁本內(nèi)酯）號峰歸屬于當歸尾和提取溶劑麻油。指標成分5-羥甲基糠醛、洋川芎內(nèi)酯I、鹽酸小檗堿、阿魏酸、藁本內(nèi)酯和姜黃素的質(zhì)量分數(shù)分別為18.75～66.96、8.37～13.96、50.18～148.76、6.90～9.81、91.22～141.23、71.33～267.54μg/g，其中鹽酸小檗堿、阿魏酸和姜黃素的轉(zhuǎn)移率分別為1.43%～3.43%、22.98%～38.01%、33.96%～73.65%。結(jié)論 采用指紋圖譜、指標成分含量測定及轉(zhuǎn)移率相結(jié)合的模式，對經(jīng)典名方黃連膏基準樣品的量值傳遞過程進行分析，可初步擬定黃連膏基準樣品的質(zhì)量標準，為其后續(xù)新藥研發(fā)提供參考。

Objective To establish the HPLC fingerprints of the benchmark samples of Huanglian Ointment (HLO, 黃連膏) and determine the contents of its index components (5-hydroxymethylfurfural, ligustilide I, berberine hydrochloride, ferulic acid, ligustilide and curcumin), to study the transfer pattern of HLO benchmark samples and lay the foundation for the development of compound formulations. Methods Sixteen batches of HLO benchmark samples were prepared, HPLC fingerprints were established, and the characteristic peaks were identified and assigned; the content of the index components in the HLO benchmark samples were determined, and the transfer pattern of the indicator components from the decoction pieces to the benchmark samples was analyzed. Results The fingerprint similarity of 16 batches of HLO benchmark samples was greater than 0.9, 17 common peaks were calibrated and the medicinal materials of each common peak were assigned. Among which, peaks 1 and 2 (5-hydroxymethylfurfural) were attributed to Dihuang (Rehmanniae Radix) and Danggui (Angelicae Sinensis Radix) tail; peaks 3 (ferulic acid) and 5 (ligustilide I) were attributed to Danggui (Angelicae Sinensis Radix) tail; peak 4 (berberine hydrochloride) was attributed to Huanglian (Coptidis Rhizoma) and Huangbo (Phellodendri Chinensis Cortex); peaks 6, 10 (sesamin), 12 (sesamolin), and 13 were attributed to the extraction solvent sesame oil; peaks 7 (bisdemethoxycurcumin), 8 (demethoxycurcumin), 9 (curcumin), and 14—17 were attributed to Jianghuang (Curcumae Longae Rhizoma); peak 11 (ligustilide) was attributed to Danggui (Angelicae Sinensis Radix) tail and the extraction solvent sesame oil. The content of 5-hydroxymethylfurfural, ligustilide I, berberine hydrochloride, ferulic acid, ligustilide, and curcumin ranged from 18.75—66.96, 8.37—13.96, 50.18—148.76, 6.90—9.81, 91.22—141.23, 71.33—267.54 μg/g, respectively. The transfer rates of berberine hydrochloride, ferulic acid, and curcumin ranged from 1.43%—3.43%, 22.98%—38.01%, 33.96%—73.65%, respectively. Conclusion The combination of fingerprinting, transfer rate and determination of the content of the indicator components was used to analyze the quantitative transfer process of the benchmark samples of the classical formula HLO, which can initially formulate the quality standard of the benchmark samples of HLO and provide reference for its subsequent development of new drugs.

R283.6

新疆維吾爾自治區(qū)重點研發(fā)項目（2022B03007-3）；新疆維吾爾自治區(qū)自然科學(xué)基金面上資助項目（2023D01A05）；中國科學(xué)院青年創(chuàng)新促進會會員項目（2022442）