目的 建立经典名方黄连膏基准样品HPLC指纹图谱并对其指标成分（5-羟甲基糠醛、洋川芎内酯I、盐酸小檗碱、阿魏酸、藁本内酯和姜黄素）进行含量测定，研究黄连膏基准样品量值传递规律。方法 制备16批黄连膏基准样品，建立HPLC指纹图谱，明确并归属各特征峰；对黄连膏基准样品中指标成分进行含量测定，分析指标成分从饮片-基准样品的传递规律。结果 16批黄连膏基准样品指纹图谱相似度均＞0.9，标定了17个共有峰，并对各共有峰进行药材归属，其中1、2（5-羟甲基糠醛）号峰归属于生地黄和当归尾；3（阿魏酸）、5（洋川芎内酯I）号峰归属于当归尾；4（盐酸小檗碱）号峰归属于黄连和黄柏；6、10（芝麻素）、12（芝麻林素）、13号峰归属于提取溶剂麻油；7（双去甲氧基姜黄素）、8（去甲氧基姜黄素）、9（姜黄素）、14～17号峰归属于姜黄；11（藁本内酯）号峰归属于当归尾和提取溶剂麻油。指标成分5-羟甲基糠醛、洋川芎内酯I、盐酸小檗碱、阿魏酸、藁本内酯和姜黄素的质量分数分别为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，其中盐酸小檗碱、阿魏酸和姜黄素的转移率分别为1.43%～3.43%、22.98%～38.01%、33.96%～73.65%。结论 采用指纹图谱、指标成分含量测定及转移率相结合的模式，对经典名方黄连膏基准样品的量值传递过程进行分析，可初步拟定黄连膏基准样品的质量标准，为其后续新药研发提供参考。

Objective To establish the HPLC fingerprints of the benchmark samples of Huanglian Ointment (HLO, 黄连膏) 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

新疆维吾尔自治区重点研发项目（2022B03007-3）；新疆维吾尔自治区自然科学基金面上资助项目（2023D01A05）；中国科学院青年创新促进会会员项目（2022442）