目的 阐明黄连解毒汤（ Huanglian Jiedu Decoction，HJD）物质基准的关键质量属性，建立HJD物质基准指纹图谱并测定其中盐酸黄连碱、表小檗碱、盐酸巴马汀、盐酸小檗碱、盐酸药根碱、盐酸黄柏碱、黄芩苷、栀子苷含量及其转移率，为后期HJD的复方制剂研究奠定基础。方法 按古代工艺制备15批物质基准，测定出膏率，建立物质基准的HPLC指纹图谱并进行相似度评价，确定共有峰，同法测定物质基准中8种成分的含量，进行饮片到物质基准量值传递分析。结果 15批HJD物质基准平均出膏率为16.02%，指纹图谱共有18个共有峰，与对照指纹图谱的相似度均大于0.9；指认出8个色谱峰分别为盐酸黄连碱、表小檗碱、盐酸巴马汀、盐酸小檗碱、盐酸药根碱、盐酸黄柏碱、黄芩苷、栀子苷。各指标成分从饮片到物质基准的转移率分别为盐酸黄连碱0.61%～1.08%，表小檗碱0.14%～0.24%，盐酸巴马汀0.93%～1.52%，盐酸小檗碱4.09%～6.36%，盐酸药根碱0.81%～1.07%，盐酸黄柏碱0.78%～1.06%，黄芩苷7.45%～12.26%，栀子苷0.42%～2.82%。结论 指纹图谱结合出膏率和多指标成分含量测定对HJD物质基准进行量值传递研究，为HJD物质基准的质量控制及复方制剂的开发提供科学依据。

Objective Clarify the key quality attributes of Huanglian Jiedu Decoction (HJD, 黄连解毒汤) material benchmark (MB), establish the fingerprint of HJD MB and determine the content of coptisine chloride, epiberberine, palmatine chloride, berberine, jatrorrhizine hydrochloride, phellodendrine chloride, baicalin, geniposide components and their transfer rate, and lay the foundation for the research of compound preparation of HJD in the later stage. Methods Fifteen batches of material benchmarks were prepared according to the ancient technology, the paste rate was determined, the HPLC fingerprint of the material benchmark was established and the similarity evaluation was conducted, and the common peaks were determined. The content of eight components in the material benchmark was determined by the same method, and the transfer value of drinking slices to the material benchmark was analyzed. Results The average paste rate was 16.02%, with 18 common peaks, and the similarity to the control fingerprint was more than 0.9; The eight peaks were coptisine chloride, epiberberine, palmatine chloride, berberine, jatrorrhizine hydrochloride, phellodendrine chloride, baicalin, geniposide. The transfer rate of each index component from drinking sheet to material benchmark was coptisine chloride 0.61%-1.08%, epiberberine 0.14%-0.24%, palmatine chloride 0.93%-1.52%, berberine 4.09%-6.36%, jatrorrhizine hydrochloride 0.81%-1.07%, phellodendrine chloride 0.78%-1.06%, baicalin 7.45%- 12.26%, and geniposide 0.42%-2.82%. Conclusions By using the combination of ointment yield and multi-index composition content determination, this method is scientific and reasonable, and provides a scientific basis for the quality control of the material benchmark and the development of compound preparation.

R283.6

中医药事业传承发展资金支持项目《重大疫情防治中药方剂储备库建设项目》(吉中医药发[2021]11号)