妇科千金方质量标志物研究

Quality Markers in Fuke Qianjin Formula

妇科千金方是治疗妇科炎症性疾病的中药复方,已被认定为国家中药保护品种和国家基本药物目录品种,并已载入《中华人民共和国药典》2020年版,分为妇科千金片和妇科千金胶囊2个品种。妇科千金方由千斤拔、金樱根、穿心莲、功劳木、单面针、鸡血藤、党参和当归8味中药组成。通过梳理妇科千金方的化学成分、质量控制、药动学和药理作用等相关文献并结合实际研究,基于“中药质量标志物理论”进行预测分析,小檗碱、巴马汀、药根碱、新穿心莲内酯苷、穿心莲内酯、新穿心莲内酯苷元、7-O-甲基汉黄芩素、染料木苷、芒柄花苷、染料木素、柚皮素、反式阿魏酸、水杨酸和Z-藁本内酯等专属性高、可测性强,可作为妇科千金方的潜在质量标志物,为其质量控制研究提供参考。

Fuke Qianjin Formula,a well-known Chinese medicine compound effective in the treatment of gynecological inflammatory diseases,has been identified as a national protected species of Chinese medicine and included in the National Essential Medicine List.It has also been recorded in the 2020 edition of the Pharmacopoeia of the People′s Republic of China,which is divided into Fuke Qianjin Tablets and Fuke Qianjin Capsules.Fuke Qianjin Formula is composed of eight herbal drugs,including Moghaniae Radix,Rosae Laevigatae Radix,Andrographis Herba,Mahoniae Caulis,Zanthoxyli Radix et Caulis,Spatholobi Caulis,Codonopsis Radix,and Angelicae Sinensis Radix.Based on the research on chemical constituents,quality control,pharmacokinetics,and pharmacological actions of Fuke Qianjin Formula,as well as the theory of Chinese medicine quality markers,the prediction and analysis indicated that berberine,palmatine,jatrorrhizine,neoandrographiside,andrographolide,andrograpanin,7-O-methylwogonin,genistin,ononin,genistein,naringenin,trans-ferulic acid,salicylic acid,and Z-ligustilide were considered potential quality markers of Fuke Qianjin Formula because of their good specificity and testability.The findings of this are expected to provide a scientific basis for quality control research on Fuke Qianjin Formula.