目的 阐明金水六君煎（Jinshui Liujun Decoction，JLD）基准样品的关键质量属性，建立其指纹图谱并测定其中甘草苷、甘草酸、芸香柚皮苷、橙皮苷、阿魏酸及地黄苷D等指标成分，探究JLD饮片-基准样品的量值传递规律，为评价其制剂质量奠定基础。方法 参考已公布的关键信息，制备20批JLD基准样品，采用UHPLC法建立指纹图谱，计算其相似度并确定共有峰归属，结合指标成分及干膏转移率对基准样品进行量值传递分析。结果 建立的20批JLD基准样品指纹图谱与对照指纹图谱（R）的相似度均大于0.98；共归属21个特征峰，其中峰4（5-羟甲基糠醛）、5、6、15（毛蕊花糖苷）归属于熟地黄；峰13（甘草苷）、19、20（甘草酸）归属于炙甘草；峰7～11、12（阿魏酸）、16（芸香柚皮苷）、17（橙皮苷）、18、19归属于陈皮；峰1、2（腺苷）、3（鸟苷）、9、12、14（洋川芎内酯I）归属于当归；峰1、3归属于清半夏；峰21（6-姜辣素）归属于生姜，茯苓无归属峰；20批JLD基准样品中指标成分甘草苷、甘草酸、芸香柚皮苷、橙皮苷、阿魏酸、地黄苷D的质量分数分别为0.251～0.366、0.282～0.552、0.291～0.390、0.700～0.967、0.040～0.062、0.059～0.155 mg/g，饮片到基准样品的转移率分别为41.30%～50.87%、24.65%～33.49%、37.78%～49.24%、16.84%～22.24%、43.10%～58.87%、43.44%～60.66%；出膏率为28.39%～34.56%，传递率为76.63%～90.78%。结论 采用指纹图谱结合多指标成分含量测定及出膏率等评价指标对经典名方JLD基准样品进行了量值传递综合考察，为JLD质量控制和制剂开发提供了科学依据。

Objective To elucidate the key quality attributes of the substance benchmark of Jinshui Liujun Decoction (JLD, 金水六君煎), establish its fingerprints and determine the content of index components, including liquiritin, glycyrrhizic acid, narirutin, hesperidin, ferulic acid and rehmannioside D. The study explores the transfer rules from JLD decoction pieces to substance benchmark, laying a material foundation for the later evaluation of JLD formulations. Methods Through reference to the published key information, 20 batches of JLD substance benchmark were prepared. UHPLC was used to establish a fingerprint and calculate the similarity, and the common peaks were identified. The transfer analysis of the substance benchmark was conducted through the content determination of the index components and the transfer rate of the dry paste. Results The 20 batches of the substance benchmark fingerprints had good similarities with the reference fingerprint (R), which were all higher than 0.98. 21 Commom peaks were assigned, among which, peaks 4 (5-hydroxymethylfurfural), 5, 6, 15 (acteoside) originated from Shudihuɑng (Rehmanniae Radix Praeparata); Peaks 13 (liquiritin), 19, 20 (glycyrrhizic acid) came from Zhigancao (Glycyrrhizae Radix et Rhizoma Praeparata cum Melle); Peaks 7—11, 12 (ferulic acid), 16 (narirutin), 17 (hesperidin), 18, 19 came from Chenpi (Citri Reticulatae Pericarpium); Peaks 1, 2 (adenosine), 3 (guanosine), 9, 12, 14 (senkyunolide I) originated from Danggui (Angelicae Sinensis Radix); Peaks 1, 3 originated from Qingbanxia (Pinelliae Rhizoma Praeparatum cum Alumine); Peak 21 (6-gingerol) originated from Shengjiang (Zingiberis Rhizoma Recens), and no peaks originated from Fuling (Poria). The mass fraction ranges of liquiritin, glycyrrhizic acid, narirutin, hesperidin, ferulic acid and rehmannioside D were 0.251—0.366, 0.282—0.552, 0.291—0.390, 0.700—0.967, 0.040—0.062, 0.059—0.155 mg/g, respectively. The transfer rate of index component from the decoction pieces to the substance benchmark was in the range of 41.30%—50.87%, 24.65%—33.49%, 37.78%—49.24%, 16.84%—22.24%, 43.10%—58.87%, 43.44%—60.66%, respectively. The extract rate was in the range from 28.39%—34.56%, and the transmission rate was in the range from 76.63%—90.78%. Conclusion This study comprehensively investigated the transfer of the JLD substance benchmark using fingerprints combined with content determination of the index components and dry paste rate evaluation, providing a scientific basis for the quality control and subsequent formulation development of JLD.

国家“重大新药创制”科技重大专项(2018ZX09721-005-003-006); 重庆市技术创新与应用发展专项(CSTB2024TIAD-STX0040)