基于标准汤剂的番泻叶(狭叶番泻)配方颗粒质量标准分析  

Analysis on Quality Standard of Sennae Folium(Cassia angustifolia)Dispensing Granules Based on Standard Decoctions

作　　者：李金鑫 董雪 段帅 曹桂云 张京华 栾永福 林永强 董晓弟 孟兆青 LI Jinxin;DONG Xue;DUAN Shuai;CAO Guiyun;ZHANG Jinghua;LUAN Yongfu;LIN Yongqiang;DONG Xiaodi;MENG Zhaoqing(Shandong Technical Innovation Center for Traditional Chinese Medicine Treatment of Respiratory Diseases,Shandong Hongjitang Pharmaceutical Group Co.Ltd.,Jinan 250103,China;Shandong Institute for Food and Drug Control,Jinan 250101,China)

机构地区：[1]山东宏济堂制药集团股份有限公司山东省中医药治疗呼吸系统疾病技术创新中心,济南250103 [2]山东省食品药品检验研究院,济南250101

出　　处：《中国实验方剂学杂志》2025年第9期192-200,共9页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：山东省重点研发计划重大科技创新工程项目(2021CXGC010511);泉城“5150”引才倍增计划项目(2021年)。

摘　　要：目的:建立基于标准汤剂的番泻叶(狭叶番泻)配方颗粒的质量标准。方法:建立15批番泻叶(狭叶番泻)标准汤剂和10批不同厂家番泻叶(狭叶番泻)配方颗粒的高效液相色谱法(HPLC)特征图谱,并进行相似度评价、层次聚类分析(HCA)及主成分分析(PCA)。针对特征图谱中的共有峰建立双标线性校正法(LCTRS)、一测多评法(QAMS),测定饮片、标准汤剂与配方颗粒中主要成分的含量,计算从饮片到标准汤剂及配方颗粒的转移率。结果:15批番泻叶(狭叶番泻)标准汤剂和10批番泻叶(狭叶番泻)配方颗粒特征图谱相似度均>0.95,共确定8个特征峰,并指认山柰酚-3,7-O-二葡萄糖苷、芹菜素-6,8-二-C-葡萄糖苷、槲皮素-3-O-龙胆二糖苷、番泻苷B、番泻苷A 5个成分。HCA、PCA结果表明,不同批次标准汤剂成分有一定差异性,但未表现出产地聚集性。15批番泻叶(狭叶番泻)标准汤剂出膏率26.54%~45.38%,山柰酚-3,7-O-二葡萄糖苷、芹菜素-6,8-二-C-葡萄糖苷、槲皮素-3-O-龙胆二糖苷、番泻苷B、番泻苷A质量分数分别为12.16~19.26、2.57~4.94、3.27~5.11、6.75~11.39、4.69~7.79 mg·g^(-1),这5个成分从饮片到标准汤剂的转移率分别为45.41%~79.02%、29.12%~55.07%、40.52%~67.90%、24.72%~49.12%、27.54%~49.34%。番泻叶(狭叶番泻)配方颗粒样品C8~C10的出膏率38.10%~39.50%,上述5个成分从饮片到配方颗粒的转移率分别为72.85%~73.58%、53.43%~53.94%、40.19%~40.74%、24.62%~25.00%、28.65%~29.11%,与饮片到标准汤剂的转移率基本一致。结论:LCTRS的预测精度更高,适用色谱柱较多,明显优于相对保留时间法。基于标准汤剂建立的番泻叶(狭叶番泻)配方颗粒质量控制标准合理可靠,不同厂家样品各项指标均在基于标准汤剂规定的范围内,可为该配方颗粒的质量控制及工艺研究提供参考。Objective:To establish the quality standards for Sennae Folium(Cassia angustifolia)dispensing granules based on standard decoctions.Methods:High performance liquid chromatography(HPLC)specific chromatograms were established for 15 batches of Sennae Folium(C.angustifolia)standard decoctions and 10 of Sennae Folium(C.angustifolia)dispensing granules from different manufacturers,and the similarity evaluation,hierarchical cluster analysis(HCA)and principal component analysis(PCA)were performed.Linear calibration with two reference substances(LCTRS)and quantitative analysis of multi-components by single-marker(QAMS)were established for the common peaks in the specific chromatograms to determine the contents of main components in the decoction pieces,standard decoctions and dispensing granules,and to calculate their transfer rates from decoction pieces to standard decoctions and dispensing granules.Results:The similarities of specific chromatograms of 15 batches of Sennae Folium(C.angustifolia)standard decoctions and 10 batches of Sennae Folium(C.angustifolia)dispensing granules were all greater than 0.95,and a total of 8 characteristic peaks were calibrated,and five of them were identified,including kaempferol-3,7-O-diglucoside,apigenin-6,8-di-C-glucoside,quercetin-3-O-gentianoside,sennoside B and sennoside A.HCA and PCA results showed that there were certain differences in the composition of different batches of standard decoctions,but no clustering was observed in the production area.As the standard decoctions,the extract rate of 15 batches of samples was 26.54%-45.38%,the contents of kaempferol-3,7-O-diglucoside,apigenin-6,8-di-C-glucoside,quercetin-3-O-gentianoside,sennoside B and sennoside A were 12.16-19.26,2.57-4.94,3.27-5.11,6.75-11.39,4.69-7.79 mg·g^(-1),and their transfer rates from decoction pieces to standard decoctions were 45.41%-79.02%,29.12%-55.07%,40.52%-67.90%,24.72%-49.12%,27.54%-49.34%,respectively.The extract rates of Sennae Folium(C.angustifolia)dispensing granules(C8-C10)were 38.10%-39.50%,the

关 键 词：番泻叶 标准汤剂 配方颗粒 双标线性校正法(LCTRS) 一测多评法(QAMS) 特征图谱 质量控制 高效液相色谱法(HPLC) 

分 类 号：R277[医药卫生—中医学] R943[理学—分析化学] O657[理学—化学]