肝复胶囊的质量标准提升研究  

Study on Improving the Quality Standard of Gan Fu Capsule

作　　者：徐鹏 黄以蓉 李敏仪 李敏[2] 谢锋 宋在鑫 黄九林[3] 彭继 XU Peng;HUANG Yirong;LI Minyi;LI Min;XIE Feng;SONG Zaixin;HUANG Jiuin;PENG Ji(Ankang Hospital of Traditional Chinese Medicine,Ankang 725000,China;College of Pharmacy,Shaanxi University of Chinese Medicine,Xianyang 712046,China;Department of Chemistry and Chemical Engineering,Ankang University,The Youth Innovation Team of Shaanxi Universities,Ankang 725000,China)

机构地区：[1]安康市中医医院,陕西安康725000 [2]陕西中医药大学药学院,陕西咸阳712046 [3]安康学院化工学院,陕西省高校青年创新团队,陕西安康725000

出　　处：《特产研究》2025年第2期114-119,共6页Special Wild Economic Animal and Plant Research

基　　金：陕西省中医药管理局项目(2022-QCYZH-050);陕西中医药大学校级高水平中医药重点学科建设临床中药学项目(2024XKZD12)。

摘　　要：为提升肝复胶囊的质量控制标准,本研究建立同时测定肝复胶囊中橙皮苷、丹酚酸B和大黄酚含量的HPLC方法。试验采用显微鉴别法对肝复胶囊处方组成丹参、大黄、青皮、枳实、水蛭、土鳖虫、厚朴、全蝎及三七进行鉴别;采用薄层色谱法(TLC)对丹参、大黄、厚朴及三七进行鉴别;建立高效液相色谱法(HPLC)同时测定橙皮苷、丹酚酸B和大黄酚含量。在显微鉴别中,大黄的草酸钙簇晶,土鳖虫的刚毛,全蝎的体壁碎片和刚毛,三七的淀粉粒,水蛭的背腹肌纤维,丹参的石细胞,青皮、枳实的草酸钙方晶及厚朴的石细胞,组织特征明显且具有专属性;TLC专属性强,斑点清晰,分离度好。橙皮苷、丹酚酸B和大黄酚分别在0.90~18.0μg(r=0.9992)、0.18~3.60μg(r=0.9990)和0.07~1.40μg(r=0.9992)范围内线性关系良好,平均加样回收率分别为100.1%,100.9%和99.4%,RSD分别为1.72%,1.99%和1.51%;本品每粒含青皮和枳实以橙皮苷(C_(28)H_(34)O_(15))计,不得少于8.81mg;每粒含丹参以丹酚酸B(C_(36)H_(30)O_(16))计,不得少于0.87mg;每粒含大黄以大黄酚(C_(15)H_(10)O_(4))计,不得少于0.06mg。本研究建立的方法专属性强,含量测定方法稳定性、重复性良好,可用于肝复胶囊的质量标准提升。To improve the quality control standard of Gan Fu capsules.To establish an HPLC method for the simultaneous determination of hesperidin,salvianolic acid B and rhubarb phenol in Gan Fu capsules.The microscopic identification method was used to identify Salvia miltiorrhiza,Rheum palmatum,Citrus reticulata,Citrus aurantium,Hirudo,Eupolyphaga sinensis,Magnolia officinalis,Scorpio,and Pana-x notoginseng in Gan Fu capsules;the thin-layer chromatography(TLC)method was used to identify Salvia miltiorrhiza,Rheum palmatum,Magnolia officinalis and Panax notoginseng;and a method of high performance liquid chromatography(HPLC)was established for deter-mination of hesperidin,salvianolic acid B,and rhubarb phenol at the same time.In the microscopic identification,the calcium oxalate cluster crystals of Rheum palmatum,the setae of Eupolyphaga sinensis,the body wall fragments and setae of Scorpio,the starch granules of Panax notoginseng,the dorsal and ventral muscle fibers of Hirudo,the stone cells of Salvia miltiorrhiza,the calcium oxalate square crystals of Cit-rus reticulata,Citrus aurantium and the stone cells of Magnolia officinal had obvious and exclusive tissue features;the TLC had strong speci-ficity and clear spots with good separation degree.The linearity of hesperidin,salvianolic acid B and rhubarb phenol was good in the ranges of 0.90~18.0μg(r=0.9992),0.18~3.60 μg(r=0.9990),and 0.07~1.40 μg(r=0.9992),and the average recoveries of the spiked samples were 100.1%,100.9%and 99.4%,with RSDs of 1.72%,1.99%and 1.51%,respectively.Each capsule of this product contained 8.81 mg of hes-peridin(C_(28)H_(34)O_(15))in the form of Citrus reticulata and Citrus aurantium,0.87 mg of salvianolic acid B(C_(36)H_(30)O_(16))in the form of Salvia miltiorrhiza,0.06 mg of rhubarb phenol(C_(15)H_(10)O_(4))in the form of Rheum palmatum per capsule.The method established in this study is ex-clusive,with good stability and reproducibility,and can be used to improve the quality standard of Gan Fu capsule.

关 键 词：肝复胶囊 薄层色谱 含量测定 质量标准提升 

分 类 号：R284[医药卫生—中药学]