文献类型：期刊文献

中文题名：藏药仁青常觉丸的指纹图谱及多指标成分含量测定的研究

英文题名：Research on Fingerprint Chromatogram and Multi-index Component Content Determination of Zang Medicine Rincheng Changjue Pills

作者：宋承佳[1];杨世辉[1];王芸[1];俞树琴[1];周强[1];高建德[1];马文俊[2]

第一作者：宋承佳

机构：[1]甘肃中医药大学药学院,甘肃兰州730000;[2]高原医学研究中心,青海西宁810000

第一机构：甘肃中医药大学药学院（西北中藏药协同创新中心办公室）

年份：2026

卷号：35

期号：8

起止页码：58

中文期刊名：中国民族民间医药

外文期刊名：Chinese Journal of Ethnomedicine and Ethnopharmacy

基金：青海省科学技术厅十大国家级科技创新平台培育建设项目-现代藏药创制全国重点实验室建设(2023ZJ-J05):特色藏药炮制研究及绿色智能制造(ZYYSDPT-2023-04);甘肃中医药大学2025年度研究生创新基金项目(2025CXCY-033)。

语种：中文

中文关键词：藏药;仁青常觉丸;质量标准;高效液相色谱法;指纹图谱

外文关键词：Zang Medicine;Renqing ChangjuePills;Quality Standards;HPLC;Fingerprint

摘要：目的:建立仁青常觉丸高效液相色谱(HPLC)指纹图谱,同时测定诃子酸、盐酸小檗碱、西红花苷Ⅱ、土木香内酯4种成分含量,并对其浸出物含量进行检测。方法:采用AgilentSB-C_(18)色谱柱(150mm×4.6mm,5μm),以0.2%磷酸溶液(A)-乙腈(B)为流动相进行梯度洗脱;流速1.0mL·min^(-1),检测波长265nm,柱温30℃,进样量20μL,建立仁青常觉丸HPLC指纹图谱及4种指标性成分含量测定方法;浸出物测定参照2020版《中国药典》通则2201热浸法进行。结果:5批样品指纹图谱相似度为0.882~0.983,共标定9个共有峰,指认诃子酸、盐酸小檗碱、西红花苷Ⅱ、土木香内酯4个成分;其含量分别为0.539~0.571mg·g^(-1)、0.221~0.281mg·g^(-1)、0.273~0.321mg·g^(-1)、2.106~2.163mg·g^(-1),各批次样品化学成分含量存在一定差异,其中诃子酸与土木香内酯含量差异较小;水浸出物含量为25.87~27.96,醇浸出物含量为25.85~29.46,RSD值均<3%,表明不同批次仁青常觉丸质量均一性较好。结论:本研究建立的仁青常觉丸HPLC指纹图谱、指标成分及浸出物含量测定方法操作简单、结果可靠,可为仁青常觉丸的质量控制提供理论依据。
Objective To establish the high performance liquid chromatography(HPLC)fingerprint of Renqing Changjue Pills and the determination methods for the contents of chebulic acid,berberine hydrochloride,crocin Ⅱ and alantolactone in it,and to determine the content of extractives.Methods A liquid chromatography column of Agilent SB-C_(18)(150 mm×4.6 mm,5μm)was used with a mobile phase of 0.2%phosphoric acid solution(A)and acetonitrile(B)for gradient elution.The flow rate was 1.0 mL·min^(-1),the detection wavelength was 265 nm,the column temperature was 30℃,and the injection volume was 20μL.A fingerprint chromatogram of Renqing Changjue Pills and a method for the determination of four index components were established.The extractives were determined by the hot maceration method as described in General Chapter 2201 of the 2020 Edition of the Chinese Pharmacopoeia.Results The similarity of the fingerprint chromatograms of the 5 batches of samples was between 0.882 and 0.983.A total of 9 common peaks were calibrated,and 4 components were identified,namely,chebulic acid,berberine hydrochloride,crocin II and alantolactone,with their contents ranging from 0.539 to 0.571 mg·g^(-1),0.221 to 0.281 mg·g^(-1),0.273 to 0.321 mg·g^(-1),and 2.106 to 2.163 mg·g^(-1),respectively.There were certain differences in the content of chemical components among the batches of Renqing Changjue Pills,among which the content differences of kaphic acid and costunolide were relatively small.The determination of the extract content showed that the water extract content was between 25.87 and 27.96,and the alcohol extract content was between 25.85 and 29.46,the RSD values were all less than 3%,indicating that the quality uniformity of Renqing Changjue Pills in different batches was relatively good.Conclusion The HPLC fingerprint chromatogram,index component and extract content determination methods of Renqing Changjue Pills established in this study are simple and reliable,which can provide a theoretical basis for the quality control of Renqing Changjue Pills.