茴芹果饮片标准汤剂质量标准研究  

Quality standard of Pimpinellae anisi fructus piece decoction

作　　者：王贺伟[1] 刘亭阳 任盈盈 田芳 穆丹丹 李超杰 宋菲 尹强 尹海龙 WANG He-wei;LIU Ting-yang;REN Ying-ying;TIAN Fang;MU Dan-dan;LI Chao-jie;SONG Fei;YIN Qiang;YIN Hai-long(Shihezi University,Shihezi Xinjiang 832003;Xinjiang Uyghur Pharmaceutical Co.,Ltd.,Urumqi 832026)

机构地区：[1]石河子大学,新疆石河子832003 [2]新疆维吾尔药业有限责任公司,乌鲁木齐832026

出　　处：《中南药学》2025年第3期725-729,共5页Central South Pharmacy

基　　金：新疆地产药材配方颗粒研制及中试技术平台搭建(No.2022LQ03020);新疆维吾尔自治区“天山英才”-优秀工程师培养计划项目。

摘　　要：目的制备茴芹果饮片标准汤剂,并对其进行含量测定及指纹图谱分析,为茴芹果配方颗粒质量标准的制定提供依据。方法制备15批茴芹果饮片标准汤剂,计算出膏率并通过检测异荭草苷的含量得到其转移率;采用高效液相色谱法(HPLC)建立茴芹果饮片标准汤剂指纹图谱,通过中药色谱指纹图谱相似度评价系统,计算指纹图谱相似度并结合聚类分析对指纹图谱进行数据分析。结果15批茴芹果饮片标准汤剂中出膏率在13.72%~22.26%,平均出膏率为19.24%,异荭草苷转移率在37.96%~62.47%,平均转移率为50.58%。经HPLC指纹图谱分析,发现共有峰7个,指认出5个峰,分别是绿原酸、异荭草苷、异牡荆素、木犀草素、芹菜素。15批茴芹果饮片标准汤剂指纹图谱相似度均大于0.95,聚类分析将15批样品分成4类。结论本研究建立了茴芹果饮片标准汤剂HPLC含量测定和指纹图谱分析方法,可为茴芹果配方颗粒的质量标准提供依据。Objective To prepare standard decoction of Pimpinellae anisi fructus pieces,measure their content and analyze fingerprint spectrum,to provide a basis for the quality standards of Pimpinellae anisi fructus formula granules.Methods Fifteen batches of Pimpinellae anisi fructus piece standard decoctions were prepared.The extraction rate was calculated,and the transfer rate of isoimperatorin was determined with its content.High performance liquid chromatography(HPLC)was used to establish the fingerprint spectrum of the Pimpinellae anisi fructus piece standard decoction.The similarity of the fingerprint spectrum was calculated with the traditional Chinese medicine chromatographic fingerprint spectrum similarity evaluation system,along with cluster analysis of the fingerprint spectrum.Results The extraction rates of the 15 batches of Pimpinellae anisi fructus standard decoctions ranged from 13.72%to 22.26%,with an average of 19.24%;the transfer rates of isoorientin ranged from 37.96%to 62.47%,with an average of 50.58%.HPLC fingerprint identified 7 common peaks,5 of which were characterized,namely chlorogenic acid,isoimperatorin,isovitexin,luteolin,and apigenin.The similarity of the fingerprint spectra of the 15 batches of Pimpinellae anisi fructus piece standard decoctions was all greater than 0.95,and cluster analysis categorized the 15 samples into 4 classes.Conclusion The study has established an HPLC content measurement and fingerprint spectrum analysis method for Pimpinellae anisi fructus piece standard decoctions,providing a basis for the quality standard of Pimpinellae anisi fructus formula granules.

关 键 词：茴芹果饮片 标准汤剂 质量标准 聚类分析 

分 类 号：R284.1[医药卫生—中药学] R927[医药卫生—中医学]