经典名方开心散基准样品HPLC指纹图谱及多指标成分含量测定研究  

HPLC fingerprints and multi-index components content determination of classical prescription Kaixin powder

作　　者：李大伟 单晓晓 汪海宣 张晓倩 杨璇 陶稳稳 黄顺旺 张彩云 LI Da-wei;SHAN Xiao-xiao;WANG Hai-xuan;ZHANG Xiao-qian;YANG Xuan;TAO Wen-wen;HUANG Shun-wang;ZHANG Cai-yun(College of Pharmacy,Anhui University of Chinese Medicine,Hefei 230012;Key Laboratory of Pharmaceutics Preparation and Application,Research Center for Modern Pharmaceutical Preparation Engineering Technology,Anhui Innovation Collaborative Center for Authentic Chinese Herbal Medicine Quality Improvement,Pharmaceutics Institute of Anhui Academy of Chinese Medical Sciences,Hefei 230012;Key Laboratory of Traditional Chinese Medicine Compound of Anhui,Hefei 230012;Hefei Food and Drug Safety Inspection and Testing Center,Hefei 230094;Hefei Innovative Medical Technology Co.,Ltd.,Hefei 231000)

机构地区：[1]安徽中医药大学药学院,合肥230012 [2]药物制剂技术与应用安徽省重点实验室,安徽省教育厅现代药物制剂工程技术研究中心,安徽省道地中药材品质提升创新协同中心,合肥230012 [3]安徽省中医药科学院药物制剂研究所,中药复方安徽省重点实验室,合肥230012 [4]合肥市食品药品安全检验检测中心,合肥230094 [5]合肥创新医药技术有限公司,合肥231000

出　　处：《中南药学》2025年第4期1109-1116,共8页Central South Pharmacy

基　　金：安徽省科技重大专项项目(No.202203a07020031);安徽省教育厅基金项目(No.KJ2021ZD0065)。

摘　　要：目的建立经典名方开心散基准样品的高效液相色谱(HPLC)指纹图谱及其6种指标性成分的定量分析方法,为其质量标准的初步拟定提供参考。方法根据开心散处方比例,混合制备15批开心散基准样品,采用HPLC法建立其指纹图谱,同时定量测定指标性成分远志[口山]酮Ⅲ、3,6'-二芥子酰基蔗糖、人参皂苷Re、人参皂苷Rb_(1)、β-细辛醚、α-细辛脑的含量。结果15批开心散基准样品的HPLC指纹图谱的相似度均大于0.9,在203 nm色谱条件下共识别出8个特征峰。所测定的6种指标性成分(含量范围)依次为远志[口山]酮Ⅲ(0.1802~0.3969 mg·g^(-1))、3,6'-二芥子酰基蔗糖(1.0032~2.0445mg·g^(-1))、人参皂苷Re(0.9586~1.5035 mg·g^(-1))、人参皂苷Rb_(1)(0.4144~0.8271mg·g^(-1))、β-细辛醚(2.3851~3.4561mg·g^(-1))、α-细辛脑(0.0286~0.0346 mg·g^(-1))。结论本研究成功建立了开心散HPLC指纹图谱及多指标成分含量测定方法,可为开心散制剂开发提供质量控制标准参考。Objective To establish the high-performance liquid chromatography(HPLC)fingerprints and quantitative analysis methods for six characteristic components of classical prescription Kaixin powder,and to provide a reference for its primary quality standards.Methods Fifteen batches of Kaixin powder were prepared by mixing according to its original prescription ratio.HPLC was used to establish its fingerprint and quantify polygalaxanthoneⅢ,3,6'-disinapoyl sucrose,ginsenoside Re,ginsenoside Rb_(1),β-asarone,andα-asarone in the Kaixin powder reference samples.Results The similarity of 15 batches of Kaixin powder reference samples was greater than 0.9,and eight characteristic peaks were identified at 203 nm.The content of the 6 components in Kaixin powder reference samples were as follows:polygalaxanthoneⅢ(0.1802~0.3969 mg·g^(-1)),3,6'-diisooctanoyl sucrose(1.0032~2.0445 mg·g^(-1)),ginsenoside Re(0.9586~1.5035 mg·g^(-1)),ginsenoside Rb_(1)(0.4144~0.8271 mg·g^(-1)),β-asarone(2.3851~3.4561 mg·g^(-1)),andα-asarone(0.0286~0.0346 mg·g^(-1)).Conclusion HPLC fingerprint of Kaixin powder with its multi-index components content have been successfully established,providing a valuable reference for its quality control.

关 键 词：开心散 经典名方 指纹图谱 含量测定 质量标准 

分 类 号：R284.1[医药卫生—中药学]