摘要
采用指纹图谱定性分析与多成分定量分析相结合的方法对金荞麦片(FDRT)、金荞麦胶囊(FDRC)和威麦宁胶囊(WMNC)3种金荞麦制剂进行质量比较研究。利用高效液相色谱法测定20批FDRT、11批FDRC和15批WMNC的指纹图谱,标定共有峰40个,采用超快速液相色谱-四极杆飞行时间质谱共鉴定了67个成分,其中6个鞣质类成分(原花青素B1、B3、C2、B2、C1和A2)、3个酚类成分(没食子酸、原儿茶酸和原儿茶醛)、4个黄酮类成分(儿茶素、表儿茶素、表儿茶素没食子酸酯和芦丁)采用对照品比对确认。以量化共有峰面积为变量,分别进行层次聚类分析、主成分分析、正交偏最小二乘判别分析,结果均显示FDRT和FDRC与WMNC存在明显质量差异,FDRT与FDRC也存在一定质量差异。对采用对照品比对确认且分离度较好的10个成分进行定量测定,发现除FDRC和WMNC中儿茶素及FDRT和FDRC中原花青素A2的平均含量无明显差异(P>0.05)外,3种FDR制剂中10个成分的平均含量均有显著差异(P<0.01或P<0.05),其中没食子酸、原儿茶酸及原儿茶醛为FDRC>FDRT>WMNC,原花青素B1和原花青素B3为FDRC>WMNC>FDRT,表儿茶素、原花青素C1及表儿茶素没食子酸酯为WMNC>FDRC>FDRT,儿茶素为FDRC和WMNC>FDRT,原花青素A2为WMNC>FDRC和FDRT。3种FDR制剂的主要成分基本相同,但存在质量差异,且FDRT和FDRC与WMNC差异明显。
This study conducted a comparative quality evaluation of three Fagopyri Dibotryis Rhizoma(FDR)preparations named FDR Tablets(FDRT),FDR Capsules(FDRC),and Weimaining Capsules(WMNC)by combining fingerprint qualitative analysis with multi-component quantitative analysis.Fingerprints of 20 batches of FDRT,11 batches of FDRC,and 15 batches of WMNC were determined by high performance liquid chromatography,40 common peaks in the fingerprints were demarcated,and 67 components were identified in these 40 common peaks by ultra-fast liquid chromatography-quadrupole time-of-flight mass spectrometry(UFLC-Q-TOF-MS/MS).Among these,6 tannins including procyanidin B1(PB1),procyanidin B3(PB3),procyanidin C2(PC2),procyanidin B2(PB2),procyanidin C1(PC1),and procyanidin A2(PA2),3 phenolics including gallic acid,protocatechuic acid,and protocatechualdehyde,and 4 flavonoids including catechin,epicatechin,epicatechin gallate(ECG),and rutin were confirmed by reference substance.Hierarchical cluster analysis,principal component analysis,and orthogonal partial least squares discriminant analysis were conducted by using the quantified peak areas of the common peaks as variables.The results consistently showed significant differences in quality between FDRT and FDRC compared to WMNC,and there were also some differences in quality between FDRT and FDRC themselves.Quantitative determination was conducted on a total of 10 components,which were verified by comparison with reference substance and exhibited good separation.The results revealed that,with the exception of no significant difference in the mean content of catechin between FDRC and WMNC,as well as in PA2 between FDRT and FDRC(P>0.05),the mean content of all 10 components across the three FDR preparations showed significant differences(P<0.01 or P<0.05).Specifically:gallic acid,protocatechuic acid,and protocatechualdehyde exhibited FDRC>FDRT>WMNC,PB1 and PB3 showed FDRC>WMNC>FDRT,epicatechin,PC1,and ECG demonstrated WMNC>FDRC>FDRT,catechin displayed both FDRC and WMNC>FDRT,and PA2 exhibited WMNC>both FDRC and FDRT.In summary,the main components contained in the three FDR preparations are basically the same;however,there are differences in quality,with FDRT and FDRC demonstrating notable differences compared to WMNC.
作者
何梦
李余佳
曹溢
戴莹
秦楠
窦志华
HE Meng;LI Yu-jia;CAO Yi;DAI Ying;QIN Nan;DOU Zhi-hua(School of Pharmacy,Nantong University,Nantong 226019,China;Department of Pharmacy,Affiliated Nantong Hospital 3 of Nantong University,Nantong 226006,China;Department of Pharmacy,Nantong Third People’s Hospital,Nantong 226006,China;Department of Pharmacy,Nantong Affiliated Hospital of Nanjing University of Chinese Medicine,Nantong 226001,China)
出处
《分析测试学报》
2025年第12期2449-2461,共13页
Journal of Instrumental Analysis
基金
南通市科技计划重点项目新冠肺炎专项(MS12022012)。
关键词
金荞麦片
金荞麦胶囊
威麦宁胶囊
质量比较
指纹图谱
超快速液相色谱-四极杆飞行时间质谱
模式识别
多成分定量分析
Fagopyri Dibotryis Rhizoma Tablets
Fagopyri Dibotryis Rhizoma Capsules
Weimaining Capsules
quality comparison
fingerprint
UFLC-Q-TOF-MS/MS
pattern recognition
multi-component quantitative analysis
作者简介
通讯作者:秦楠,硕士,主管中药师,研究方向:中药药理,E-mail:qinnan12345@126.com;通讯作者:窦志华,博士,副教授,主任中药师,研究方向:中药药效物质及质量评价研究,E-mail:zhihuadou@163.com。
