机构地区:[1]康美药业股份有限公司,广东深圳518000 [2]成都市中西医结合医院中药剂科,四川成都610041 [3]绵阳市食品药品检验所,四川绵阳621000 [4]新乡医学院生命科学技术学院,河南新乡453000
出 处:《中药新药与临床药理》2024年第9期1420-1427,共8页Traditional Chinese Drug Research and Clinical Pharmacology
摘 要:目的建立川芎茶调散和川芎茶调颗粒的高效液相色谱(HPLC)指纹图谱,结合体外抗血小板聚集活性,比较二者的差异,并挖掘川芎茶调散和颗粒抗血小板聚集活性的物质基础,为其质量控制和临床应用提供依据。方法建立20批川芎茶调散与7批川芎茶调颗粒的HPLC指纹图谱,运用SPSS 27.00统计软件进行系统聚类分析;同时测定其体外抗血小板聚集活性,运用SIMCA-P 14.0统计软件进行偏最小二乘法回归分析,分析HPLC指纹图谱与血小板聚集活性的关系,并筛选质量差异标志物。结果HPLC指纹图谱标定26个共有峰,鉴定出16个成分,系统聚类分析显示川芎茶调散和川芎茶调颗粒各聚为一类。川芎茶调散和川芎茶调颗粒的HPLC指纹图谱和体外抗血小板聚集活性存在明显差异。综合相关系数和VIP值两个指标,确定17个共有峰与抗血小板聚集活性呈正相关且VIP值均大于1,筛选出抗血小板聚集活性的有效成分群,分别为橙皮苷、迷迭香酸、蒙花苷、胡薄荷酮、阿魏酸松柏酯、Z-藁本内酯、羌活醇、欧前胡素、异欧前胡素和色谱峰7、9、12、14、16、17、19、23等成分作为二者的质量差异标志物。结论该研究建立了川芎茶调散和川芎茶调颗粒的HPLC指纹图谱,该方法能够同时检测川芎茶调散和川芎茶调颗粒的多种有效成分。川芎茶调散和颗粒在有效成分的含量和抗血小板聚集活性上存在明显的差异,并且散剂质量优于颗粒剂。该研究为川芎茶调散和颗粒的整体质量控制及临床应用提供了参考。Objective To establish the HPLC fingerprint of Chuanxiong Chatiao San(CXCTS)and Chuanxiong Chatiao Granules(CXCTG),and to compare their quality difference by using HPLC fingerprint in combination with anti-platelet aggregation activity in vitro.This study explores the material basis of anti-platelet aggregation activity of CXCTS and CXCTG to provide a reference for the quality control and clinical application.Methods HPLC fingerprint for 20 batches of CXCTS and seven batches of CXCTG were established,and systematic clustering analysis was conducted using SPSS 27.00 statistical software.In addition,the in vitro anti-platelet aggregation activity was determined.The relationship between HPLC fingerprint spectrums and anti-platelet aggregation activity was analyzed by using SIMCA P-14.0 statistical software for partial least squares analysis(PLS).The markers of quality difference of CXCTS and CXCTG were screened.Results A total of 26 common peaks in the fingerprint and 16 components were identified.Systematic clustering analysis showed that CXCTS and CXCTG were clustered into two categories.There were significantly differences in HPLC fingerprint and anti-platelet aggregation activity between CXCTS and CXCTG.Combining correlation coefficient and VIP value,we confirmed 17 common peaks,which showed positive correlation with anti-platelet aggregation activity and the VIP values were greater than one.The effective fractions of anti-platelet aggregation activity were screened out.Among the above-mentioned fractions,hesperidin,rosmarinic acid,buddleoside,pulegone,coniferyl ferulate,(Z)-ligustilide,notopterol,imperatorin,isoimperatorin,peak 7,9,12,14,6,17,19,and 23 were picked out as the quality difference markers.Conclusion HPLC fingerprint spectrum of CXCTS and CXCTG was established in this study.The established method can detect multiple active components in both formulations.There was significant difference between CXCTS and CXCTG on the content of active ingredients and anti-platelet aggregation activity.The former is
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