摘要
目的通过薄层色谱(TLC)法、高效液相色谱(HPLC)法以及指纹图谱的建立对强力脑清素片进行质量控制。方法采用TLC对强力脑清素片中的主要组分刺五加浸膏、五味子流浸膏和鹿茸精进行定性鉴别,以HPLC对君药刺五加浸膏中主要有效成分紫丁香苷、刺五加苷E、异嗪皮啶同时进行定量测定,并利用HPLC对强力脑清素片建立指纹图谱。结果强力脑清素片TLC色谱中的斑点清晰,与对照品斑点颜色一致。HPLC法测定强力脑清素片中紫丁香苷、刺五加苷E、异嗪皮啶分别在22.74~454.80、16.112~322.240、4.152~83.040μg/mL线性关系良好,平均回收率分别为95.48%、98.22%、100.75%,质量分数分别为0.42~0.65、0.12~0.15、0.26~0.37 mg/片。指纹图谱的相似度>0.95,指认出6个共有成分,分别为刺五加浸膏中紫丁香苷、异嗪皮啶、刺五加苷E;五味子流浸膏中五味子醇甲、五味子甲素、五味子乙素。结论TLC、HPLC结合指纹图谱方法对强力脑清素片能实现全面的质量控制,且操作简便、重现性良好。
Objective To determine the effective components of Qiangli Naoqingsu Tablets by TLC-HPLC and to study the fingerprint of the whole variety.Methods TLC of powerful brain slice of the main components in the clear element acanthopanax extract,the extract of fructus schisandrae flow and antler extract qualitative identification,by HPLC to gentleman medicine acanthopanax extract main effective component in the lilacs glycosides,acanthopanax nucleoside E,different oxazine organism under the condition of the same chromatographic determination of content,and use the HPLC to strong clear element to establish fingerprint of brain research.Results The spots in TLC were clear,aligned with those in the control and the color was consistent.The linear relationship of syringin,eleutheroside E and isofraxidin in Qiangli Naoqingsu Tablets was determined by HPLC in the range of 22.74-454.80μg/mL,16.112-322.240μg/mL and 4.152-83.040μg/mL,respectively.The average recovery rates were95.48%,98.22%and 100.75%,respectively,and their contents were 0.42-0.65,0.12-0.15,0.26-0.37 mg/tablet.Fingerprint similarity>0.95,identified six common components,respectively,in acanthopanax extract:syringin,eleutheroside E and isofraxidin;fructus schisandrae A,fructus schisandrae A and fructus Schisandrae B in schisandrae flow extract.Conclusion TLC-HPLC and fingerprint chromatogram can control the quality of Qiangli Naoqingsu Tablets,and the operation is simple and reproducible.
作者
倪术仁
郭景文
赵红艳
倪育淳
国锦琳
NI Shuren;GUO Jingwen;ZHAO Hongyan;NI Yuchun;GUO Jinlin;无(Shanxi university of traditional Chinese medicine,Jinzhong 030619,China;Shanxi Institute for Food and Drug Control,Taiyuan 030031,China;Shanxi Hospital of Traditional Chinese Medicine,Taiyuan 030000,China;Chengdu University of TCM,Chengdu 610072,China)
出处
《药物评价研究》
CAS
2021年第8期1688-1695,共8页
Drug Evaluation Research
