摘要
目的建立五味子的质量控制方法,评价南北五味子及其制剂肝复康丸的质量。方法采用高效液相色谱法测定,色谱柱为Poroshell 120 EC-C_(18)柱,以流动相A(21%四氢呋喃)与流动相B(乙腈)实施梯度洗脱(0~15 min时90%A→81%A,15~40 min时81%A→68%A,40~60 min时68%A→30%A,60~61 min时30%A→90%A,61~70 min时90%A),流速为0.6 mL/min,柱温为30℃,检测波长为238 nm和288 nm。结果五味子醇甲、五味子乙素、五味子甲素、五味子酯甲、安五脂素的质量浓度分别在0.2018~201.8μg/mL、0.03201~32.01μg/mL、1.139~113.9μg/mL、1.244~124.4μg/mL、1.326~132.6μg/mL范围内与峰面积线性关系良好。其中,北五味子中的五味子醇甲、五味子甲素含量较高,而南五味子中的五味子酯甲、五味脂甲素、安五子素含量较高,不同厂家的肝复康丸中五味子来源不一致。结论该方法准确、可靠,可用于南北五味子及其制剂肝复康丸的质量评价。
Objective To establish a quality control method for Schisandrae Chinensis Fructus,and to evaluate the quality of Kadsura longipedunculata and Schisandra chinensis and the quality of Ganfukang Pills.Methods The high-performance liquid chromatography(HPLC)method was adopted,the chromatographic column was the Poroshell 120 EC-C_(18) column,the mobile phase was 21%tetrahydrofuran(A)-acetonitrile(B)with gradient elution(90%A→81%at 0-15 min,81%A→68%A at 15-40 min,68%A→30%A at 40-60 min,30%A→90%A at 60-61 min,and 90%A at 61-70 min),the flow rate was 0.6 mL/min,the column temperature was 30℃,the detection wavelengths were 238 nm and 288 nm.Results The linear ranges of schisandrol A,schisandrin B,deoxyschizandrin,schisantherin A and anwuligan were 0.2018-201.8μg/mL,0.03201-32.01μg/mL,1.139-113.9μg/mL,1.244-124.4μg/mL,and 1.326-132.6μg/mL respectively.Among them,the contents of schisandrol A and deoxyschizandrin in Schisandra chinensis were relatively high,while those of schisantherin A,deoxyschizandrin and anwuligan in Kadsura longipedunculata were relatively high.The sources of Schisandrae Chinensis Fructus in different manufacturers of Ganfukang Pills were inconsistent.Conclusion This method is accurate and reliable,which can be used for the quality evaluation of Kadsura longipedunculata and Schisandra chinensis and Ganfukang Pills.
作者
黄小琴
翟晔
HUANG Xiaoqin;ZHAI Ye(Taizhou Institute of Drug Inspection,Taizhou,Jiangsu,China 225300)
出处
《中国药业》
CAS
2024年第S01期11-14,共4页
China Pharmaceuticals
关键词
高效液相色谱法
南五味子
北五味子
肝复康丸
指标成分
含量测定
HPLC
Kadsura longipedunculata
Schisandra chinensis
Ganfukang Pills
indicator components
content determination
