复方降脂片质量评价与控制研究  

Quality evaluation and control of compound Jiangzhi Tablets

作　　者：李慧勇 那微 李广生 林林 笔雪艳 石岩[2] LI Hui-yong;NA Wei;LI Guang-sheng;LIN Lin;BI Xue-yan;SHI Yan(Heilongjiang Institute for Drug Control,Heilongjiang Harbin 150088,China;National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]黑龙江省药品检验研究中心,黑龙江哈尔滨150088 [2]中国食品药品检定研究院,北京102629

出　　处：《中国医院药学杂志》2021年第24期2541-2546,共6页Chinese Journal of Hospital Pharmacy

基　　金：2018年药典委药品标准提高课题(编号:411)。

摘　　要：目的:基于复方降脂片的现行标准,对其质量评价及质量控制进行研究。方法:分别建立复方降脂片中的蒲公英、山楂及槲寄生的薄层色谱鉴别方法;建立测定复方降脂片中五味子醇甲、五味子醇乙、五味子甲素和五味子乙素含量的HPLC方法,使用C_(18)(250 mm×4.6 mm,5μm)色谱柱,柱温35℃,以乙腈-水为流动相,梯度洗脱,流速1.0mL·min^(-1),检测波长217 nm,进样量10μL。结果:薄层色谱方法分离度好,斑点清晰且具有良好的耐用性;五味子醇甲、五味子醇乙、五味子甲素和五味子乙素分别在0.0049~0.0490 mg·mL^(-1)、0.0016~0.0164 mg·mL^(-1)、0.0016~0.0161 mg·mL^(-1)和0.0033~0.0330 mg·mL^(-1)范围内呈良好的线性,平均回收率分别为100.4%、99.8%、112.8%和108.9%,RSD分别为2.6%、1.4%、0.6%和5.5%。10批样品中五味子醇甲、五味子醇乙、五味子甲素和五味子乙素的平均含量分别为0.108 mg/片、0.026 mg/片、0.024 mg/片和0.043 mg/片。4种成分含量总和的均值为0.201 mg/片。结论:本文所建立的方法可实现对复方降脂片的准确定性和定量测定,可用于该品种质量的评价与控制。OBJECTIVE To explore the methods of quality evaluation and control for compound Jiangzhi Tablets based upon its current standard.METHODS Thin-layer chromatography(TLC)methods were established for the identifications of Taraxaci Herba,Crataegi Fructus and Visci Herba in Jiangzhi Tablets.High performance liquid chromatography(HPLC)was utilized for determining the contents of schisandrol A,schisandrol B,deoxyschisandrin and schisandrin B.A C_(18)column(250 mm×4.6 mm,5μm)was eluted by acetonitrile-water at a flow rate of 1.0mL·min^(-1)in gradient elution.The temperature of column was 35℃and the detection wavelength217 nm.The injection volume was 10μL.RESULTS The spots were distinct with a satisfactory separation.During HPLC,the calibration curves of schisandrol A,schisandrol B,deoxyschisandrin and schisandrin B were linear in the ranges of 0.0049-0.0490,0.0016-0.0164,0.0016-0.0161 and 0.0033-0.0330 mg·mL^(-1)respectively.Their mean recoveries were 100.4%,99.8%,112.8%and 108.9%with the RSD of 2.6%,1.4%,0.6%and 5.5%.The mean quantities of schisandrol A,schisandrol B,deoxyschisandrin and schisandrin B in 10 batches of samples were 0.108,0.026,0.024 and 0.043 mg in one tablet respectively.The total sum was 0.201 mg in one tablet.CONCLUSION The methods for qualitative and quantitative detection of compound Jiangzhi Tablets may be applied for quality evaluation and control for compound Jiangzhi Tablets.

关 键 词：复方降脂片 五味子醇甲 五味子醇乙 五味子甲素 五味子乙素 质量标准 

分 类 号：R286.0[医药卫生—中药学]