基于5种特征性成分综合评价二至丸的质量  

Comprehensive Evaluation of Quality of Erzhiwan Based on Five Characteristic Components

作　　者：范妙璇[1] 谭成[1] 王萌萌[1] 杜小伟[1] 刘颖[1] 王京辉[1] 陈有根[1] 傅欣彤[1] FAN Miao-xuan;TAN Cheng;WANG Meng-meng;DU Xiao-wei;LIU Ying;WANG Jing-hui;CHEN You-gen;FU Xin-tong(Beijing Key Laboratory of Composition Analysis and Bioassessment of Chinese Medicine,Beijing Institute of Drug Control,Beijing 102206,China)

机构地区：[1]北京市药品检验所中药成分分析与生物评价北京市重点实验室

出　　处：《中国实验方剂学杂志》2018年第17期88-92,共5页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：2013年国家药品计划抽验专项

摘　　要：目的：建立二至丸中5种特征性成分特女贞苷、红景天苷、酪醇、木犀草素、蟛蜞菊内酯同时检测的含量测定方法，并据此评价所收集的11批二至丸样品的质量。方法：采用PhenomenexGeminiC．。色谱柱（4．6mm×250mm，5斗m），流动相乙腈（A）-0．2％甲酸水溶液（B）梯度洗脱（0-15min，10％-30％A；15-25min，30％-33％A；25-30min，33％A）。流速1mL·min-，检测波长225nm和349am，柱温30℃。结果：5个成分的分离度良好，红景天苷、酪醇、特女贞苷、木犀草素和蟛蜞菊内酯的线性范围依次为202．55-12153，84．55-5073，244．30-14657．72，2．56-153．72，2．32-139．2ng。加样回收率平均值处于95．61％-103．47％，RSD均〈2．O％。结论：建立的含量测定方法简便、准确，重复性好，可用于市售二至丸样品的含量测定和质量控制。11批样品中5个特征性成分含量差异较大，特女贞苷含量差异〉60倍，最低值0．15mg·g-1，最高值10．22mg·g-1，其原因可能与原料质量和执行标准等因素有一定关系。Objective： To evaluate the quantity of 11 batches of Erzhiwan samples by establishing a HPLC method for simultaneous determination of five characteristic components （specnuezhenide, salidroside, tyrosol, luteolin and wedelolactone） in this preparation. Method： Phenomenex Gemini Cls column （4.6 mmx 250 mm, 5 p·m） was employed with mobile phase of aeetonitrile-0.2% formic acid solution for gradient elution （0-15 min, 10%-30% A; 15-25 rain, 30%-33% A; 25-30 min, 33% A）, flow rate was 1 mL ＂min-I, detection wavelengths were 225 nm and 349 nm, column temperature was set at 30 ℃. Result： Salidroside, tyrosol, specnuezhenide, luteolin and wedelolactone were well separated with linear ranges of 202.55-12 153, 84.55-5 073, 244.30-14 657.72, 2.56-153.72, 2.32-139.2 ng, respectively; their average recovery rates were between 95.61% to 103.47% with RSD 〈 2.0%. Conclusion： This determination of five components is simple, accurate and reproducible for the quality control of Erzhiwan. The contents of these five components in 11 batches of samples are quite different. The content of specnuezhenide in samples is ranged from 0. 15 rag .g-i to10.22 mg g-1, which may be caused by the materials, the operative norms and other factors.

关 键 词：二至丸 女贞子 墨旱莲 特女贞苷 质量控制 蟛蜞菊内酯 

分 类 号：R22[医药卫生—中医基础理论] R289[医药卫生—中医学]