关于中国药典淫羊藿药材定量指标的商榷

Evaluating the Rationality of the Quantification Marker for the Quality Control of Epimedii Folium

目的:通过测定箭叶淫羊藿野生品和栽培品中朝藿定C、淫羊藿苷、鼠李糖基淫羊藿次苷Ⅱ3种黄酮类成分含量,对中国药典淫羊藿药材定量指标的合理性进行评价。方法:建立HPLC-DAD方法,色谱柱为Alltima C_(18)(250 mm×4.6 mm,5μm);流动相:乙腈(A)-水(B),梯度洗脱;检测波长270 nm。对野生和栽培箭叶淫羊藿及不同干燥方法处理的样品进行分析测定。结果:箭叶淫羊藿各样品中朝藿定C含量最高,达2.0%以上,未检测到淫羊藿苷。结论:中国药典淫羊藿药材以淫羊藿苷为定量指标,箭叶淫羊藿难以达标,造成资源浪费,建议中国药典修订定量指标或将箭叶淫羊藿单列。

Objective ： To evaluate the rationality of the quantification marker for the quality control of Epimedii Folium in the Chi- nese Pharmacopoeia by quantifying the content of epimedin C,icariin and 2＂-O-rhamnosyl icariside Ⅱ in the folium of Epimedium sagit- tatum. Methods：HPLC-DAD method with an Alltima C18 column was established. The mobile phase was consisted of acetonitrile（ A ）- water（B） with gradient elution. The UV detection was set at 270 nm. Wild and cultivated samples with different drying methods were an- alyzed. Results：The content of epimedin C was the highest（ ≥ 2.0% ） ,but no icariin was detectable in all samples at the present condi- tions. Conclusion ： The standard with icariin as the quantification marker in the Chinese Pharmacopoeia is not suitable for the quality con- trol of Epimedium sagittatum. Standard revision of Epimedii Folium or individual monograph for Epimedium sagittatum is recommended so as to make full use of Epimedium sagittatum resources.