摘要
目的完善金关片质量标准。方法采用薄层色谱(TLC)法对续断、秦艽、丹参、淫羊藿、黄芪进行鉴别。建立高效液相色谱(HPLC)法测定双酯型生物碱,以AQ Welch C_(18)色谱柱(4.6 mm×250.0 mm,5μm),以乙腈-四氢呋喃(25∶15)为流动相A,以0.1 mol/L醋酸钠溶液作为流动相B,检测波长235 nm,梯度洗脱,柱温35℃,流速1.0 mL/min。结果建立的TLC法专属性强、分离度好、阴性无干扰;3种双酯型乌头碱HPLC含量测定方法专属性较TLC强,线性关系良好,相关系数为0.999 5~0.999 9;回收率为94.4%~99.2%。结论该法操作简便、重现性好、结果准确,可作为该制剂的质量控制方法。
Objective To perfect the quality standard of Jinguan Tablets.Methods Dipsaci Radix,Gentianae Macrophyllae Radix,Salviae Miltiorrhizae Radix et Rhizoma,Epimedii Folium and Astragali Radix were identified by adopting the thin-layer chromatography(TLC).The high performance liquid chromatography(HPLC)for determining diester type alkaloids was established,with AQ Welch C18column(4.6mm×250.0mm,5μm)as the chromatographic column,acetonitrile-tetrahydrofuran(25∶15)as the mobile phase A and0.1mol/L sodium acetate solution as the mobile phase B.The detection wavelength was at235nm for conducting the gradient elution,the column temperature was at35℃and the flow rate was1.0mL/min-1.Results The established TLC method had strong specificity and good separation degree without negative interference;the HPLC content detection method for3kinds of diester type aconitine had stronger specificity than TLC,the linear relation was good,the correlationcoefficient(r)was0.9995-0.9999andtherecoveryratewas94.4%-99.2%.Conclusion This method is easy to operate with good reproducibility and accurate results,and can serve as the quality control method of this preparation.
作者
罗亚玲
李冰
耿昭
苟琰
LUO Yaling;LI Bing;GENG Zhao;GOU Yan(Sichuan Provincial Institute for Food and Drug Control,Chengdu,Sichuan 611731,China;Leshan Municipal Hospital of Traditional Chinese Medicine,Leshan,Sichuan 614000,China)
出处
《现代医药卫生》
2018年第6期845-848,共4页
Journal of Modern Medicine & Health
关键词
雷公藤内酯
金关片
质量标准
色谱法
薄层
色谱法
高压液相
Triptolide
Jinguan Tablets
Quality standard
Chromatography,thin layer
Chromatography,high pressure liquid
作者简介
罗亚玲(1978—),主管中药师,主要从事中药学的研究工作
