金莲清热胶囊质量标准研究?

目的提高和完善金莲清热胶囊的质量标准。方法采用薄层色谱法(TLC)对金莲清热胶囊中金莲花、大青叶、玄参和苦杏仁进行定性鉴别;采用高效液相法(HPLC),色谱柱为Phenomenex Luna C18(2)100A(250 mm×4.6 mm,5μm),以乙腈-0.4%乙酸铵溶液(15∶85)为流动相,流速1.0 m L/min,检测波长340 nm,柱温30℃,进行牡荆苷含量测定。结果金莲花、大青叶、玄参和苦杏仁的薄层色谱主斑点清晰,分离良好;牡荆苷在0.06~0.57μg(r=0.999 9)线性良好,平均加样回收率为99.7%,RSD为2.1%。结论建立的TLC和HPLC方法专属性强、准确、重复性好,可用于金莲清热胶囊的质量控制。

Improving the quality standard for Jinlian Qingre Capsule

Objective To improve the quality standard of Jinlian Qingre Capsule. Methods Chinese Globeflower Flower(Trollii Chinensis Flos, Jinlianhua),Dyers Woad Leaf(Folium Isatidis, Daqingye), Figwort Root ( Srophulariae Radix, Xuanshen ) and Bitter Apricot Seed ( Semen Armeniacae Amarum, Kuxingren) in Jinlian Qingre Capsule were identified using thin layer chromdograph ( TLC) . The content of vitexin was detected using HPLC with a Phenomenex Luna C18 (2)100A column(250 mm × 4. 6 mm,5μm), a mobile phase of acetonitrile- 0. 4% ammonium acetate(15∶85)at the flow rate of 1. 0 mL/min, detection wave length at 340 nm and the column temperature at 25 ℃. Results Main spots of Chinese Globeflower Flower,Dyers Woad Leaf,Figwort Root and Bitter Apricot Seed in TLC were clear and sepa-rated well. A good linearity was obtained for vitexin in the range of 0. 06~0. 57 μg(r=0. 999 9)with mean sample recovery rate of 99 . 7% and RSD of 2 . 1%. Conclusion Method of TLC and HPLC estab-lished in this study which appears to be highly specific,accurate and repeatable can be used in the quality control of the Jinlian Qingre Capsule.