手足口合剂质量标准的建立

The esablishment of quality standard for Shouzukou mixture

[目的]建立手足口合剂的质量标准。[方法]采用薄层色谱(TLC)法对方中黄芩、黄柏、栀子、蒲公英、黄连进行定性鉴别;采用高效液相色谱(HPLC)法对黄芩苷进行含量测定。色谱柱为Shim-pack VP-ODS(150 mm×4.6 mm),流动相为甲醇∶水∶冰醋酸(40∶60∶1),检测波长为280 nm,柱温为40℃,流速为1.0 mL/min。[结果]TCL色谱中能明显检出黄芩、黄柏、栀子、黄连、蒲公英;黄芩苷在0.270～0.720μg范围内线性关系良好(r=0.999 9);平均回收率为100.80%(RSD=1.11%)。[结论]该法操作简便、结果准确、重复性好,可用于手足口合剂的质量控制。

[Objective] To esablish the quality standard for Shouzukou Mixture. [Methods] Scutellaria baicalensis, Coptis Chinensis, Golden cypress, Cape jasmine, dandelion were identificated by TLC; chlorogenic acid in Shouzukou Mixture was determinated by HPLC. Parameters： Shim-pack VP-ODS （4.6 mm× 150 mm）, methyl alcohol： water：glacial acetic acid （40：60：1）; gradient elution ;a flow rate of 1.0 mL/min; detection wavelength of 280 nm; column temperature 40 ℃. [Results] All five tranditional Chinese medicine could be checked by using TLC; HPLC determination of haicalin in the range of 0.270-0.720 μg was good linear with a good relationship. Average recovery was 100.8%. [Conclusion] The method is simple, accurate and reliable, and suitable for the quality control.