摘 要：目的 建立甘露消毒膠囊的定性鑒別和定量測定質(zhì)量標(biāo)準。方法 采用薄層色譜法對豆蔻、石菖蒲、川貝母、連翹進行定性鑒別；采用高效液相色譜法對制劑中黃芩苷進行定量測定。色譜柱為 Kromasil C18（250 mm×4.6 mm，5 μm），以甲醇-水-磷酸（47∶53∶0.2）為流動相，檢測波長為278 nm，柱溫為35 ℃，體積流量為1.0 mL/min，理論塔板數(shù)按黃芩苷峰計不低于5 000。結(jié)果 在薄層色譜中能檢測出豆蔻、石菖蒲、川貝母、連翹4味藥材；建立的測定方法中，黃芩苷的線性范圍為0.103～0.618 μg，平均回收率為100.9%。結(jié)論 所建立的定性、定量方法準確可行，重現(xiàn)性好，可作為甘露消毒膠囊的質(zhì)量標(biāo)準。

Abtract: Objective To establish the quality standard of Ganlu Xiaodu Capsules including qualitative identification and quantitative determination．Methods TLC was applied to the qualitative identification of Amomi Fotundus Fructus，Acori Tatarinowii Rhizoma，F(xiàn)ritillariae Cirrhosae Bulbus，and Forsythiae Fructus，and HPLC was applied to the quantitative determination of baicalin．The analytical column was Kromasil C18（250 mm×4.6 mm，5 μm），and the mobile phase was methanol - water - phosphoric acid（47∶53∶0.2）．The detection wavelength was at 278 nm，and the column temperature was at 35 ℃．The volume flow was 1.0 mL/min．Results Amomi Fotundus Fructus，Acori Tatarinowii Rhizoma，F(xiàn)ritillariae Cirrhosae Bulbus，and Forsythiae Fructus could be identified by TLC．The linear relationship was in the range of 0.103—0.618 μg for baicalin，and the average recovery was 100.9%．Conclusion This method is accurate and highly reproducible．It can be used for the quality control of Ganlu Xiaodu Capsules．

中國檢驗檢疫科學(xué)研究院院長基金項目(食品添加劑安全風(fēng)險評估研究)；質(zhì)檢總局課題(2009IK310)