[关键词]
[摘要]
摘 要:目的 建立甘露消毒胶囊的定性鉴别和定量测定质量标准。方法 采用薄层色谱法对豆蔻、石菖蒲、川贝母、连翘进行定性鉴别;采用高效液相色谱法对制剂中黄芩苷进行定量测定。色谱柱为 Kromasil C18(250 mm×4.6 mm,5 μm),以甲醇-水-磷酸(47∶53∶0.2)为流动相,检测波长为278 nm,柱温为35 ℃,体积流量为1.0 mL/min,理论塔板数按黄芩苷峰计不低于5 000。结果 在薄层色谱中能检测出豆蔻、石菖蒲、川贝母、连翘4味药材;建立的测定方法中,黄芩苷的线性范围为0.103~0.618 μg,平均回收率为100.9%。结论 所建立的定性、定量方法准确可行,重现性好,可作为甘露消毒胶囊的质量标准。
[Key word]
[Abstract]
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,Fritillariae 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,Fritillariae 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.
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[基金项目]
中国检验检疫科学研究院院长基金项目(食品添加剂安全风险评估研究);质检总局课题(2009IK310)