甘露消毒胶囊的质量标准研究  

Study on quality control of Ganlu Xiaodu Capsules

作　　者：张林林[1,2] 高文远[1] 王顺仙[2] 董欣[2] 郑国华[2] 

机构地区：[1]天津大学药物科学与技术学院,天津300072 [2]天津药物研究院,天津300193

出　　处：《现代药物与临床》2010年第5期369-372,共4页Drugs & Clinic

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 C1(8250mm×4.6mm,5μm),以甲醇-水-磷酸(47:53:0.2)为流动相,检测波长为278nm,柱温为35℃,体积流量为1.0mL/min,理论塔板数按黄芩苷峰计不低于5000。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0.103～0.618μg,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。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 min×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.

关 键 词：甘露消毒胶囊 黄芩苷 质量标准 薄层色谱 高效液相色谱 

分 类 号：R927.11[医药卫生—药学]