感冒灵胶囊质量标准的研究

Study on Quality Standard of Ganmaoling capsules

目的：建立感冒灵胶囊的质量标准。方法：以2-4苦、金盏银盘以及岗梅为对照药材进行薄层鉴别；采用C18色谱柱，流动相为乙腈-0．03mol／1磷酸氢二铵（磷酸调pH至3．1）（12：88），进样量10μl，柱温为20℃，检测波长214nm，流速为1．0ml．min^-1。结果：薄层图谱斑点清晰，阴性对照无干扰；对乙酰氨基酚、咖啡因、马来酸氯苯那敏分别在101．17～2023．40μg／ml、2．00-40．09μg／ml和2．05～40．93μg／ml范围内线性关系良好，精密度RSD分别为0．05％、0．09％、0．17％（n=8），平均回收率分别为100．4％、99．6％、99．6％。结论：结果准确，方法重复性好，可作为该制剂的质量控制指标。

Objective：To establish the quality standard for Ganmaoling capsules （Hillock mei, JinZhan silver plate,Trigeminal bit- ter, Acetaminophen, etc. ）. Methods： To regard JinZhan silver plate, hillock mei, and trigeminal bitter as control medicinal materials to conduct thin-layer identification;To adopt C 18 Chromatographic column,The phase is A cetonitrile-0.03mol/I, Diammonium hydrogen phosphate, （ Use Phosphoric acid to control pH to 3.1 ）, （ 12：88 ）The Sample volume is 10 ix 1, The column temperature is 20℃,The de- tection wavelength is 214rim,the fluid rate is 1.0ml/min, Results： TLC spots developed were fairly clear, and the blank test showed no interference.Acetaminophen ,caffeine,and chlorpheniramine maleate all show good linear relationship respectively within the range be- tween 101.17 and 2023.40μ g/ml, 2.00 and 40.09μ g/ml, 2.05 and 40.93 μ g/ml ; The Precision is0.05%, 0.09%, 0.17%respectively, The average recovery rate is 100.4%, 99.6%, 99.6% respectively. Conclusion： The result is accurate, the method has good reproducibility, It an be used to control the quality of this preparation.