医院制剂感冒颗粒质量标准研究

Study on quality standards of hospital preparation Ganmao granules

目的：建立医院制剂感冒颗粒的质量标准。方法采用薄层色谱法（T LC ）对黄芩、黄柏、柴胡进行薄层鉴别；采用高效液相色谱法（HPLC）测定黄芩苷的含量，色谱柱为Agilent HC唱C18（250 mm ＆#215;4．6 mm ，5μm），流动相为甲醇唱0．2％磷酸（43∶57），流速为1．0 ml／min ，柱温30℃，检测波长为280 nm。结果黄芩、黄柏、柴胡的薄层色谱图均斑点清晰，阴性无干扰；黄芩苷在1．81～72．40μg／ml范围内浓度与峰面积线性关系良好（r＝0．9999），平均回收率为98．55％，RSD为1．91％（n＝9）。结论本研究建立的鉴别方法重现性更好，确定了黄芩苷的含量测定方法，增强了该制剂质量的可控性。

Objective To establish a quality standard for Ganmao granules of hospital preparations .Methods Radix Scutellariae ,cortex phellodendri and radix bupleuri were identified by thin layer chromatography （TLC） qualitatively .High performance liquid chromatography （HPLC） was used for the content of baicalin .The determination was performed on Agilent HC-C18 column （250 mm ＆#215; 4 .6 mm ,5 μm） at 30 ℃ with mobile phase composed of methanol-0 .2% phosphoric acid （43∶57） at the flow rate of 1 .0 ml/min .The detection wavelength was set at 280 nm .Results In TLC chromatograms ,the spectra of different test products had spots of the same color at corresponding sites ,with no interference from negative control .A good linearity range of baicalin was 1 .81~72 .40 μg/ml （r=0 .999 9） .The average recovery rate was 98 .55% （RSD=1 .91% ,n=9） .Conclusion The quality standard was established and the method of identification has good reproducibility .The method of determination of baicalin content improved the controllability of formulated quality of Ganmao granules .