清热解毒胶囊质量研究

目的:完善提高清热解毒胶囊的质量标准。方法:采用薄层色谱法对处方中金银花、栀子、连翘、麦冬、龙胆、黄芩进行定性鉴别;同时测定处方中绿原酸和黄芩苷含量。采用CAPCELL PAK C18(5μm,4.6mm×250mm)为色谱柱,以乙腈-0.1%磷酸水溶液为流动相,梯度洗脱,流速1mL·min~(-1),检测波长326nm,柱温30℃。结果:薄层色谱鉴别专属性强,重复性好。样品中的绿原酸和黄芩苷峰按照拟定的试验方法测定分离度良好,分别在0.0479μg~0.957μg(r=0.9999)、0.153μg~3.064μg(r=0.9999)范围内与峰面积呈现良好的线性关系;加样回收率分别为92.7%(RSD=1.9)和98.9%(RSD=2.0)。经HPLC测定,10批样品中2个成分的含量分别为绿原酸3.74~4.51mg·g~(-1),黄芩苷18.94~21.76mg·g~(-1)。结论:该法简便、专属、准确,可用于清热解毒胶囊的质量控制。

Quality study on Qingre Jiedu capsule

Honeysuckle, Fructus Gardeniae, Fructus Forsythiae, Radix Ophiopogonis, Radix Gentianae and Scutellaria Baicalensis were indentified by TLC. The content of chlorogenic acid and baicalin were determined by HPLC. The chromatographic separation was carried out on a CAPCELL PAK C18 column (5 μm,4.6 mm×250 mm)with a mobile phase consisting of acetonitrile-0.1% phosphoric acid solution in a gradient mode at a flow rate of 1.0 mL·min-1 . The UV detection wavelength was set at 326 nm while the column temperature was at 30℃.There was a good linear relationship within the range of 0.0479-0.957μg (r =0. 9999) and 0.153-3.064 μg (r =0. 9999) for chlorogenic acid and baicalin, respectively. The average recoveries of the two components were 92.7% (RSD =1.9%) and 98.9% (RSD =2.0%), respectively. The method is simple, exclusive, accurate and can be used for determination and quality control of qingrejiedu capsules.