清热解毒胶囊质量研究  

Quality study on Qingre Jiedu capsule

作　　者：刘志荣 李安平 杨锡 杨平荣 胡旭东 

机构地区：[1]甘肃省药品检验研究院,兰州730070

出　　处：《分析仪器》2017年第3期88-94,共7页Analytical Instrumentation

基　　金：国家标准提高项目(53)

摘　　要：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。Honeysuckle, Fructus Gardeniae, Fructus Forsythiae, Radix Ophiopogonis, Radix Genti-anae 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 C15 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, respective-ly. 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.

关 键 词：清热解毒胶囊 TLC HPLC 绿原酸 黄芩苷 

分 类 号：R286.0[医药卫生—中药学]