金黄连口服液质量标准的提高  

Improvement of the Quality Standard for Jinhuanglian Oral Liquid

作　　者：李龙[1,2] 马善波[1] 王锦[1] 白娟 陈莹[1] 石小鹏[2] 杨志福[2] 文爱东[2] 曹金一[2] 

机构地区：[1]陕西中医药大学药学院,陕西咸阳712083 [2]第四军医大学西京医院药剂科

出　　处：《中国药师》2017年第10期1876-1878,共3页China Pharmacist

基　　金：军队医疗机构制剂标准提高科研专项课题(编号:14ZJZ12-2)

摘　　要：目的:建立金黄连口服液的质量提高标准。方法:采用TLC法对金银花、黄芩、连翘中的绿原酸、黄芩苷、连翘苷进行定性鉴别;采用HPLC法定量测定金银花中绿原酸的含量,色谱柱:Promosil C_(18)色谱柱(250 mm×4.6 mm,5μm,Agela technologies公司);流动相:乙腈-0.4%磷酸(10∶90);检测波长为327 nm;流速:1.0 ml·min^(-1);进样量:10μl,柱温:25℃。结果:薄层鉴别斑点清晰,在与对照药材相同的位置上,显相同颜色的荧光斑点,阴性样品无干扰;绿原酸含量在5.325~170.400μg·m^(-1)之间,线性良好(r=0.999 8),平均回收率为97.95%,RSD为2.04%(n=6)。结论:本方法结果可靠,操作简便,可作为金黄连口服液的质量控制方法。Objective：To improve the quality standard for Jinhuanglian oral liquid. Methods：The three herbs in the preparation, Honeysuckle, Scutellaria Baicalensis Georgir and St John＆#39;s Wort, were identified by TLC qualitatively. The content of chlorogenic acid in Lonicerae Japonicae Flos was determined by HPLC. The chromatographic separation was carried out on a Promosil C18 （250 mm × 4. 6 mm,5 μm） column at 25℃. The mobile phase consisted of acetonitrile-0. 4% phosphoric acid （10 ：90） with gradient elution at a flow rate of 1. 0 ml·min -1 , and the injection volume was 10μl. The detection wavelength was 327 nm. Results：The spots in TLC were clear without any interference. The linear range of chlorogenic acid was 5.325-170.400 μg·ml-1（r=0.9998）. The average recovery was 97. 95% and the RSD was 2. 04%（n=6）. Conclusion：The method is reliable and easy to operate,which can be used as the quality control method for Jinhuanglian oral liquid.

关 键 词：金黄连口服液 质量标准 高效液相色谱法 薄层色谱法 

分 类 号：TQ460.72[医药卫生—药物分析学]