复方甘草麻黄碱片的定性定量研究  

Study on the quality standard for Compound Glycyrrhiza Ephedrine Tablets

作　　者：吴玲[1] 胡淼[2] 

机构地区：[1]江苏省省级机关医院,南京210024 [2]南京医科大学,南京210029

出　　处：《西北药学杂志》2012年第5期427-429,共3页Northwest Pharmaceutical Journal

摘　　要：目的制定复方甘草麻黄碱片的质量标准。方法采用TLC法对甘草、杏仁等药材进行鉴别;用HPLC法测定制剂中盐酸麻黄碱的含量,流动相为2mL.L-1磷酸溶液-乙腈(95∶5),流速为1.0mL.min-1,紫外检测波长为210nm。结果各薄层定性鉴别色谱中,所鉴别的药材薄层色谱特征明显,在与对照药材相应的位置上,显相同颜色的斑点,而阴性无干扰。盐酸麻黄碱质量浓度在1.712～53.80μg.mL-1范围内,r为0.999 5,平均回收率为99.0%,RSD为0.7%。结论处方中甘草和杏仁的TLC定性鉴别专属性好,盐酸麻黄碱含量测定方法准确,简单,专属性和重复性良好,可用于该制剂的定性定量控制。Objective To establish the test methods for the quality control of Compound Glycyrrhiza Ephedrine Tablets. Methods Glycyrrhiza and Semen armeniacae amarum were identified by thin-layer chromatography （TLC）. The content of ephedrine hydrochloride in Compound Glyeyrrhiza Ephedrine Tablets was determined by high performance liquid chromatography （HPLC）. Results The TLC identification for the two herbs was highly specific. The linearity of ephedrine hydrochloride was obtained over the range of 1. 712-53.80 bμg· mL^-1 （r=0. 999 5）. The average recovery of ephedrine hydrochloride was 99. 0% with RSD of 0.7%. Conelusion The established method is specific,accurate and reproducible. This quality standard is effective in the quality control of Compound Glycyrrhiza Ephedrine Tablets.

关 键 词：复方甘草麻黄碱片 质量标准 TLC HPLC 

分 类 号：R917[医药卫生—药物分析学]