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提高咳露口服液质量标准的研究
引用本文:杨东花,刘峰,马久太,卢新义,党艳妮,韩翠.提高咳露口服液质量标准的研究[J].西北药学杂志,2011,26(5):324-327.
作者姓名:杨东花  刘峰  马久太  卢新义  党艳妮  韩翠
作者单位:1. 陕西中医学院,陕西,咸阳,712046
2. 陕西步长制药有限公司,陕西咸阳712000;陕西省中药制药工程技术研究中心,陕西咸阳712000
基金项目:国家重点新产品计划项目,陕西省重点新产品计划项目,陕西省"13115"科技创新工程技术研究中心
摘    要:目的提高完善咳露口服液的质量标准。方法在国家药品标准的基础上,新增采用TLC法对处方中的麻黄、薄荷脑、甘草、川贝母、枇杷叶、紫菀进行定性鉴别,改进黄芩TLC鉴别方法,同时新增HPLC法对吗啡进行含量测定。结果吗啡在0.0456~0.182 4μg(r=0.999 9)范围内呈良好的线性关系,平均回收率为100.1%,RSD为1.2%(n=6)。结论该方法简便,重复性好,可全面有效控制咳露口服液的质量。

关 键 词:咳露口服液  吗啡  薄层色谱法  高效液相色谱法

Study on quality standard improvement of Kelu Oral Liquid
YANG Donghua,LIU Feng,MA Jiutai,LU Xinyi,DANG Yanni,HAN Cui.Study on quality standard improvement of Kelu Oral Liquid[J].Northwest Pharmaceutical Journal,2011,26(5):324-327.
Authors:YANG Donghua  LIU Feng  MA Jiutai  LU Xinyi  DANG Yanni  HAN Cui
Institution:YANG Donghua1,LIU Feng2,3*,MA Jiutai2,3,LU Xinyi2,DANG Yanni2,HAN Cui2,3(1.Shaanxi College of Chinese Medicine,Shaanxi Xianyang 712046,China,2.Shaanxi Buchang Pharmaceutical Co.Ltd.Shaanxi Xianyang 712000,3.Shaanxi Engineering and Research Center for Traditional Chinese Medicine,Shaanxi Xianyang 712000,China)
Abstract:Objective To consummate the quality standard for Kelu Oral Liquid. Methods Ephedrae herba ,1-menthol, Glycyrrhizae Radi3: et rhizoma ,Fritillariae cirrhosae Bulhus, Eriobotryae Foliurn ,Asteris Radix et rhizome in preparation were identified by TLC. The identification method of Radix Scutellariae was improved,and the content of morphine was determined by HPLC. Re- sults The calibration curves of morphine was in good linearity over the range of 0. 045 6-0. 182μg ( r =0. 999 9) ,and the average recovery was 100.1% ( RSD= 1.2%, n = 6 ). Conclusion The method is simple, convenient and reproducible, which can be used to control the quality of Kelu Oral Liquid.
Keywords:Kelu Oral Liquid  morphine  TLC  HPLC  
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