咳喘丸质量标准的建立  

Establishement of Quality Standard for Kechuan Pills

作　　者：谢耀轩 罗雅丽 刘秋桃 王淑红 王铁杰 Xie Yaoxuan;Luo Yali;Liu Qiutao;Wang Shuhong;Wang Tiejie(Shenzhen Institute for Drug Control,Guangdong Shenzhen 518057,China)

机构地区：[1]深圳市药品检验研究院,广东深圳518057

出　　处：《中国药师》2020年第12期2469-2473,共5页China Pharmacist

摘　　要：目的:建立咳喘丸的质量标准。方法:采用显微鉴别法鉴别处方中甘草、荆芥、炒紫苏子;采用TLC法鉴别处方中蜜麻黄、苦杏仁、甘草;采用HPLC法测定处方中盐酸麻黄碱和盐酸伪麻黄碱的含量,色谱柱:Agilent Eclipse Plus C18柱(250 mm×4.6 mm,5μm);流动相:乙腈-0.1%磷酸溶液(3∶97);流速:1.0 ml·min-1;检测波长:210 nm;进样量:10μl。结果:在显微鉴别中,显微特征明显,检出甘草、荆芥、炒紫苏子;在TLC鉴别中,TLC色谱斑点清晰,检出蜜麻黄、苦杏仁、甘草;盐酸麻黄碱在2.014~100.7μg·ml-1浓度范围内呈现良好的线性关系(r=1.0000),平均回收率为100.3%,RSD为0.80%(n=9);盐酸伪麻黄碱在2.048~102.400μg·ml-1浓度范围内呈现良好的线性关系(r=1.0000),平均回收率为100.7%,RSD为1.62%(n=9);本品每1 g含蜜麻黄以盐酸麻黄碱(C10H15NO·HCl)和盐酸伪麻黄碱(C10H15NO·HCl)的总量计,不得少于0.60 mg。结论:该方法简便、准确可靠,精密度、稳定性、重复性良好,可用于咳喘丸的质量控制。Objective:To establish the quality standard for Kechuan pills.Methods:Glycyrrhiza uralensis,Schizonepeta tenuifolia and roasted Perilla seed were identified by microscopic identification method.Honey Herba ephedrae,bitter almond and Glycyrrhiza were identified by TLC.The contents of ephedrine hydrochloride and pseudoephedrine hydrochloride in the formulation were determined by HPLC with an Agilent eclipse plus C18column (250 mm×4.6 mm,5μm).The mobile phase was acetonitrile-0.1%phosphoric acid solution (3∶97) and the flow rate was 1.0 ml·min-1.The detection wavelength was at 210 nm and the injection volume was 10μl.Results:The microscopic characteristics were obvious and Glycyrrhiza,Schizonepeta and fried Perilla were detected out in the microscopic identification.The TLC spots were clear and Honey Ephedra,bitter almond and Glycyrrhiza were detected out in TLC identification.The calibration curve was linear within the range of 2.014-100.7μg·ml-1for ephedrine hydrochloride(r=1.000 0) and the average recovery was 100.3%with the RSD of 0.80%(n=9).The calibration curve was linear within the range of 2.048-102.4μg·ml-1for pseudoephedrine hydrochloride(r=1.000 0) and the average recovery was 100.7%with the RSD of 1.62%(n=9).Honey Herba ephedrae contained in every one gram of the product calculated by the total amount of ephedrine hydrochloride (C10H15NO·HCl) and pseudoephedrine hydrochloride (C10H15NO·HCl) should not be less than 0.60 mg.Conclusion:The method is simple,accurate and reliable with good precision,stability and reproducibility,and can be used for the quality control of Kechuan pills.

关 键 词：咳喘丸 质量标准 显微鉴别法 薄层色谱法 高效液相色谱法 盐酸麻黄碱 盐酸伪麻黄碱 

分 类 号：TQ460.72[医药卫生—药物分析学]