五味甘露药浴洗剂中麻黄成分盐酸麻黄碱和盐酸伪麻黄碱的含量测定方法的优化  

Optimization of quantitative determination method for the content of Ephedrine Hydrochloride and Pseudoephedrine Hydrochloride in Wuwei Ganlu Medicinal Bath Wash

作　　者：龙成 常立强 高琛 索正加 代威 权富家 LONG Cheng;CHANG Liqiang;GAO Chen;SUO Zhengjia;DAI Wei;QUAN Fujia(Department of Scientific Innovation and Entrepreneurship,Arura Tibetan Medicine Co.,Ltd.,Qinghai Province,Xining 810003,China)

机构地区：[1]青海省金诃藏药股份有限公司科创事业部,青海西宁810003

出　　处：《中国当代医药》2024年第19期10-14,21,共6页China Modern Medicine

摘　　要：目的本研究旨在通过优化样品前处理方法与液相色谱条件,建立一种可以准确测定藏药五味甘露药浴洗剂中盐酸麻黄碱和盐酸伪麻黄碱的总含量的测定方法。方法前处理方法为精密量取样品3 ml,加入甲醇后超声提取45 min,放冷后定容至25 ml,精密量取续滤液1 ml,置于中性氧化铝柱上,使用50%甲醇9 ml洗脱,收集洗脱液并定容至10 ml;色谱条件:色谱柱为Aglient Eclipse Plus,C18(250 mm×4.6 mm,5μm);流动相为乙腈-0.2%磷酸溶液(3∶97);进样量20μl;检测波长210 nm;流速1 ml/min;柱温30℃。结果盐酸麻黄碱的线性范围为7.232~28.928μg/ml(r^(2)=0.9995,n=7),盐酸伪麻黄碱的线性范围2.704~10.816μg/ml(r^(2)=0.9992,n=7)线性关系良好,二者含量之和的平均加样回收率为100.33%,相对标准偏差(RSD)=0.3%(n=8)。结论本方法可同时测定盐酸麻黄碱和盐酸伪麻黄碱两种成分,操作简便,结果准确,重复性好,可用于五味甘露药浴洗剂的质量控制。通过该方法的应用,可以确保产品符合规定标准,保障产品质量,同时为相关研究和生产提供了可靠的技术支持。Objective To accurately determine the total content of ephedrine hydrochloride and pseudoephedrine hydrochloride in Wuwei Ganlu Medicinal Bath Wash,and to optimize sample pretreatment methods and liquid chromatographic conditions.Methods Accurately measuring 3 ml of the sample was entailed in the pre-treatment method,followed by ultrasonic extraction with methanol for 45 minutes.After cooling,the solution was brought to a final volume of 25 ml.A precise amount of 1 ml of the filtrate was collected and placed on a neutral alumina column.Elution was carried out with 9 ml of 50%methanol,the eluate was colleted and adjusted to a final volume of 10 ml.Chromatographic conditions:the chromatographic column was Aglient Eclipse Plus,C18(250 mm×4.6 mm,5μm),and the mobile phase was acetonitrile-0.2%phosphoric acid solution(3∶97)and the injection volume was 20μl.The wavelength was 210 nm.The flow rate was 1 ml/min.The column temperature was 30℃.Results The linear range of ephedrine hydrochloride was 7.232~28.928μg/ml(r^(2)=0.9995,n=7),and the linear range of pseudoephedrine hydrochloride was 2.704~10.816μg/ml(r^(2)=0.9992,n=7),the linear relationship was good,and the average sample recovery rate of the sum of the two contents was 100.33%,the relative standard deviation(RSD)=0.3%(n=8).Conclusion This method can be used to determine ephedrine hydrochloride and pseudoephedrine hydrochloride at the same time,which is easy to operate,accurate and reproducible,and can be used for quality control of Wuwei Ganlu Medicinal Bath Wash.Through the application of this method,it can ensure that the product meets the specified standards,ensure the quality of the product,and provide reliable technical support for related research and production.

关 键 词：五味甘露药浴洗剂 盐酸麻黄碱 盐酸伪麻黄碱 高效液相色谱法 

分 类 号：R29[医药卫生—民族医学]