慢支咳喘膏的质量标准研究  

Quality Standard of Manzhi Kechuan Cream

作　　者：陈瑶[1] 肖芳[1] 冯琳珊[1] 肖鹏 董慧 刘祖祥[1] 邹启发[1] 

机构地区：[1]云南省第一人民医院药剂科,昆明市650000 [2]云南白药集团股份有限公司技术质量部,昆明市650000

出　　处：《中国药房》2011年第23期2184-2186,共3页China Pharmacy

摘　　要：目的:建立慢支咳喘膏的质量控制方法。方法:采用薄层色谱(TLC)法对方中麻黄、黄芪、甘草进行鉴别;采用高效液相色谱法对制剂中盐酸麻黄碱和盐酸伪麻黄碱进行含量测定。结果:TLC专属性好、斑点清晰;盐酸麻黄碱、盐酸伪麻黄碱进样量分别在1.3～32.5(r=0.9997)、3.4～85μg(r=0.9998)范围内与其峰面积积分值呈良好线性关系,麻黄碱、盐酸伪麻黄碱的平均回收率分别为97.84%、97.85%,RSD分别为0.63%、1.10%(n均为9)。结论:本试验建立的方法简便、准确、重现性好,能有效控制慢支咳喘膏的质量。OBJECTIVE：To establish the method for the quality control of Manzhi kechuan cream.METHODS：Herba Ephedrae,Astragalus membranaceus and Radix Glycyrrhizae in the preparation were identified by TLC.The content of ephedrine and pseudoephedrine in preparation was determined by HPLC.RESULTS：TLC spots were specific and clear.A good linearity was obtained over 1.3～32.5 μg（r=0.999 7） of ephedrine and 3.4～85 μg（r=0.999 8） of pseudoephedrine.The average recoveries of ephedrine and pseudoephedrine were 98.23%and 99.51% and RSDs were 2.15% and 1.56% respectively（n=9）.CONCLUSION：The method is simple,accurate and reproducible for the quality control of Manzhi kechuan cream.

关 键 词：慢支咳喘膏 质量标准 盐酸麻黄碱 盐酸伪麻黄碱 高效液相色谱法 

分 类 号：R284.1[医药卫生—中药学] R283.621[医药卫生—中医学]