麻黄止嗽胶囊质量标准的建立  

Study on the Quality Standard for Mahuangzhisou Capsules

作　　者：雷成康 郭玲[2] 

机构地区：[1]西安市食品药品检验所,西安710054 [2]陕西师范大学

出　　处：《中国药师》2016年第4期681-685,共5页China Pharmacist

基　　金：国家药典委员会2010年国家药品标准提高研究课题(编号:146)

摘　　要：目的:提高麻黄止嗽胶囊质量标准。方法:采用薄层色谱法鉴别制剂中细辛、五味子、川贝母、桔梗、橘红五味药材,并用高效液相色谱法测定橘红的含量。结果:建立了细辛、五味子、川贝母、桔梗、橘红五味药材的薄层色谱鉴别法,空白样品无干扰;建立了高效液相色谱法测定橘红含量的方法,橙皮苷浓度在3.03~302.80μg·ml^(-1)范围内线性关系良好,r=0.999 9,平均加样回收率为99.80%(RSD=0.49%,n=9)。结论:该质量标准具有简便、准确的优点,可有效控制该制剂的质量。Objective： To improve the quality standard for Mahuangzhisou capsules. Methods： A TLC method was used to identify five components including Asari Radix Et Rhizoma,Schisandrae Chinensis Fructus,Fritillariae Cirrhosae Bulbus,Platycodonis Radix and Citri Exocarpium Rubrum in the capsules. An HPLC method was used to determine the content of Citri Exocarpium Rubrum. Results： The TLC identification method for Asari Radix Et Rhizoma,Schisandrae Chinensis Fructus,Fritillariae Cirrhosae Bulbus,Platycodonis Radix and Citri Exocarpium Rubrum was established without any interference. The HPLC method for the determination of Citri Exocarpium Rubrum was established,and the linear concentration of hesperidin was 3.03-302.80 μg·ml^（-1）（ r= 0.999 9）,and the average recovery was 99.80%（ RSD = 0.49%,n = 9）. Conclusion： The new quality standard is simple and accurate,which can effectively control the quality of the preparation.

关 键 词：麻黄止嗽胶囊 质量标准 薄层色谱 高效液相色谱 

分 类 号：TQ460.72[医药卫生—药物分析学]