奋乃静片溶出度测定方法改进  

Improvement of Dissolution Test Method of Perphenazine Tablets

作　　者：周建玉[1] 张玥 

机构地区：[1]天津市药品检验所,天津300070 [2]天津市滨海新区食品药品监督管理局,天津300457

出　　处：《中国药业》2014年第21期47-49,共3页China Pharmaceuticals

基　　金：国家药典委员会科研课题;项目编号:1112

摘　　要：目的根据2010年版《中国药典》药典科研课题任务书的要求,为了更好地控制和评价各厂家产品质量,对奋乃静片的溶出度测定方法进行了研究,建立奋乃静片剂的溶出度测定方法。方法以0.1 mol/L盐酸900 m L为溶出介质,溶出45 min（薄膜衣片30 min）,采用紫外分光光度法在254 nm波长处进行测定。结果奋乃静质量浓度线性范围是0.2~7.0μg/m L,回归方程为A=0.081 9 C＋0025,r=1（n=9）;平均加样回收率为100.7%,RSD=1.34%（n=9）。结论该方法快速准确,可作为奋乃静片的质量控制方法。Objective To study the dissolution test method for better controlling and evaluating the products from various factories and to establish the dissolution test method of Perphenazine Tablets according to the requirement of the pharmacopoeia research project assignment in the Chinese Pharmacopoeia（ 2010 edition）. Methods The dissolving medium was 0. 1 mol / L hydrochloric acid 900 m L and the dissolution time was 45 min（ film coated tablets 30 min）. Then the UV spectrophotometric method was adopted to conduct the detection at the wavelength of 254 nm. Results The linear range of perphenazine was 0. 2- 7. 0 μg / m L, A = 0. 081 9 C ＋ 0025, r = 1（ n = 9）;the average recovery rate was 100. 7%,RSD = 1. 34%（ n = 9）. Conclusion This method is rapid and accurate and can be used as the quality control method of Perphenazine Tblets.

关 键 词：奋乃静片 溶出度 紫外分光光度法 

分 类 号：R927.11[医药卫生—药学] R971.41