中国药房2013，Vol.24Issue(21)：1988-1990,3.DOI:10.6039/j.issn.1001-0408.2013.21.24
国内外不同厂家厄贝沙坦片在多种溶出介质中的溶出情况比较
Comparison of the Dissolution of Irbesartan Tablets from Different Domestic and Foreign Factories in Different Mediums
摘要
Abstract
OBJECTIVE:To compare the dissolution of Irbesartan tablets from 3 domestic factories and 1 foreign original product in 4 different mediums.METHODS:The dissolution rates of samples were determined by paddle method,and HPLC method was adopted for quantitative analysis.The dissolution profiles of Irbesartan tablets from 4 different factories in 4 different mediums (pH 1.2 hydrochloric acid solution,pH 4.0 acetate buffer,pH 6.8 phosphate buffer and water) were made,and the similarity was investigated according to the f2 factors method.RESULTS:Compared with original products,the tablets from 3 domestic factories were dissolved similarly in pH 1.2 hydrochloric acid solution with f2＞50; the f2 of the tablets from factory B in pH 6.8 phosphate buffer,factory C in pH 4.0 acetate buffer and water,factory D drugs in water were all lower than 50.CONCLUSIONS:There are significant differences in the dissolution profiles of Irbesartan tablets from domestic and foreign factories in different mediums.It is necessary to strengthen monitoring of drug dissolution profiles in different mediums,to ensure homogeneity and stability of the quality of the same product from different manufacturers.关键词
厄贝沙坦片/溶出曲线/相似因子/高效液相色谱法Key words
Irbesartan tablets/ Dissolution profiles/ Similarity factors/ HPLC分类
医药卫生引用本文复制引用
贾孟良,杨红英,贾玉燕,谢守霞,练宏新,王玉..国内外不同厂家厄贝沙坦片在多种溶出介质中的溶出情况比较[J].中国药房,2013,24(21):1988-1990,3.基金项目
广东省医院药学研究基金资助(No.2012A03) （No.2012A03）
深圳市科技计划资助项目(No.201103339) （No.201103339）
