不同厂家奈韦拉平片的溶出度对比研究

Abstract

目的考察国产奈韦拉平片与进口制剂的体外溶出度情况,并比较其体外溶出相似性。方法分别考察各厂家奈韦拉平片在pH 2.0磷酸盐缓冲液中的溶出度,并比较了国产奈韦拉平片与进口制剂分别在pH 1.2盐酸水溶液、pH 2.0磷酸盐缓冲液、pH 4.5醋酸盐缓冲液、pH6.8磷酸盐缓冲液4种介质中溶出行为相似性。结果各厂家奈韦拉平片在pH 2.0磷酸盐缓冲液60min时溶出度均高于75%;有3个厂家的奈韦拉平片在4种溶出介质中的溶出曲线与进口制剂相似。结论不同厂家生产的奈韦拉平片溶出行为有显著差异,可能会影响药物在体内的生物利用度。

OBJECTIVE To investigate the in vitro dissolution of nevirapine tablets from different manufacturers and imported preparation, and to compare their in vitro dissolution similarity. METHODS The in vitro dissolution of the products from 4 different manufacturers were investigated in pH 7.2 phosphate buffer solution. And compared the similarity of 3 different manufacturers and imported preparation in 5 kinds of media： pH 1.2 hydrochloric acid so- lution, pH 4. 5 acetate buffer solution, pH 6.8 phosphate buffer solution, pH 7.2 phosphate buffer solution and water. RESULTS The dissolution rate of nevirapine oral suspension from 4 different manufacturers reached more than 80% within 60min. The dissolution profiles of nevirapine oral suspension from 2 different manufacturers were similar to imported preparation. CONCLUSION There are significantly difference among the quality of nevirapine oral sus- pension from different manufacturers,which may influence the drug bioavailability in vivo.