不同厂家布洛芬混悬液的溶出度对比研究

Comparative Study on Dissolution Profiles of Ibuprofen Suspension from Different Pharmaceutical Manufacturers

目的:比较国产布洛芬混悬液和进口制剂的溶出曲线相似性,为全面评价布洛芬混悬液的质量提供依据。方法:分别考察各厂家布洛芬混悬液在pH 7.2磷酸盐缓冲液中的溶出度,并比较国内3个厂家布洛芬混悬液与进口制剂分别在pH1.2盐酸溶液、pH 4.5醋酸盐缓冲液、pH 6.8磷酸盐缓冲液、pH 7.2磷酸盐缓冲液和水5种溶出介质中溶出行为相似性。结果:各厂家布洛芬混悬液在pH 7.2磷酸盐缓冲液60 min时溶出度均达到80%以上;3个厂家的布洛芬混悬液溶出曲线与进口制剂溶出曲线相比较,有两个厂家的制剂与进口制剂相似性达到要求。结论:不同厂家生产的布洛芬混悬液,其溶出行为有明显差异。

Objective： To compare the similarity of dissolution curves of domestic ibuprofen suspension and the imported preparation to provide the basis for the comprehensive quality evaluation of ibuprofen suspension. Methods： The in vitro dissolution of the products from four different manufacturers was investigated in pH 7.2 phosphate buffer solution. The similarity of dissolution behavior was compared with that of the imported preparation in pH 1.2 hydrochloric acid solution, pH 4.5 acetate buffer solution, pH 6.8 phosphate buffer solution, pH 7.2 phosphate buffer solution and water, respectively. Results： The dissolution rate of ibuprofen suspension from the four different manufacturers reached above 80% in 60 min. The dissolution profiles of ibuprofen suspension from two different manufacturers were similar with that of the imported preparation. Conclusion： The dissolution behavior of ibuprofen suspension from different manufacturers is significantly different.