国内外口服美洛昔康的溶出度对比研究

目的比较口服美洛昔康的国产制剂与进口制剂的溶出度。方法采用体外溶出度法,以pH7.4磷酸盐缓冲液为溶出介质,紫外-可见分光光度法为测定方法。结果进口美洛昔康溶出快速均匀,其溶出率在5 min时能达到50%,30 min时能达到70%的溶出限量;国产制剂中,各个厂家的溶出率不均匀,且75%的溶出限量大约需45 min。结论目前国内生产的口服美洛昔康虽能满足现行质量标准要求,但其溶出度等与进口制剂仍存在差距。

Comparative study on dissolution of homemade and imported oral meloxicam

Objective To compare the dissolution(in vitro)of homemade and imported oral meloxicam.Methods Ultraviolet-visible absorption spectroscopy was used with the dissolution medium of phosphate buffer(pH 7.4).Results The imported meloxicam had a rapid and uniform dissolution,the dissolution rate of it achieved 50% at the beginning of 5 min,and the 75% limited dissolution needed 30 min.The dissolution rate of homemade meloxicam produced by various manufacturers was uneven,and the 75% limited dissolution needed 45 ...