不同厂家盐酸坦索罗辛缓释胶囊释放曲线对比研究

Comparative studies on dissolution profiles of tamsulosin hydrochloride sustained release capsules from different pharmaceutical manufacturers

目的:通过对比不同厂家生产的已通过或视同通过一致性评价的盐酸坦索罗辛缓释胶囊样品在4种释放介质中的释放曲线,比较其体外释放差异。方法:分别以pH 6.8磷酸盐缓冲溶液、pH 4.0磷酸盐缓冲溶液、pH 1.2盐酸溶液和水作为释放介质测定释放曲线,其相似度用相似因子(f_(2))法分析。结果:自研生产的3批产品在4种介质中的释放曲线均与参比制剂高度相似。A企业产品在4种介质中、C企业产品在3种介质中、B和D企业产品仅在2种介质的释放曲线与参比制剂相似。结论:不同厂家制剂的释放行为有很大差异。

Objective:To evaluate the differences of the in vitro release by comparing the dissolution curves of tamsulosin hydrochloride sustained release capsules that had passed or were deemed to have passed consistency evaluation produced by various manufacturers in four different dissolution mediums.Methods:Their dissolution profiles in pH 6.8 phosphate buffer,pH 4.0 phosphate buffer,pH 1.2 hydrochloric acid solution and water were determined by HPLC,respectively and their similarity was analyzed by a similarity factor(f_(2))method.Results:The release curves of the three batches of self-developed products in the four media were highly similar to those of the reference preparation.The release profiles of Company A product in four media,Company C product in three media,and Company B and D products in only two media were similar to those of the reference preparation.Conclusion:The release behavior of the formulations varies greatly from manufacturer to manufacturer.