国产与原研洛索洛芬钠片的体外溶出曲线一致性的比较

Comparison on the stripping curve of the domestic Loxoprofen Sodium tablets and the original products

目的比较国产与原研的洛索洛芬钠片在四种溶出介质中溶出曲线的相似性,为重庆市巴南区人民医院甄选药品及临床用药提供理论依据。方法采用仿制药溶出一致性评价制备标准溶出条件,选择纯水、pH=1.2盐酸溶液、pH=4.0醋酸缓冲液和pH=6.8磷酸盐缓冲液作为溶出介质,对该院在用的3个批次的国产洛索洛芬钠片与原研药样品进行溶出曲线对比研究,分别考察仿制药与原研药品分别在四种溶出介质的溶出行为,并用f2因子比较法比较溶出曲线。结果在以水、pH=1.2盐酸溶液、pH=4.0醋酸盐缓冲液和pH=6.8磷酸盐缓冲液为溶出介质的条件下仿制药3个批次样品的f2因子分别为61.01、59.77、64.10;62.81、65.40、67.30;67.49、61.08、70.50;61.73、54.06、56.95。结论国产的仿制药样品与原研药在4种不同pH值的溶出介质中的溶出曲线相似。

Objective To observe the similarity of dissolution profiles of domestic Loxoprofen Sodium tablets and the original products. Methods Based on the authorized dissolution determination method, the dissolution of 3 batches domestic products and the original products were tested in different mediums （water, pill. 2 hydrochloric acid solution, pH4. 0 acetate buffer, pH6.8 phosphate buffer）. The stripping curves were evaluated by f2 factor. Results The f2 factors of 3 domestic batches were 61.01,59. 77 and 64.10 in water,62.81,65.40 and 67.30 in pill. 2 hydrochloric acid solution,67.49,61.08 and 70.50 in pH4.0 acetate buff- er,61. 73,54. 06 and 56.95 in pH6.8 phosphate buffer. Conclusion The stripping curves of the domestic and the original products was similar in 4 different dissolution mediums.