采用原研制剂制备米诺膦酸片及体外溶出度的一致性考察

Preparation of Minodronic Acid Tablets Using Innovator Products and In Vitro Consistency Investigation of Their Dissolubility

制备米诺膦酸片,并以原研制剂为参比制剂,采用f_2相似因子法对两者体外溶出度的一致性进行考察.建立合适的体外溶出度测定方法,研究参比制剂的溶出情况,通过单因素试验对辅料的用量进行筛选,制备出米诺磷酸片.比较自制品与原研制剂在不同溶出介质中的溶出行为,评价两者体外溶出行为的相似性.结果表明:制备的米诺膦酸片剂与原研制剂在4种不同pH值溶出介质中的溶出相似因子f_2均大于50;制备的米诺膦酸片剂与原研制剂体外溶出行为相似.

To prepare minodronic acid tablets,in vitro dissolution profile was investigated by f_2 similarity factor with the innovator products as a reference.The in vitro dissolution test method was established and the dissolution profile of innovator products was investigated,and then minodronic acid tablets were prepared by screening excipient dosage using single factor experiment.By comparing the dissolution behavior of the test tablets with the innovator products in four kinds of dissolution medium,the similarity was evaluated.The results showed that the dissolution similarity factor f_2 of the minodronic acid tablets and innovator products in four dissolution media with different pH values were all larger than 50.Besides,the dissolution behavior in vitro of the prepared tablets was similar to that of the innovator products.