米格列奈钙片的溶出度研究

Study on dissolution of Mitiglinide Calcium Hydrate Tablets

目的建立米格列奈钙片剂溶出度的测定方法,比较自制样品与原研品在4种溶出介质中溶出曲线。方法以水900 mL为溶剂,桨法,转速为75 rpm,溶出度的测定采用高效液相色谱法。结果米格列奈钙在2.775-33.300μg·mL^-1范围内,线性关系良好（r=0.999 9）,平均回收率为99.38%,自制样品与原研品在4种溶出介质中溶出行为都很相似。结论建立的米格列奈钙片剂溶出度测定方法简便、准确、可靠,可较好地控制该片剂质量,自制样品与原研品体外溶出行为很接近。

Objective To establish a dissolution determination method of Mitiglinide Calcium Hydrate Tablets and compare the self -made sample with the original preparation by stripping curves in four different dissolution media.Methods The dissolution was determined with paddle method （75 rpm）in 900 mL water and detected by HPLC.Results There was a good linearity over the range of 2.775 -33.300 μg·mL ^-1 with a correlation coefficient r =0.999 9,and average recovery was 99.38%.Dissolution behaviors of self -made sample and original preparation are similar in four different dissolution media.Conclusion The method was simple,accurate,reliable and the quality of Mitiglinide Calcium Hydrate Tablets can be well controlled by this method.The dissolution behaviors of two samples were very similar in vitro.