市售不同厂家格列齐特缓释片的体外释放度比较

Comparison of release rates of gliclazide sustained-release tablets from different manufactures in different dissolution mediums

目的:考察市售6个不同厂家格列齐特缓释片(A、B、C、D、E、F)体外释放度并与达美康缓释片进行比较,为全面评价药品质量提供依据。方法:按照《中华人民共和国药典》2010版有关格列齐特缓释片释放度测定的规定,采用第一法,以p H 7.4磷酸盐缓冲盐(PBS),p H 4.5 PBS和水为释放介质,用高效液相色谱法测定释放度,计算累积释放百分率,并绘制溶出曲线,与达美康进行比较,计算出相似因子;进行释药曲线拟合,确定释药机制比较溶出参数。结果:6个厂家产品在p H 7.4 PBS中释放度均符合要求,除E厂家外其余厂家产品与达美康相似因子均大于50,但只有D厂家在3种不同介质中,均与达美康格列齐特缓释片相似因子大于50,溶出参数T50、Td与达美康差异也较小。结论:仅有少数厂家的释放曲线在3种介质中与原研厂家相似,建议与原研厂家释放曲线不一致的相关厂家应对影响制剂释放的辅料及生产工艺进行改进,提高产品质量。

Objective：To investigate the release rates of different gliclazide sustained-released tablets in vitro by comparing them with that of dlamicronmr to provide the basis for a comprehensive evaluation of the qulity of gliclazide sustained-release tablets. Methods：According to China pharmacopie （2010 edition）, the release rates of different gliclazide sustained-released tablets in 3 different dissolution mediums with pH 7.4, pH4.5 and 7 were determined by using intellectual diffusion meter （ZRS-8）. HPLC was used to test the concentration, calculate the cumulative dissolution percentage and draw the dissolution curve .The differences in dissolution curves were compared by similarity factor. And the parameters of m, T50 and Td were calculated and compared with those of dlamicronmr. Results：The f2 factors of six manufactures’ products with dlamicronmr were greater than 50 except for E tablets in dissolution medium with pH 7.4. Only f 2 factors of D tablet were greater than 50 in 3 different dissolution mediums and the differences in the parameters of m,T50 and Td were smaller. The differences in batches in B tablet were greater and in A tablet smaller. Conclusion：Few manufacturers’ drugs have similar characters with original drug in all 3 different dissolution mediums. The pharmaceutical manufacturers should improve the product quality by changing the formula and manufacturing process.