格列齐特缓释片释放度研究

目的参考日本药品品质再评价工程对溶出度研究的方法，研究了格列齐特缓释片释放度质量要求．并考察了国内仿制药的释放情况。方法采用桨法，以磷酸盐缓冲液（pH6．8）为释放介质，转速为100r／min，选择226nm／290nm双波长法，运用FODT-601型光纤药物溶出度实时测定仪在线监测药物的释放曲线。结果格列齐特在6．6—39．6ug／mL范围内呈现良好的线性关系（r≥0．9993），采用拟定的方法测定国内5家生产企业的5批样品的释放度，结果差异较大。结论本文建议的释放度要求更能体现药品的生物利用度，能有效的控制产品内在质量。

Drug Release Test of Gliclazide Sustained-Release Tablets

Objective To develop a quality criteria for the release of Gliclazide sustained-release tablets according to the method of dissolution studies in the Project of Drug quality Re-evaluation in Japan. To test the release situation of several domestic generic drugs. Methods The paddle method was adopted, the phosphate buffer （pH6.8） was used as the medium, and the rotation speed was 100 r/min. The release profiles were determined by fiber-optical chemical sensor dissolution test （FOCSDT） system with 226 nm/290 nm double wavelength method. Results The standard curve of Gliclazide displayed a good linearity （r≥0. 999 3 ） in the range from 6.6 to 39.6 ug/mL. Five batches sample from 5 factories were detected by this method, their drug release results differed from each other. Conclusion The release quality criteria could illustrate the bioavailability, it can effectively control the quality of the product.