【摘要】 目的:筛选和研究格列齐特缓释片处方及工艺。方法:制备不同处方的格列齐特缓释片并进行释放度测定,筛选最佳处方及制备工艺。结果:确定了以羟丙基甲基纤维素(HPMC)K4M、E50处方量分别为17、35g作为基本骨架材料,磷酸氢钙91g为填充剂,硬脂酸镁为润滑剂的处方;由其制备的格列齐特缓释片释放度结果与参比样品基本相似。结论:以最佳处方制备的格列齐特缓释片释放度符合《中国药典》标准。更多还原

【Abstract】 OBJECTIVE: To optimize the formula and preparation technology of gliclazide controlled-release tablets. METHODS: Gliclazide controlled-release tablets were prepared in different formulations and the release rates of the prepared tablets were determined to obtain the optimum formula and preparation technology. RESULTS: The optimized formula of gliclazide controlled-release tablets were determined as follow: with HPMC(K4M)=17g and HPMC(E50)=35g as matrix materials; Calcium hydrogen phosphate=91g as the bulking agent and magnesium stearate as lubricant. Gliclazide controlled-release tablets showed a similar release rate as the reference samples. CONCLUSION: The releasing rate of gliclazide controlled-release tablets prepared in the optimized formula is in line with the standards stated in China Pharmacopeia.更多还原