盐酸二甲双胍缓释片处方筛选及工艺研究

对盐酸二甲双胍缓释片的处方及工艺进行筛选和研究。方法：根据释放度作为判断原则，对缓释骨架材料、填充剂、粘合剂、润滑剂及包衣材料的种类、规格、用量及工艺等进行了考察，并在此基础上采用正交试验1．9(3^4)方案对处方进行筛选。结果：以HPMC K100M及HPMC K15M作为盐酸二甲双胍缓释片的基本骨架材料，微晶纤维素作为填充剂，硬脂酸镁为润滑剂，4％HPMCE5的70％乙醇溶液适量作为粘合剂制成片芯，采用薄膜包衣法，以欧巴代的70％乙醇溶液作为薄膜包衣材料，制得盐酸二甲双胍缓释骨架片。结论：本制剂工艺简单，所用各种辅料均为国产化，成本低，制得盐酸二甲双胍缓释片释放度符合规定。

Study on the Formulation and Preparation of Methormin Hydrocloride Controlled-release Tablets

Objective: To screen the formulation of methormin hydrocloride controlled release tablets and optimize the preparation of the controlled release tablets. Methods: The type, quality, amount, and preparation method of matrix material, bulking agent, adhensive material, lubricant, and coating material were surveyed by using release rate as the only judging criterion. On the basis of the survey result, orthogonal test of L9(3 4) was employed to screen the formulation. Results: The tablet core was prepared with HPMC K100M and HPMC K15M as matrix materials for methormin hydrocloride controlled release tablets, microcrystaline cellulose as the bulking agent, magnesium stearate as lubricant, 4% HPMC and E5, and 70% ethanol as adhensive material. Methormin hydrocloride matrix tablets were prepared by using 70% ethanol solution of Opadry as film coating material. Conclusion: The preparation method is simple and reliable, and most additives are domestic ones with lower costs. The release rate of methormin hydrocloride controlled release tablets is up to standard.