熔融法制备盐酸二甲双胍缓释片及其稳定性考察

目的:制备盐酸二甲双胍缓释片并考察其稳定性.方法:以十八醇为骨架材料,采用熔融法制备盐酸二甲双胍缓释片,以体外释放度为评价指标,正交试验设计优化处方,并对制剂进行稳定性考察.结果:十八醇用量和加热温度显著影响盐酸二甲双胍释药速率.优化处方下制备的缓释片体外释放曲线10h内符合Higuchi方程,24个月内主药含量、释放度、有关物质及其他检查项目未见明显变化.结论:通过使用适量十八醇,可获得具有理想释药行为的盐酸二甲双胍缓释片,该制剂稳定性良好.

On Preparation and Stability of Metformin Hydrochloride Sustained-Release Tablets by Means of Melting

The objective of the article is to prepare metformin hydrochloride sustained-release tablets by means of melting,and to investigate the stability of tablets.The method of studying Metformin hydrochloride sustained-release tablets are prepared by means of melting,with octadecanol as the matrix.The preparation techniques are optimized by orthogonal experiments with release rate in vitro as the evaluation index.The results show that the release rate of tablets is mainly controlled by amount of octadecanol and heating temperature.Release rate in vitro of the tablets prepared by optimized formulation accords with Higuchi equation.The tablets are stable in 24 months.The conclusion is that,with suitable amount of octadecanol,the metformin hydrochloride sustained-release tablets with ideal release behavior and good stability can be obtained.