摘要
目的:制备复方阿仑膦酸钠缓释片并考察其体外释放度。方法:以羟丙基甲基纤维素(HPMC)、乙基纤维素(EC)、无水乳糖处方用量为因素,体外释放度为指标,用正交试验优化处方,以湿法制粒压片制备制剂,并考察其体外释放度。结果:筛选最优处方为HPMC 80mg、EC 20mg、无水乳糖20mg。所制制剂可持续12h释药,释放行为符合Higuchi方程。结论:所制缓释片的处方合理,具有良好的缓释效果。
OBJECTIVE: To prepare compound alendronate sodium sustained - release tablet and to investigate its drug release profile in vitro. METHODS: Hydroxy propyl methylcellulose (HPMC), ethylcellulose (EC), and lactis anhydrous were used to prepare sustained - release tablets by wet granule compression technique with release rate in vitro as index. Orthogonal experiment was conducted to optimize the formula. The release rate of the tablets in vitro was investigated. RESULTS: The optimized formula was as follows: HPMC 80 mg, EC 20 mg, and lactis anhydrous 20 mg. 12 h drug release of the preparation was achieved, and the drug release behavior in vitro fitted Higuchi equation. CONCLUSION: The sustained-release tablet is reasonable in formula and satisfactory in slow release efficacy.
出处
《中国药房》
CAS
CSCD
北大核心
2008年第34期2690-2692,共3页
China Pharmacy
关键词
阿仑膦酸钠
缓释片
正交设计
体外释放度
Alendronate sodium
Sustained - release tablet
Orthogonal design
Release rate in vitro