摘要
目的研制一种马来酸曲美布汀缓释片,并对比自研马来酸曲美布汀缓释片与原研药的体外释放情况。方法测定自研药与原研药在p H 1.2、p H 4.0、p H 5.2、p H 6.8及水5种介质中的释放度,采用相似性f^2因子法评价不同p H介质条件下两种制剂释放曲线的相似性。结果两制剂在p H 1.2、p H 4.0、p H 5.2、p H 6.8及水介质中的f^2因子分别为88.3,60.2,84.9,65.7,70.0,均大于50。结论自研药与原研药体外释放行为一致。
OBJECTIVE To prepare a Trimebutine Maleate Extended-release tablet,and compare the in vitro Release Behavior of Self-prepared Trimebutine Maleate Extended-release Tablet and Original Preparation. METHODS The release behavior of the self-prepared preparation and original preparation were inspected in p H 1. 2,p H 4. 0,p H 5. 2,p H 6. 8 buffer solution and water; the f^2 factor method was used to evaluate the consistency of the in vitro release behavior between the two preparations. RESULTS The f^2 factors of the two preparations in p H1. 2,p H 4. 0,p H 5. 2,p H 6. 8 and water buffer solution were 88. 3,60. 2,84. 9,65. 7,70. 0,respectively. All of the f^2 factor values were greater than 50. CONCLUSION The self-prepared preparation shows consistent in vitro release behavior with that of the original preparation.
出处
《海峡药学》
2016年第6期4-7,共4页
Strait Pharmaceutical Journal
基金
2009粤港关键领域重点突破项目(佛山专项)(项目编号:2009Z006)
关键词
马来酸曲美布汀
缓释片
释放度
F2因子
一致性评价
Trimebutine Maleate
Extended-release Tablet
Release Rate
f2 factor
Consistency Evaluation
