摘要
目的制备帕司烟肼缓释片并对其进行质量评价。方法以体外释放度试验为手段,通过单因素试验考察帕司烟肼缓释片的处方及工艺,采用相似因子法和综合评分法进行评价,采用数学模型拟合研究药物的释放机制。结果帕司烟肼缓释片的处方和制备工艺为:帕司烟肼300mg,羟丙基甲基纤维素(HPMC K4M)100mg,片剂硬度为6kgf;缓释片中对氨基水杨酸和异烟肼的释放机制符合non-Fickian扩散机制。结论此处方工艺制备的帕司烟肼缓释片释药行为稳定,简便可行,易于工业化生产。
OBJECTIVE To prepare and evaluate the Pasiniazide Sustained--Release Tablets. METHODS By dissolution test,formulation and technology factors were investigated by the single-factor test and confirmed by similarity factor and grading method. Mathematic models were used to imitate the drug release. RESULTS The pasiniazide sustained-release tablet was composed of 300rag pasiniazide and 100mg hydroxypropylmethyl cellulose,and the hardness of tablets was 6kgf. The drug release mechanism of aminosalieylic acid and isoniazid in tablets followed non-fickian diffusion mechanism. CONCLUSION Using this formulation and technology above,the drug release from the Pasiniazide Sustained--Release Tablets was stable,it was simple and easy to be industrialized.
出处
《齐鲁药事》
2009年第7期427-431,共5页
qilu pharmaceutical affairs
关键词
帕司烟肼
异烟肼
对氨基水杨酸
缓释片
相似因子
Pasiniazide
isoniazid
aminosalicylic acid
sustained-release tablets
similarity factor
