吲哚美辛缓释片制备工艺及体外溶出特性的研究

The study of preparation and in vitro release properties of sustained release tablets of indomethacin

目的：采用新型骨架材料甲壳胺制备吲哚辛缓释片。方法：单因素考察法考察工艺因素如压力及甲壳胺粒度对缓释作用的影响，利用正交设计优化处方。结果：甲壳胺粒度小于１５４μｍ 时，抗张强度在（４ ．０ ±１０ ．０）ｋｇ 范围内，对甲壳胺缓释作用无明显影响，当抗张强度大于１３ｋｇ ，时，药物释放明显减慢，优化后的处方可达到美国药典ⅩⅩⅡ版对缓释制剂体外溶出的要求。结论：该片剂处方合理，制备工艺简单易行，适合工业化大生产。

OBJECTIVE:Preparation of sustained release tablet of indomethacin using chitosan as matrix.METHOD:Using single factor method to study the effect of particle size of chitosan and hardness of tablet on drug release profile,using orthogonal design method to optimize the prescription.RESULTS:The hardness of tablet and particle size of chitosan have very weak effect on drug release profile.The release of optimized prescription accords with the pharmacopoeia of american ⅩⅩⅡ.CONCLUSION:The prescription is in reason and the preparation is easy,it is suitable for manufacturing industries.