摘要
目的:研制吲哚美辛(IDM)肠溶滴丸,并考察其体外释药特性。方法:选用PEG6000为基质,用正交试验筛选IDM滴丸的最佳处方及工艺,并采用聚丙烯酸树脂Ⅱ为肠溶材料对其进行包衣,制备IDM肠溶滴丸。转篮法对其体外释药特性进行考察,并与市售IDM肠溶片进行比较。结果:筛选出IDM滴丸最佳制备条件为:IDM与总基质的质量比为1∶3,滴速为65滴/min,滴制温度为90℃,冷凝液温度为5℃。IDM肠溶滴丸及市售IDM肠溶片在酸性介质中几乎不释药,而在pH为6.8的磷酸盐缓冲液中,IDM肠溶滴丸的释药速度显著高于市售肠溶片(P<0.05)。结论:IDM肠溶滴丸具有明显肠溶效果,同时可加快IDM在肠道中的释放速度,值得进一步研究。
To prepare indometacin （IDM） enteric dropping pills and study the drug release in vitro. Methods： Using PEG6000 as the base, the optimal formula and preparation process of IDM dropping pills were screened by an orthogonaldesign. IDM dropping pills were coated by polyacrylic resin ti as the enteric coating material. Compared with the marketed IDM enteric tablets, the drug release of IDM enteric dropping pills in vitro was studied using a suspended basket method. Results： The optimal preparation con-ditions of IDM dropping pills were as follows ： the ratio of IDM and base was 1 ： 3, the dropping speed was 65 drops/rain, the dropping temperature was 90℃ and the temperature of the cooling solvent was 5℃. IDM dropping pills and the marketed tablets were both with little drug release in acidic solvent. In pH 6.8 phosphate buffer solution, IDM enteric dropping pills showed much quicker drug release than the marketed enteric tablets （P 〈 0.05）. Conclusion ： IDM enteric dropping pills exhibit enteric effect and quick drug release in vitro, which are Valuable to be studied further.
出处
《中国药师》
CAS
2014年第5期713-716,共4页
China Pharmacist
关键词
吲哚美辛
肠溶
滴丸
体外释药
Indometacin
Enteric
Dropping pills
Drug release in vitro
