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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。
Objective: To develop indomethacin (IDM) enteric dripping pills and study its in vitro release characteristics. Methods: Using PEG6000 as matrix, orthogonal test was used to screen the best prescription and technology of IDM dropping pills, and coated with polyacrylic acid Ⅱ as enteric material to prepare IDM enteric dripping pills. Spin-basket method to investigate its in vitro release characteristics and compared with the commercially available IDM enteric-coated tablets. Results: The optimum preparation conditions of IDM dropping pills were as follows: the mass ratio of IDM to the total matrix was 1: 3, the dropping speed was 65 drops / min, the dropping temperature was 90 ℃ and the condensing temperature was 5 ℃. IDM enteric-coated drops and the commercially available IDM enteric-coated tablets almost did not release drug in acidic medium, while in the phosphate buffer with pH 6.8, the release rate of IDM enteric-coated pills was significantly higher than that of the commercial enteric-coated tablets (P <0.05). Conclusion: IDM enteric dripping pills have obvious enteric effect and can accelerate the release of IDM in the intestine, which deserves further study.