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消炎痛(吲哚美辛indomethacin)临床用于治疗风湿性和类风湿性关节炎。近年也有报道用于治疗出血热多尿期、癌症、抗休克等。但长期使用其对胃肠道和中枢神经系统的副作用可达35～50%,其中枢神经系统症状往往与过高血药浓度有关。美国药典第二十二版已收载了消炎痛缓释胶囊。国内已有报道利用丙烯酸树脂材料包衣颗粒制得了缓释胶囊,并经体内实验证明可避免普通胶囊开始时的高血药浓度,但颗粒包衣技术生产设备要求较高,在我国较难普及。本文采用湿法制粒技术,用国产乙基纤维素为骨架制备了消炎痛缓释颗粒,装囊后制得消炎痛缓释胶囊。
Indomethacin indomethacin is clinically used to treat rheumatic and rheumatoid arthritis. In recent years, there are also reports for the treatment of hemorrhagic fever, polyuria, cancer, anti-shock and so on. But long-term use of its gastrointestinal and central nervous system side effects up to 35 to 50%, and its central nervous system symptoms are often associated with excessive plasma concentrations. The United States Pharmacopoeia twenty-second edition has been contained indomethacin sustained-release capsules. China has reported the use of acrylic resin coating particles made of sustained-release capsules, and in vivo experiments proved that ordinary capsules can be avoided at the beginning of high plasma concentration, but the particle coating technology requires higher equipment, more difficult in our country universal . In this paper, wet granulation technology, made with ethylcellulose as the skeleton of sustained-release granules of indomethacin, after capsule filled with indomethacin sustained-release capsules.