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目的:研制替硝唑胃漂浮缓释胶囊,延长药物在胃内的滞留时间,使其在感染部位能维持较长作用时间,提高疗效,降低药物不良反应。方法:用紫外分光光度法测定药物含量,制定胶囊的质量标准,进行制剂稳定性研究和胶囊体外释放特性研究。结果:胶囊质量稳定,在人工胃液中可漂浮10 h,体外0.5～5 h的释放与普通胶囊相比具明显的缓释作用。结论:提示替硝唑胃漂浮胶囊是一种理想的缓释胶囊,能延缓释放时间,降低药物不良反应的发生率。
OBJECTIVE: To develop tinidazole gastric floating sustained-release capsules and to prolong the residence time of the drug in the stomach so as to prolong the action time in the infected site, improve the curative effect and reduce adverse drug reactions. Methods: The content of the drug was determined by UV spectrophotometry, the quality standard of the capsule was established, the stability of the preparation and the in vitro release characteristics of the capsule were studied. Results: The capsules were stable in quality and could float in artificial gastric juice for 10 h. The release in 0.5 ~ 5 h in vitro was obviously delayed release compared with normal capsules. Conclusion: Tinidazole gastric floating capsule is an ideal sustained release capsule, which can delay the release time and reduce the incidence of adverse drug reactions.