替硝唑胃漂浮缓释胶囊的制备及体外释放特性

Preparation of Hydrodynamic Balanced System for Extended Release Capsules of Tinidozale and Release Characteristics

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。

Objectives: To prepare a hydrodynamic balance system for extended release capsule of tinidazole, which could be detained in stomach for longer time to raise the therapy efficacy. Method: The content of tinidazole was determined by UV-spectropho-tometry to establish a quality standard of the capsule. The stability of preparation and the release characteristics of capsules were studied. Results: The quality of capsule was stable. In artificial gastric juice, these capsules could float for 10 hours, and drug liberation from the capsules was a zero-order release before 5 hours in ritro. Conclusion: The hydrodynamic balanced system of tinidazole capsule is an ideal extended release agent.