复方甲硝唑缓释栓的制备及体外释放度考察

Preparation and Release Rate in Vitro of Compound Metronidazole Sustained-release Suppository

目的:制备适合老年人用的复方甲硝唑缓释栓,并考察其体外释放度。方法:以甲硝唑和硝酸咪康唑为主药,羟丙基甲基纤维素为骨架材料,利用热熔法制备缓释栓剂;同时采用篮法,以0.5%十二烷基硫酸钠溶液为介质,硝酸咪康唑为对象,进行体外释放度评价。结果:所制制剂外观、性状良好,可持续12h释药,体外释放行为符合Higuchi方程。结论:该制剂制备工艺合理、简单易行,并具有良好的体外释药特性,符合缓释制剂的要求。

OBJECTIVE： To prepare Compound metronidazole Sustained-release suppository for the old, and to investigate in vitro release rate. METHODS： Sustained-release suppository was prepared by heat melting method using metronidazole and miconazole nitrate as main components and with hydroxypropylmethylcellulose （HPMC） as the skeleton material. The in vitro release rate of sustained-release suppository was investigated with basket method using 0.5% sodium lauryl sulfate as medium and miconazole nitrate as subject. RESULTS： The prepared suppository was sound in characteristics and appearance. The prepared suppository released sustainably during 12 h, in vitro releases model of it conformed to the Higuchi equation. CONCLUSION： The preparation technology is reasonable, easy and feasible. Prepared suppository is characterized with sound release rate and conforms to the requirements of sustained-release preparation.