恩诺沙星缓释片的制备及质量评价研究

Preparation and quality evaluation of enrofloxacin sustained-release tablets

以恩诺沙星为模型药物,羟丙基甲基纤维素(HPMC)为骨架材料,乳糖与纤维素为稀释剂,5%聚乙烯吡咯烷酮(PVP)为黏合剂,硬脂酸镁为润滑剂,采用湿法制粒压片工艺制备恩诺沙星缓释片。采用紫外分光光度仪、片剂硬度测试仪、溶出度测试仪等仪器对恩诺沙星缓释片中的主药含量、硬度、体外释放度和膨胀度等进行评价。结果表明:恩诺沙星缓释片主药含量及硬度均符合规定,且在放置60 d后片剂在外观上仍保持完整,光洁,色泽均匀;制备的恩诺沙星缓释片在12 h之内基本释放完全,表明具有一定的缓释效果。

In this research,enrofloxacin was selected as the model drug to prepare sustained-release tablets by the wet granulation compression method using HPMC as the skeleton material,lactose and cellulose as diluent,5%PVP as binder,and magnesium stearate as lubricant. The sustained-release tablets have smooth surface,good color and shape. The sustained-release tablets quality parameters,such as drug content,hardness,in vitro release and swelling degree,were investigated by using UV-visible spectrophotometer,tablet hardness tester,dissolution tester and other measuring instruments. The results showed that the drug content and hardness of sustained-release tablets meet the requirements,and tablets remains keep intact in appearance,smooth and uniform color after 60 d. The prepared enrofloxacin sustained-release tablets could released substantially completely within 12 h,indicating that the such tablets has a certain slow-release effect.