格列齐特缓释片的研制
格列齐特,,格列齐特；缓释制剂；正交试验设计；制备工艺；累积释放率,1仪器与试药,2方法与结果,3讨论
摘 要 目的：研究格列齐特缓释片的制备方法,筛选最佳制备工艺条件。方法：采用正交试验设计，以处方工艺中羟丙基甲基纤维素、微晶纤维素的用量及缓释片的硬度为试验因素，每个因素取三个水平，按正交试验表的安排进行实验,并确定其最佳制备工艺条件，按优化后的结果选择实验条件，进行重复实验，用体外溶出实验考察其缓释释放效果。结果：制备的缓释片在2、6、12 h的累积释放率分别为29.91%±1.38%、61.77%±1.13%和 95.89%±0.81%。结论：按优化结果选择的制备工艺所制备的格列齐特缓释片其缓释效果与预测值基本吻合，工艺的重复性较好，体外累积释放率符合要求。关键词 格列齐特；缓释制剂；正交试验设计；制备工艺；累积释放率
Study of the sustained release drug delivery system of gliclazide
ZHANG Jixing,CHEN Yanzhong
(Department of Pharmaceuticals,Guangdong College of Pharmacy,Guangzhou, Guangdong 510224,China)
Abstract Objective: To investigate the preparation method of sustained release gliclazide tablets. Method：The process was studied by orthogonal experiment design using orthogonal form L9(34)with the drug accumulated release as the evaluation quota to decide the best preparing condition,and the three factors were the amount of HPMC,MC,and the compaction pressure on the quality of the sustained release tablets.Three batches of the optimum formulation were produced. and the release behavior of the sustained release drug delivery system containing gliclazide was determined in vitro. Results：The result showed that the the sustained release drug delivery system containing gliclazide prepared could meet all the requirements,with the the drug accumulated release of 29.91%±1.38%,61.77%±1.13%,and 95.89%±0.81% at 2 h,6 h,and 12 h respectively. Conclusion：The methods of the optimization are useful for the sustained release drug delivery system containing gliclazide. ......
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