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作 者:李伟[1] 张志宏[1] 杜玍妮[1] 聂淑芳[1] 杨星钢[1] 潘卫三[1]
出 处:《中国新药杂志》2008年第3期233-236,共4页Chinese Journal of New Drugs
摘 要:目的:优化格列齐特推拉式渗透泵的处方,并对影响释放度的各种因素进行考察。方法:以紫外分光光度法对格列齐特推拉式渗透泵的体外释放度曲线进行测定,应用f2因子法为手段,对不同处方中药物释放曲线的相似性进行评价,对处方进行优化。结果:包衣增重、片心硬度及助推层中氯化钠的用量对药物的释放曲线有显著影响,释药孔径大小、转速以及打片时的填料顺序对释放曲线无显著性影响。结论:应用推拉式渗透泵系成功制备了格列齐特渗透泵,控释时间达12 h。Objective:To optimize the formulation of gliclazide push-pull osmotic pump system (PPOP) and investigate the influencing factors on drug release from such system. Methods:The dissolution profiles of model drug were drawn through detecting samples by UV method, f2 factor was employed to evaluate the similarity of dissolution profiles of different formulations in order to optimize the formulation. Results : The dissolution of model drug was influenced dramatically by coating level, hardness of the tablet core and NaCl amount in the push layer, but influenced little by orifice size, stirring rate, and the excipient loading sequence when pressing the tablets. Conclusion:Gliclazide push-pull osmotic pump was prepared and it could release drug at a controlled rate up to 12 hours.
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