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出 处:《中国新药杂志》2008年第9期760-763,共4页Chinese Journal of New Drugs
基 金:甘肃省自然科学基金(ZS001-A23-057-Y);甘肃省药物临床前研究重点实验室开放基金资助(GSKFKT-0602)
摘 要:目的:以氢溴酸高乌甲素为模型药物研究脉冲释放片剂并同时考察用包衣的方法制备脉冲给药系统的可行性。方法:以氢溴酸高乌甲素为模型药物,制备适宜的片芯;以乙基纤维素和丙烯酸树脂Ⅱ号的乙醇溶液包衣,采用滚转包衣法,制备氢溴酸高乌甲素脉冲释放片剂。通过体外释放度实验,考察片芯和衣层对片剂释药行为的影响。结果:片芯处方、包衣层厚度及包衣处方对氢溴酸高乌甲素脉冲释放片的释药行为均有影响。结论:通过调整片芯中崩解剂的用量、包衣层的厚度和组成,可以得到具有不同释药时滞的氢溴酸高乌甲素片剂。Objective:To investigate the preparation of pulsatile-release tablets of lappaconitine hydrobromide. Methods:Lappaconitine hydrobromide (LH) was used as model drug. The core was prepared,then the outer film was pan-coated by ethylcellulose/Eudragit Ⅱ , which dissolved in anhydrous alcohol. The effect of the core and the film on pulsatile-release tablets of lappaconitine hydrobromide was investigated under release test. Results:The release of lappaconitine hydrobromide was influenced by the formulation of the core and the thickness and composition of the coating film. Conclusion:The pulsatile-release tablets with different lag times could be prepared by ad- justment of the amount of disintegrants,the thickness and composition of the coating film.
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