甲巯咪唑单室三层(夹芯)渗透泵制剂的制备

China Pharmaceuticals(2015)

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Abstract
目的:以甲巯咪唑(thiamazole)为模型药物研究易溶性药物单室三层渗透泵片的制备。方法以主药甲巯咪唑和羟丙基甲基纤维素(HPMC)混合制作药物层片芯,用乙基纤维素(EC)和 HPMC 混合制作上下包裹两层,并对片芯处方组成和外包层处方比例优化;用相似因子法考察体外释放条件。结果药物层片芯最佳组合是甲巯咪唑10 mg 和 HPMC K15 m 60 mg,上下包裹层皆为 HPMC K100 m 30 mg和 EC 10 mg。释放介质和转速对药物释放无显著影响。结论该渗透泵片制备简便,能较好地控制甲巯咪唑8 h 匀速释药。夹芯渗透泵片免去了包衣和打孔等烦琐过程,减少了工序,制备过程简化、易操作。
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Key words
thiamazole,single room three layers (sandwich) pump tablets,easily soluble drugs,controlled release,similarity factor
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