甲巯咪唑单室三层(夹芯)渗透泵制剂的制备

Preparation of Single Room Three Layers(Sandwich )Pump Tablets of Thiamazole

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。

Objective A sulfhydryl imidazole （thiamazole） as the model drug research easily soluble drug single room three layer prepa-ration of osmotic pump tablets. Methods To the main drug a sulfhydryl imidazole and HPMC mixed layer of core making drugs, with ethyl cellulose and HPMC mixed up and down two floors. Formulation and outsourcing and the slice of core layer prescription proportion optimization; With similarity factor method to investigate the in vitro release condition. Results Drug core layer of the best combination is a imidazole 10 mg and HPMC K15 m 60 mg, up and down the parcel layer are HPMC K100 m 30 mg and 10 mg ethyl cellulose. The release medium and speed had no significant effect on drug release. Conclusions The osmotic pump tablets preparation is simple, can well control the a sulfhydryl imidazole 8 h drug release at a constant speed. sandwich osmotic pump tablet was relieved from the cumbersome process, such as coating and stiletto reduce a lot of process, the preparation process is simple.