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目的对复方盐酸伪麻黄碱/马来酸溴苯那敏单层渗透泵控释片的处方进行考察。方法采用HPLC法对渗透泵的体外释放度进行测定,采用单因素优化渗透泵的处方。结果优化后处方为:含药层中羟丙基甲基纤维素K15M(hydroxypropyl methyl cellulose,HPMCK15M)150mg、衣膜中含聚乙二醇1500(polyethylene glycol,PEG1500)质量浓度为1.5g·L-1、衣膜增量为7%。本渗透泵片恒速释药,12h累积释药率达85%以上。结论本渗透泵片制备简便,能在12h内良好的控制盐酸伪麻黄碱及马来酸溴苯那敏的零级释放。
Objective To investigate the prescription of compound pseudoephedrine hydrochloride / bromobenzene maleate monolayer osmotic pump controlled release tablets. Methods The HPLC method was used to determine the in vitro release of osmotic pump. The single factor was used to optimize the osmotic pump. Results The optimized prescription was 150mg hydroxypropyl methyl cellulose (HPMCK15M) contained in the drug-containing layer, the mass concentration of polyethylene glycol (PEG 1500) contained in the film was 1.5g · L- 1, film coating increment of 7%. The osmotic pump constant release drug, 12h cumulative release rate of 85% or more. Conclusion The preparation of this osmotic pump tablet is simple and can control zero-order release of pseudoephedrine hydrochloride and bromobenzene maleate within 12 hours.