盐酸阿米替林微孔渗透泵控释片的制备及其体外释放度的考察

Study on the Preparation and Drug Release in Vitro of Amitriptyline Hydrochloride Porosity Osmotic Pump Controlled-release Tablets

目的:优化盐酸阿米替林微孔渗透泵控释片的处方及考察其体外释放度。方法:以体外累积释放度为评价指标,对渗透压促进剂的种类和用量、致孔剂聚乙二醇含量和包衣膜增重率等因素分别进行单因素和正交试验优化处方,并进行体外释放度考察。结果:最优处方为渗透压促进剂为乳糖,用量为190mg,聚乙二醇含量为10,包衣膜增重率为4;优化处方所制制剂体外释放行为符合零级释放规律。结论:优化处方合理,制剂体外释药缓慢、平稳。

OBJECTIVE： To optimize the formula of Amitriptyline hydrochloride porosity osmotic pump controlled-release tablets （AHPT） and to investigate in vitro drug release of it. METHODS： The formula of AHPT was optimized by single-factor test and orthogonal design with in vitro drug release rate as evaluation index using type and amount of osmotic promoter, the content of PEG400 and the rate of weight growth of coating membrane as factors. RESULTS： Optimal formula was as follows： osmotic promoter was lactose 190 mg, the content of PEG400 was 10%, the rate of weight growth, of coating membrane was 10%. In vitro drug release behavior of AHPT was up to the character of zero-order drug release. CONCLUSION： Optimized formula is reasonable, and drug release in vitro of preparation is slow and steady.