乙基纤维素作为包衣材料在缓释盐酸苯丙醇胺树脂上的应用

 目的：考察影响药树脂体外溶出的因素，制备缓释盐酸苯丙醇胺(PPA·HCl)树脂。方法：以不同粘度规格的乙基纤维素(EC)为包衣膜材料制备缓释PPA·HCl树脂，以体外溶出试验，考察了树脂粒径、EC粘度、EC包衣增重百分率、EC分散介质(水或乙醇)以及体外释放介质的pH值和离子强度对上述缓释药树脂体外溶出的影响。结果：上述因素对药树脂的释药均有不同程度的影响，以EC 200 Pa·s包衣增重达150 g·kg^-1时，包衣药树脂在0.1 mol·L^-1HCl中的释放符合美国药典23版缓释PPA·HCl胶囊的要求。结论：用乙基纤维素为包衣膜材料，可以制备缓释PPA·HCl树脂。

Ethylcellulose as sustained release coating membrane of phenylpropanolamine·HCL-resin complexes

To prepare sustained phenylpropanolamine*HCl (PPA*HCl)-resin complexes and to study the factors influencing the in vitro dissolution of it. METHOD: The sustained PPA*HCl-resin complexes were prepared by coating the complexes with different kinds of ethylcellulose (EC) as coating embranes. The factors influencing the release rate of PPA*HCl from the complexes, such as resin particle size, the viscosity and thickness of coating membrane, the dispersion medium of EC (water or alcohol) as well as the pH and ion strength of dissolution medium were studied in detail. RESULTS: The factors above all influenced the dissolution of the complexes to ifferent extent. When prepared by EC 200 Pa*s (150 g*kg-1), the dissolution of the coated complexes in 0.1 mol*L-1 HCl accorded with the requirements of sustained PPA*HCl capsules of USP ⅩⅩⅢ. ONCLUSION: The sustained PPA*HCl can be prepared by coating the drug-resin complexes with EC.