摘要
目的制备雷贝拉唑钠肠溶片并考察处方工艺与质量。方法根据辅料相容性结果,采用单因素法筛选片芯处方,片芯包肠溶衣后与肠溶胶囊进行体外溶出度的比较。结果所研制的雷贝拉唑钠肠溶片耐酸力、体外溶出度及稳定性均良好,质量符合药典要求。结论优选的雷贝拉唑钠肠溶片处方工艺合理,成品质量稳定。
Objective To prepare Rabeprazole Sodium Enteric-coated Tablets and inspect the formulation and quality.Methods According to the results of materials compatibility,the prescription of tablet core was screened by single factor method.The dissolution of enteric-coated tablet core in vitro was compared enteric-coated capsules.Results The acid strength,vitro dissolution and stability of prepared Rabeprazole Sodium Enteric-coated Tablets were good,and the quality met requirements of pharmacopoeia.Conclusion The optimized prescription process of Rabeprazole Sodium Enteric-coated Tablets was reasonable,and the quality was stable.
出处
《药学研究》
CAS
2013年第6期345-347,共3页
Journal of Pharmaceutical Research
关键词
雷贝拉唑钠
肠溶片
辅料
Rabeprazole sodium
Enteric-coated tablet
Excipient
