摘要
目的:采用双层渗透泵技术制备元胡止痛渗透泵片并进行处方优化。方法:测定各处方在2,4,6,8,10,12 h时的累积释放度,以f2相似因子作为释药曲线相似性的判断标准,采用单因素实验分别考察片芯处方和包衣处方对元胡止痛渗透泵片体外释药行为的影响。结果:含药层聚氧乙烯分子量和用量、促渗剂种类和用量、包衣增重可显著影响元胡止痛渗透泵片体外释药;助推层聚氧乙烯、促渗剂的用量对其体外释药无显著影响。优化处方制备的元胡止痛渗透泵片的释药方程为:Q=7.094 t-4.188,r=0.995 0,符合零级模型,且体外释药行为不受释放条件等因素影响。结论:采用双层渗透泵技术研制的元胡止痛渗透泵片制备工艺可行,缓释特征显著,可用于元胡止痛方的剂型现代化。
OBJECTIVE To prepare Yuanhu Zhitong osmotic pump tablets using push-pull osmotic pump technology and optimize its prescription.METHODS Cumulative release of different prescription was detected within 2,4,6,8,10,12 h,respectively.Similar factor of f2 was used as criterion of similarity between drug release curves.Single factor tests were designed to study effects of core formula and coating formula on drug releases of Yuanhu Zhitong osmotic pump tablets.RESULTSDrug release of Yuanhu Zhitong osmotic pump tablet was relatively closely with kinds and dosages of PEO,kinds and dosages of penetrating agent in drug layer and coating weight.Drug releases of preparation had no significant influences on dosages of PEO and penetrating agent in push-pull layer.Drug release equation of optimized Yuanhu Zhitong osmotic pump tablets was follows：Q=7.094t-4.188,r=0.995 0.It met zero order model and drug releases were not affected by release conditions in vitro.CONCLUSION Double layer osmotic pump technology is a feasible reparation technique for Yuanhu Zhitong osmotic pump tablets,which has notable property of sustained release and is available for modern dosage form research of Yuanhu Zhitong prescription.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2015年第23期2083-2088,共6页
Chinese Journal of Hospital Pharmacy
基金
国家"十二五"重大新药创制科技重大专项经费资助课题(编号:2013ZX09J13109-05C)
关键词
元胡止痛方
双层渗透泵片
f2相似因子
单因素实验
Yuanhu Zhitong prescription
push-pull osmotic pump tablets
similar factor of f2
single factor tests
