盐酸地芬尼多单层渗透泵控释片处方与制备工艺优化  

Optimization of the Prescription and Preparation Process of Difenidol Hydrochloride Single-Layer Osmotic Pump Controlled-Release Tablets

作　　者：曾媛 朱兰琼 彭瑛 熊菁 吴芬 刘辉 ZENG Yuan;ZHU Lanqiong;PENG Ying;XIONG Jing;WU Fen;LIU Hui(Department of Pharmacy of Medical Security Center,The General Hospital of Central Theater Command of the PLA,Wuhan,Hubei,China 430070;College of Pharmacy,Southern Medical University,Guangzhou,Guangdong,China 510515;The 74th Army Hospital of the PLA,Guangzhou,Guangdong,China 510515;College of Pharmacy,Hubei University of Chinese Medicine,Wuhan,Hubei,China 430065)

机构地区：[1]中国人民解放军中部战区总医院医疗保障中心,湖北武汉430070 [2]南方医科大学药学院,广东广州510515 [3]中国人民解放军陆军第七十四集团军医院,广东广州510515 [4]湖北中医药大学药学院,湖北武汉430065

出　　处：《中国药业》2021年第9期22-26,共5页China Pharmaceuticals

基　　金：国家“十三五”重大新药创制科技重大专项课题[2018ZX09J18110-002];军队后勤科研项目[CLB18J043]。

摘　　要：目的优选盐酸地芬尼多单层渗透泵控释片的处方与制备工艺。方法采用单因素法考察片芯处方、包衣膜处方和体外释放条件,以累积释放度和f2相似因子为评价指标,采用L9(34)正交试验优选盐酸地芬尼多单层渗透泵控释片的最佳处方,并进行验证。结果最佳制备工艺条件为氯化钠90 mg,聚氧乙烯N1020 mg,聚乙二醇1500与包衣液配比8 g∶1000 mL,包衣增重4.50%。结论制备的盐酸地芬尼多单层渗透泵控释片缓释特征显著,且优化后的工艺合理、可行。Objective To optimize the prescription and preparation process of Difenidol Hydrochloride Single-Layer Osmotic Pump Controlled-Release Tablets.Methods Single-factor method was used to screen the core prescription,coating prescription and the release conditions in vitro.L9(34)orthogonal test was used to optimize and verify the prescription of Difenidol Hydrochloride Single-Layer Osmotic Pump Controlled-Release Tablets with cumulative release and f2 similarity factor as the evaluation indexes.Results The optimum prescription conditions were as follows:90 mg of sodium chloride(NaCl),20 mg of polyoxyethylene N10(PEO-N10),8 g∶1000 m L of polyethylene glycol 1500(PEG1500)-coating solution ratio,and 4.50%of coating weight gain.Conclusion The sustained-release characteristics of Difenidol Hydrochloride Single-Layer Osmotic Pump Controlled-Release Tablets are significant,and the optimized process is reasonable and feasible.

关 键 词：盐酸地芬尼多 单层渗透泵 控释片 正交试验 累积释放度 f2相似因子 制备工艺 

分 类 号：R971[医药卫生—药品] R983[医药卫生—药学]