中国药房2016，Vol.27Issue(7)：959-961,962,4.DOI:10.6039/j.issn.1001-0408.2016.07.29
玄归止痛分散片的处方工艺研究
Preparation Process of Xuangui Zhitong Dispersible Tablets
摘要
Abstract
OBJECTIVE:To prepare Xuangui zhitong dispersible tablets and optimize its formulation technology. METHODS:Using disintegration time as index,single factor test was conducted for filler,disintegrating agent,the types and amount of adhe-sives and compression pressure. The amount of mixed disintegrating agent,avicel and gum arabic were optimized by orthogonal test. The tablet quality by optimized formulation was detected,and disintegration time,the content and dissolution rate of tetrahy-dropalmatine were determined;the similarity of in vitro dissolution rate of dispersible tablets and dropping pills were evaluated by similarity factor test. RESULTS:The optimized formulation was composed of 25% MCC as fillers,9% PVPP and 9% L-HPC as mixed disintegrants,85% ethanol solution as adhesives,micro-silica gel 2%,compression pressure of 3.0 kg/cm2. The average dis-integration time was 1.22 min,and the content of tetrahydropalmatine was 1.097 mg/g. The accumulative dissolution rate was more than 80% at 10 min and more than 90% at 15 min. The similarity factor f2 of dissolution curve was 62,using dropping pills as ref-erence preparation. CONCLUSIONS:Xuangui zhitong dispersible tablet had a rapid disintegration and the behavior of dissolution is similar to Xuangui zhitong dropping pills.关键词
玄归止痛分散片/处方工艺/正交试验/延胡索乙素含量/崩解时限/溶出度/相似因子Key words
Xuangui zhitong dispersible tablets/Formulation technology/Orthogonal test/Content of tetrahydropalmatine/Dis-integration time/Dissolution rate/Similarity factor分类
医药卫生引用本文复制引用
杨鹏,张琰,刘梅,党学良,郑璇,范梅..玄归止痛分散片的处方工艺研究[J].中国药房,2016,27(7):959-961,962,4.基金项目
第四军医大学唐都医院科技创新发展基金自主创新探索项目 （）
