国产与原研丙戊酸钠缓释片的体外释放度考察  

Domestic and Original Sodium Valproate Sustained-release Tablet in Releasing Rate in Vitro

作　　者：郑晓林[1] 李勇文[2] 

机构地区：[1]广西医科大学第五附属医院,柳州市545001 [2]桂林医学院药学院,桂林市541004

出　　处：《中国药房》2009年第7期532-533,共2页China Pharmacy

摘　　要：目的:比较国产与原研丙戊酸钠缓释片的体外释放特性。方法:采用《中国药典》溶出度测定法第二法和电位滴定法测定其体外释放度,根据威布尔分布和Excel计算出释放度参数(T50,Td,m),并对参数进行方差分析和两两q检验。结果:国产与原研丙戊酸钠缓释片的T50与Td有统计学差异(P<0.01);斜率m无统计学差异(P>0.05),两厂家各批样品之间释放参数无统计学差异。结论:国产与原研丙戊酸钠缓释片在考察期内累积释放量基本一致;释放前期国产制剂释药速率大于原研制剂;两厂家制剂工艺稳定,但质量存在差异。OBJECTIVE： To evaluate the releasing characteristics of domestic and original sodium valproate sustained- release tablet in vitro. METHODS： The drug releasing rates of the tablests were determined according to dissolution method Ⅱ of the Chinese Pharmacopoeia and potentiometry. The parameters of the releasing rate （T50, Td, and m） were obtained by the weibull disposition and excel. Analysis of variance of the parameters were statistically evaluated by q - test. RESULTS： There were significant differences between the domestic and original sodium valproate sustained- release tablets in T50 and Td （P 0.01）, but the slope rate m had no statistical difference （P 〉0.05）, nor in release parameters. CONCLUSIONS： There was no difference in accumulative releasing amount between domestic and original sodium valproate sustained- release tablets in study period, but the domestic tablets showed higher release velocity at the initial release period. The two tablets were both stable in technology, but different in quality.

关 键 词：丙戊酸钠 缓释片 释放度 

分 类 号：R944.4[医药卫生—药剂学] R971.6[医药卫生—药学]