f_2法与AV值法评价国内不同厂家格列齐特缓释片与原研制剂的体外释放曲线的相似性  

Evaluation of the Similarity of Dissolution Curves in vitro between Gliclazide Sustined-release Tablet and Original Preparations from Different Domestic Manufacturers by f_2 and AV Value

作　　者：陈艳君[1,2] 胡容峰[1,2,3] 朱双双[1,2] 周红[1,2] 

机构地区：[1]安徽中医药大学药学院,合肥230038 [2]省部共建新安医学教育部重点实验室,合肥230038 [3]安徽省中药研究与开发重点实验室,合肥230038

出　　处：《中国药房》2016年第9期1230-1233,共4页China Pharmacy

基　　金：国家科技支撑计划项目(No.2012BAI26B03);国家自然科学基金资助项目(No.81274100);安徽省学术和技术带头人及后备人选学术科研活动经费资助项目(No.皖人社秘2011-381号-26)

摘　　要：目的:考察国内不同厂家格列齐特缓释片与原研制剂的体外释放曲线的相似性,评价药品内在质量。方法:采用桨法转速为50 r/min,以水、pH 6.0磷酸氢二钠-枸橼酸缓冲溶液、pH 6.8磷酸盐缓冲溶液为释放介质进行体外释放试验,对受试制剂与参比制剂的释放曲线的相似性采用相似因子(f_2)法与两条溶出曲线相似性参数(AV值)法进行比较。结果:通过f_2法与AV值法比较,发现在3种释放介质中A、C、D厂家受试制剂与参比制剂释放曲线均相似,而B厂家受试制剂与参比制剂释放曲线仅在pH 6.8磷酸盐缓冲溶液中相似。结论:同f_2法一样,AV值法也可用于口服固体制剂体外释放曲线的相似度评价。国内不同厂家格列齐特缓释片释放度行为不尽相同,其产品质量具有一定差异性。OBJECTIVE：To explore the similarity of dissolution curves in vitro between Gliclazide sustined-release tablet and original preparations from different domestic manufacturers,and evaluate the internal quality. METHODS：Paddle method was used at rate of 50 r/min,in vitro release test was conducted with release media of pH 6.0 Disodium hydrogen phosphate-citrate buffer solution and pH 6.8 Phosphate buffer solution to compared the similarity of dissolution curves in vitro between Gliclazide sustined-release tablet and original preparations by similarity factor f2 and method of AV value. RESULTS：Similarity factor f2 and method of AV value showed the dissolution curves of test preparations in manufacturer A,C and D and reference preparations were similar in 3 media,while only the dissolution curves of test preparations in manufacturer B and standard preparations were similar in pH 6.8 Phosphate buffer solution. CONCLUSIONS：As well as factor f2,method of AV value can also be used to evaluate the similarity of oral solid preparations in vitro dissolution curve profiles. The results show that there are differences between the Gliclazide sustined-release tablet and original preparations from different domestic manufacturers,and there is significant difference in quality.

关 键 词：格列齐特缓释片 释放曲线 相似因子法 两条溶出曲线相似性参数法 

分 类 号：R917[医药卫生—药物分析学]