对照品法与自身对照法差异性研究——格列喹酮片药物溶出度方法学探讨  

Study on the Difference of Control Article Method and Own Control Method:Approaching Drug Dissolution Technology of Gliquidone Tablets

作　　者：张奇洲[1] 陈坚[1] 孔彬 李新霞[1] 

机构地区：[1]新疆医科大学药学院,乌鲁木齐830054 [2]新疆富科思生物技术发展有限公司,乌鲁木齐830011

出　　处：《中国药品标准》2008年第1期13-16,共4页Drug Standards of China

摘　　要：目的:考察引起溶出度结果差异的原因,进一步探讨合理的分析方法。方法:用格列喹酮对照品和药片粉分别配置系列溶液,于同一坐标系内建立标准曲线并进行比较。使用光纤药物溶出仪应用两种标准曲线方程时,比较格列喹酮片的溶出度差异。结果:格列喹酮片粉溶液中加入二甲基甲酰胺(DMF)助溶,不同温度下过滤时格列喹酮均不损失。采用光纤药物溶出仪检测格列喹酮片溶出度,可避免由于过滤操作引起的误差。结论:制备自身对照溶液应根据具体情况适量加入助溶剂,此外,取样分析应及时过滤,检测。光纤药物溶出仪实时、在线、过程检测药物溶出度,检测结果直观、真实、准确、快捷。Objective：To inspect the reasons why drug dissolution is different and approach the reasonable analytical method deeply. Method： To set up standard curve to compare with them at the same coordinate system, blending a series of solution of different concentration with gliquidone control article and medicine powder individually. Comparing the difference of the dissolution of gliquidone tablets by fiber-optic dissolution test system which use two different standard curve equations. Results： It is no loss of gliquidone when filtering medicine powder solution which include dimethylformamide（DMF） as an auxiliary solvent at different temperature. Detecting dissolution of gliquidone tablets by fiber-optic dissolution test system automatically. We can avoid error which caused by filter manipulation. Conclusion：According to specific circumstance, auxiliary solvent should be add into properly when blending own control solution,in addition, samples which removed from the vessels must be filtered and detected promptly. An in-situ, real time, on-line and process analysis of drug dissolution by fiber-optic dissolution test system automatically, the result is direct-viewing, actual, accurate and fast.

关 键 词：格列喹酮片 光纤药物溶出仪 药物溶出度 自身对照法 

分 类 号：R969[医药卫生—药理学] R927.1[医药卫生—药学]