摘要
目的研究一种实时、在位监测药物固体制剂体外溶出度的测定方法———光纤化学药物溶出度过程实验法,考察本方法与《中国药典》2000版溶出度测定方法的差异。方法将双分支光纤分别连接光源和检测器,光纤公共端部直接插入溶出杯中,检测药物溶出度,通过改变药典规定吡嗪酰胺的测试波长,实现溶出度过程分析。结果方法学考察吡嗪酰胺在310nm处,浓度在60.00～280.00mg·L-1范围内吸收度与浓度成线性,r=0.9999,日内日间精密度为0.8%和1.1%(n=6),平均回收率97.8%,实现检测吡嗪酰胺溶出度,可直接从溶出曲线上提取相关参数,与《中国药典》2000版溶出度测定方法比较,两种测定方法无统计学意义(P>0.05)。结论光纤化学药物溶出度过程实验法通过改变吡嗪酰胺测试波长,不经过滤稀释,获得药物在体外的溶出曲线,数据信息完整。
Objective To study a method which can monitor the dissolution rate of drug by on-line Fiber optic chemical sensor dissolution test(FOCSDT), and compare the difference of this method with Ch.P(2000). Method Bifurcated optical fiber was used to connect light source and detector and the common end was dipped into the dissolution vessel. The dissolution process was monitored through computer. Result The standard curve of pyrazinamide was linear with the concentration ranged from 60.00～280.00 mg·L -1 , r=0.999 9. The recovery by FOCSDT method was 97.8%.The RSD (n=6) of within-day and day-to-day were 0.8% and 1.1%, respectively. The parameters obtained by FOCSDT had no significant difference compared with those by the method in Ch.P 2000 (P>0.05). Conclusion This processing analysis could obtain the dissolution information of the drug.
出处
《西北药学杂志》
CAS
2005年第3期99-100,共2页
Northwest Pharmaceutical Journal
基金
新疆维吾尔自治区高技术发展计划资助项目(200311110)
