光纤药物在位溶出度/释放度监测仪实时监测甲硝唑维B_6片体外溶出度

The Real-Time FOCSDT Detection Method and Conditions for Dissolution Test of Metronidazole and Vitamin B_6 Tablets

采用光纤化学传感技术,建立了实时、在位监测固体复方制剂体外溶出度的测定方法。分支光纤一端连接光源,公共端部探头浸入溶出液,另一端连接检测器,计算机记录并处理数据。实验显示,甲硝唑维B6片中甲硝唑的高、中、低浓度组回收率分别为100.8%,99.8%和100.6%;RSD分别为2.5,0.8,1.1;维生素B6的高、中、低浓度组回收率分别为98.8%,100.8%和98.8%;RSD分别为4.1,4.1,2.5。该法可监测药物溶出的全过程,显示药物实时溶出曲线图,直接提取相关溶出参数。表明,光纤化学溶出度过程监测法能够有效的测定固体药物的体外溶出度,并能真实地反映药物溶出的全过程。

A method to monitor the dissolution rate of drug on-line fiber optic chemical sensor dissolution test（FOCSDT） was studied. Bifurcated optical fiber was used to connect the light source and detector, and the common end was dipped in the dissolution vessel. The dissolution process could be monitored through computer. The results show that the high, middle and low concentration group＇s recovery of metronidazole is 100. 8%, 99.8% and 100.6%; and RSD is 2.5, 0. 8 and 1.1 respectively, The high, middle and low Concentration group＇s recovery of vitamin B6 is 98.8%, 100.8% and 98. 8%; and RSD is 4.1, 4.1 and 2. 5 respectively. This process of analysis can test the whole process of drug and get dissolution graph. The study shows that this process analysis can reflect the real dissolution of drug and obtain the total information.