研制了光纤-光学传感-药物溶出监测仪并应用于复方氯唑沙宗片的实时-原位体外溶出度.分支光纤的一端与光源相接,另一端与检测器连接,其公共端部探头浸入于盛于溶出杯中的溶解液中.借联机的计算机进行数据记录及处理,对复方氯唑沙宗片的组分对乙酰氨基酚和氯唑沙宗的回收率在低、中、高三个浓度水平进行了试验,结果依次为98.3%,102.3%和103.1%及108.6%,98.7%和97.7%,其相应的RSD值为1.0%,1.4%和0.4%及1.7%,1.6%及1.3%.应用此监测仪对药片的溶出全过程进行了监控,并显示了药物的溶解曲线,相关的溶出参数可随时提取.试验证明,使用该仪器可获得药物溶出全过程的真实情况的信息.

A optic fiber chemical sensor drug dissolution monitor (OFCSDSM) was fabricated and applied to real-time and situ monitoring of dissolution of compound chlorzoxazone tablets.One end of the bifurcated optic fibre was connected with the light source,and the other end with the detector,while the probe at the common end was dipped into the dissolving solution contained in the dissolution vessel.Data logging and processing were performed by a hyphenated computer.Recoveries of paracetamol (a component of the chlorzoxazone tablet) at 3 concentration levels (low,middle and high) were tested and results of 98.3%,102.3% and 103.1% were obtained correspondingly,with respective RSD values of 1.0%,1.4% and 0.4%.Recoveries of the main component,chlozoxazone were also tested at 3 concentration levels,and results of 108.6%,98.7% and 97.7% were obtained with respective RSD values of 1.7%,1.6% and 1.3%.Whole process of the dissolution was monitored and a dissolution curve of the drug was displayed.Related dissolution parameters could be abstracted timely.It was proved that by the use of OFCSDSM,informations of real situation of the drug dissolution process could be obtained.