盐酸多西环素片体外溶出度过程分析

Processing analysis on dissolution rate of Doxycycline Hyclate Tablets

目的:在自行研制的溶出度过程分析系统上建立药物溶出度自动监测技术。方法:以分支光纤为光传输媒介,分别连接光源和检测器,光纤公共端部直接插入溶出杯实时监测盐酸多西环素片的溶出过程。结果:盐酸多两环素在20～115 μg/ml范围内线性关系良好,r=0.9999。方法的回收率为97.8%～99.9％,日内、日间的RSD分别为2.8％和3.2％。经与中国药典2000版方法对照,提取的参数差异无统计学意义。结论:本法获得的数据信息完整,反映了药物在体外的溶出过程,相应软件的使用实现了药物溶出度监测的智能化,替代了繁琐的传统测试方法。

Objective: To establish processing analysis method for the dissolution test of Doxycyclinc Hyclatc Tablets by Fiber-Optical Chemical Sensor Dissolution Test system. Methods: Bifurcated optical fiber was used to connect light source and detector and the common end was dipped in the dissolution vessel. The dissolution procession can be monitored through computer. Results: The standard curve of Doxycycline Hyclate was linear with the concentration changed from 20 to 115 μg/ml, r = 0. 999 9. The recovery by FOCSDT method was 97. 8%~99. 9%. The RSD (n = 6) of within day and day-to-day were less than 5. 0%. The parameters obtained by FOCSDT had no significant difference compared with the method in Ch. P 2000 ( P >0. 05). Conclusion: This procession analysis can reflect the real dissolution of drug and obtain the total information.