光纤溶出法在吲哚美辛凝胶膏剂释放度检测中的应用  

Application of optical fiber dissolution instrument in the test of release of indomethacin cataplasm

作　　者：邢绍蓉 陈华[2] 左宁[2] 

机构地区：[1]烟台大学,烟台264000 [2]中国食品药品检定研究院,北京100050

出　　处：《药物分析杂志》2017年第5期771-776,共6页Chinese Journal of Pharmaceutical Analysis

基　　金：国家重大新药创制(2015ZX09303001002)

摘　　要：目的:建立光纤溶出法对吲哚美辛凝胶膏剂释放度进行检测。方法:光纤溶出法使用光纤溶出仪按照中国药典桨碟法实验,以0.9%氯化钠溶液-乙醇(50∶50)为释放介质,温度为32℃,体积为900 mL,转速为100 r·min^(-1)。对各取样时间点获得的样品平行进行HPLC法测定,通过测定结果的比较来验证光纤溶出法的准确性,并通过不同工艺处方的样品依法检验来验证光纤溶出法的区分性。结果:光纤溶出法通过比较所获得的释放曲线,HPLC法与光纤溶出法释放相关性良好,而不同工艺处方的样品之间差异显著。结论:所建立的光纤溶出法准确简便,对不同工艺处方的样品也有一定的区分性。Objective： To establish a method using optical fiber dissolution instrument to test the release of indomethacin cataplasm. Methods： The test was carried out using the paddle over disk method with optical fiber dissolution instrument. The medium was 900 mL of the mixture of 0.9% NaC1 solution and ethanol （ 50 ： 50 ）, the temperature was 32 ℃ and the rotation speed was 100 r· min^-1. After analyzing the samples at special time point by HPLC, the accuracy of optical fiber dissolution method was evaluated by comparing the results. The discrimination of the method was justified by comparing the results from samples made by different formulation. Results： By comparing the dissolution profiles, it showed the good correlation between HPLC and optical fiber dissolution methods while the distinguish difference existed within samples made by different formulation. Conclusion： The optical fiber dissolution method is accurate and convenient. The method can distinguish the samples made by different formulations.

关 键 词：透皮给药系统 透皮贴剂 非甾体抗炎药 凝胶膏剂 吲哚美辛 释放度 释放曲线 高效液相色谱法 光纤溶出法 

分 类 号：R917[医药卫生—药物分析学]