光纤溶出法在吲哚美辛凝胶膏剂释放度检测中的应用

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% NaCl 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.

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