| 张丽,吕慧侠,陈登俊,孙宏张,程开生.吲达帕胺在释放介质中的稳定性及影响因素[J].中国药品标准,2019,20(2):143-148 |
| 吲达帕胺在释放介质中的稳定性及影响因素 |
| Stability and Influencing Factors Study of Indapamide in Release Medium |
| 投稿时间：2018-10-11 修订日期：2019-04-04 |
| DOI： |
| 中文关键词: 吲达帕胺 释放介质 稳定性 影响因素 金属离子 |
| 英文关键词: indapamide release medium stability influencing factors metal ion |
| 基金项目: |
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| 摘要点击次数: 798 |
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| 中文摘要: |
| 目的：考察吲达帕胺在不同pH介质中的稳定性情况及影响其稳定性的主要因素。方法：采用高效液相色谱法（HPLC），考察不同温度、pH及Fe3+浓度条件下溶液稳定性情况，并考察加入不同稳定剂对于吲达帕胺降解的影响。结果：吲达帕胺在pH 1.0~3.0介质中的降解与t1/2呈线性关系，pH的降低、温度的升高及金属离子（Fe3+）的增加会加速吲达帕胺的降解。依地酸二钠或维生素C能有效减少其在酸性溶液下的降解。结论：吲达帕胺溶液在pH 1.0~3.0介质中不稳定，影响其降解的主要因素包括pH、温度和金属离子（Fe3+）；在pH 4.5、pH 6.8及水介质中稳定。依地酸二钠或维生素C是有效的稳定剂。 |
| 英文摘要: |
| Objective: To investigate the stability of indapamide in different pH media and the main factors affecting its stability. Methods: The stability of solutions under different temperature, pHs and metal ion(Fe3+) concentrations were tested by HPLC method. The effect of different stabilizing agents proventing the degradation of indapamide were investigated. Results: A degradation tendency linearly related to t1/2 in pH 1.0~3.0 media for indapamide was found. The degradation rate was accelerated with the decrease of pH, the increase of temperature and the increase of metal ion (Fe3+) concentration. Disodium edetate or vitamin C could effectively reduce its degradation in acid solution. Conclusion: Indapamide solution was unstable in the medium of pH 1.0~3.0, and the main factors influencing its degradation are pH, temperature and metal ion (Fe3+). It was stable in pH 4.5, pH 6.8 and aqueous media. Disodium edetate or vitamin C can be an effective stabilizing agent. |
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