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  • 匿名
关注:1 2013-05-23 12:21

求翻译:The chemical stability of enalapril maleate in tablet dosage forms consisting of different formulation excipients has been studied in this work. The influence of various parameters such as heat, moisture, light and the drug-matrix was investigated. The degradation of enalapril maleate has been followed by using an HPLC method, which was demonstrated to be specific, stability indicating, accurate and precise. The degradation kinetics of enalalpril maleate in phosphate buffer solutions of pH values in the range of 2.2-10.5 were observed to be psuedo first order throughout the whole pH range studied. Enalapril maleate alone showed high stability for temperature under dry and humid conditions, however it became unstable when mixed with the drug-matrix in its tablet formulations and exposed to the same conditions. The pathway of degradation of enalapril maleate was found to be pH dependent. The extent of degradation of two different enalapril maleate tablet formulations (product A of a basic drug-matrix and product B of an acidic drug-matrix) has been investigated. The degree of degradation of the product with acidic matrix was significantly less than that of the basic matrix under same temperature and humidity conditions. In fact, diketopiperazine and enalaprilat degradants were mainly associated with the degradation of the product with the acidic matrix and that with the basic matrix, respectively. Dry enalapril maleate powder showed some photolysis, which was more significant with daylight (3.3%) compared with that under UV light (0.2%). Although the product with the acidic matrix showed some photolysis but the effect was not pronounced and the % recovery of enalapril was almost complete and within the acceptable experimental errors. However, the product with the basic matrix showed almost no response for photolysis.是什么意思?

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The chemical stability of enalapril maleate in tablet dosage forms consisting of different formulation excipients has been studied in this work. The influence of various parameters such as heat, moisture, light and the drug-matrix was investigated. The degradation of enalapril maleate has been followed by using an HPLC method, which was demonstrated to be specific, stability indicating, accurate and precise. The degradation kinetics of enalalpril maleate in phosphate buffer solutions of pH values in the range of 2.2-10.5 were observed to be psuedo first order throughout the whole pH range studied. Enalapril maleate alone showed high stability for temperature under dry and humid conditions, however it became unstable when mixed with the drug-matrix in its tablet formulations and exposed to the same conditions. The pathway of degradation of enalapril maleate was found to be pH dependent. The extent of degradation of two different enalapril maleate tablet formulations (product A of a basic drug-matrix and product B of an acidic drug-matrix) has been investigated. The degree of degradation of the product with acidic matrix was significantly less than that of the basic matrix under same temperature and humidity conditions. In fact, diketopiperazine and enalaprilat degradants were mainly associated with the degradation of the product with the acidic matrix and that with the basic matrix, respectively. Dry enalapril maleate powder showed some photolysis, which was more significant with daylight (3.3%) compared with that under UV light (0.2%). Although the product with the acidic matrix showed some photolysis but the effect was not pronounced and the % recovery of enalapril was almost complete and within the acceptable experimental errors. However, the product with the basic matrix showed almost no response for photolysis.
问题补充:

  • 匿名
2013-05-23 12:26:38
在这项工作,研究了片剂型组成的不同配方辅料马来酸依那普利的化学稳定性。各项参数,如热、 水分、 光和药物矩阵的影响进行了调查。马来酸依那普利降解跟着使用高效液相色谱方法,它被证实为特定、 指示、 准确和精确的稳定性。Enalalpril 马来酸的 pH 值范围内的 2.2 10.5 磷酸缓冲溶液中的降解动力学观察研究,以便将整个 ph 值范围仿真一阶。酸依那普利单显示干燥和高温高湿条件下温度高稳定性,但是它变得不稳定时掺在其片剂型药物矩阵和暴露相同的条件。马来酸依那普利降解途径发现要依赖的 ph 值。被调查的两个不同的依那普利马来酸片配方 (产品 A 基本药物矩阵和产品 B 的酸性药物矩阵) 退化程度。酸性矩阵产品退化程度是显著低于相同的温度和湿度条件下的基本矩阵。事实上,diketopiperazine 和普利 degradants 分别与降解酸性矩阵与产品和基本矩阵的主要相关联。干依那普利马来酸粉显示一些光,其中有较显著的夏时制 (3.3%) 相比,根据 UV 光 (0.2%)。虽然与酸性矩阵产品显示一些光,但影响不明显和依那普利 %恢复了几乎完整和内可接受的实验误差。但是,基本矩阵产品显示几乎没有响应的光。
 
 
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