论文部分内容阅读
目的考察不同p H对托拉塞米注射液稳定性的影响。方法将不同p H(7.5~11.0)的托拉塞米注射液样品置稳定性试验箱内,分别于5、10 d时取样检测,采用HPLC测定托拉塞米中有关物质和含量的变化,同时考察样品的性状和p H的变化情况。结果所制备的托拉塞米注射液样品在所设定的实验条件下,除p H 7.5的样品外,其他样品在稳定性观察中均未出现明显的性状改变,p H8.5以下的样品中有关物质明显升高,含量降低。结论高p H有利于托拉塞米注射液的稳定性,有必要适当调高现行托拉塞米注射液质量标中的p H值。
Objective To investigate the effect of different p H on the stability of torsemide injection. Methods Torasemide injection samples with different p H (7.5 ~ 11.0) were placed in a stability chamber and sampled at 5 and 10 days respectively. The contents of torsemide in the samples were determined by HPLC. At the same time to examine the characteristics of the sample and p H changes. Results The samples of toracemide injection prepared under the set experimental conditions, except p H 7.5 samples, other samples in the stability of the observed no significant changes in the traits, p H8.5 the following samples In the relevant substances was significantly increased, reduced content. Conclusion High p H is beneficial to the stability of torsemide injection. It is necessary to appropriately adjust the p H value in the quality standard of torasemide injection.