温度对门冬氨酸鸟氨酸注射液有关物质的影响研究

Studies on the Influence of Temperature on Related Substances of Ornithine Aspartate Injection

目的 对门冬氨酸鸟氨酸注射液的稳定性进行研究,为该产品的处方工艺开发和剂型合理性提供依据。方法 采用高效液相色谱法,对高温试验条件下的门冬氨酸鸟氨酸注射液进行有关物质含量测定。结果 60℃高温储存条件下未检测出马来酸、精氨酸、杂质Ⅱ和其他未知杂质,线性回归统计分析表明杂质Ⅰ和富马酸的日增长速率分别为0.9934%和0.0043%。结论 该产品需要通过处方工艺的改进进一步提升药品质量,门冬氨酸鸟氨酸更适宜于研制开发成冻干粉针剂。

OBJECTIVE To provide the basis for the formulation process development and rationality of dosage form by studying on the stability of ornithine aspartate injection.METHODS The content of related substances in ornithine aspartate injection under high temperature was determined by HPLC.RESULTS Maleic acid,arginine,impurity Ⅱ and other unknown impurities were not detected in samples stored at 60 ℃.The linear regression statistical analysis showed that the daily growth rates of impurity I and fumaric acid were 0.9934% and 0.0043%,respectively.CONCLUSION The quality of the product needs to be further improved through the improvement of the prescription process.Ornithine aspartate is more suitable for the development of lyophilized powder for injection.