阿司匹林精氨酸盐注射液的制备及其稳定性研究

Preparation of aspirin arginine salt and its injection and study on their stability

目的 制备阿司匹林精氨酸盐及其注射液 ,并测定含量 ,考察稳定性。方法 阿司匹林与精氨酸反应生成阿司匹林精氨酸盐 ,精制后以注射用水为溶剂制成阿司匹林精氨酸盐注射液 ,用紫外 -可见分光光度法测定其含量 ,考察阿司匹林精氨酸盐及其注射液在 30 ,4 5 ,6 0℃及 30 ,35 ,4 0 ,4 5℃的稳定性。结果 阿司匹林精氨酸盐在高温下不稳定 ,初步确定其注射液的有效期为 1.32年。结论 阿司匹林精氨酸盐及其注射液制备方法可行 。

Objectives To study the preparation and stability of aspirin arginine salt and its injection. Methods Aspirin arginine salt was prepared by reaction of aspirin with arginine and its injection was prepared by dissolving the purified salt in injective water. The content of the injection was determined by UV-VIS spectrometry. The material and its injection's stabilities were studied on conditions of 30,45,60℃ and 30,35,40,45℃ respectively. Results Aspirin arginine salt and its injection were successfully prepared. The salt was unstable in high temperature and its injection's period of validity was 1.32 years. Conclusions The preparation methods of aspirin arginine salt and its injection were established. The material and the preparation were stable in normal temperature.