肌苷口服液杂质分析及肌苷溶液的稳定性研究

Analysis of impurity in inosine oral solution and investigation of stability of inosine liquor

目的分析影响肌苷口服液澄明度的主要原因,并考察2%肌苷溶液在加热情况下和碱性条件下的稳定性。方法用高效液相色谱法确认肌苷口服液中的杂质,并通过测定2%肌苷溶液在不同时间不同条件下的含量来考察其稳定性。结果肌苷口服液中主要杂质为次黄嘌呤,2%肌苷溶液在60℃以下和弱碱性条件下较为稳定。结论次黄嘌呤和肌苷的析出是影响肌苷口服液澄明度的主要原因,2%肌苷溶液在70℃和80℃条件下的降解符合一级动力学反应,在pH值13.5时的降解符合零级动力学反应。

Purpose The main reason for effecting the transparence of inosine oral solution was analyzed and the stability of 2 % inosine liquor was investigated under the condition of heat and basicity respectively. Methods The HPLC method was used to analyze the impurity in inosine oral solution. The content of 2 % inosine liquor on different conditions was determined to investigate its stability. Results Hypoxanthine is the main impurity in inosine oral solution. 2 % inosine liquor was stable at the temperature of 60 ℃ and in the surrounding of alkalescence. Conclusion The effects of the transparence of inosine oral solution are the cause of inosine and hypoxanthine precipitation from it. The degradation process is consistent with the equation of first order kinetics at 70℃ and 80℃ and consistent with the equation of zero order kinetics at pH 13.5.