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目的:制备甘草酸二铵注射液,建立其质量控制方法,并考察其稳定性和安全性。方法:优化处方组成与制备工艺,采用紫外分光光度法测定甘草酸二铵的含量,采用高效液相色谱法测定有关物质,进行常规注射剂检查。结果:甘草酸二铵检测浓度在24.96～58.24μg.mL-1线性关系良好(r=0.999 9),其平均回收率为99.1%,RSD 0.34%。加速试验6月和长期留样试验12月,稳定性良好。结论:制备工艺简便可行,质量可控,稳定性良好。
Objective: To prepare diammonium glycyrrhizinate injection and establish its quality control method, and investigate its stability and safety. Methods: The composition and preparation process of prescription were optimized. The content of diammonium glycyrrhizinate was determined by UV spectrophotometry. The related substances were determined by high performance liquid chromatography (HPLC), and routine injections were performed. Results: The linear range of diammonium glycyrrhizinate was 24.96 ~ 58.24μg.mL-1 (r = 0.999 9). The average recovery was 99.1% and the RSD was 0.34%. Accelerated tests June and long-term retention tests December, good stability. Conclusion: The preparation process is simple and feasible, the quality is controllable and the stability is good.