不同处方注射用甘草酸二铵的稳定性考察

摘要

目的 考察不同处方的注射用甘草酸二铵的稳定性.方法 按2010年版附录进行影响因素试验,重点考察性状、溶液的颜色、pH、有关物质等评价指标.结果 稳定性试验数据表明,不同处方的样品稳定性存在较大差异.样品中有关物质随放置时间的变化因处方不同而呈现不同趋势.结论 不同处方影响注射用甘草酸二铵的稳定性.%Objective To investigate the stability of diammonium glycyrrhizate for injection with different formulas. Methods According to the stability testing of pharmaceutical preparations and guiding principles in the appendix of the Chinese Pharmacopoeia( edition 2010, Vol. Ⅱ),the influencing factors test was performed with the major investigation on the evaluation indexes of character,color of the solution, pH and related substances. Results The data of stability test indicated that the bigger difference existed in the stability of diammonium glycyrrhizate for injection with different formulas. The related substances in the samples of diammonium glycyrrhizate for injection with different formulas showed different trends with the change of storage time due to different formulas. Conclusion Different formulas affect the stability of diammonium glycyrrhizate for injection.