目的 研究冰醋酸涂剂的稳定性,并鉴定其有关物质的化学结构.方法 采用酸碱滴定法对不同溶剂、不同贮藏方法下冰醋酸涂剂的主药乙酸含量进行定量测定,采用气相色谱法对冰醋酸涂剂中未知成分副产物进行了鉴定.结果 冰醋酸涂剂中乙酸与乙醇形成了副产物乙酸乙酯,在放置过程中,醋酸含量下降,而乙酸乙酯含量增加,但冰箱保存比常温下降慢；而醋酸水溶液中醋酸含量没有变化,经鉴定冰醋酸涂剂中的有关物质为乙酸乙酯,为主药冰醋酸和乙醇形成的副产物.结论 《中国人民解放军医疗机构制剂规范》2002版及《中国医院制剂规范》第2版收载的冰醋酸涂剂不稳定,建议在冰箱中贮藏.%Objective To study the stability of glacial acetic acid paint and to characterize its related substance. Methods Neutralization micrometric method was used to determine acetic acid of the medicine in different solvents and by different storage method. The related substance was determined by GC. Results During storage,the content of acetic acid in the preparation decreased quickly while that of ethyl acetate increased. Acetic acid of the paint in the fridge decreased mores lowly than at room temperature. However, acetic acid in glacial acetic acid water solution was very stable. The related substance was ethyl acetate, the side product of acetic acid and ethanol. Conclusion The glacial acetic acid paint is unstable at room temperature and should be stored in the fridge.
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