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目的建立甲癣涂剂中冰醋酸和乙酸乙酯的含量测定方法,根据稳定性研究结果,修改处方工艺。方法 GC法测定冰醋酸和乙酸乙酯的含量,用此方法比较处方改进前后甲癣涂剂的稳定性。结果冰醋酸和乙酸乙酯均在0.20~6.0mg·ml-1浓度范围内线性关系良好,冰醋酸低、中、高3个浓度的方法平均回收率分别为99.1%、101.2%、100.3%,乙酸乙酯低、中、高3个浓度的方法平均回收率分别为99.7%、100.3%、101.3%;原工艺制备的甲癣涂剂在室温下保存的有效期仅为7d。结论根据稳定性研究结果,建议修改原处方,去掉原处方中溶解水杨酸的乙醇和丙酮,利用二甲基亚砜溶解水杨酸,以保证制剂的稳定性。
OBJECTIVE To establish a method for the determination of glacial acetic acid and ethyl acetate in oncosis paints. According to the stability study results, modify the prescription process. Methods The contents of glacial acetic acid and ethyl acetate were determined by GC method. The stability of onychomycosis paint before and after prescription was compared by this method. Results The results showed that the average recoveries of glacial acetic acid and ethyl acetate were all within the range of 0.20-6.0 mg · ml-1. The average recoveries were 99.1%, 101.2% and 100.3%, respectively. The average recoveries of the ethyl acetate at low, medium and high concentrations were 99.7%, 100.3% and 101.3%, respectively. The onychomycosis paint prepared by the original process was only stored for 7 days at room temperature. Conclusion Based on the results of the stability study, it is suggested to modify the original prescription, to remove the ethanol and acetone dissolved salicylic acid in the original prescription and to dissolve the salicylic acid with dimethyl sulfoxide to ensure the stability of the preparation.