甲癣涂剂的稳定性研究

Stability of Glacial Acetic Acid in Paint for Onychomycosis

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 content determination of glacial acetic acid and acetic ether in paint for onychomycosis so as to improve formula technology based on the finding of stability. Methods A GC method was adopted to determine the content of glacial acetic acid and acetic ether and to compare the stability between the pro-prescription and new prescription. Results The calibration curve of glacial acetic acid and acetic ether was linear within the concentration range of 0. 20-6. 0 mg·ml-1. The average recovery of glacial acetic acid was99. 1%,101. 2%,100. 3%,respectively,and that of acetic ether was 99. 7%,100. 3%,101. 3% for the low,middle,high control samples,respectively. The expiration date of paint for onychomycosis prepared with pro-prescription was only 7 days preserved at room temperature. Conclusion Alocohol and acetone should be removed from pro-prescription,and the stability of this preparation can be guaranteed by dissolving salicylic acid in dimethyl sulfoxide.