基于实验数据分析水杨酸苯酚贴膏现行质量标准

The Current Quality Standard of Salicylic Acid Phenol Patch was Analyzed based on Experimental Data

目的 基于实验数据探讨水杨酸苯酚贴膏现行质量标准的质量。方法 采用高效液相色谱法(HPLC)测定市售6家企业57批次水杨酸苯酚贴膏中水杨酸及苯酚含量。结果 该方法专属性、精密度、准确度、范围及线性等方法学考察项目均符合规定。6家生产企业的水杨酸苯酚贴膏中水杨酸含量均高于100%,在101%~109%之间;苯酚含量均低于10%,其中A、D、E、F 4家低于1%。结论 现行质量标准已无法有效控制产品质量,建议修订质量标准。

Objective To explore the current quality standards for salicylic acid phenol patch based on experimental data.Methods HPLC method was used to determine the content of salicylic acid and phenol in 57 batches of salicylic acid phenol patch from 6 commercial enterprises.Results The specificity,precision,accuracy,range,and linearity of this method are all in compliance with regulations.The content of salicylic acid in the salicylic acid phenol patch of 6 production enterprises is higher than 100%,ranging from 101%to 109%;The phenol content is all below 10%,with A,D,E and F below 1%.Conclusion The current quality standards are no longer effective in controlling product quality,and it is recommended to revise the quality standards.