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目的 :延缓复方间苯二酚洗剂放置过程中被氧化的过程 ,提高制剂稳定性。方法 :在《中国医院制剂规范》处方基础上加入金属离子络合剂 0 .0 3 %依地酸二钠 (EDTA 2Na)和抗氧剂 0 .0 1%硫代硫酸钠组成新处方 ,对照观察原处方与新处方制剂放置 1个月、3个月的外观变化 ,并分别以碘量法测定酚浓度。结果 :原处方制剂外观色泽明显改变 ,酚浓度下降至低于规定下限 ;新处方制剂外观色泽无变化 ,酚浓度稳定在规定范围。结论 :对于含酚类成分的制剂 ,加入适当抗氧剂和金属离子络合剂是保证制剂质量稳定的可靠方法。
OBJECTIVE: To delay the oxidation process of compound resorcinol lotion and improve its stability. Methods: A new prescription of metal ion complexing agent 0. 3% disodium edetate (EDTA 2Na) and antioxidant 0.1% sodium thiosulfate was added to the prescription of " Observed the original prescription and the new prescription preparations placed 1 month, 3 months the appearance of change, respectively, and iodometric method for the determination of phenol concentration. Results: The appearance color of the original formulation obviously changed, the phenol concentration dropped below the prescribed lower limit; the appearance color of the new prescription formulation did not change, and the phenol concentration was stable within the specified range. CONCLUSIONS: For formulations containing phenolic compounds, the addition of appropriate antioxidants and metal ion complexing agents is a reliable method of ensuring a stable formulation.