痤疮露Ⅱ号搽剂的质量控制研究

Study on Quality Control of AcneⅡLiniment

目的制备痤疮露Ⅱ号搽剂并建立其质量控制方法。方法以乳糖酸红霉素为主药制备痤疮露Ⅱ号搽剂,采用紫外分光光度法在482 nm波长处测定乳糖酸红霉素的含量。结果制剂为无色透明液体,乳糖酸红霉素质量浓度的线性范围为16～48μg/mL(r=0.999 8),平均回收率为99.75%,RSD为1.29%(n=6)。结论本制剂制备工艺简便可行,疗效显著,质量稳定可控。

Objective To prepare Acne ⅡLiniment and to establish its quality control method.Methods The Acne ⅡLiniment was prepared with erythromycin lactobionate as main component.The content of erythromycin lactobionite was measured by UV spectrophotometry at detection wavelength of 482 nm.Results The preparation was colorless and clear liquid.The linear range of erythromycin lactobionite was 16-48 μg/mL（r=0.999 8）,with the average recovery rate of 99.75%,RSD=1.29%（n=6）.Conclusion The method is convenient and feasible technology,apparent effect and controllable quality.