痤疮搽剂的制备及质量控制

Preparation and Quality Control of Acne Liniment

目的制备痤疮搽剂并建立痤疮搽剂中各组分的含量测定方法。方法以75%乙醇为溶剂,将水杨酸、氯霉素、甲硝唑制成搽剂,用紫外分光光度法和联立方程组法测定各组分的含量。结果水杨酸浓度线性范围是11.25～33.75μg/mL,r=0.9999,平均回收率为101.07%,RSD为0.356%;氯霉素浓度线性范围是4.8～16.8μg/mL,r=0.9998,平均回收率为98.31%,RSD为0.364%;甲硝唑浓度线性范围是2.677～9.370μg/mL,r=0.9998,平均回收率为98.38%,RSD为0.331%。结论该制剂制备方法简便,含量测定方法准确,质量稳定可控。

Objective To prepare the salicylic acid liniment and to establish the quality control method for this medicine Methods Salicylic acid was taken as the chief components of the liniment; the contents of the chief components was determined by ultraviolet spectrophotometry method. Results The standard curve of salicylic acid was linear in the concentration of 11.25-33.75 μg/mL（r=0. 999 99）, the average recovery was 101.07%, and the relative standard deviation was 0. 356%. The standard curve of chloramphenicol was linear in the concentration of 4. 8 - 16. 8 μg/mL（ r = 0. 999 8）, the average recovery was 98.31%, and the relative standard deviation was 0. 364%. The standard curve of metronidazole was linear in the concentration of 2. 677-9. 370 μg/mL（ r=0. 9998）, the average recovery was 97. 92%, and the relative standard deviation was 0. 556%. Conclusion The preparation is simple in preparation, accurate in content determination, stable and reliable in quality.