氧化锌软膏的质量控制研究

目的建立氧化锌软膏的质量控制方法。方法采用配位滴定法测定氧化锌的含量,化学法鉴别锌盐,装量差异应符合中国药典(2010年版二部)涂剂项下有关的各项规定。结果 3批样品化学鉴别均呈正反应,阴性对照不干扰测定。氧化锌含量测定线性范围为23.0～115.0mg;回归方程为Y=4.3442X+0.4054,r=0.9999,平均回收率为100.3%,相对标准偏差(RSD)为1.3%(n=9)。结论本法简便灵敏,重复性好,专属性强,能有效控制氧化锌软膏的质量。

The quality control of zinc oxide ointment

Objective To establish the method for quality control of zinc oxide ointment. Methods The coor- dination titration method was used to determinate the content of Zinc Oxide, and chemical method to identify the zinc salt. The loading capacity difference should be conformed to various relative provisions （Chinese Pharmacopoeia 2010 version two of I T. ）. Results In chemical indentification, three batches of samples were found positive reaction, and the negative control did not interfere the determination. The determined linear range of zinc oxide was 23.0~115.0 rag; the regression equation was Y=4.3442X＋0.4054, r=0.9999, the average recovery was 100.3%, RSD was 1.3% （n=9）. Conclusion This method, simple, sensitive, had good repeatability and strong specificity. Thus, it could effectively control the quality of boric acid ointment.