炉甘石洗剂的质量控制

目的建立炉甘石洗剂的质量控制方法。方法采用配位滴定法测定氧化锌的含量,化学法鉴别碳酸盐、锌盐、铁盐、甘油,装量差异应符合涂剂项下有关的各项规定(中国药典2010年版二部附录IT)。结果三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=4.3442 x+0.4054,r=0.9999,平均回收率为100.4%,RSD为0.7%(n=9)。结论本法简便灵敏,重复性好,专属性强,能有效控制炉甘石洗剂的质量。

Quality Control of Calamine Lotion

Objective To establish the method for controlling the quality of calamine lotion. Methods We determinated the content of zinc oxide by using of coordination titration method. The identifying of carbonate, zinc salt, ferric salt, glycerol and volume difference, by using of chemical method, was conformed to the pigmentum of relevant provisions （Chinese Pharmacopoeia 2010 version two of IT）. Results Three batches of samples were positive identification of the chemical reaction. And the negative control did not interfere in the content determination. The determination of Zinc Oxide was linear in the range of 23.0-115.0 rag. And the regression equation was y = 4.3442 x＋0.4054,r=0.9999. The average recovery was 100.4%, RSD was 0.7% （n=9）. Conclusion This method is simple and sensitive along with good repeatability and strong specificity. It can effectively control the quality of calamine lotion.