氧化锌乳膏的质量控制  

Preparation and Quality Control of Zinc Oxide Emulsion

作　　者：杨宗学[1] 孙舒[1] 李青[1] 凌俐[1] 谈恒山[2] 

机构地区：[1]解放军第82医院,149临床部,江苏连云港222042 [2]南京军区总医院临床药理科,江苏南京210002

出　　处：《解放军药学学报》2007年第3期219-221,共3页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的氧化锌乳膏剂进行质量控制。方法取处方量油相与水相分别置玻璃烧杯中,置水浴加热75℃使其熔化后,在相同温度条件下,两液合并搅拌至凝(约50℃)时加入氧化锌即得乳膏剂,采用络合量法乙二胺四醋酸二钠标准滴定液测定氧化锌的含量。结果氧化锌乳膏制剂稳定,氧化锌在16%～24%浓度范围内线性关系良好(r=0.9999)。平均回收率为99.55%,RSD为0.25%(n=9)。结论本制剂处方工艺设计合理,质量控制方法简便易行。Aim To study the preparation of zinc oxide emulsion and to establish a method of quality control . Methods The oil phase and water phase was taken according to the prescription quantity and put in the glass beaker respectively,then heated to 75℃ on the water bath to melt under the same temperature. The two liquids were merged and stirred to clot（about 50℃ ）. After that,zinc oxide was added and stirred and the emulsion was obtained. EDTA-2Na titrand was used to measure the content of zinc oxide according to complexiometry. Results The product was stable ,and the linearity relation was good when zinc oxide concentration ranged from 16% to 24%, r = 0.999 9. The average recovery rate was 99.55% （ RSD =0.25% , n = 9）. Conclusion The preparation technique of the emulsifying agent is designed reasonablly and its method of quality control is feasible.

关 键 词：氧化锌 乳膏剂 质量控制 

分 类 号：R917[医药卫生—药物分析学]