复方硫唑乳膏的质量控制  

The Development of the Compound Sublimed Sulfur and Metronidazole Cream and the Quality Control

作　　者：杨宗学[1] 

机构地区：[1]解放军第82医院149临床部,江苏连云港222042

出　　处：《解放军药学学报》2009年第2期182-183,共2页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的制备复方硫唑乳膏剂并进行质量控制。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℃)时加入升华硫、甲硝唑及醋酸氯已定即得乳膏剂。采用碘量法用碘滴定液(0.05mo.lL-1)测定硫的含量。结果该制剂稳定,硫含量在3%～8%浓度范围内线性关系良好(r=0.9998)。加样回收率试验,平均回收率为99.52%,RSD为0.20%(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 make the compound sublimed sulfur and metronidazole cream and to control the quality. Methods The prescribed amount of oil phase and water phase was respectively added to glass breakers and heated to 75℃ in the water bath to melt. Under the same temperature, the two solutions were mixed to condense（ about 50℃ ） before being added into sublimed sulfur, metronidazole and chlorhexidine acetate to obtain the cream. The iodine titrating solution （0.05mol·L^-1 ） was tested using the iodometric method for the content of sulfur. Results The preparation was stable ; the content of sulfur was 3 % - 8 % ; the internal linear relation was good （ r = 0.999 8 ） ; the average recovery was 99.52% and RSD was 0.20% （ n = 9）. Conclusion The design of the process of this preparation is sound ,and the method of quality control is simple and user-friendly.

关 键 词：硫 复方硫唑乳膏 质量控制 

分 类 号：R927.2[医药卫生—药学]