复方环磷酰胺软膏的制备及质量控制  

Preparation and Quality Control of Compound Cyclophosphamide Ointment

作　　者：杨宗学[1] 孙舒[1] 凌俐[1] 

机构地区：[1]中国人民解放军第149医院,江苏连云港222042

出　　处：《解放军药学学报》2003年第6期471-473,共3页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的　研制具有治疗皮肤局部蕈样肉芽肿 (MF)的外用化疗制剂 ,建立测定主药环磷酰胺含量的方法。方法　制备复方环磷酰胺软膏剂 ,建立质量标准。进行稳定性试验、刺激性试验。结果　质量标准可行 ,平均回收率 99.36 %。本制剂性质稳定 ,无刺激性。结论　本品处方工艺合理 ,质量稳定 ,是早期蕈样肉芽肿局部化疗的有效制剂。Aim To prepare the external preparation of chemotherapeutics for treated local mycosis fungoides(MF) and to establish a method for the determination of cyclophosphamide.Methods Compound cyclophosphamide ointment were pnepared and the quality specification were establishod.The stimulation and the stability test were conducted.Results The method of quality control is feasible,and the average recovery was 99.36%,the correlective test proves that the preparation is stable and has no irritation to skin.Conclusion The preparation technique of the ointnent is reasonable and quality is steady.it is an available chemotherapeutics preparation in treated local MF.

关 键 词：复方环磷酰胺软膏 治疗 化疗制剂 蕈样霉菌病 MF 

分 类 号：R979.1[医药卫生—药品]