摘要
目的:探讨壬二酸软膏的处方优化与质量控制方法。方法:以聚乙二醇(PEG)和丙二醇为软膏基质,采用反射线单纯形法进行处方优化。结果:5℃/40℃放置24h,软膏有良好的伸展性与稳定性,软膏中壬二酸可溶解。并建立了质量控制方法。结论:壬二酸PEG软膏处方合理、工艺简单、质量稳定。反射线单纯形法将拓展单纯形法在处方优化设计的用途。
OBJECTIVE To optimize the formula of azelaic acid unguent and set up its quality control regulations. METHODS It was optimized the formula of azelaic acid unguent by reflect-line simplex method. Polyethylene glycol （PEG） and propylene glycol were utilized as unguent base. RESULTS The optimized unguent appeared good readability and stability after placed 24hr at 50℃/40℃. Azelaic acid was dissolvable in PEG unguent. Its quality control regulations were set up successfully. CONCLUSION The azelaic acid PEG unguent was obtained with suitable formula, simple manufacture and stable property. The reflect-line simplex method should expand the utilization of simplex method in formula optimization.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2008年第17期1477-1479,共3页
Chinese Journal of Hospital Pharmacy
关键词
壬二酸
聚乙二醇
软膏剂
单纯形法
反射线
azelaic acid
Polyethylene glycol
unguent
simplex method
reflec-line
