以聚乙二醇为基质的浓苯甲酸水杨酸软膏的处方筛选和稳定性评价研究  

Prescription Screening and Stability Investigation of Concentrated Benzoic Acid and Salicylic Acid Ointments with PEG as the Matrix

作　　者：傅峰[1,2] 施孝金[1] 郁韫超[1] 黄荣飞[2] 宋钟娟[2] 

机构地区：[1]复旦大学附属华山医院药剂科,上海200040 [2]复旦大学附属华东医院药剂科,上海200040

出　　处：《中国药学杂志》2012年第22期1829-1833,共5页Chinese Pharmaceutical Journal

摘　　要：目的研究浓苯甲酸水杨酸软膏的制备工艺并建立质量控制方法。方法采用正交实验法筛选最佳基质处方,以乙醇或二甲基亚砜溶解苯甲酸和水杨酸,以聚乙二醇400和聚乙二醇4000作为水溶性软膏基质制备软膏;建立性状、鉴别、检查、含量测定等质控方法,同时考察制剂的长期稳定性。结果新处方解决了软膏粒度不合格的问题,长期稳定性考察的各项结果均符合药典相关规定。以HPLC同时测定软膏中苯甲酸和水杨酸的含量,平均回收率分别在99.6%～100.6%,99.4%～100.2%之间,RSD为0.52%和0.39%。结论该制剂制备工艺简便可行,制剂性质稳定,质控方法可靠。OBJECTIVE To study the preparation of concentrated benzoic acid and salicylic acid ointment and establish the quali- ty control system. METHODS To choose the best basic formula with orthogonal design test. The ointment was prepared by ethanol or DMSO as the solvent for benzoic acid and salicylic acid, and PEG400 and PEG4000 were used as the water-soluble ointment matrix. To establish the quality control method such as character, identification, inspection and content determination etc. In addition, the perma- nent stability investigation was conducted to ointment product. RESULTS The new prescription has solved the unqualified granularity problem. The results of the permanent stability investigation meet the standards of Chinese Pharmacopoeia. Contents of benzoic acid and salicylic acid were simultaneously measured by HPLC ; the average recoveries were within 99. 6% - 100. 6% ,99.4% - 100. 2%, respectively; the RSDs were 0. 52% and 0. 39% ,respectively. CONCLUSION The ointment is easy to prepared and the quality is stable. The quality control method is reliable.

关 键 词：苯甲酸 水杨酸 软膏剂 高效液相色谱法 质量标准 

分 类 号：R944[医药卫生—药剂学]