肤康祛斑凝胶的制备与质量控制  

Preparation and Quality Control of Fukang Freckle-Removing Gel

作　　者：苏华[1] 乔立业[1] 陈星[1] 王曙东[1] 任海祥[1] 

机构地区：[1]南京军区南京总医院制剂科,南京210002

出　　处：《医药导报》2013年第7期924-927,共4页Herald of Medicine

基　　金：南京军区南京总医院青年基金课题(2012046)

摘　　要：目的制备肤康祛斑凝胶,并建立其质量控制方法。方法以卡波姆-940为凝胶的主要基质,建立性状、鉴别、检查、含量测定等质量控制方法。采用高效液相色谱法测定熊果苷和维甲酸含量,均采用Lichrospher-C18色谱柱(4.6 mm×250 mm,5μm)。熊果苷测定条件:流动相水-甲醇(90∶10),流速1.0 mL.min-1,检测波长283 nm,进样量10μL,柱温25℃;维甲酸测定条件:流动相甲醇-水-冰醋酸(90∶10∶0.1),用三乙胺调节pH至6.5,流速1.0 mL.min-1,检测波长343 nm,进样量为10μL,柱温25℃。结果熊果苷在0.055 3～0.276 5 mg.mL-1的范围内呈良好的线性关系,r=0.999 9,平均回收率为99.89%,RSD为1.03%(n=9)。维甲酸在0.009 9～0.089 0 mg.mL-1的范围内呈良好线性关系,r=0.999 9,平均回收率为99.53%,RSD为1.08%(n=9)。结论肤康祛斑凝胶的制备工艺简单,质量可控。Objective To prepare fukang freckle-removing gel and establish a method for its quality control. Methods Fukang freckle-removing gel was prepared using carbopol-940 as the matrix, and evaluated by quality control methods. Arbutin and ratinoic acid were both determined by HPLC on Lichrospher-Cls column（250 mm×4.6 mm,5 μm）at room temperature. The essay for Arbutin was conducted with water - methanol （90 ： 10 ） as the mobile phase. The flow rate was 1.0 mL · min-1 and the detection wavelength was 283 nm. The essay for ratinoic acid was conducted with methanol-water-glacial acetic acid （90 ： 10 ： 0.1 ,pH 6.5 ） as the mobile phase. The flow rate was 1.0 mL · min-1 and the detection wavelength was 343 nm. Results The concentration and peak area of arbutin was linear within the range of 0. 055 3-0. 276 5 mg · mL^-1 （ r = 0.999 9）. The average recovery was 99.89% （ RSD= 1.03% ）. The linear concentration range of ratinoic acid was 0. 009 9- 0. 089 0 mg · mL^-1（r= 0. 999 9） with the recovery rate of 99.53% （ RSD = 1.08% ）. Conclusion Thc preparation of fukang freckle-removing gel is simple and quality control method is controllable.

关 键 词：肤康祛斑凝胶 熊果苷 维甲酸 质量控制 

分 类 号：R286[医药卫生—中药学] TQ460.6[医药卫生—中医学]