复方壬二酸乳膏的制备及质量控制

目的:制备复方壬二酸乳膏并建立其质量控制方法。方法:以维生素E、壬二酸为主药制备乳膏;采用高效液相色谱法测定其中维生素E的含量;以容量分析法测定壬二酸、维生素C的含量。结果:所制备乳膏涂展性好,性状、鉴别、检查等均符合2005年版《中国药典》相关规定;维生素E检测浓度的线性范围为124.5～415.0μg.mL-1(r=0.9999),平均回收率为98.53%(RSD=1.01%);壬二酸、维生素C的平均回收率分别为100.02%(RSD=0.65%)、98.99%(RSD=0.97%)。结论:本制剂组方合理,制备工艺简便可行,质量稳定可控。

Preparation and Quality Control of Compound Azelaic Acid Cream

OBJECTIVE:To prepare compound azelaic acid cream and to establish its quality control method.METHODS:Compound azelaic acid cream was prepared with vitamin E and azelaic acid as principal agents;the content of vitamin E was determined by HPLC while the contents of azelaic acid and vitamin C were determined by volumetry.RESULTS:The prepared cream was well-spread and its character,identification,and tests etc were all in line with the related standards stated in China Pharmacopeia(2005 edition).The linear range of vitamin E was 124.5～ 415.0μ g · mL-1(r=0.999 9),with average recovery at 98.53%(RSD=1.01%).The average recovery for azelaic acid was 100.02%(RSD=0.65%)and that for vitamin C was 98.99%(RSD=0.97%).CONCLUSION:The preparation had reasonable formulation,simple preparation technology and stable and controllable quality.