摘要
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。
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 124.5-415.0μg·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.
出处
《中国药房》
CAS
CSCD
北大核心
2007年第28期2202-2203,共2页
China Pharmacy
