摘要
目的:制备尿素维E珍珠乳膏并建立其质量控制方法。方法:以尿素、维生素E、珍珠粉等为组方,用水包油基质制备尿素维E珍珠乳膏;分别采用高效液相色谱法和紫外分光光度法测定制剂中维生素E和尿素的含量。结果:所制制剂为白色乳膏,各项检查均符合《中国药典》相关规定;维生素E、尿素检测浓度的线性范围分别为40.0～200.0、125.0～500.0μg·mL-(1r=0.9999、0.9998),平均回收率分别为99.9%(RSD=1.0%,n=9)、100.4%(RSD=1.4%,n=9)。结论:本制剂制备工艺简单,质量控制方法均较灵敏、准确、重复性好、专属性强,可用于该制剂的质量控制。
OBJECTIVE： To prepare urea vitamin E pearl cream, and to establish quality control method of it. METHODS： Urea vitamin E pearl cream was prepared with urea, vitamin E, pearl powder and oil-water matrix, etc. UV spectrophotometry and HPLC were used to determine the content of urea and vitamin E. RESULTS： The prepared preparation was white cream and its quality was in line with the standard stated in Chinese Pharmacopeia （2005 edition）. The linear ranges of vitamin E and urea were 40.0～200.0 μg·mL-1 （r=0.999 9） and 125.0～500.0 μg·mL-1 （r=0.999 8）. The average recoveries were 99.9% （RSD=1.0%, n=9） and 100.4% （RSD=1.4%, n=9）. CONCLUSION： The preparation method is simple. The quality control method is accurate and sensitive, specific, and reproducible for the quality control of urea vitamin E pearl cream.
出处
《中国药房》
CAS
CSCD
北大核心
2010年第33期3126-3128,共3页
China Pharmacy
