摘要
目的:制备柠檬苦素乳膏并考察其质量稳定性.方法:以柠檬苦素为主药制备乳膏剂,采用HPLC测定主药含量及有关物质,色谱条件为Zorbax SB-C18色谱柱(4.6 mm×150 mm,5μm),Zorbax SB-C18保护柱(4.6 mm×12.5 mm,5 μm),流动相水-乙腈(42∶58),检测波长207 nm,流速1.0 mL· min-1,柱温室温,进样量20μL,考察3批样品的初步稳定性.结果:柠檬苦素乳膏呈乳白色,鉴别、检查项均符合相关规定,线性范围20.26~101.3 mg·L-1,平均回收率99.6%(RSD 0.68%).3批样品中柠檬苦素质量分数100.4% ~ 101.6%,除了在高湿或高温条件下体积会略有增大或减小,其他检测在不同环境中均稳定.结论:该制剂工艺简单、质量可控,应置于阴凉于燥处保存.
Objective:To prepare limonin creams and investigate its quality stability.Method:Creams was prepared with limonin as raw material,HPLC was adopted to determined the content and related substances of limonin,chromatographic conditions were as follows:Zorbax SB-C18 column (4.6 mm × 150 mm,5 μm),Zorbax SB-C18 guard column (4.6 mm × 12.5 mm,5 μm),mobile phase of water-acetonitrile (42 ∶ 58),detection wavelength 207 nm,flow rate 1.0 mL · min-1,column temperature at room temperature,injection volume 20 μL,stability of three batches of limonin creams were carried out.Result:Limonin creams showed milky white,its identification and inspection items were in line with relevant regulations,the linear range of limonin was 20.26-101.3 mg ·L-1 with average recovery of 99.6% (RSD 0.68%).The mass fraction of limonin in three creams samples was 100.4%-101.6%,quality of samples was stable in different environments except in high humidity or high temperature,where volume would be slightly increased or decreased.Conclusion:This preparation technology was simple and controllable,it should be saved in cool and dry place.
出处
《中国实验方剂学杂志》
CAS
北大核心
2013年第20期8-11,共4页
Chinese Journal of Experimental Traditional Medical Formulae
基金
国家科技重大专项重大新药创制项目(2012ZX09303009-002)
江苏省中医药领军人才(LJ200906,LJ200907)
江苏高校优势学科建设工程项目(2010)
2011年度江苏省高等学校优秀科技创新团队(苏教科[2011]11号)
关键词
柠檬苦素乳膏
制备
质量控制
稳定性
方法学考察
有关物质
limonin creams
preparation
quality control
stability
methodological study
related substances