柠檬苦素乳膏的制备与质量控制

Preparation and Quality Control of Limonin Creams

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,5 μm),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20 μL,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,应置于阴凉干燥处保存。

Abstract:

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.