柠檬苦素乳膏的制备与质量控制

Preparation and Quality Control of Limonin Creams

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.