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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,5μm),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,应置于阴凉干燥处保存。
Objective: To prepare limonin cream and study its quality stability. Methods: The limonene was used as the main drug to prepare the cream. The main drug content and related substances were determined by HPLC. The chromatographic conditions were Zorbax SB-C18 column (4.6 mm × 150 mm, 5 μm), Zorbax SB-C18 column mm × 12.5 mm, 5 μm), mobile phase water-acetonitrile (42:58), detection wavelength at 207 nm and flow rate of 1.0 mL · min-1 at the column temperature of 20 μL. Results: The limonene cream was milky white. Identification and inspection items were in accordance with relevant regulations. The linear range was 20.26 ~ 101.3 mg · L-1 with an average recovery of 99.6% (RSD 0.68%). The contents of limonin in three batches of samples ranged from 100.4% to 101.6%, except the volume increased slightly or decreased under high humidity or high temperature, and the other tests were stable in different environments. Conclusion: The preparation process is simple, quality controllable, should be stored in a cool dry place.