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目的制备注射用桂利嗪制剂,建立质量研究方法,对其中的桂利嗪进行含量测定及有关物质检查。方法以质量浓度为200 g·L-1的羟丙基-β-环糊精(HP-β-CD)对桂利嗪进行包合增溶,冷冻干燥法制备注射用桂利嗪粉针剂。采用反相高效液相色谱法,检查该制剂的含量及有关物质。所用色谱条件为C18柱(200 mm×4.6 mm,5μm I.D.)流动相:乙腈-0.01 mol·L-1磷酸二氢铵缓冲液-三乙胺(体积比为1000:900:13),以磷酸调节pH值为4.71;检测波长:254 nm;柱温:40℃。结果制备注射用桂利嗪3批,所得制剂外观、再分散性及澄清度良好。含量为102%~104%,有关物质检查<1%。结论该制备方法不加入任何有机溶剂,工艺简单,重现性好。HPLC方法简便、快速、准确,适用于该制剂的含量测定及有关物质检查。
Objective To prepare the preparation of cinnarizine for injection and to establish a quality research method to determine the contents of cinnarizine and related substances. Methods The cinnarizine was encapsulated and solubilized with hydroxypropyl-β-cyclodextrin (HP-β-CD) of mass concentration 200 g · L-1, and the cinnarin injection for injection was prepared by freeze-drying method. Using reversed-phase high performance liquid chromatography, check the content of the preparation and related substances. The chromatographic conditions used were C18 column (200 mm × 4.6 mm, 5 μm ID), mobile phase: acetonitrile-0.01 mol·L-1 ammonium dihydrogen phosphate buffer-triethylamine (volume ratio 1000: 900: 13) The pH was adjusted to 4.71; detection wavelength: 254 nm; column temperature: 40 ° C. Results Three batches of cinnarizine for injection were prepared. The appearance, redispersibility and clarity of the obtained preparations were good. Content of 102% to 104%, the relevant material inspection <1%. Conclusion The preparation method does not add any organic solvents, the process is simple, good reproducibility. HPLC method is simple, rapid and accurate, suitable for the determination of the content of the preparation and related substances.