【摘要】 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。更多还原

【Abstract】 Objective To prepare cinnarizine for injection,and develop a quality control method to determine cinnarizine and its related substances.Methods 2-Hydroxypropyl-β-cyclodextrin was used at a concentration of 200 g·L-1to enhance the solubility of cinnarizine,and the preparation was finally obtained by freeze–drying technique.A RP–HPLC method was preformed to determine cinnarizine and its related substances.The column was C18(200 mm×4.6 mm,5μm); mobile phase was acetonitrile-0.01 mol·L-1ammonium dihydrogen phosphate buffer–triethylamine(1000:900:13,V:V),with pH value 4.71 adjusted by phosphoric acid; the UV detector wavelength was set at 254 nm; the column temperature was kept at40℃; the flow rate was 1.0 mL·min–1.Results Three lots of cinnarizine for injection were prepared.Appearance,clarity and reconstituted property met standards.The content and related substances were102%~104% and <1%,respectively.Conclusions The preparation method without any organic solvent is simple and convenient.The HPLC method is fast,accurate and suitable for the quality control of cinaarizine injection.更多还原