克班宁注射剂原料药的质量标准研究

Quality control of the raw materials of crebanine injection

建立克班宁(crebanine)注射剂原料药的质量控制方法.方法:采用TLC进行定性鉴别.以RP-HPLC法Zirchrom ODS柱(250 mm×4.6 mm,15 μm)定量测定,流动相为甲醇-水-三乙胺(88:12:0.05),流速:1.0 mL·min-1,检测波长282 nm.结果:供试品与对照品在薄层板相同位置上显相同斑点;克班宁的峰面积与浓度呈线性关系,线性范围为0.9～10.8μg,r=0.999 7,平均加样回收率为99.4%～102.7%,RSD为1.3%～1.9%,10批样品含量均大于90%.结论:本法简便、准确、可靠,可作为该原料药的质量控制方法.

Objective： To establish the quality control of the raw materials for crebanine injection. Methods ： The identification of the raw materials was conducted by TLC ; and quantitative assay was completed by HPLC composed of Zirchrom ODS column （250 mm × 4.6 mm,5 μm）, a mobile phase with a flow rate of 1.0 mL· min^- 1 （ mechanol-water-triethylamine 88 ： 12 ： 0.05）, and UV detection at 270 nm. Results： The TLC development raw materials showed the coincident spots Rf with the standard reference. The linearity of the peak areas versus concentration of crebanine was observed within 0.9- 10.8 μg（ r = 0.999 7）. The mean recovery rate was 99.4% - 102.7%, and RSD was 1.3% - 1.9%. Concentrations for 10 batches of crebanine samples by this procedure were more than 90%. Conclusion： The simple, accurate and reliable method can be used the quality control of the raw materials for crebanine injection.