HPLC法测定中药血塞通氯化钠注射液中三种组分的含量

Determination of Three Constituents in Ginsenoside-Sodium Chloride Injection By HPLC

目的 建立血塞通氯化钠注射液的质量控制方法。方法 采用HPLC法测定制剂中的人参皂苷Rb1、人参皂苷Rg1和三七皂苷R1的含量。色谱柱为Shim -packCLC -ODS(4 .6× 2 5 0mm) ;测定人参皂苷Rb1流动相为 :乙腈 - 0 .0 5 %磷酸水溶液(35∶6 5 ) ;测定人参皂苷Rg1、三七皂苷R1流动相为 :乙腈 - 0 .0 5 %磷酸水溶液 (2 5∶75 ) ;流速为 1.5ml/min ;检测波长 2 0 3nm。结果 各组分峰面积与进样量呈良好线性关系。线性范围分别是 :人参皂苷Rb10 .79～ 3.94 μg ,人参皂苷Rg10 .6 2～ 3.2 1μg,三七皂苷R10 .6 5～ 3.5 7μg。平均回收率 :人参皂苷Rb110 0 .14 % ,RSD =0 .73% ;人参皂苷Rg199.6 6 % ,RSD =0 .72 % ;三七皂苷R110 0 .99% ,RSD =0 .5 9%。结论 本法简便、快速、灵敏、准确、重现性好 ,可作为该制剂的质量控制方法。

Aim To establish a method to control the quality of Gisenoside-Sodium chloride injection.Methods The three constituents of ginsenoside Rb 1,ginsenoside Rg 1,notoginsenoside R 1 were determined by HPLC method.Chromatographic conditions included Shim-pack CLC-ODS colun,mobile phase using of Acetonitrile and 0.05% Phosphoric acid (35∶65) for determining ginsenoside Rb 1,Acetonitrile and 0.05% Phosphoric acid (25∶75) for determining ginsenoside Rg 1 and notoginsenoside R 1.The flow rate was 1.5ml/min.Detection wavelength was 203nm.Results A good linearity was obtained respectively in the range of 0.79～3.94μg for ginsenoside Rb 1,0.62～3.21μg for ginsenoside Rg 1 and 0.65～3.57μg for notoginsenoside R 1.The average recovery rates of ginsenoside Rb 1,ginsenoside Rg 1 and notoginsenoside R 1 were 100.14% (RSD=0.73%),99.66% (RSD=0.72%),100.99%(RSD=0.59%),respectively.Conclusion The method appeared to be simple,quick,sensitive,accurate,reproducible and could be used for the quality control of Gisenoside-Sodium chlonide injection.