肝精补血素口服液质量标准的完善

The improvement of specification of Ganjingbuxuesu Oral Liquid

目的:修订并提高肝精补血素口服液的质量标准。方法:研究并建立了党参、枸杞子的薄层色谱鉴别;建立了HPLC法测定维生素B_1的含量;修订方中枸橼酸铁铵的含量测定方法;建立肝精膏的标准。结果:党参、枸杞子的薄层图谱均与相应的对照药材在相同位置上显现相同颜色的斑点,且阴性样品无干扰。HPLC法测定维生素B_1采用的色谱柱为Agela VenusilASB-C18柱(粒径5μm, 4.6 mm×250 mm),流动相为乙腈-0.1%磷酸(每100 mL含0.5 g十二烷基硫酸钠)(50∶50),检测波长为246 nm,维生素B_1在47.58~570.96 ng进样范围内线性关系良好,标准曲线为Y=2 316.1X-12 943,r=0.999 7;回收率为101.6%(RSD=2.4%)。结论:肝精补血素口服液的质量标准经完善后,方法可行,有利于保障该药品的质量。

Objective:To revise and improve the specification of Ganjingbuxuesu Oral Liquid.Methods:TLC identification of Codonopsis radix and Lycii fructus was studied and established.HPLC method was established for the determination of Vitamin B 1.The test method of ferric ammonium citrate was revised and the specification of liver essence cream was established.Results:The TLC of Codonopsis radix and Lycii fructus showed the same color spots in the same positions with the corresponding control herbs,and the negative samples had no interference.Vitamin B 1 was determined in Agela Venusil asb-C 18 column(4.6 mm×250 mm,5μm)under the isocratic elution of acetonitrile-0.1%phosphoric acid(0.5 g sodium dodecyl sulfate per 100 mL)(50∶50).The detection wavelength was 246 nm,and the recovery was 101.6%with RSD as 2.4%.The linear range of Vitamin B 1 fell into 47.58-570.96 ng,and the regression equation was Y=2316.1X^(-1)2943(r=0.9997).Conclusion:The improved specification of Ganjingbuxuesu Oral Liquid is feasible and can guarantee the product quality.