康达心口服液质量标准提高研究

Study on Quality Standard Improvement for Kangdaxin Oral Liquid

目的:改进并提高康达心口服液的质量标准。方法:采用薄层色谱法对康达心口服液中的白术进行定性鉴别,并通过改进展开剂,提升黄芪的鉴别速度;采用高效液相法进行定量检测,色谱柱为Sapphire-C_(18)反相硅胶柱(250mm×4.6mm,5μm),采用梯度洗脱法,流动相为乙腈-甲醇-0.1%磷酸溶液,流速为1mL/min,柱温为30℃,进样量10μL,紫外检测波长设为230nm,同时测定康达心口服液中芍药苷、阿魏酸及丹酚酸B的含量。结果:白术TLC斑点清晰,分离良好;黄芪薄层鉴别操作时间由2.5h缩短至1.5h,且专属性强,斑点明显;测定的各组分在一定范围内呈良好线性关系(r≥0.9951),回收率在99.42%~102.68%之间、RSD在0.40%~1.11%之间,精密度、重复性、稳定性试验的RSD也均符合要求。结论:该方法准确可靠,可行性及重复性好,可为提高康达心口服液的质量评价提供参考依据。

Objective:To improve the quality standard of Kangdaxin Oral Liquid.Methods:Rhizoma Atractylodis Macrocephalae in Kangdaxin Oral Liquid was identified by TLC,and the identification speed of Radix Astragali was improved by making the developing agent better;On the quantitative side,the HPLC analysis was performed on a Sapphire-C_(18)Column(250mm×4.6mm,5μm)with the mobile phase of acetonitrile,methanol and 0.1%phosphoric acid aqueous solution,the gradient elution was used at a flow rate of 1mL/min.The column temperature was 30℃,and was measured at 230nm,the injection volume was 10μL.The HPLC was used for simultaneous determining the contents of paeoniflorin,ferulic acid and salvianolic acid B in the preparation.Results:The TLC spots of Atractylodes macrocephala were clear and well separated.The TLC identification time of Astragalus membranaceus was shortened from 2.5 hours to 1.5hours,with clear spots and strong specificity.The components showed a good linear relationship(r≥0.9951)within a certain range,the recoveries were 99.42%~102.68%,RSD was in the range of 0.40%~1.11%.The RSDof precision,repeatability and stability tests also met the requirements.Conclusion:The method is accurate,reliable,feasible and reproducible,and can provide reference for improving the quality evaluation of Kangdaxin Oral Liquid.