Chinese Journal of Pharmacovigilance ›› 2012, Vol. 9 ›› Issue (9): 516-519.

• Orginal Article • Previous Articles     Next Articles

Study on Quality Control Methodology of Alkaloid Substance from Radix et Rhizome Sophorae Tonkinensis Based on Acute Toxicity

ZHENG Li-na1,2 , REN Hai-yong3 , LI Su-jun4 , SUN Rong1*   

  1. 1Shandong Academy of Chinese Medicine, Shandong Jinan 250014, China;
    2 Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China;
    3 JinanXinglin BiologyTechnologyLimited Company, Shandong Jinan 250101, China;
    4 Shandong University of Traditional Chinese Medicine, Shandong Jinan 250355, China; 5Harbin University of Commerce, Heilongjiang Harbin150000, China
  • Received:2011-03-03 Online:2012-09-10 Published:2015-08-07

Abstract: Objective Under the guidance of the acute toxicity of different components of Radix et Rhizome Sophorae Tonkinensis, the quality control methodology of alkaloid substance from Radix et Rhizome Sophorae Tonkinensis was studied. Methods HPLC was used to determine the content of matrine and oxymatrine in all-components, water extract, alcohol extract of Radix et Rhizome Sophorae Tonkinensis. The YWG-NH2 column(250mm× 4.6mm,5μm) with the solvent system consisting of acetonitrile anhydrous ethanol-3% phosphoric acid solution(80:10:10) was used. The detection wavelength was at 205nm by UV spectrometry and the column temperature was 30℃.The flow rate was 1.0mL-1min. Results During 0.102-2.04 g, the linear regression of matrine was favorable. During 0.156~3.12 g, the linear regression of oxymatrine was favorable. The average recovery rates were all more than 99%. In the determination of matrine and oxymatrine in different components of Radix et Rhizome Sophorae Tonkinensis, it was found that the size order of the content of matrine is water extract>alcohol extract >all-component, and the content of oxymatrine is all-components>alcohol extract>water extract. Conclusion The method that matrine and oxymatrine was determined by HPLC has good linearity, precision, stability and reproducibility, high recovery. There is a certain relationship between the content of matrine and oxymatrine and acute toxicity in different components of Radix et Rhizome Sophorae Tonkinensis, but not completely consistent.

Key words: Rhizome et Rhizome Sophorae Tonkinensis, matrine, oxymatrine, acute toxicity