基于急毒的山豆根生物碱类物质质量控制方法学研究  

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

作　　者：郑丽娜 任海勇 李素君[4] 谢元璋[5] 孙蓉[1] 

机构地区：[1]山东省中医药研究院,山东济南250014 [2]天津中医药大学,天津300193 [3]济南杏林生物技术有限公司,山东济南250101 [4]山东中医药大学,山东济南250355 [5]哈尔滨商业大学,黑龙江哈尔滨150000

出　　处：《中国药物警戒》2012年第9期516-519,共4页Chinese Journal of Pharmacovigilance

基　　金：国家重点基础研究发展计划(973)中医基础理论专项资助项目(2009CB522802);山东省科技平台建设项目(2008GG2NS02021)

摘　　要：目的以山豆根不同组分的小鼠急毒研究为导向,进行山豆根毒性物质基础生物碱类物质的质量控制方法学研究。方法用高效液相色谱法测定山豆根全组分、水提组分、醇提组分中苦参碱和氧化苦参碱的含量。色谱条件:色谱柱用氨基键合硅胶为填充剂(250mm×4.6mm,5μm),流动相:乙腈-无水乙醇-3%磷酸溶液(80:10:10),流速:1.0mL/min,检测波长:205nm,柱温:30℃。结果苦参碱进样量在0.102～2.04 g范围内,氧化苦参碱进样量在0.156～3.12 g范围内与峰面积呈良好的线性关系,平均回收率均在99%以上。对山豆根不同组分中的苦参碱和氧化苦参碱的含量测定,发现苦参碱的含量大小为:水提组分>醇提组分>全组分,氧化苦参碱的含量大小为:全组分>醇提组分>水提组分。结论高效液相色谱法测定山豆根中苦参碱和氧化苦参碱的含量,此方法线性关系良好,精密度、稳定性、重现性均较好,回收率较高。山豆根不同组分中苦参碱、氧化苦参碱的含量大小与急性毒性间均有一定的关系,但不完全一致。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 Raddx 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 Rad/x et Rhizome 5ophorae Tonkanensis. 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 0.102-2.04μg, the linear regression of matrine was favorable. During 0.156-3.12μg, 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 mathhe 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 Ra＆x et Rhizome Sophorae Tonkinensis, but not completely consistent.

关 键 词：山豆根 苦参碱 氧化苦参碱 急毒 

分 类 号：R282[医药卫生—中药学] R285.5[医药卫生—中医学]