苦参提取物的质量标准研究

Study on quality standard of Sophora flavescens root extract

作为2015年版《中国药典》科研任务的一部分，拟建立新增品种苦参提取物的质量标准。参照《中国药典》2010年版附录相关方法，对不同批次苦参提取物的水分、灰分进行测定；以三叶豆紫檀苷、槐属二氢黄酮G、氧化苦参碱和氧化槐果碱为指标，采用薄层色谱法进行定性鉴别；采用高效液相色谱法测定氧化苦参碱、苦参碱、氧化槐果碱与槐果碱的含量；以槐属二氢黄酮G为指标，采用紫外分光光度法测定总黄酮的含量。结果表明薄层色谱斑点清晰，分离度好；苦参提取物中含氧化苦参碱、苦参碱、氧化槐果碱和槐果碱的质量分数分别为3．87％～11．1％，0．970％～4．33％，1．30％～2．59％，0．260％～1．14％，含总黄酮的质量分数为3．88％～7．93％。首次建立的苦参提取物质量控制方法重复性好，起草的质量标准可行，能够用于苦参提取物及其制剂的质量控制。

As a part of the project for the Chinese Pharmacopoeia （2015 edition）, the quality standard of Sophora flavescens root extract was investigated and established. According to the methods described in the Appendix of Chinese Pharmacopoeia （2010 edi- tion）, the water and ash inspections were carried out. The marker components trifolirhizin, sophoraflavanone G, oxymatrine and oxyso- phocarpine in the samples were identified by qualitative TLC. The determination of oxymatrine, matrine, oxysophocarpine and sopho- carpine was conducted by HPLC and the total flavonoids were measured by ultraviolet spectrophotometry, using sophoraflavanone G as reference substance. The results indicated the spots on the plate were clear with good resolution and the contents of oxymatrine, ma- trine, oxysophocarpine and sophocarpine in the 13 batches of the samples were 3.87%-11.1% , 0. 970%-4. 33% , 1.30%-2. 59% and 0. 260% -1.14%, respectively. The total fiavoids in the 13 batches of the samples were 3.88% -7.93%. In the study, the valida- ted methods were reproducible and the established quality standard was feasible, which could be used for the quality control of S. fla- vescens root extract and related preparations.