苦参提取物的质量标准研究(1)
[摘要]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。
[关键词]苦参提取物;质量标准;总黄酮;生物碱;含量测定
Study on quality standard of Sophora flavescens root extract
, http://www.100md.com
ZHAO Feng-chun1，2， LI Hao1，3， CHEN Liang-mian1，2， GAO Hui-min1，2*， ZHANG Qi-wei1，2， WANG Zhi-min1，2*， WU Pi-e4
(1.Institute of Chinese Materia Medica， China Academy of Chinese Medical Sciences， Beijing 100700， China;
2.National Engineering Laboratory for Quality Control Technology of Chinese Herbal Medicine， Beijing 100700， China;
3. School of Traditional Chinese Medicine， Capital Medical University， Beijing 100069， China;
, 百拇医药
4. Sichuan Institute for Food and Drug Control， Chengdu 611731， China)
[Abstract]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 edition)， the water and ash inspections were carried out. The marker components trifolirhizin， sophoraflavanone G， oxymatrine and oxysophocarpine in the samples were identified by qualitative TLC. The determination of oxymatrine， matrine， oxysophocarpine and sophocarpine 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， matrine， 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 flavoids in the 13 batches of the samples were 3.88%-7.93%. In the study， the validated methods were reproducible and the established quality standard was feasible， which could be used for the quality control of S. flavescens root extract and related preparations.
, http://www.100md.com
[Key words]Sophora flavescens root extract; quality standard; total flavonoids; alkaloids; quantification
doi：10.4268/cjcmm20150216
中药提取物是我国中药出口的主流，2013年一季度植物提取物出口额为3.3亿美元，占中药商品出口额的47%[1]。中药提取物是部分中成药生产的原料，并可应用于营养补充剂、化妆品、保健品等相关产品中，具有广阔的市场前景。然而，当前在中药提取物的生产和监管过程中存在诸多问题，给中成药的质量和公众用药安全带来一定的隐患，亟需国家出台关于中药提取物的相关规定，明确其法定的原料药地位。, 百拇医药(赵凤春 李浩 陈两绵 高慧敏 张启伟 王智民 伍丕娥)
[关键词]苦参提取物;质量标准;总黄酮;生物碱;含量测定
Study on quality standard of Sophora flavescens root extract
, http://www.100md.com
ZHAO Feng-chun1，2， LI Hao1，3， CHEN Liang-mian1，2， GAO Hui-min1，2*， ZHANG Qi-wei1，2， WANG Zhi-min1，2*， WU Pi-e4
(1.Institute of Chinese Materia Medica， China Academy of Chinese Medical Sciences， Beijing 100700， China;
2.National Engineering Laboratory for Quality Control Technology of Chinese Herbal Medicine， Beijing 100700， China;
3. School of Traditional Chinese Medicine， Capital Medical University， Beijing 100069， China;
, 百拇医药
4. Sichuan Institute for Food and Drug Control， Chengdu 611731， China)
[Abstract]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 edition)， the water and ash inspections were carried out. The marker components trifolirhizin， sophoraflavanone G， oxymatrine and oxysophocarpine in the samples were identified by qualitative TLC. The determination of oxymatrine， matrine， oxysophocarpine and sophocarpine 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， matrine， 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 flavoids in the 13 batches of the samples were 3.88%-7.93%. In the study， the validated methods were reproducible and the established quality standard was feasible， which could be used for the quality control of S. flavescens root extract and related preparations.
, http://www.100md.com
[Key words]Sophora flavescens root extract; quality standard; total flavonoids; alkaloids; quantification
doi：10.4268/cjcmm20150216
中药提取物是我国中药出口的主流，2013年一季度植物提取物出口额为3.3亿美元，占中药商品出口额的47%[1]。中药提取物是部分中成药生产的原料，并可应用于营养补充剂、化妆品、保健品等相关产品中，具有广阔的市场前景。然而，当前在中药提取物的生产和监管过程中存在诸多问题，给中成药的质量和公众用药安全带来一定的隐患，亟需国家出台关于中药提取物的相关规定，明确其法定的原料药地位。, 百拇医药(赵凤春 李浩 陈两绵 高慧敏 张启伟 王智民 伍丕娥)