中药饮片标准汤剂的质量评价案例——连翘Quality evaluation of medicinal herb decoction——Forsythiae Fructus
徐姣;赵嵘;代云桃;朱超;李琦;友田健久;王丹丹;陈士林;
XU Jiao;CHAO Jung;DAI Yun-tao;ZHU Chao;LI Qi;Takehisa Tomoda;WANG Dan-dan;CHEN Shi-lin;Institute of Chinese Materia Medica,China Academy of Chinese Medicinal Sciences;School of Chemistry and Biological Engineering,University of Science and Technology Beijing;College of Medicine and Nursing,Dezhou University;Shanghai Traditional Chinese Medicine Co.,Ltd.;Tsumura & Co.;Waters Corporation (Shanghai);
摘要(Abstract):
该研究的目的是建立连翘标准汤剂的质量评价方法。收集有代表性的连翘12批制备标准汤剂,计算出膏率、指标成分转移率和溶液pH等参数,评价工艺的稳定性;建立指标成分含量测定和指纹图谱方法,采用UPLC-Q-TOF-MS对主要色谱峰进行结构确认,明确连翘标准汤剂中的主要化学成分。连翘标准汤剂中指纹图谱相似度均>0.9;连翘标准汤剂平均出膏率(15.53±6.27)%,连翘酯苷A的平均转移率为(38.0±10.2)%。建立了系统评价连翘标准汤剂的质量评价方法,为所有源于连翘水煎液的制剂的质量标准制定提供参考,所得连翘标准汤剂相似度高、质量均一性良好。
To establish the quality control methods for the standard decoction of Forsythiae Fructus. Twelve batches of representative Forsythiae Fructus were collected to prepare standard decoction of Forsythiae Fructus,and then the parameters such as extraction ratio,transfer rate of the index components and pH value of the solution were calculated to evaluate the stability of the process. The simultaneous determination method of target components and fingerprint method were established,and ultra performance liquid chromatography-quadrupole time-of-flight mass spectrometry(UPLC-Q-TOF-MS) was used to identify the main common peaks in the fingerprint to clarify the main chemical constituents in the decoction. The similarities of the fingerprints of standard decoction of Forsythiae Fructus were more than 0. 9. The average extraction ratio of the standard decoction of Forsythiae Fructus was(15. 53 ± 6. 27) %,and the transfer rate of forsythiaside A was(38. 0 ± 10. 2) %. The method for evaluating the quality of standard decoction of Forsythiae Fructus was presented,providing reference for the quality control of products stemmed from the water extract of Forsythiae Fructus,with high similarity and uniform quality.
关键词(KeyWords):
标准汤剂/煎液;连翘;质量评价;指纹图谱;质谱鉴定;出膏率;转移率
standard decoction of single medicinal herb;Forsythiae Fructus;quality evaluation;fingerprint;mass spectrometry;extraction ratio;transfer rate
基金项目(Foundation): 中国中医科学院“十三五”重点领域研究专项(ZZ10-007)
作者(Author):
徐姣;赵嵘;代云桃;朱超;李琦;友田健久;王丹丹;陈士林;
XU Jiao;CHAO Jung;DAI Yun-tao;ZHU Chao;LI Qi;Takehisa Tomoda;WANG Dan-dan;CHEN Shi-lin;Institute of Chinese Materia Medica,China Academy of Chinese Medicinal Sciences;School of Chemistry and Biological Engineering,University of Science and Technology Beijing;College of Medicine and Nursing,Dezhou University;Shanghai Traditional Chinese Medicine Co.,Ltd.;Tsumura & Co.;Waters Corporation (Shanghai);
Email:
DOI: 10.19540/j.cnki.cjcmm.20171023.008
参考文献(References):
- [1]张红梅,宋景政,谭红胜,等.从汤剂到颗粒剂:中药配方颗粒20年回顾与展望[J].世界科学技术——中医药现代化,2012,14(4):1740.
- [2]陈士林,刘安,朱广伟,等.中药饮片标准汤剂研究策略[J].中国中药杂志,2016,41(10):1367.
- [3]中国药典.一部[S].2015:170.
- [4]雷建林,李艳桃,聂会生,等.HPLC法测定不同产地连翘药材中连翘苷的含量[J].中华中医药学刊,2012(1):202.
- [5]胡静,马琳,张坚,等.连翘的研究进展[J].中南药学,2012(10):760.
- [6]王娅丽,杨建雄,柴渭莉.连翘叶中连翘苷类成分的提取工艺研究[J].西北药学杂志,2006,21(1):9.
- [7]叶良红,龚晓红,李芸霞,等.青翘和老翘中多种成分含量的比较[J].中药与临床,2013,4(2):6.
- 标准汤剂/煎液
- 连翘
- 质量评价
- 指纹图谱
- 质谱鉴定
- 出膏率
- 转移率
standard decoction of single medicinal herb - Forsythiae Fructus
- quality evaluation
- fingerprint
- mass spectrometry
- extraction ratio
- transfer rate
- 徐姣
- 赵嵘
- 代云桃
- 朱超
- 李琦
- 友田健久
- 王丹丹
- 陈士林
XU Jiao- CHAO Jung
- DAI Yun-tao
- ZHU Chao
- LI Qi
- Takehisa Tomoda
- WANG Dan-dan
- CHEN Shi-lin
- Institute of Chinese Materia Medica
- China Academy of Chinese Medicinal Sciences
- School of Chemistry and Biological Engineering
- University of Science and Technology Beijing
- College of Medicine and Nursing
- Dezhou University
- Shanghai Traditional Chinese Medicine Co.
- Ltd.
- Tsumura & Co.
- Waters Corporation (Shanghai)
- 徐姣
- 赵嵘
- 代云桃
- 朱超
- 李琦
- 友田健久
- 王丹丹
- 陈士林
XU Jiao- CHAO Jung
- DAI Yun-tao
- ZHU Chao
- LI Qi
- Takehisa Tomoda
- WANG Dan-dan
- CHEN Shi-lin
- Institute of Chinese Materia Medica
- China Academy of Chinese Medicinal Sciences
- School of Chemistry and Biological Engineering
- University of Science and Technology Beijing
- College of Medicine and Nursing
- Dezhou University
- Shanghai Traditional Chinese Medicine Co.
- Ltd.
- Tsumura & Co.
- Waters Corporation (Shanghai)