薄层色谱法在当前中药质量标准中的应用探讨  

Discussion About Application of Thin Layer Chromatography in Current Quality Standard Control

作　　者：邓哲[1,2] 荆文光 刘安 DENG Zhe;JING Wen-guang;LIU An(Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences,Beijing 100700,China;China National Traditional Chinese Medicine Co.Ltd.,Beijing 102600,China)

机构地区：[1]中国中医科学院中药研究所,北京100700 [2]中国中药有限公司,北京102600

出　　处：《中国实验方剂学杂志》2019年第7期201-206,共6页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：中国中医科学院"十三五"重点领域研究专项(ZZ10-007);北京市科委"十病十药"研发专项(Z171100001717029)

摘　　要：薄层色谱鉴别在历版《中国药典》中的应用经历了从无到有、从少到多的过程;而薄层扫描含量测定在最近几版《中国药典》中的应用比例逐渐降低。随着对中药质量标准体系要求的进一步提高,薄层色谱法的不足之处陆续显现,如仪器普及率低、设备并不简单、结果重复性和稳定性较差、鉴别速度及准确性不及高效液相色谱法、展开剂毒性大等,逐渐不合时宜。在制定中药质量标准时,研究者不应该墨守成规,薄层色谱鉴别也不应该是雷打不动的定性鉴别必备选项。高效液相色谱法具备完全取代薄层色谱法的可行性,薄层色谱法可作为高效液相色谱法的补充。为充分降低检测成本、缩短检测周期、提高鉴别效率,笔者建议中药质量标准体系应该大幅减少薄层色谱鉴别方法的应用,增加高效液相特征图谱鉴定,尽量做到"一个条件,一张图谱";除非确有必要,《中国药典》等国家质量标准体系应将薄层色谱鉴别作为推荐方法,而非强制标准。The application of thin layer chromatography(TLC)in Chinese Pharmacopoeia experienced from scratch to less to more,but the proportion of thin layer chromatographic scanning used in recent editions of Chinese Pharmacopoeia has decreased.With the further improvement of the quality standard system of traditional Chinese medicine(TCM),the shortcomings of TLC identification methods have been gradually revealed,such as the low penetration rate of instrument,poor repeatability and stability of the results,lower identification speed than high performance liquid chromatography(HPLC)and so on.Thus it gradually became untimely.In the process of formulating quality standard control of TCM,researchers should not be conformist,and TLC identification should not be a necessary choice for the qualitative identification.And HPLC has the possibility to completely replace TLC,but TLC can be used as a supplement to HPLC.In order to fully lower testing cost,shorten testing cycle,improve the efficiency of identification,we suggested quality standard system of TCM should be sharply reduced TLC identification method and increased identification of HPLC characteristic spectrum;and try to do"one condition,one map".Unless absolutely necessary,national quality standards(such as Chinese Pharmacopoeia)should use TLC identification as a recommended method rather than a mandatory standard.

关 键 词：薄层色谱法 质量标准 高效液相色谱法 《中国药典》 特征图谱 

分 类 号：R22[医药卫生—中医基础理论] R28[医药卫生—中医学]