Planta Med 2011; 77 - P_98
DOI: 10.1055/s-0031-1273627

Methods of Replacement of Standard References used for the Quality Control of Phytomedicines

F Wei 1, Z Min 2, YU Hui 3, XL Cheng 1, S Yan 1, XY Xiao 1, RC Lin 1
  • 1Research and Inspection Center of Traditional Chinese Medicine and Ethnomedicine, National Institute for Food and Drug Control, State Food and Drug Administration, 2 Tiantan Xili, 100050 Beijing, P. R. China
  • 2Shenzhen Institute for Drug Control, 28 Gaozhongxin Nanshan District, Shenzhen 518057, P. R. China
  • 3Beijing University of Chinese Medicine, 11 Beisanhuan Zhonglu, 100029 Beijing, P. R. China

Standardization of TCM products can be difficult, because every crude plant drug contains complex mixtures and because the constituents responsible for the claimed effects are often unknown. In the present scenario, many analysis-based studies, especially chromatographic technologies, regarding chemical and quality control researches on TCM have been conducted in the past 20 years in China, and the present trend demands increased emphasis on research of fingerprints of plant drugs, which can provide more useful information for consistency and quality evaluation of TCM products. Consistency in composition and biologic activity are essential requirements for the safe and effective use of TCM products. The use of chromatographic techniques and marker compounds to standardize TCM products can significantly promote batch-to-batch consistency. However, the serious shortage of marker compounds and standard chemical reference substances, has greatly interfered with the performance and implementation of quality control of phytomedicines. The aim of this paper is to take some typical research examples with methods of replacement of standard references used for determination of herbal medicines. Determination by replacement of standard references can be an economic, efficient, and practical method.