Chinese Medicine Regulatory Office

Analysis of Chemical Markers of Chinese Materia Medica in Baifeng Wan

Baifeng Wan is a well-known and popular proprietary Chinese medicine (pCm). In Hong Kong market, most of the Baifeng Wan products are modified from Pharmacopeia formulations with varying compositions. As the compositions of these products are complicated, analysis of the chemical markers is susceptible to interference from matrix or other chemical components. The purpose of this research project is to develop and validate analytical methods for determination of chemical markers of Chinese Materia Medica (CMM) commonly found in Baifeng Wan. GCMTI has employed different analytical techniques, such as high performance liquid chromatography-diode array detection (HPLC-DAD) and high performance liquid Chromatography tandem mass spectrometry (LC-MS/MS), to establish qualitative and/or quantitative methods for determination of the chemical markers in CMM of Baifeng Wan, including Ginseng Radix Et Rhizoma, Cyperi Rhizoma, Paeoniae Radix Alba, Astragali Radix, Salviae Miltiorrhizae Radix Et Rhizoma and Glycyrrhizae Radix Et Rhizoma etc. The methods are validated according to the quality requirements of the Hong Kong Laboratory Accreditation Scheme.


Features

  • Methods are validated to ensure method accuracy and stability;
  • Simple methods;
  • Advanced and traditional instrumentation are adopted for the analysis.

This project has set out validated testing methods for the Chinese medicine (CM) industry and testing sectors as reference. The CM traders could adopt the testing methods as quality control methods. In addition, by testing chemical markers of more characteristic CMMs, the CM industry could establish distinctive quality standards and strengthen the quality control for the pCm products, so as to establish the brand image of Hong Kong in Chinese medicine.

Testing Methods



*This project intends to provide reliable analytical methods that could be used as quality control methods for determining the targeted chemical marker(s) in the Baifeng Wan products. When using these methods, it is the user's responsibility to assess whether these test methods are applicable to their products.