Chinese Medicine Regulatory Office

Analysis of Chemical Markers in Proprietary Chinese Medicines Containing Psoraleae and Ginseng

Purpose

In Hong Kong, there are a variety of proprietary Chinese medicines (pCm) containing psoraleae (補骨脂) and ginseng (人參) for nourishing and Yang invigorating. They are available in different prescriptions, such as fur sea pill (海狗丸), pilose antler pill (鹿茸丸) and deer’s tail pill (鹿尾羓丸). They are commonly found in dosage forms like water-honey pill, honey pill, capsule etc. Nevertheless, the analysis of the chemical markers in psoraleae and ginseng, namely psoralen, isopsoralen and ginsenosides, in these pCm presents a great challenge due to susceptibility to interference from the matrix and other chemical components.

This project aims to develop and validate testing methods for qualitative and quantitative analysis of chemical markers in psoraleae and ginseng in pCm for nourishing and Yang invigorating. Different analytical techniques, including high performance liquid chromatography-diode array detection (HPLC-DAD) and high performance liquid chromatography tandem mass spectrometry (LC-MS/MS) would be employed for the analysis. With psoralen and ginseng as the core components, different pCm on the market would be analysed to ensure the applicability and effectiveness of the testing methods.


Features

  • Validated in accordance with the quality control requirements of the Hong Kong Laboratory Accreditation Scheme to ensure the method accuracy and reliability;
  • Applicable to various types of pCm with high specificity for the analysis of chemical markers in psoraleae and ginseng;
  • Adopted advanced and traditional instrumentations to achieve comprehensive and robust analysis.

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 proprietary Chinese medicines containing psoraleae and ginseng. When using these methods, it is the user's responsibility to assess whether these test methods are applicable to their products.