Chinese Medicine Regulatory Office

Reference DNA Sequence Library for Chinese Materia Medica (CMMRSL)


Traditionally, macroscopic and microscopic methods have been used as routine approaches for the identification Chinese Materia Medica (CMM). In the presence of morphological and tissue characteristics of CMM, they can be examined and identified unequivocally. In recent years, there has been a growing interest in the development of DNA-based methods as a complementary approach for species identification, especially for discrimination of closely related species. DNA-based testing methods and technical guidance have been published by international authorities such as Pharmacopoeia of the People’s Republic of China, U.S. Pharmacopeia and British Pharmacopoeia.

This research project aims at developing DNA barcode test method and establishing Reference DNA Sequence Library for Chinese Materia Medica (CMMRSL). Through the use of DNA technologies, we may enhance the genetic traceability between Chinese medicines and their plant / animal species origin for the sake of ensuring efficacy and safety of clinical application of Chinese medicines being used originated from proper medicinal plant/ animal. The method was validated in accordance with relevant HOKLAS requirements as well as developed a quality control plan for testing. The continuous development of CMMRSL currently curated reference DNA sequences of Panax ginseng C. A. Mey, Panax quinquefolium L., Panax notoginseng (Burk.) F. H. Chen, Cervus nippon Temminck and Cervus elaphus Linnaeus.


Features

  • Recognition: the selected barcodes are adopted in national Pharmacopeias or widely accepted by the scientific communities for the purpose of species identification;
  • Selection: CMMRSL furnishes up to three DNA barcodes for each specimen to strengthen discrimination capability and flexibility;
  • Genetic traceability and reliability: CMMRSL highly relies on specimen collections (included voucher specimens and authentic CMM) of known provenience with good collection records. Each specimen and the corresponding medicinal material have been authenticated by experts and well documented, which enhances the genetic traceability between CMM and original species. To ensure the quality and validity of reference DNA sequences, two independent measurements for each reference material would be conducted;
  • Transferability: conduct method validation in accordance with HOKLAS requirements.


Our research outcomes is open to the public, especially to the CM and testing industries, not only to elevate local testing standards to provide versatile testing services for more economic opportunities but also promote the development of Chinese medicine testing and certification.


Testing methods
(English version only)

Reference DNA Sequence Library for Chinese Materia Medica