Chinese Medicine Regulatory Office

Analysis of Cornu Cervi Pantotrichum by DNA Method as a Complementary Approach


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

This research project aims at developing DNA-based testing methods for the identification of animal-derived CMM - Cornu Cervi Pantotrichum. This project is divided into two parts. In the first part, a screening method for differentiation of two genuine deer species of Cervi Cornu Pantotrichum, i.e. Cervus nippon Temminck and Cervus elaphus Linnaeus, from each other was developed and validated. By adopting specific-polymerase chain reaction (specific-PCR) technique, the procedure is relatively simple, suitable for rapid screening of decoction pieces of Cervi Cornu Pantotrichum.


Features

  • A validated screening method;*
  • Simple operation without DNA sequencing analysis;
  • Relatively low-cost test.


In the second part, DNA barcoding testing method for identification of animal-derived CMM and quality control system were developed and validated in accordance with the requirements of the Hong Kong Laboratory Accreditation Program. The generation of reference DNA barcode sequences of Cornu Cervi Pantotrichum, i.e. C. nippon and C. elaphus was completed in order to provide more comprehensive reference data for identification.


Features

  • A validated testing method;
  • According to the requirements of Hong Kong Laboratory Accreditation Program to conduct method validation;
  • Provide reference sequences of 3 DNA barcodes.

We hope that the developed DNA-based testing methods and quality control system can complement the current testing methods for identification of Cornu Cervi Pantotrichum, which help CM sectors to distinguish unscrupulous suppliers and avoid buying and selling of problematic products, protect their brand images and interests, and effectively solve the difficulties encountered by CM sectors in discriminating the authenticity of the products.


Testing methods
(English version only)


Reference DNA Sequence Library for Chinese Materia Medica


*The screening method intends to provide a rapid screening of decoction pieces of Cornu Cervi Pantotrichum. It is the user’s responsibility to assess the suitability for other sample types when adopting this method. When further confirmation of the identity of tested sample is required, other testing methods subject to the testing purpose, such as DNA barcoding for identification of animal-derived CMM, may be employed as a complement.