Chinese Medicine Regulatory Office

Study on the Identification of Sinopodophylli Radix et Rhizoma and its Confused Species by DNA Method

Sinopodophylli Radix et Rhizoma (Radix or Rhizoma Podophylli emodis) is the dried root and rhizome of Sinopodophyllum hexandrum (Royle) Ying. It is a toxic Chinese Materia Medica (CMM) specified in Schedule 1 of the Chinese Medicine Ordinance (Cap. 549). Owing to similar appearance, it has been confused with other CMMs, Clematidis Radix et Rhizoma (Clematis chinensis, C. hexapetala and C. manshurica) and Gentianae Radix et Rhizoma (Gentiana scabra and G. rigescens). Incidents of poisoning have been reported following the misconsumption of Sinopodophylli Radix et Rhizoma as its confused CMMs. Since Sinopodophylli Radix et Rhizoma contains podophyllotoxin and deoxypodophyllotoxin, inappropriate use or dosage may cause poisoning or even death.

This study aims to develop and validate a DNA-based method for differentiating Sinopodophylli Radix et Rhizoma from its confused CMMs. The developed method is based on polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) technology. By providing a cost-effective alternative to traditional methods, this approach serves to refine the identification of Sinopodophylli Radix et Rhizoma and enhance the quality control framework for Chinese medicines. Furthermore, this innovation facilitates robust regulatory enforcement and establishes a scalable model for developing identification assays for other toxic CMMs, thereby safeguarding public health.

Features

  • Highly species-specific analysis for Sinopodophylli Radix et Rhizoma;
  • A cost-effective approach without requiring DNA sequencing;
  • Simple, time-efficient procedure suitable for rapid screening of Sinopodophylli Radix et Rhizoma.

Testing Methods


*This project intends to provide a reliable method for identification of Sinopodophylli Radix et Rhizoma. When using this method, it is the user's responsibility to assess whether this method is applicable to their products.