Standards Development

Scope

This document specifies the quality and safety requirements and test methods of Corydalis yanhusuo tuber [the dried tuber of Corydalis yanhusuo W. T. Wang], including raw and processed Corydalis yanhusuo tuber.

This document is applicable to raw and processed Corydalis yanhusuo tuber that are sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal material) and decoction pieces derived from this tuber.

Purpose

Through in-depth research in this project, we systematically reviewed and integrated existing quality standards for Corydalis yanhusuo tuber, established a complete and effective analysis method, and conducted scientific testing on samples from different origins and processed using different methods to comprehensively evaluate the overall quality of C. yanhusuo tuber. Based on this, we will standardize, unify, and enhance the quality control measures for the effectiveness and safety of C. yanhusuo tuber, and develop a scientific, objective, and reasonable international standard for C. yanhusuo tuber. Specific indicators include quality requirements, sampling methods, testing methods, testing reports, packaging, storage, transportation, marking, and labeling, etc. By establishing ISO standard for C. yanhusuo tuber, we aim to enhance its intrinsic quality related to safety and effectiveness, promote market order, and boost international trade.

C. yanhusuo tuber is the dried rhizome of C. yanhusuo W.T.Wang (Fam. Papaveraceae) with the effects of promoting blood circulation and relieving pain. It is widely used in China and around the world, and is served as an important ingredient in various traditional Chinese medicine formulations. There are nearly 100 prescriptions which include C. yanhusuo tuber in the Chinese Pharmacopoeia, such as the tables, capsules, dripping pills of the Yuanhu Zhitong series. And the dripping pills of the Yuanhu Zhitong obtained registration in Singapore successfully in 2019. As a bulk and commonly used medicinal herb, C. yanhusuo tuber has a significant demand in the international market. According to the data of China customs statistics, C. yanhusuo tuber has been exported to more than 30 major countries and regions, including the United States of America, France, Malaysia, Korea, Spain, Japan, India, Holland, Brazil, and Russian Federation, etc. From 2018 to 2022, the total export volume of C. yanhusuo tuber from China reached 4,688 tons with 42.61 million dollars. In the updated version of ISO/TR 23975 “Traditional Chinese medicine -Priority list of single herbal medicines for developing standards” of ISO/TC249, C. yanhusuo tuber ranks 33rd, indicating a high priority for the development of standards.

C. yanhusuo tuber is recorded in Chinese Pharmacopoeia (ChP), Hong Kong Chinese Materia Medical Standards (HKCMMS), Japanese Pharmacopoeia (JP), Korea Pharmacopoeia (KP), European Pharmacopoeia (EP) and British Pharmacopoeia (BP), etc. Although the standards can evaluate the C. yanhusuo tuber, the difference still exists among them, such as the different standards, and the different compositions determined with its different limitations. For example, the origin of C. yanhusuo tuber is the same in the ChP, JP, EP and BP as the tuber of the C. yanhusuo W.T.Wang, but the KP also records another origin which from the same family and genus C. ternate Nakai. The extractive is required in ChP and HKCMMS, while it is not required in the JP, KP, EP and BP. And there are different components and its limitation among these pharmacopoeia or standards in the analysis. Therefore, it is of great practical significance to improve and coordinate the standards based on the pharmacopoeias of different countries and to develop international standards that meet market demands in order to promote international trade in C. yanhusuo tuber.