Characterization and Comparison Analysis of WHO Monographs on Selected Medicinal Plants and ISO Standards of Chinese Materia Medica / 中国结合医学杂志

Medicinal plants or Chinese materia medica (CMM) are now attracting worldwide attention as they have increasingly prominent advantages over chemical drugs in disease treatment and healthcare. Since the 1990s, World Health Organization (WHO) and International Organization for Standardization established the Technical Committee of Traditional Chinese Medicine (ISO/TC 249) have carried out the development of quality standards on medicinal plants or CMMs respectively, and a considerable number of monographs and international standards have been published. Since the two international organizations adhere to different principles, the standards they develop naturally have different emphasis. Driven by market demand and international trade, ISO mainly takes quality, efficacy and safety into consideration when developing standards, while WHO pays more attention to clinical practice, quality control and medication guidance. Up to now, there is a lack of comparative analysis on the records, background, principles, basic content, and main requirements of quality standards on medicinal plants or CMMs respectively published by WHO and ISO. Therefore, based on international standards of CMM developed by ISO/TC 249 platform and WHO Monographs on Selected Medicinal Plants, this paper systematically compares the purposes, selected principles, standard-developing process, basic content, and main quality requirements to summarize their similarities and differences, and find their merits, aiming to serve as a reference to the development of international standards for CMMs that helps them go global.

Feasibility research of setting ISO international standard of Sinomenii Caulis based on the literature / 国际中医中药杂志

To conduct research and stipulate international standards of Chinese herbal medicine under the guildance of International Organization for Standardization (ISO) has become a new hot spot of internationalization and standardization of traditional Chinese medicines. International organization for standardization/technical committee of traditional Chinese medicine (ISO/TC249) provides a international platform to develop the standards of Chinese herbal medicine. Sinomenii Caulis, as a traditional Chinese medicine with obvious clinical effect which is used internationally, it’s necessary to establish a unified quality and safety control standards at international level. The current literature showed that there are many aliases of Sinomenii Caulis, and the problem of its variety confusion and adulteration is serious. Sinomenine-based alkaloids were the main pharmacological active components of Sinomenii Caulis. By analyzing the pharmacopoeias of China, Japan, South Korea and Europe, it was found that both Chinese and European Pharmacopoeias take sinomenine as the quality control indicator of Sinomenii Caulis. The Japanese and South Korean pharmacopoeias had similar quality control requirements of Sinomenii Caulis, and the South Korean pharmacopoeia pays more attention on safety requirements. Thus, it is suggested that setting ISO standards of Sinomenii Caulis requires the collection of global trade data and samples of Sinomenii Caulis for future quality and safety research.