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Background of the development of ephedrine alkaloids-free Ephedra Herb extract (EFE)

Kampo medicines containing Ephedra Herb, such as maoto, kakkonto, and makyokansekito, are used to treat patients at the early stage of virus infection. However, use of Ephedra Herb requires caution in patients with cardiovascular disease, hypertension, or nephropathy, and in elderly patients, because ephedrine alkaloids in the herb induce adverse effects, including hypertension, palpitations, insomnia, and dysuria. To reduce the adverse effects of Ephedra Herb, we utilized cation-exchange column chromatography to eliminate ephedrine alkaloids from Ephedra Herb extract, resulting in an ephedrine alkaloids-free Ephedra Herb extract (EFE). Furthermore, we first presented our findings, "Our approaches to the new drug application of ephedrine alkaloids-free Ephedra Herb extract (EFE): Toward a breakthrough in natural medicines in Japan," at the 136th Annual Meeting of the Pharmaceutical Society of Japan (Yokohama) from March 26 to 29, 2016. Subsequently, we have found that EFE suppresses the pathways of SARS-CoV-2 entry into host cells, and we believe that EFE may be useful for patients in the early stages of infection. Therefore, we have initiated doctor-led clinical trials to confirm the safety and effectiveness of EFE in COVID-19 patients. At this symposium, we will further discuss the progress and challenges in applying for approval of novel herbal medicines based on the development process of EFE preparation.

Development and challenges of a novel crude drug extract product to prevent aggravation of infection in COVID-19 patients in the early stages

The 142nd Annual Meeting of the Pharmaceutical Society of Japan (Nagoya)

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[S15-1]Background of the development of ephedrine alkaloids-free Ephedra Herb extract (EFE)

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