[S15] Development and challenges of a novel crude drug extract product to prevent aggravation of infection in COVID-19 patients in the early stages

Sat. Mar 26, 2022 4:00 PM - 6:00 PM [Room D] Conference Room 141+142 (Bldg. 1: 4F)

Organizer: Sumiko Hyuga (Oriental Med. Res. Ctr., Kitasato Univ.), Yukihiro Goda (NIHS)

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 136^th 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.

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座長挨拶：合田幸広（国立衛研） (4:00 PM - 4:05 PM)

4:05 PM - 4:25 PM

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

○Sumiko Hyuga¹ (1. Oriental Med. Res. Ctr., Kitasato Univ.)

4:25 PM - 4:40 PM

[S15-2] Antiviral effect of EFE (Ephedrine alkaloids-free Ephedra Herb extract)

○Masashi Uema¹ (1. NIHS)

4:40 PM - 4:55 PM

[S15-3] Pre-clinical studies on pharmacodynamics of EFE on COVID-19 antiviral drug

○Masashi Hyuga¹ (1. NIHS)

4:55 PM - 5:15 PM

[S15-4] Challenge for development of new natural medicinal products

○Yukihiro Goda¹ (1. NIHS)

5:15 PM - 5:25 PM

[S15-5] Quality control of EFE

○Nahoko Uchiyama¹ (1. NIHS)

5:25 PM - 5:45 PM

[S15-6] Interim report of exploratory physician-led clinical trial to investigate the efficacy and safety of EFE in early-stage COVID-19 patients

○Hiroshi Odaguchi¹ (1. Oriental Med. Res. Ctr., Kitasato Univ.)

ラウンドテーブルディスカッション (5:45 PM - 6:00 PM)

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