National Institute of Health Sciences, 25-26 Tonomachi 3-chome, Kawasaki-ku, Kawasaki, 210-9501, Japan.
J Nat Med. 2022 Sep;76(4):732-747. doi: 10.1007/s11418-022-01639-w. Epub 2022 Jul 23.
Foods and pharmaceuticals play key roles in public health and welfare and ensuring that these products meet their quality assurance standards is a top priority in health and medical care. Quality assurance of natural products is essential in pharmaceutical sciences because the outset of a medicine is a natural, crude drug. Regulatory science underpins scientific regulations and is closely related to the quality assurance of foods and pharmaceuticals to ensure their safety and efficacy. During my time at the National Institute of Health Sciences, Japan, from 1986 to present, the regulatory science of natural products has been my main research focus. This review discusses 24 studies related to the regulatory science of natural food additives, 26 related to foods, 23 related to borderline products, 16 related to illicit psychotropic mushrooms, plants, and agents, and 57 related to herbal medicines. In later sections, the regulatory science for ethical Kampo products with new dosage forms and herbal medicines that use Kampo extracts as active pharmaceutical ingredients are discussed. My experience from the early twenty-first century in research projects on the bioequivalence of Kampo products and the development of ephedrine alkaloid-free Ephedra Herb extract demonstrate that regulatory science is crucial for developing new drugs.
食品和药品在公共卫生和福利中起着关键作用，确保这些产品符合质量保证标准是医疗保健的首要任务。天然产品的质量保证在制药科学中至关重要，因为药物的起点是天然的、粗制药物。监管科学是科学法规的基础，与食品和药品的质量保证密切相关，以确保它们的安全性和有效性。在我 1986 年至今在日本国立保健医疗科学院的任职期间，天然产品的监管科学一直是我的主要研究重点。这篇综述讨论了 24 项与天然食品添加剂监管科学相关的研究、26 项与食品相关的研究、23 项与边缘产品相关的研究、16 项与非法精神蘑菇、植物和制剂相关的研究以及 57 项与草药相关的研究。在后面的部分中，讨论了具有新剂型的伦理坎波产品和使用坎波提取物作为活性药物成分的草药的监管科学。我在 21 世纪初参与的关于坎波产品生物等效性的研究项目和无麻黄碱麻黄草药提取物的开发经验表明，监管科学对于开发新药至关重要。
