美国植物药开发与审评.pdf

从从首首个个植植物物药药NNDDAA批批准准探探讨讨 美美国国植植物物药药开开发发与与审审评评 1 报报告告内内容容 11 植物药背景介绍 22 FDA植物药产品行业指南 33 FDA批准的首个植物药 44 美国植物药 发现状 2 包含来自植物成分的产品A product that contains as ingredients vegetable materials, which may include plant materials, algae, macroscopic fungi, or combinations thereof, that is used as a drug. It may be available as (but not limited to) a solution (tea, e.g.), powder, tablet, capsule, elixir, topical or injectable. 什什么么是是植植物物药药？？ Excluded fermentation products, highly purified [or chemically modified] botanical substances, genetically modified plants, allergenic extracts and vaccines which contain botanical ingredients 3 植植物物药药&&膳膳食食补补充充剂剂 药药品品 ➢ 缓解、治疗、治愈、诊断或预防疾病或其相关症 状 （疾病声明） 膳膳食食补补充充剂剂 ➢ 保持 康 （结构或功能声明） 植植物物药药 vvss..膳膳食食补补充充剂剂 ➢ 以用途及标签区分 Source：FDA Food,DrugandCosmeticsAct 4 5 6 “One species” – “One compound” – “One drug” (i.e., highly purified) Mixtures were looked at, ut eventually a andoned A purified active compound may ecome a drug 从从植植物物开开发发新新药药的的方方法法 Semi-synthetic derivatives may also ecome drugs “One/multiple species” – “Multiple compounds” – “One otanical drug” Example: VeregenTM (kunecatechins/sinecatechins) • 一个或多个种属