Abstracts The importance and the present status of TCM chemical standard in China were briefly reviewed. Standard is an essential factor in the quality control of Traditional Chinese Medicine (TCM). The research and application of standard gives an important meaning to the promotion of Chinese herbal medicine quality control, the assurance of the drugs quality, and the safety and efficacy of public drug use. the current supply of TCM chemical standard is extremely limited in China. Chemical standard that is provided by National Institution of the Control of Pharmaceutical and Biological Products (NICPBP) is no more than 400 types, and the quality of the standards await to be raised. This seriously hinders the development of the quality control technique of TCM. In order to improve the quality and quantity of TCM chemical standards, industrialization of TCM chemical standards is necessary. In addition, the strategies for development of industrialization on Chinese medicine chemical standards are proposed based the perspectives of macroeconomics and microeconomics: To strengthen the research on TCM chemical standards and establishment of chemical standards database; To establish a foundation to manage funding for supporting research on preparation and commercialization of chemical standards; To pay attention to technical personnel, technological innovation, techno-economics; To establish patents share union on chemical standards, and to study how to protect intelligent property right during the R&D of TCM standard in the international cooperation. The new strategies are a) the market-oriented supply and demand system of chemical reference compounds for Chinese medicine is trend, and it should be improved using various methods. b) To consider either Hong Kong or Macau as the leading city on the industrialization of TCM chemical standards. [Keywords] TCM chemical standard, industrialization, strategy

中文摘要 安全和有效是評價藥物的關鍵,中藥化學對照品的匮乏制約了中藥品質控制 技術的發展,成為阻礙中藥發展的瓶頸。本文首先介紹了國內外化學對照品行業 的情況,簡述中國生物製品檢驗所的中藥標準品的供應情況,並初步統計了我國 商業中藥化學對照品供應機構和企業的供應情況,總結了國內外化學對照品供應 模式的優缺點。接著本文就中藥化學對照品在中藥研究中的重要作用,及化學對 照品數量,質量緊缺的現實概況,提出中藥化學對照品產業化概念,指出產業化 的必要性。並且就化學對照品產業化可行性建立一個多因素分析方法,並對化學 對照品市場需要、研發生產、推廣流通、存在風險,法律基礎等五個方面進行分 析。其中就研發生產部分,提出了中藥化學對照產業化研發的難點所在,並就技 術上從原料選著、提取分離、純化等進行了分析。法律方面,歸納出我國中藥對 照品產業應參考的法律條目。 本文在策略中,較為詳細的提出加強對中藥化學對照品的開發研究形成化學 對照品資料庫,促進加大技術設備投資和技術創新,形成中藥對照品研發技術的 專項基金會,形成以知識產權為基礎的中藥化學對照品行業聯盟。並提出創新策 略兩個:1)商用化學對照品(商業標準的載體)產業化需引入市場機制。該策略 提倡並論證了中藥標準因該商業化,實現中藥商業標準,而標準的載體-商用中 藥化學對照品更需要以顧客價值理論為指導的市場化模式:2) 選擇澳門成立中 藥化學對照品供應中心。該策略分析港澳地區的優勢,並比較了澳門成立的優 勢,提出供應中心五大組建原則:分階段,分產品,分地點,實驗室,網路五大 原則。並應用多因素分析方法,對莪術及薑黃進行了產品優化。並嚴格制定了實 驗室管理規範。 關鍵字: 中藥化學對照品 產業化 策略