Since long ago, the quality question of the Chinese native medicine products continuously puzzle the Chinese native medicine to move towards the world. First, although passed through more than 40 years construction, our country Chinese native medicine production and the research although obtains made great strides, but overall standard still very low, this mainly displayed in the Chinese native medicine enterprise quantity many, the scale small, the benefit low, technical development and innovation ability weak, the production craft and the equipment were backward, and lacked the unification management standard. Next, because the quality of our country Chinese native medicine is unstable. Chinese native medicine lacks the quality standard and don't achieve the European and American related drugs are even the food basic request. These reasons have been seriously hindered the Chinese native medicine to enter the international market. The quality question of the Chinese native medicine receives more and more attention, this topic embarks from the Chinese native medicine internationalization goal, analyzes the quality question of the Chinese native medicine, the Chinese native medicine commodity exportation meets the technical barrier and the international domestic authentication market development situation. I seek the Chinese native medicine and the authentication union spot, finally obtains the establishment of Chinese native medicine quality authentication the necessity and the feasibility. According to drugs spot check situation which SFDA issued in each quarter, at present our country Chinese native medicine commodities has the more serious quality problem. The developed country establish technology barrier for our country Chinese native medicine, the quality question of the Chinese native medicine commodities seriously affects the Chinese native medicine exportation. The reason is because of the quality standard of our country Chinese native medicine research lag, the majority of quality standards of Chinese native medicines and the international plant medicine standard have the very big disparity. The Chinese native medicine lacks one of international competition strength. Therefore in the plant medicine international market competition, who first has the international authority's quality standard and the examination center, which can have the competition the initiative? Authentication is the union is standard and qualified evaluates the formula (qualified formula including sample, examination, examination formula, appraisal, confirmation and qualified guarantee formula, registration, approval authorizes and synthesizes formula and so on) the best method. The standard is the formulation qualified evaluates the formula the foundation, through qualified evaluates the formula examination product whether conforms to the standard, two unions constituted the authentication entire process. The authentication and the standard relations may use with the breath to share a common fate described. Therefore proposed unifies the authentication with the Chinese native medicine standard, through implementation authentication promotion Chinese native medicine standardization. This topic has carried on the Chinese native medicine quality authentication necessary analysis from the Chinese native medicine class commodity existence serious quality question and the authentication and the Chinese native medicine relational aspect, then from the national policy, authenticated the market nature, the scale as well as the customer demand, the international latent authentication competitor analysis aspect has discussed the establishment Chinese native medicine quality authentication feasibility, and finally proposed some established our country Chinese native medicine quality authentication the strategy. Key words: Chinese native medicine; Chinese native medicine commercial quality authentication: Chinese native medicine authentication quality standard

長期以來,中藥產品的質量問題一直困擾著中藥走向世界。这主要是由于我国 缺乏與國際接軌的質量標準和規範,達不到歐美有關的藥品甚至是食品的基本要 求,嚴重阻礙了中藥進入國際市場。 中藥的質量問題越來越受到關注,本課題從中藥國際化的目的出發,分析中藥 質量標準現狀和問題,提出建立中藥商業品質認證的必要性;再通過分析政策、技 術和市場需求方面的可行性,最終提出構建出中藥商業認證的模擬方案。 根據我國國家食品藥品監督管理局每季度發佈的各類藥品抽驗情況來看,目前 我國中藥類商品(中藥材、中藥飲片、中成藥)存在較嚴重的品質問題。發達國家 紛紛對我國的中藥設置技術壁壘,中藥類商品的品質問題嚴重影響到我國中藥的出 口。歸咎其根本原因是因為我國中藥品質標準研究滯後,大部分中藥的品質標準與 國際植物藥的標準有很大的差距,這是我國中藥缺乏國際競爭力的主要原因之一。 因此在植物藥國際市場競爭中,誰先擁有國際權威的質量標準和認證機構,誰就會 具有競爭的主動權。 因此提出把認證同中藥商業標準結合起來,通過實施認證促進中藥的標準化。 認證活動是結合標準和合格評定程式(合格程式包括取樣、檢驗、檢測程式、評估、 驗證和合格保證程式、註冊、認可批准及綜合程式等)的最佳手段。實施中藥商業 品質認證的關鍵和難點是建立中藥商業品質標準。本課題根據文獻資料分析以及從 實際出發,對如何建立、怎樣建立中藥商業品質標準以及如何推廣進行了分析,並 提出相應的策略。 最後通過模擬建立中藥商業質量認證方案,把中藥商業質量認證運用到中藥材 的實際認證中。 關鍵字:中藥、中藥商業質量認證、中藥商業質量標準