中華藥典的過去、今日與未來展望

Revolution: The Past, Present and Future of the Chinese Pharmacopeia

林美智(Mei-Chih Lin) ； 陳惠玲(Hui-Ling Chen) ； 陳惠芳(Hwei-Fang Cheng)

《臺灣臨床藥學雜誌》 24卷4期 (2016/12) Pp. 290-299

https://doi.org/10.6168/FJCP.2016.2404.04

摘要

各國均有出版該國家之藥典以供藥品開發、藥政管理及藥品檢驗之依據，我國藥事法1 及藥師法2 將中華藥典納為藥品製造品質管理規範之一，且藥品查驗登記審查準則3 明訂藥品與原料藥之檢驗規格以中華藥典、十大醫藥先進國家出版之藥典或其他經中央衛生主管機關採用之藥典為主，可知藥品之上市與藥典息息相關。回顧中華藥典近85 年之歷史，有前輩之努力，然醫藥科技之日新月異，全球藥典也順應趨勢，不斷更新內容，比對中華藥典與國外藥典差距甚多，藥品個論不足，遇有重大事件恐面臨無裁量依據之窘境。藥典各試驗方法也應順應科技之進步，不斷地更新與修正。中華藥典編修工程巨大繁複，應思精進策略，使藥典內容更實質化，並與國際接軌，以符合現代產業及政府管理單位之需求。

關鍵字

中華藥典 ； 藥典 ； 個論 ； 檢驗規格

並列摘要

The Pharmacopoeia of a country is served as official reference for drug development, pharmaceutical product analyses, and regulatory management of drugs. The Chinese Pharmacopeia has been referred in the Pharmaceutical Affairs Act and Pharmacists Act as an official document for references on the manufacture and quality control of the pharmaceutical products. The Regulations for Registration of Medicinal Products officially requires the specifications of products, certificates of analysis for pharmaceutical products and active pharmaceutical ingredients (APIs), respectively, be compliant with the Chinese Pharmacopeia, Pharmacopeias issued by the top ten developed countries, or Pharmacopeias adopted by Ministry of Health and Welfare. Therefore, Pharmacopeia is essential to the development and marketing of drugs. The Chinese Pharmacopeia has been in uses for 85 years since its inaugural edition and updated in interval years. Nonetheless, there are still disparities in the analytical methods/specifications and increasing number of the monographs, compared to the national Pharmacopeias. To keep up with the fast and constant advancements of pharmaceutical technologies innovated and development of new drugs discovered by the pharmaceutical industry, more in-depth and rapid updates are critically in demand especially on the monographs to which novel technologies and thus the product specifications are associated with. Being edited annually or whenever necessary in order to bridge for the international harmonization, the Chinese Pharmacopeia shall then meet the needs of the pharmaceutical industry and regain its discretionary status for the uses of the regulatory authorities.

並列關鍵字

Chinese Pharmacopeia ； Pharmacopeia ； Monograph ； Specification of Product