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药典是一个国家或地区为保证药品质量、确保人民用药安全有效而制定的技术法典。《中国药典》2010年版的颁布,代表着中国药品质量控制和标准规范水平又上到一个新的阶段。开启了我国药品标准化的新时代,笔者在了解发达国家药典的基础上简要对《中国药典》2010年版的体系理念进行了梳理,并把这些理念归纳后分层次概括成核心理念、专业体系理念、政策引导性理念和标准规范管理性理念。并在此基础上尝试从药典前言、凡例和附录编排上直观的表达
Pharmacopoeia is a technical code developed by a country or region to ensure the quality of medicines and ensure the safety and effectiveness of medicines used by the people. The promulgation of the 2010 edition of “Chinese Pharmacopoeia” represents a new stage in the quality control and standardization of pharmaceutical products in China. Opened a new era of pharmaceutical standardization in our country. On the basis of understanding Pharmacopoeia of developed countries, the author briefly reviewed the system concept of “2010 edition of Chinese Pharmacopoeia” and summed up these concepts into the core concept of core concept, the concept of professional system, Policy Guiding Concept and Standard Management Concept. And on this basis, try to express intuitively from the pharmacopoeial preface, examples and appendix arrangements