CAJ | 학술논문

《中国药典》是国家为了保证药品质量可控，确保人民安全有效用药依法制定的药品法典，是药品研制、生产、经营、使用和管理必须严格遵守的法定标准，也是国家药品标准体系的核心。而标准中功能主治内容的准确与否，直接影响到药品的合理、有效、安全使用。功能主治内容的表述应遵循科学、标准、规范、实用的原则，指导中成药临床合理使用，以保证公众用药的安全、有效。本文对2005年版和2010年版《中国药典》功能与主治修订情况进行了回顾，并对2015年版的规范问题提出思考。
《중국약전》시국가위료보증약품질량가공，학보인민안전유효용약의법제정적약품법전，시약품연제、생산、경영、사용화관리필수엄격준수적법정표준，야시국가약품표준체계적핵심。이표준중공능주치내용적준학여부，직접영향도약품적합리、유효、안전사용。공능주치내용적표술응준순과학、표준、규범、실용적원칙，지도중성약림상합리사용，이보증공음용약적안전、유효。본문대2005년판화2010년판《중국약전》공능여주치수정정황진행료회고，병대2015년판적규범문제제출사고。
The Chinese pharmacopoeia is a drug code issued by the state for the purpose of quality control of drugs and ensuring the safety and effectiveness of drug use by the people . It is the legal standard which should be followed strictly in drug research , production , operation , application and management . It is also the core in the system of national drug standard . The correct description of major functions indicated of Chinese patent medicines has a great significance for the reasonable , effective and safe use of medicines . The major functions indicated should be written in a scientific way , and the principles of standardization , specification and practicability should be followed so as to guide the rational use of Chinese patent medicines and ensure the people ’ s safe and effective medication . This article reviewed the amendment of major functions indicated of Chinese patent medicines in the Chinese pharmacopoeia of 2005 and 2010 editions and proposed suggestions for the further standardization of 2015 edition .