第十五章药品标准的制订.ppt

;第一节 概述 Part I Summary 第二节 药品质量标准的主要内容 Part Ⅱ Main Contents of quality standards of drugs 第三节 药品质量标准与起草说明示例 Part Ⅲ Examples of the laying down of quality standards of drugs and the drafting exptanation ;? 一 制订药品质量标准的目的和意义 The purpose and the meaning of the laying down of quality standards of drugs. 二 药品质量标准的分类及其制订 The Classification and the laying down of quality standards of drugs.;（一）法定的药品质量标准 Lawful quality standards of drugs 1.中国药典Chinese Pharmacopoeia. 2.部 2.部颁标准Issued drug standards by The People’s Republic of China Sanitation Ministry. 3.地方标准Local standards. （二）临床研究用质量标准 Standards of drugs used in clinical study. ;（三）暂行或试行药品标准 Drug standards of the temporary and the trying to carry out. （四） 企业标准 Enterprise standards. ; 三、 制订药品质量标准的原则 The principle of the laying down quality standards of drugs. （一）安全有效性 Safety and effectiveness （二）先进性 Advanced （三）针对性 ;四、研究及制订药品质量标准的基础 Bases of the studying and the laying down quality standards of drugs. （一）文献资料的查阅及整理 （二）对有关研究资料的了解 五、药品质量标准的制订工作的长期性 The long term characteristic of the laying down quality standards of drug ;第二节 药品质量标准的主要内容 Part Ⅱ Main Contents of quality standards of drugs 一 名称 Names. ; 二 性状 Characteristics. 外观与臭味 Appearances and fumes. 理化常数 Physical and Chemical constants. 溶解度 Solubility ; 熔点 Melting point ; 比旋度 Specific optical rotation ; 晶型 Crystal shape ; 吸收系数 Absorption coefficient ; 相对密度 Relative density ; 馏程 Distillation range ; 凝点 Solidifying point ; 折光率 , 其它 Others. ;三 鉴别 Identification （一）可选用的方法 Optional analysis methods 化学法 Chemical analysis methods. ??化常数测定法 Determinations of Physical and Chemical Constants. 仪器分析法Instrument analysis methods 生物检