药剂学 药典.ppt

Pharmacopoeia（药典） Brief introduction （简介） pharmacopoeia is a national record Drug Codex standards, specifications, usually presided over by the State Drug Administration compilation, promulgation and implementation of international pharmacopoeia by recognized international organizations or the relevant national consultations compiled. Pharmaceutical standards for medicines developed to strengthen quality supervision and management, quality assurance, guarantee safe and effective medication, maintaining peoples health plays a very important role. （药典是一个国家记载药品标准、规格的法典，一般由国家药品监督管理局主持编纂、颁布实施，国际性药典则由公认的国际组织或有关国家协商编订。制定药品标准对加强药品质量的监督管理、保证质量、保障用药安全有效、维护人民健康起着十分重要的作用。） Pharmaceutical standards is an important part of modern pharmaceutical production and quality management,and it is the legal basis for drug production, supply, use and supervision departments to follow. Connotation of quality of medicines includes three aspects: authenticity, purity, quality degrees. Concentrated expression of the three is the use of the effectiveness and safety. Therefore, drug standards generally include the following: legal name, source, character, identity, purity checks, content (potency or activity) measured category, dosage, specifications, storage, preparation and so on. （药品标准是药品现代化生产和质量管理的重要组成部分，是药品生产、供应、使用和监督管理部门共同遵循的法定依据。药品质量的内涵包括三方面：真伪、纯度、品质优良度。三者的集中表现是使用中的有效性和安全性。因此，药品标准一般包括以下内容：法定名称、来源、性状、鉴别、纯度检查、含量（效价或活性）测定、类别、剂量、规格、贮藏、制剂等等。） The development of Pharmacopoeia(药典的发展) Pharmacopoeia important feature is its legal nature and style of standardization. China s first pharmaceutical books, more accepted in the Tang Chunfeng 659 AD , Su Jing and other 22 people ordered the compilation of the New Revised Materia Medica . The book is 54 volumes, collection contains 844 kinds of medicines , called the worlds first a legal pharmacopoeia . 15th century advances in promoting the development of the printing press in Modern European Pharmacopoeia codification. Many countries have drawn u