Microsoft Word CHN EML _primary level_-Notes.doc

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1 国家基本药物目录 ( 基层医疗卫生机构配备使用部分 ) (2009 版 ) 说明 Explanatory notes for <national essential medicine list (for primary healthcare facilities)> (version 2009) 基本药物是适应基本医疗卫生需求, 剂型适宜, 价格合理, 能够保障供应, 公众可公平获得的药品国家基本药物目录是医疗机构配备使用药品的依据 Essential medicines are the drugs for meeting with the basic healthcare requirement with proper dosage form, rational price, and supply-guarantee and fair accessibility for public. National essential medicines list (EML) is the basis for healthcare facility drug allocation and use. 国家基本药物目录包括两部分 : 基层医疗卫生机构配备使用部分和其他医疗机构配备使用部分本目录为基层医疗卫生机构配备使用部分 ( 以下简称药物目录基层部分 ) National EML consists of two parts: primary healthcare facility EML and EML for other facilities. This EML was made for primary healthcare facilities (abbreviated as <EML. primary version>). 1

2 一目录的构成 1. EML composition 药物目录基层部分中的药品包括化学药品和生物制品中成药中药饮片 3 部分 <EML. Primary version> includes three medicinal catalogs, which are chemical and biological drugs, traditional Chinese formulated medicines & traditional Chinese cut crude herbs. 目录后附有索引化学药品和生物制品为中文笔画索引中文拼音索引和英文索引 ; 中成药为中文笔画索引中文拼音索引 Index is appended. Chemical and biological medicines are indexed with Chinese character stroke, Chinese spell and English in alphabetical. Chinese traditional formulated drugs are indexed with Chinese character stroke and Chinese spell. 二目录的编排 2.EML editing 除在备注一栏标有注释的药品外, 化学药品和生物制品中成药按药品品种编号, 不同剂型同一主要化学成分或处方的编一个号, 重复出现时标注 * 号 ; 药品编号的先后次序无特别的涵义 Excepting the drugs with notes in remark column, chemical, biological and traditional formulated Chinese drugs are ranked by drug class; all the dosage forms sharing with a major same chemical entity are assigned with the same catalog number, asterisk * indicates the 2

3 drug repetition. The drug catalog number does not have any special meaning. 三目录的分类 3. Drug classification 化学药品和生物制品主要依据临床药理学分类, 共 205 个品种 ; 中成药主要依据功能分类, 共 102 个品种 ; 中药饮片不列具体品种, 用文字表述 205 chemical and biological drugs were classified by clinical pharmacological properties in principle; 102 traditional formulated Chinese medicines were classified by their therapeutic function; all the traditional Chinese crude drugs did not listed specific species but with literal description. 四目录中品种的名称 4. Drug names in EML 除在备注一栏标有注释的药品外, 化学药品和生物制品名称采用中文通用名称和英文国际非专利药名称 (International Nonproprietary Names,INN) 中表达的化学成分的部分, 剂型单列主要化学成分部分与药物目录基层部分中的名称一致且剂型相同, 而不同酸根或不同盐基的化学药品, 均属于药物目录基层部分的药品 ; 中成药采用药品通用名称 Excepting the drugs with notes in remark column, the chemical and biological drugs adopted the Chinese generic names and chemical composition names in English described in International Nonproprietary Names (INN). Dosage forms were listed in another column. All the 3

4 medicines which posses the same major chemical composition and dosage form with the drugs listed in <EML.primary version> are deemed to the <EML.primary version>, even though their compounds appear with different acidic radical or basic form. Traditional Chinese formulated medicines listed in generic names. 五目录中品种的剂型 5. Dosage form in EML 化学药品和生物制品剂型在中华人民共和国药典 (2005 年版 ) 制剂通则规定的基础上进行归类处理, 未归类的剂型以药物目录基层部分标注的为准 The dosage forms of chemical and biological drugs were classified by the general principles for medicinal preparations described in <Pharmacopoeia of PRC >(version 2005), otherwise, the unspecified dosage forms refer to <EML. primary version>. 化学药品和生物制品中的口服常释剂型包括口服普通片剂肠溶片分散片, 硬胶囊肠溶胶囊软胶囊 ( 胶丸 ); 口服缓释剂型包括缓释片控释片, 缓释胶囊控释胶囊 ; 外用软膏剂型包括软膏剂乳膏剂 ; 注射剂包括注射液注射用无菌粉末注射用浓溶液剂型编排的先后次序无特别的涵义 The regular oral dosage forms for chemical and biological drugs include oral tablet, enteric-coated tablet, dispersible tablet, hard capsule, enteric- coated capsule and soft capsule (gel capsule); oral sustained-releasing forms include sustained-releasing tablet, 4

5 controlled-releasing tablet, sustained- releasing capsule and controlled-releasing capsule; topical ointment forms include ointment and cream; injecting forms include injection, sterilized powder for injection and concentrated solution for injection. The dosage form order does not have any special meaning. 中成药的剂型不单列, 以药品名称栏中标注的为准 In stead of specified column, the dosage form of traditional Chinese formulated medicines are indicated in the column of drug name, 六对备注栏中注释的说明 6. Explanation for the notes in remark column ( 一 ) 化学药品和生物制品 (1) Chemical & biological drugs 注释 1: 目录第 9 号头孢呋辛包括头孢呋辛酯 Note 1: cefuroxime in catalog 9 including cefuroxime axetil. 注释 2: 目录第 33 号抗艾滋病用药是指国家免费治疗艾滋病的药品 Note 2: Anti-HIV drugs in catalog 33 indicating the drugs containing in national AIDS free treatment program. 注释 3: 目录第 36 号青蒿素类药物是指卫生部办公厅印发的抗疟药使用原则和用药方案 ( 修订稿 ) 中所列的以青蒿素类药物为基础的复方制剂联合用药的药物和青蒿素类药物注射剂 Note 3: Artemisinins in catalog 36 indicating the compound preparations, drugs for combination therapy 5

6 and injections making from artemisinin, which were listed in <principle and regimens for anti-malarial (revised version)> issued by General Office of MOH. 注释 4: 目录第 146 号胰岛素是指动物源胰岛素, 包括短效中效长效及预混胰岛素 Note 4: Insulin in catalog 146 indicating animal-originating insulin, which including regular, intermediate-acting, prolonged-acting and premix insulin. 注释 5: 目录第 185 号抗蛇毒血清包括抗蝮蛇毒血清抗五步蛇毒血清抗银环蛇毒血清抗眼镜蛇毒血清 Note 5: snake antivenin in catalog 185 including agkistrodon halys antivenin, agkistrodon acutus antivenin, bungarus multicinctus antivenin and Naja antivenin. 注释 6: 目录第 186 号国家免疫规划用疫苗是指纳入国家免疫规划的疫苗 Note 6: Vaccines for National Immunization Program indicating the vaccines included in the National Immunization Program. 注释 7: 目录第 188 号硫酸钡包括 Ⅰ 型 Ⅱ 型 Note 7: Barium sulfate in catalog 188 including type Ⅰand type Ⅱ. 注释 8: 目录第 205 号避孕药是指纳入中华人民共和国人口和计划生育委员会印发的计划生育避孕药具政府采购目录中的避孕药 Note 8: Contraceptives in catalog 205 indicating drugs included in <Governmental Procurement List of Birth Control Drugs & Devices> issued by Population & Birth 6

7 Control Committee of PRC. ( 二 ) 中成药 (2)Traditional Chinese Formulated Medicines 注释 1 注释 2 注释 6: 目录第 12 号牛黄解毒丸 ( 胶囊软胶囊片 ) 第 13 号牛黄上清丸 ( 胶囊片 ) 第 100 号颈舒颗粒处方中的牛黄为人工牛黄 Note 1, Note 2 and Note 6: Bezoar containing in bezoar antidotal pills (capsule, soft capsule, tablet) in catalog 12, bezoar shangqing pills (capsule, tablet) in catalog 13 and Jingshu granule in catalog 100 meaning artificial bezoar. 注释 3: 目录第 29 号安宫牛黄丸处方中的麝香为人工麝香, 牛黄为天然牛黄体内培植牛黄或体外培育牛黄 Note 3: Musk containing in Angong bezoar pills meaning artificial musk and bezoar meaning natural, in vivo or in vitro cultural calculus bovis. 注释 4 注释 5: 目录第 50 号麝香保心丸第 75 号马应龙麝香痔疮膏处方中麝香为人工麝香, 牛黄为人工牛黄 Note 4,note 5: Both musk and bezoar containing in Musk Heart pills in catalog 50 and Mayinglong Musk Hemorrhoid Ointment in catalog 75 meaning artificial products. 七关于中药饮片 7. Traditional Chinese cut crude medicines 中药饮片的国家标准是指中华人民共和国药典卫生部部颁标准和国家食品药品监督管理局局颁标准收载 7

8 的药材及饮片标准中药饮片的基本药物管理暂按国务院有关部门关于中药饮片定价采购配送使用和基本医疗保险给付等政策规定执行 National standards of traditional Chinese cut crude medicines referring to the standards of medical material and cut crude drug described in <Pharmacopoeia of PRC>, issued by MOH or SFDA. The administration for essential cut crude TCM pricing, procurement, delivery, use and healthcare insurance reimbursement implements the regulations and rules issued by the State Council and its subsidiaries. 8

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Print HONG KONG PHARMACEUTICAL JOURNAL VOL 16 NO 1 (Supplement 1) Jan March 2009 ISSN 1727-2874 A Consolidated List of Poisons, Antibiotics and Dangerous Drugs Last update: February 2009 The Pharmaceutical Society