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1、2034E 药用物质第 1 页 共 10 页04/2013:2034EP 7.5SUBSTANCES FOR PHARMACEUTICAL USE药用物质DEFINITION 定义Substances for pharmaceutical use are any organic or inorganic substances that are used as active substances or excipients for the production of medicinal products for human or veterinary use. They may be obtai
2、ned from natural sources or produced by extraction from raw materials, fermentation or synthesis.药用物质是指人用或兽用医疗产品生产中所使用的活性物质或辅料，其可能是有机的或无机的物质。这些物质可能是从自然途径获取，或从原料中萃取、发酵或合成得到。This general monograph does not apply to herbal drugs, herbal drugs for homoeopathic preparations, herbal drug preparations, ext
3、racts, or mother tinctures for homoeopathic preparations, which are the subject of separate general monographs (Herbal drugs (1433), Herbal drugs for homoegopathic preparations (2045), Herbal drug preparations (1434), Extracts (0765), Mother tinctures for homoeopathic preparations (2029). It does no
4、t apply to raw materials for homoeopathic preparations, except where there is an individual monograph for the substance in the non-homoeopathic part of the Pharmacopoeia.本通论不适用于草药制品、顺势疗法制剂用草药、草药制剂、提取物、或顺势闻法制剂的药酒母体，这些品种应参照各自的各论（草药制品（1433）、顺势疗法制剂用草药（2045）、草药制剂（1434）、提取物（0765）、或顺势闻法制剂的药酒母体（2029）。也不适用于顺
5、势疗法制剂用的原料，除非在药典的非顺势疗法部分另有各论。Where a substance for pharmaceutical use not described in an individual monograph of the Pharmacopoeia is used in a medicinal product prepared for the special needs of individual patients, the need for compliance with the present general monograph is decided in the light
6、of a risk assessment that takes account of the available quality of the substance and its intended use.如果某种药用物质在药典里没有各论，这种物质用于满足个别病人的特殊需求的医疗产品制备，则应该考虑可以获得的该物质的质量及其用途，基于风险评估来决定该药用物质需符合的相关总论要求，且该物质应满足这些要求。Where medicinal products are manufactured using substances for pharmaceutical use of human or ani
7、mal origin, the requirements of chapter 5.1.7. Viral safety apply.如果药品生产中使用的药用物质是人类或动物来源，则需要满足 5.1.7 病毒安全性的要求Substances for pharmaceutical use may be used as such or as starting materials for subsequent formulation to prepare medicinal products. Depending on the formulation, 2034E 药用物质第 2 页 共 10 页ce
8、rtain substances may be used either as active substances or as excipients. Solid substances may be compacted, coated, granulated, powdered to a certain fineness, or process in other ways. A monograph is applicable to a substance processed with an excipient only where such processing is mentioned in
9、the definition section of the monograph.药用物质可能会直接使用，或用作药用产品生产的原料。根据剂型不同，特定的物质可能会用作活性物质，或用作辅料。固体物质可能会被压制、涂层、整粒、磨粉至特定细度，或经过其它形式的加工。只有当某加工在各论定义部分被提及时，该各论方适用于与辅料一起加工的物质。Substance for pharmaceutical use of special grade. Unless otherwise indicated or restricted in the individual monographs, a substance f
10、or pharmaceutical use is intended for human and veterinary use, and is of appropriate quality for the manufacture of all dosage forms in which it can be used. 特殊规格药用物质。除另有说明，或在各论中有限制外，药用物质适用于人兽通用，具备的品质可以用于使用该药用物质的所有制剂形式。Polymorphism. Individual monographs do not usually specify crystalline or amorph
11、ous forms, unless bioavailability is affected. All forms of a substance for pharmaceutical use comply with the requirements of the monograph, unless otherwise indicated.多晶型。除非对生物利用度会造成影响，各论中通常不说明晶形或非晶型形态。除非另有说明，物质的所有形态均符合各论的要求。PRODUCTION 生产Substances for pharmaceutical use are manufactured by proced
12、ures that are designed to ensure a consistent quality and comply with the requirements of the individual monograph or approved specification. 药用物质应根据程序进行生产，The manufacture of active substances must take place under conditions of good manufacturing practice. 活性物质的生产应在 GMP 条件下进行。The provisions of gene
13、ral chapter 5.10 apply to the control of impurities in substances for pharmaceutical use.总论 5.10 适用于药用物质中的杂质控制。Whether or not it is specifically stated in the individual monograph that the substance for pharmaceutical use:无论在各论中是否申明为药用，该药用物质 Is a recombinant protein or another substance obtained as
14、a direct gene product based on genetic modification, where applicable, the substance also complies with 2034E 药用物质第 3 页 共 10 页the requirements of general monograph Products of recombinant DNA technology (0784); 如果是重组蛋白质或另一物质为基于基因修饰的直接基因产品，适当时，该物质应符合通论 0784 重组 DNA 技术产品要求 Is obtained from animals susc
15、eptible to transmissible spongiform encephalopathies other than by experimental challenge, where applicable, the substance also complies with the requirements of the general monograph Products with risk of transmitting agents of animal spongiform encephalopathies (1483); 如果是动物来源物质，可能会有 TSE 风险，适用时，该物
16、质还应符合通论 1483 具有 TSE 风险的产品要求 Is a substance derived from a fermentation process, whether or not the micro-orgnisms involved are modified by traditional procedures or recombinant DNA (rDNA) technology, where applicable, the substance also complies with the requirements of the general monograph Products of fermentation (1468). 如果是经发酵工艺生产获得，无论是传统发酵还是采用 DNA 重组微生物发酵技术，适用时，该物质应符合通论 1468 发酵产品的要求。If solvents are used during production, they are of sui
