EP 2034 药用质(中英文).doc

04/2013:2034 EP 7.5 SUBSTANCES 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 obtained 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, extracts, 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 not 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 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 animal 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 fo