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药监局:天然药物一般不应以野生动植物为原材料--亲稳舆论引导监测室
2013-02-06

  中新网2月5日电 据国家食品药品监督管理局网站消息,国家食品药品监督管理局近日印发《天然药物新药研究技术要求》。《技术要求》明确,为保障资源的可持续利用及保护生态环境,天然药物一般不应以野生动植物为原材料

February 5, according to the state food and drug administration website news,State food and drug administration issued recently[Natural medicine new drug research technical requirements].[Technical requirements]clear,To ensure the sustainable utilization of Marine resources and protect the ecological environment,Natural drugs generally should not be to wild animals and plants as raw material.

  《技术要求》提出,天然药物的研制应当符合现代医药理论,注重试验研究证据,体现临床应用价值,保证药物的安全有效和质量稳定均一。

[Technical requirements]Put forward,The development of natural medicine shall conform to the modern medical theory,Pay attention to test research evidence,Reflect clinical application value,Ensure that drug is safe and effective and stable quality uniform.

  《技术要求》提出,为保障资源的可持续利用及保护生态环境,天然药物一般不应以野生动植物为原材料,若确需使用非重点保护野生动植物为原材料的,应提供相关研究资料证明相应品种的生产不会对资源及生态环境产生不利影响,如可使用不影响其生长、繁殖的药用部位为原材料等。

[Technical requirements]Put forward,To ensure the sustainable utilization of Marine resources and protect the ecological environment,Natural drugs generally should not be to wild animals and plants as raw material,If you really need to use the protection of wild animals and plants as raw material,Shall provide related research data demonstrate the corresponding varieties of production resources and ecological environment will not produce adverse effect,If can use do not affect its growth/The breeding of medicinal parts as raw material, etc.

  《技术要求》规定,为保证上市后天然药物质量的稳定均一,应对天然药物的生产进行全过程质量控制。应研究明确天然药物所含活性成份,并建立全面反映天然药物质量的标准。

[Technical requirements]provisions,In order to ensure the quality of natural medicine listed after the uniform stability,Deal with natural drug production process quality control.Research should be clear natural drugs contain active ingredients,And set up the comprehensive reflect natural drug quality standard.


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