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食药监局:未发现云南白药严重不良反应报告--亲稳网络舆情监控室
2013-02-07

  2月5日,香港卫生署发布公报称,要求对云南白药散剂等5个品种予以回收。昨天(6日),国家食品药品监督管理局称,已经关注云南白药安全性问题,对云南白药的不良反应进行了监测,未发现严重的不良反应报告。

On February 5,Hong Kong department of health issued bulletin said,Required to yunnan baiyao powder five varieties to recovery.yesterday(6),State food and drug administration said,Yunnan baiyao safety has paid close attention,Yunnan baiyao adverse reactions to the monitoring,Not found serious adverse reactions report.

  香港卫生署称,此前化验发现,由内地制造在香港销售的五款云南白药产品含有未标示的乌头类生物碱。根据产品注册资料及中药文献,有关中成药的成分不应包含此类成分,因此发出指令,要求回收。据了解,乌头类生物碱可能带有毒性,如使用不当,将会引致口唇和四肢麻痹、恶心、呕吐及四肢无力等不适症状,严重者更会导致呼吸困难和心率失常并危及生命。

Hong Kong department of health said,After tests found,From the mainland in Hong Kong manufacturing sales of five new yunnan baiyao products contain not labeled aconitum alkaloids.According to the product registration information and literature of traditional Chinese medicine (TCM),The traditional Chinese medicine composition should not include such component,So send instruction,Demand recovery.It is understood,Aconitum alkaloids with may be toxic,If use undeserved,Will cause oral and limb paralysis/nausea/Vomiting and limbs weakness and discomfort symptoms,Some may even can lead to difficulty breathing and arrhythmia and endanger life.

  国家药监局昨日发布公告称,在此之前已注意到近期媒体对云南白药含乌头碱的关注,及时约谈了企业有关负责人。云南白药也在其官网贴出公告,就此事做出说明,称含有乌头碱类成分的药材在炮制前后毒性完全不同。通过炮制,乌头碱水解成乌头次碱并进一步水解成苯甲酰乌头原碱,可使毒性大大降低。

Country's drug watchdog said yesterday issued,Before this has noticed the recent media to yunnan baiyao containing aconitine attention,Timely interviewed the enterprise relevant person in charge.Yunnan baiyao in its website and post it,The matter to explain,Say containing aconitine class composition of the materials in the before and after processing toxicity completely different.Through the processing,Aconitine hydrolysis into aconitum time base and further hydrolysis into benzoyl aconitum original base,Can make the toxicity is greatly reduced.

  这种说法在国家药监局的公告中也有体现,药监局表示“如果企业严格按照国家食品药品监督管理局批准的配方工艺以及药品生产质量管理规范(GMP)的要求组织生产,其产品总体是安全的。”。

This statement in the country, the administration's announcement was also present in,'s drug watchdog said"If the enterprise in strict accordance with the state food and drug administration approved technics and the quality control standard for pharmaceutical production(GMP)Organize production requirements,The overall product is safe.".

  对云南白药的不良反应进行了监测,未发现严重的不良反应报告。为进一步保障公众用药安全,国家食品药品监督管理局提醒公众,要在医生的指导下,严格按说明书使用云南白药,不要超剂量使用,不要长时间使用。如出现严重不良反应,应及时就医,并报告当地食品药品监管部门。虽然目前在香港相关产品已经被责令收回。但迄今为止,云南白药并未提及是否会在大陆采取召回措施。(记者 孙莹)

Yunnan baiyao adverse reactions to the monitoring,Not found serious adverse reactions report.To further ensure the safety of medication,State food and drug administration to remind the public,In under the guidance of doctors,Strictly in accordance with the instructions to use yunnan baiyao,Don't use ultra dose,Don't use for a long time.If appear serious adverse reaction,Should be timely medical,And report to the local food and drug supervision department.Although at present related products have been in Hong Kong shall be ordered to withdraw.But so far,Yunnan baiyao did not mention in the mainland will take recall measures.(Reporter SunYing)


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