12家药企涉案被查 12 home medicine enterprises involved was found

　　亳州药企“涉染”始末 The traditional Chinese medicine enterprises"In dyeing"occupied

　　《中国经济周刊》记者 赵磊 实习生 徐娅｜安徽报道

[China economic weekly]Reporter ZhaoLei interns XuYa | anhui reports

　　“12家涉案企业的相关涉嫌违法行为还在调查之中，这些企业目前还在停产。”10月16日，安徽省食品药品监督管理局(下称“安徽药监局”)副局长宣庆生回应《中国经济周刊》的采访。

"12 home involving enterprise related suspected illegal behavior is under investigation,These enterprises are in production."On October 16,,In anhui province, the food and drug administration(said"Anhui's drug watchdog")Deputy director XuanQingSheng response[China economic weekly]interview.

　　9月8日，国家食品药品监督管理局(下称“国家药监局”)发布公告称，近期安徽药监局查获一批违法染色增重的中药饮片生产企业，责令严重违规的8家中药饮片生产企业停产整顿，收回6家企业的GMP(药品生产质量管理规范)证书，对12家企业进行立案调查。亳州市经过GMP认证的中药饮片生产公司达到58家，所有涉案企业占亳州中药饮片生产企业的20%以上。

On September 8,,State food and drug administration(said"The administration's national")Releases announcement to say to,Recently, the administration's anhui seized a number of illegal dyeing weight gain of Chinese medicine yinpian production enterprise,Shall be ordered to make serious illegal 8 Chinese medicine yinpian production enterprise production rectification,Take six enterprise GMP(The quality control standard for pharmaceutical production)certificate,On 12 enterprises to initiate an investigation.Bozhou city after GMP certification of Chinese medicine yinpian production companies achieve 58 home,All involved in enterprise of bozhou Chinese medicine yinpian production enterprise of more than 20%.

　

　上游难监管 Upstream difficult supervision

　　“9月8日被曝光的12家企业，他们的不合格产品均出现在源头上。”曝光后第12天，宣庆生接受《中国经济周刊》采访时强调。

"September 8, 12 enterprises by exposure,Their unqualified products appear in the source."Day 12 after exposure,XuanQingSheng accept[China economic weekly]Interview stressed.

　　此次涉案的“染色”主要指金胺O染色，金胺O又名碱性嫩黄，属于接触性致癌物，对皮肤黏膜有轻度刺激，可引起结膜炎、皮炎和上呼吸道刺激症状，长期过量食用，将对人体肾脏、肝脏造成损害。在国外早已列为禁用染料，国家卫生部在2008年将其列为非食用物质。增重主要是用铝盐和镁盐增加重量，即使有的掺入物质对人体无害，也会影响药性。

The involved"dyeing"Refers to auramine O dyeing,Auramine O and name alkaline bright yellow,Belong to contact sex carcinogens,To the skin with mild stimulation mucous membrane,Can cause conjunctivitis/Dermatitis and upper respiratory tract stimulus symptoms,Long-term excessive edible,Will on human kidney/Liver damage.In overseas is already listed as forbidden dyes,The state ministry of health in 2008 as its non-food substances.Weight gain is mainly with aluminum salt and magnesium salt increases the weight,Even if some incorporation substance in harmless,Also can affect medicinal properties.

　　“不管对人体有无伤害，只要改变它原来的性质，都是违法的。”中国药科大学教授杨中林说。

"No matter whether damage to human body,As long as change its original nature,Are illegal."China pharmaceutical university professor YangZhongLin said.

　　安徽中正中药材饮片有限公司生产车间负责人周雷斌告诉《中国经济周刊》，很多农民和收购中介为自身利益在原材料上做手脚。 “一是‘问题中药材’市场需求大，有些人觉得不上色的中药材不好看，就买有问题的原料，既利于储存又美观。二是有些农民种植的中药数量太大，没法完全干燥，只能通过加重等措施弥补损失。”这种情况不仅在较大中药材种植基地有，在其他中药材产地也很普遍——亳州当地的中药材种植户提供的中药原料，质量也无法完全保障。

Anhui CKS Chinese herbal medicine yinpian co., LTD., the production workshop ZhouLeiBin tell[China economic weekly],Many farmers and acquisitions intermediary for their own interests in juggle with raw materials. "One is‘Problems Chinese herbal medicine’Market demand is big,Some people don't think of Chinese herbal medicine not good-looking color,Buy has a problem of raw materials,Not only for the storage and beautiful.The second is some farmers grow too large number of traditional Chinese medicine,Can't completely dry,Only through the increase of the measures make up the loss."This situation not only in large Chinese herbal medicine planting base have,In other Chinese herbal medicine origin is also very common - bozhou local Chinese herbal medicine of traditional Chinese medicine raw materials to provide farmers,Quality also is unable to fully protect.

　　除此次曝光的染色、增重、掺假外，硫黄熏蒸法在市场上也大行其道，这主要也应用在原材料上。很多种植中药材的农民选择用硫黄防虫防腐。一药厂老板给记者举例：“甘肃党参90%(出售时)没有晒干，为防止发霉变质就用硫黄熏蒸。”本刊记者了解到，从2005年起，《药典》已不再允许使用硫黄熏蒸法。

In addition to the exposure of dyeing/Weight gain/Adulterate the,Sulfur fumigation in the market is popular,This is mainly also used in raw material.A lot of planting Chinese herbal medicine farmers choose sulfur corrosion protection against insects.A pharmaceutical factory boss give reporter for example:"Gansu codonopsis pilosula 90%(sold)No dry,To prevent mildew metamorphism with sulfur fumigation."This reporter learned,Since 2005,[pharmacopoeia]Is no longer allowed to use sulfur fumigation.

　　“现在染色、增重等违法行为主要发生在农村加工经营户，比较分散、隐蔽。对此，亳州市开展了市县乡村四级联动整治，共捣毁了10个窝点，现在还在追查之中。”宣庆生介绍。

"Now dyeing/Weight gain illegal activities such as the mainly in rural processing enterprises,Is more dispersive/concealed.this,Bozhou city cities and counties to carry out the country level 4 linkage control,A total of 10 smashed the cache,Now also in the track of."XuanQingSheng introduced.

　　很多中药饮片企业为防止原材料有问题，去原材料产地采购原料时都会派专业的业务员和化验员。但即使是经验十分丰富的采购人员有时候也很难辨别原材料是否出现问题。

Many Chinese medicine yinpian enterprise to prevent raw material has a problem,To raw material purchasing raw material origin of all send professional salesman and laboratory technician.But even experience is very rich purchasing personnel is sometimes difficult to distinguish between raw materials whether there will be a problem.

　　“药材是否染色、增重等，外观看不出来，需要监管，难度也很大。”宣庆生也说。

"Medicinal materials whether dyeing/Weight gain, etc,The watch out,Need supervision,Difficulty is very big also."XuanQingSheng also said.

　

　采购，“恶之源” purchasing,"The source of evil"

　　“我有高血压，挂20多天盐水了，刚回公司，就出了这么大的事。”9月13日，老沈对《中国经济周刊》说。老沈是亳州一中药饮片厂负责人，他的企业位于亳州市谯城区工业园区，为国家药监局曝光的12家企业之一。他的企业在本地并不大，可生产200多种饮片，亳州规模较大的中药饮片企业产品一般都有1000种左右。

"I have high blood pressure,Hang more than 20 days the brine,Just back to the company,Just out of such a big thing."On September 13,Old shen to[China economic weekly]said.Old shen bozhou is a Chinese medicine yinpian factory chief,His business is located in bozhou city qiaocheng district industrial park,For the country's drug watchdog exposure of one of the 12 enterprises.His enterprise in local is not big,It can produce more than 200 kinds of yinpian,Bozhou large Chinese medicine yinpian enterprise products generally has about 1000 species.

　　据老沈对《中国经济周刊》描述，此次自己的企业被调查，源自该厂研究所一名业务员的失误：“今年3月，这名业务员从江西省樟树市中药材市场买进一批中药饮片，我们没有再检验，也没有送相关部门检测，直接售往上海某药企。未售出的运到仓库储藏。”沈所提及的樟树市有“南国药都”之称，安徽亳州的部分中药材来源于此。

According to the old shen to[China economic weekly]description,The own enterprise are investigated,From the research institute a salesman mistakes:"In march this year,This salesman from jiangxi province ZhangShuShi Chinese herbal medicine market to buy some Chinese medicine yinpian,We no longer inspection,Also didn't send relevant departments detection,Direct sale to Shanghai some medicine enterprises.Unsold to warehouse storage."Shen ZhangShuShi have mentioned"Austral medicine"said,Bozhou in anhui province part of the Chinese herbal medicine originates from here.

　　“5月16日，我们接到安徽药监局通知，要对中药饮片进行大规模检查。我们送检的产品中，包括从樟树市中药材市场买进的那批中药饮片，有30多公斤。”老沈说。

"On May 16,,We received notice of anhui's drug watchdog,To Chinese medicine yinpian check on a large scale.We cleared of products,Including ZhangShuShi Chinese herbal medicine market buy from the group of Chinese medicine yinpian,There are more than 30 kg."Old shen said.

　　在对涉嫌违法经营的企业采访中，安徽国鑫中药饮片有限公司、安徽福春堂中药饮片有限公司、亳州市凯利中药饮片有限公司的回应都与老沈的亳州市贡药饮片厂的表述基本一致：“依据生产记录和出厂记录，出现问题的中药饮片都是从外地采购来的。”

In the suspected illegal business enterprise interview,Anhui countries xin Chinese medicine yinpian co., LTD/Anhui f spring hall Chinese medicine yinpian co., LTD/Bozhou city kelly Chinese medicine yinpian co., LTD., response and the old shen bozhou city gong medicine yinpian factory statement basic consistent:"According to the records of production and delivery record,Problems of traditional Chinese medicine yinpian were from other places to purchase."

　　与亳州市贡药饮片厂一样，现在这几家企业同样被停产整改。

And bozhou city gong medicine yinpian as factory,Now that a few enterprises are also suspend production rectification.

　　樟树医药集团公司销售部的龚思宝对记者说，樟树是一个以中药材为主的农副产品交易流通中心，主要由个体经营户对外销售中药材原料，也有部分商铺经营中药饮片，这些中药产品质量参差不齐。“自今年6月份开始，樟树中药材市场监管力度开始加强，真正做到挨家挨户地检查。”龚思宝介绍。

Camphor tree pharmaceutical group company of the sales department GongSiBao told reporters,Camphor tree is a Chinese herbal medicine mainly agricultural and sideline products trade &circulation center,Mainly by individual manage door foreign sales of Chinese herbal medicine raw materials,There are some shops business Chinese medicine yinpian,The traditional Chinese medicine product quality is uneven."Since the start of June this year,Camphor tree Chinese herbal medicine market supervision dynamics began to strengthen,Truly from door to door check."GongSiBao introduced.

　　周雷斌告诉记者，绝大部分从其他地方采购来的中药饮片并不被允许贴牌包装，也不能入库储藏。

ZhouLeiBin told reporters,Most from other places to purchase the Chinese medicine yinpian did not have a permit to stick a card packaging,Also cannot warehousing storage.

　　“按照《中华人民共和国药典》(下称《药典》)和《安徽省中药饮片炮制规范》，除指定中药饮片外，饮片生产企业不能采购市场上炮制好的饮片贴牌包装。”周雷斌说，这是为了防止各企业间的炮制差异而使饮片达不到要求。此外，安徽药监局在税收上也对饮片生产企业作出规范。“直接从产地采购来的饮片税收要比原材料高。”

"According to the[Pharmacopoeia of the People's Republic of China](said[pharmacopoeia])and[Anhui province Chinese medicine yinpian processing standard],In addition to the designated Chinese medicine yinpian,Yinpian production enterprise cannot purchase market processing good yinpian OEM packaging."ZhouLeiBin said,This is to prevent the enterprise processing between the difference and make yinpian can not reach the requirements.In addition,Anhui regulators on tax for yinpian production enterprise to make the standard."Directly from origin to purchase tax prepared than raw materials high."

　　“如果采购私人作坊的饮片，药监局一律以假药论处，饮片全部没收，还要按采购价格的3到5倍罚款。即使买自GMP认证企业，不合格也要罚款1到3倍。”周雷斌向《中国经济周刊》透露，安徽药监局一旦发现饮片生产企业购进非指定饮片时，将有以上处罚。

"If purchasing private workshop yinpian,The administration's all fake to punish,Yinpian all confiscated,Also according to the purchasing price 3 to 5 times a fine.Even if buy from GMP authentication enterprise,Don't qualified to also want to a fine one to three times."ZhouLeiBin to[China economic weekly]revealed,Anhui's drug watchdog once found yinpian production enterprise purchase not appointed when prepared,There will be above punishments.

　　至截稿前，记者多次联系亳州市贡药饮片厂，电话一直无人接听，对其公司从市场上进购的中药饮片是否为“指定饮片”尚无说法。

To press before,Many times reporter contact bozhou city gong medicine yinpian factory,The telephone has been no one answer,The company from the market for progress of Chinese medicine yinpian whether for"Designated yinpian"That there is no.

　　自检把关 Self checks

　　安徽药监局在亳州中药市场的例行检查一直较为频繁。“自3月份以来，我们常规性例行检查一直都有， 3月、5月、8月、9月，每次各有针对性。”亳州市药监局局长刘青山对《中国经济周刊》记者说。

Bozhou in anhui regulators on traditional Chinese medicine market routine inspection have been more frequent."Since since march,We routine routine inspection have been, march/may/August/September,Every time the targeted."Bozhou city, the administration's director of LiuQingShan[China economic weekly]reporters.

　　除例行检查，安徽药监局还要求中药饮片生产企业有自检能力，尤其是此次国家药监局曝光亳州12家中药饮片企业的问题后，要求所有经过GMP认证的中药饮片生产企业必须购买中药材检测设备。

In addition to routine check,Anhui's drug watchdog also requires Chinese medicine yinpian production enterprises have self-checking capability,Especially in the country's drug watchdog exposure bozhou dozen Chinese medicine yinpian after the problem of enterprises,Require all after GMP certification of Chinese medicine yinpian production enterprise must buy Chinese herbal medicine testing equipment.

　　周雷斌回顾：“按照《药品生产质量管理规范》，GMP认证的中药饮片生产企业在中药饮片生产加工中要有正规的检验设备，检验药品是否合格。但此前中药饮片生产企业如果没有条件购买设备，可以委托当地监管部门化验企业生产的产品是否合格。不过，自9月8日后，安徽药监局规定，所有GMP认证中药饮片生产企业都必须自己配备这些检测设备。”

ZhouLeiBin review:"According to the[The quality control standard for pharmaceutical production],GMP certification of Chinese medicine yinpian production enterprises in the Chinese medicine yinpian production process to have regular inspection equipment,Test drugs if they are qualified.But after Chinese medicine yinpian production enterprise if no conditions to buy equipment,Can entrust local regulators assay enterprise production product is qualified.but,Since September 8 in the future,The administration's provisions in anhui province,All GMP authentication Chinese medicine yinpian production enterprise must themselves equipped with these testing equipment."

　　9月20日，宣庆生接受《中国经济周刊》采访时称，“这些企业的中药饮片在哪个环节上染色，药监局还在调查中。现在检验的不合格的产品已经基本全部销毁。”

On September 20th,XuanQingSheng accept[China economic weekly]contrasesness,"The enterprise of the Chinese medicine yinpian in which links dyeing,The administration's is under investigation.Now check the unqualified products has been basically destroyed."

　　对于被立案调查的企业来说，损失尚难以估量。老沈说：“我一点办法都没有，损失两三年都弥补不了。我们根据订单生产，停产时间长了，客户就会逐渐断了。”另一个被调查企业安徽福春堂中药饮片有限公司的工作人员李健军也对《中国经济周刊》表示：“这不是一件小事，公司销售已经受到影响。”

For the investigation for enterprises,It is difficult to measure the loss.Old shen said:"I have a little way,Losses are make up for two or three years.We according to the production orders,Idling time long,The customer will gradually broke."Another survey enterprise anhui f spring hall Chinese medicine yinpian co., LTD. Staff to LiJianJun also[China economic weekly]said:"This is not one of those things,The company's sales have been affected."

　　亳州12家涉案中药饮片企业也包括中国(亳州)上海雷允上中药饮片厂，该公司上海华山路店经理室回应本刊记者，称销售未受影响。

Bozhou dozen involving Chinese medicine yinpian enterprise including China(bozhou)Shanghai LeiYun on Chinese medicine yinpian factory,The company Shanghai on the huashan road store manager room response to this reporter,Says sales unaffected.

　　上海国大药房南大路店的销售员也表示，其中药饮片销量正常：“我们的货源很多，一旦发现哪家供应商的产品出现问题，产品立刻下架、退货，更换其他货源的产品。”

Shanghai guoda pharmacy south road shop salesman said,The Chinese medicine yinpian sales normal:"We supply many,Once found a supplier's product problems,Products from the shelves immediately/return,Replace other source products."

　　国家药监局对亳州市部分中药饮片生产公司的曝光，在某种程度上推动了没有上榜的中药饮片企业的销售。南京药业股份有限公司的余晓军(化名)9月20日就表示，“自9月8日国家药监局曝光以来，我们销售反而变好了，新增了和几家医院的合作关系。”

The administration's state of bozhou city part of Chinese medicine yinpian production company's exposure,To a certain extent promote the no list of Chinese medicine yinpian enterprise sales.Nanjing pharmaceutical co., LTD. YuXiaoJun of(alias)On September 20th said,"Since September 8 countries since the administration's exposure,We sell it better,The new and a few hospitals relations of cooperation."

　　“文件下达后，所有未购置检测设备的厂家都在忙着订购仪器。”周雷斌告诉《中国经济周刊》。

"Issued documents after,All not purchase detection equipment manufacturers are busy order instrument."ZhouLeiBin tell[China economic weekly].

　　10月19日，周雷斌再次接受《中国经济周刊》采访时表示，“我们的检验设备已经下过订单，价值50多万元。原来订的十七八万元的设备只能用来检测金胺O染色，因此又买了一些其他的设备，基本能对自己销售的产品进行全检。”

On October 19,ZhouLeiBin accept again[China economic weekly]Interviews that,"Our inspection equipment has the order,Value more than ten thousand yuan.The original order of seventeen ten thousand yuan equipment can only be used to detect auramine O dyeing,Therefore and bought some other equipment,The basic of sales products perform full inspection."

　　在这期间，亳州市贡药饮片厂负责人之一王朝明(化名)正在陕西采购中药材，为恢复生产后尽快投入中药饮片的生产加工做准备。

During this period,Bozhou city gong medicine yinpian factory is one of the chief WangChaoMing(alias)Are shaanxi purchasing Chinese herbal medicine,To restore production as soon as possible after input Chinese medicine yinpian production and processing to prepare.