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The author:(作者)qqpublished in(发表于) 2013/11/21 1:34:40 Food and Drug Administration： enterprises must be noted on the prescription of traditional Chinese medicine of poisonous Chinese traditional medicine
Guizhou City newspaper, according to the economic daily news reported, argued a lot of toxic Chinese herbs medicine attracted the attention of authorities. A few days ago, State Food Drug Administration issued on the revision of the notice of the statement toxic varieties of herbal medicine (hereinafter notice) for enterprises must be noted on the prescription of traditional Chinese medicine, and additional warnings in the appropriate place.
Notifications are presented, a total of 28 kinds of medicinal herbs was recognized as a toxic material, contain such toxic Chinese medicine products facing manual modifications. At the same time, has proven toxic, easily lead to serious adverse effects of herbal medicine instructions should be modified.
Reporter rough statistics found, facing the star company tongrentang under a variety of proprietary Chinese medicines and drug product specifications change, listed companies in baiyunshan scenic spot, Guangzhou, tonghua Golden Horse also have drugs were involved.
28 species of toxic Chinese medicinal materials need to be vigilant
In August this year, tongrentang niuhuang jiedu tablets by United Kingdom pharmaceutical supervisory departments to alert public opinion to traditional Chinese medicine challenged to reach the top.
Notification in the requires, where prescription in the contains medical with toxicity drug management approach under (State orders 23rd,) in the containing of 28 species toxicity herbs made of TCM pieces (contains toxicity of concoction products) of proprietary Chinese medicines varieties, related drug production enterprise should in its manual "ingredients" items Xia marked the toxicity TCM pieces name, and in corresponding location increased warning language: "this products containing XXX".
Notice also requested that the prescription contains other has proven toxic, easily lead to serious adverse effects of herbal medicine, pharmaceutical producing enterprises shall, in accordance with the above request to amend the instructions. At the same time, drug firms should also be based on monitoring data and reports of adverse reactions related to security information, complement instructions in a timely manner according to regulations, "notes" and other content security.
Industry insiders say, is a major national drug regulatory progress, publicly indicated toxic ingredients you can alert your physicians and patients.
Yunnan baiyao was after Hong Kong's Department of health to ban early this year, Yunnan baiyao Group subsequently issued a recognition of toxic Chinese medicinal materials radix aconiti kusnezoffii, while Yunnan baiyao Group expressed serious adverse events are not detected, but then came out with three causes of the legal evening news appeared unwell after taking Yunnan baiyao and even death cases. On both sides of the debate, Yunnan baiyao refused on grounds of secret formula for making its formula, denying contain aconitine, the Court cannot determine the relationship between the two, the patient loses.
State regulation of proprietary Chinese medicines
Reporter rough combing found that varieties of traditional Chinese medicines containing toxic Chinese medicinal materials, including not only the innovative medicines for cancer of sodium norcantharidin, also include common drugs huoxiangzhengqi water.
Pinellia ternata is one of 28 species of toxic Chinese medicinal materials, Baidu's statistics show that local raw pinellia Ternate on the human body has a strong pungent and neurotoxicity, whole toxic, toxicity larger tubers, raw food poisoning caused by 0.1~1.8g, serving few makes mouth numb. Number of manufacturing activities of Huoxiang zhengqi pinellia ternata water composition instruction in both, but does not express in the drug package insert, contraindications and adverse reactions of drugs is also blank.
Tonghua Golden Horse pharmaceutical industry drug Tablet contains Aconitum 37 injuries, is one of 28 species of toxic Chinese medicinal materials, to not reveal their warranty Department staff reporter said that they will comply with the notification requirement for drug package insert changes, but for now the pill has been discontinued for a long time and has not received a lot of cases of adverse reactions.
Toad is Toad skin gland secretions, stronger toxicity, six spirits pill as well as Guangzhou baiyunshan pharmaceutical factory of tongrentang fresh pills containing Toad venom in the ingredients listed.
Reporter called tongrentang brand, told reporters about their staff responsible for propaganda, however the journalist repeatedly dialed the propaganda Department's phone were unanswered. Then, on behalf of the patient consulted Guangzhou baiyunshan pharmaceutical factory, quality inspection departments of the plant's staff told reporters, the toxic components of the product as aconite, but has been concocted, toxicity can be controlled, but also collected cases of severe adverse reactions.
Shortly after the publication of notices, notification requirements released in State Food Drug Administration of Xiaoyan Lidan Tablet specifications to modify.
Public information display, Xiaoyan Lidan tablet as a heat, removing dampness, choleretic medication, the main component of andrographis Paniculata, Kai Huang Cao, hard wood, according to the State food and Drug Administration Office of up to 120 product registration information, manufacturers including Luofu Mountain Lane, Guangdong, Guangzhou Baiyun mountain, pharmaceutical, etc.
Wood is not on the national list of 28 kinds of medicinal herbs, but the State Food Drug Administration requires drug notes added in this product contain drugs for a small wood, not long suit. At the same time, adverse reactions and notes from before is not clear, an increase of adverse reactions include nausea, vomiting, abdominal pain, sensitive content such as shock, jerking around.
Industry insiders said, which means that the State regulation of proprietary Chinese medicines would be more rigorous.
(Original title: toxic essential modifications required specifications)
贵州都市报讯 据《每日经济新闻》报道，争论颇多的含毒中药材入药引起了有关部门的关注。日前，国家食药监总局发出《关于修订含毒性中药饮片中成药品种说明书的通知》(以下简称通知)，要求中药企业必须在处方中注明，且在相应位置增加警示语。
通知显示，共有28种中药材被认定为有毒材料，含有这类有毒中药产品说明书面临修改。同时，含有其他已被证明具有毒性、易导致严重不良反应的中药饮片的中成药品种也应对说明书进行修改。
记者粗略统计发现，中成药明星企业同仁堂旗下多款药品面临产品说明书修改，而上市公司广州白云山、通化金马等也均有药品被卷入。
28种有毒中药材需警惕
今年8月，同仁堂牛黄解毒片遭英国医药监管部门警示让舆论对中药的质疑达到顶峰。
通知中要求，凡处方中含有《医疗用毒性药品管理办法》(国务院令第23号)中收载的28种毒性药材制成的中药饮片(含有毒性的炮制品)的中成药品种，相关药品生产企业应在其说明书【成分】项下标明该毒性中药饮片名称，并在相应位置增加警示语：“本品含XXX”。
通知还要求，处方中含有其他已被证明具有毒性、易导致严重不良反应的中药饮片的中成药品种，相关药品生产企业也应按照上述要求修订说明书。同时，药企还应根据不良反应监测数据及文献报道的相关安全性信息，按规定及时补充完善说明书【注意事项】等安全性内容。
业内人士表示，这是国家对于药品监管的一大进步，公开注明有毒成分可以对医生和患者进行警示。
在今年初云南白药遭到香港卫生署禁售后，云南白药集团随后发文承认含有有毒中药材草乌，虽然云南白药集团表示未检测到严重不良反应，但是《法制晚报》随即梳理出了三起因服用云南白药后出现身体不适甚至死亡的案例。在双方的辩论中，云南白药均以保密配方为由拒绝提供其原料配方，否认含有乌头碱，法庭也无法断定二者之间关系，患者因此败诉。
国家对中成药监管趋严
记者粗略梳理发现，含有有毒中药材的中药品种，不仅包括治疗癌症的创新药去甲斑蝥酸钠，还包括常用药藿香正气水。
生半夏是28种有毒中药材之一，百度资料显示，生半夏对人体局部有强烈的刺激性，并有神经毒性，全株有毒，块茎毒性较大，生食0.1~1.8g即可引起中毒，服少量可使口舌麻木。多家药厂生产的藿香正气水的成分说明书中均包括生半夏，但是在药品说明书中并未明示，药品的禁忌和不良反应中也为空白。
通化金马药业的药品三七伤药片中含有草乌，属于28种含毒中药材之一，其质保部的工作人员对未表明身份的记者表示，他们会遵照通知的要求对药品说明书进行修改，不过目前该药片已停产很久，且并未收到很多不良反应案例。
蟾酥为蟾蜍表皮腺体的分泌物，毒性较强，同仁堂的六灵丸以及广州白云山制药总厂的活心丸所列的产品成分中均含有蟾酥。
记者致电同仁堂品牌部，其工作人员告诉记者此事为宣传部负责，然而记者屡次拨打宣传部的电话均无人接听。随后，记者以患者的名义向广州白云山制药总厂进行咨询，该厂质量检测部门的工作人员对记者表示，此款产品的毒性成分为附子，但是已经经过炮制，毒性可控，而且也未收集到严重不良反应的案例。
通知发布后不久，国家食药监总局就发布通知要求消炎利胆片的说明书进行修改。
公开资料显示，消炎利胆片为一种清热、祛湿、利胆的药物，其主要成分为穿心莲、溪黄草、苦木，国家食药监总局的数据显示有多达120条的产品注册信息，生产厂家包括广东罗浮山国药、广州白云山、修正药业等。
苦木并不在国家所列的28种药材之列，但是国家食药监总局要求药品注意事项中增加本品所含苦木有小毒，不宜久服的内容。同时，不良反应和注意事项中也由之前的尚不明确，增加了不良反应包括恶心、呕吐、腹痛、敏性休克、全身抽搐等内容。
业内人士表示，这意味着国家对中成药的监管将更加严格。
(原标题：含毒重要需修改说明书)
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