Food and Drug Administration: 28 kinds of toxic Chinese herbal medicines should be wary of the state's strict supervision on Chinese patent medicines

According to the China report hall, the controversial use of toxic Chinese herbal medicines has also attracted the attention of relevant departments Recently, the State Food and Drug Administration issued the notice on Revising the specifications of Chinese patent medicines containing toxic Chinese herbal pieces (hereinafter referred to as the notice), which requires Chinese herbal enterprises to indicate in their prescriptions and add warning words at corresponding positions According to the notice, a total of 28 kinds of Chinese herbal medicines are identified as toxic materials, and the product manual containing such toxic Chinese herbal medicines is facing revision At the same time, the manual should also be modified for the varieties of Chinese patent medicines containing other pieces of Chinese herbal medicines that have been proved to be toxic and easy to cause serious adverse reactions According to the rough statistics, many drugs under Tongrentang, a star enterprise of Chinese patent medicine, are facing the revision of product specifications, while the listed companies Guangzhou Baiyunshan and Tonghua Jinma are also involved 28 kinds of poisonous traditional Chinese medicine should be vigilant Related research report on traditional Chinese medicine construction of traditional Chinese medicine base and feasibility study report on the 12th Five Year Plan Analysis and investment prospect prediction of traditional Chinese medicine industry Industry Financial Strategy Research Report (2008) more analysis of the pharmaceutical industry in August this year, Tongrentang Niuhuang antidote tablet was warned by the British pharmaceutical regulatory authority, which made the public opinion to question the traditional Chinese medicine to the top According to the notice, where the prescription contains the Chinese patent medicine varieties (processed products containing toxicity) made of 28 kinds of toxic drugs collected in the measures for the administration of toxic drugs for medical use (Order No 23 of the State Council), the relevant drug manufacturers shall indicate the name of the toxic Chinese herbal medicine pieces under the description [ingredients], and add the warning words: "this product contains XXX " The notice also requires that the prescription contains other kinds of Chinese patent medicines that have been proved to be toxic and easy to cause serious adverse reactions, and relevant drug manufacturers should also revise the instructions in accordance with the above requirements At the same time, pharmaceutical enterprises shall timely supplement and improve the safety content such as the instruction [precautions] according to the adverse reaction monitoring data and the relevant safety information reported in the literature Industry insiders said that this is a major progress in the country's drug regulation, and that public labeling of toxic ingredients can alert doctors and patients At the beginning of this year, Yunnan Baiyao was banned by the Hong Kong Department of health Yunnan Baiyao group later issued a document admitting that it contained the poisonous traditional Chinese medicine Caowu Although Yunnan Baiyao group said it had not detected serious adverse reactions, the legal evening news immediately sorted out three cases of physical discomfort or even death after taking Yunnan Baiyao In the debate between the two sides, Yunnan Baiyao refused to provide its raw material formula on the basis of confidential formula, denied that it contained aconitine, and the court could not determine the relationship between the two, so the patient lost the lawsuit According to the state's strict regulation on Chinese patent medicines, the varieties of Chinese herbal medicines containing toxic Chinese herbal medicines include not only the innovative drug NORCANTHARIDATE sodium for cancer treatment, but also the commonly used drug Huoxiang Zhengqi water Raw Pinellia ternate is one of the 28 kinds of toxic Chinese medicinal materials According to Baidu data, raw Pinellia ternate has a strong irritant effect on the local part of the human body, and has neurotoxicity The whole plant is toxic, and the tuber is highly toxic Eating raw 0.1-1.8g can cause poisoning, and taking a small amount can make the tongue numb The ingredients of Huoxiang Zhengqi water produced by many pharmaceutical factories include Pinellia ternata, but it is not clearly stated in the drug specification, and the drug taboo and adverse reactions are also blank The drug sanqishang tablet of Tonghua Jinma Pharmaceutical Co., Ltd contains Radix Aconiti, which is one of the 28 kinds of toxic Chinese herbal medicines The staff of the quality assurance department told the unidentified reporters that they would modify the drug manual according to the requirements of the notice However, the tablet has been stopped for a long time and has not received many adverse reactions Toad is the secretion of the epidermis gland of toad, which has strong toxicity The product ingredients listed in Liuling pill of Tongrentang and Huoxin pill of Guangzhou Baiyunshan Pharmaceutical General Factory contain toad The reporter called the brand Department of Tongrentang, and its staff told the reporter that the matter was in the charge of the publicity department However, the reporter repeatedly called the publicity department and no one answered Subsequently, the reporter consulted Guangzhou Baiyunshan Pharmaceutical General Factory in the name of the patient The staff of the quality inspection department of the factory told the reporter that the toxic component of this product is aconite, but it has been processed, the toxicity is controllable, and no serious adverse reaction cases have been collected Shortly after the issuance of the notice, the State Food and Drug Administration revised the instruction manual of Xiaoyan Lidan tablets According to the public information, Xiaoyan Lidan tablet is a kind of heat clearing, dampness removing and choleretic medicine Its main ingredients are Andrographis paniculata, Xihuangcao and Kuki The data of the State Food and Drug Administration shows that there are as many as 120 product registration information The manufacturers include Guangdong Luofushan national medicine, Guangzhou Baiyunshan, modified medicine, etc The bitter wood is not among the 28 kinds of medicinal materials listed by the state, but the State Food and drug administration requires to add the content that the bitter wood contained in this product has small toxicity and should not be taken for a long time At the same time, the adverse reactions and precautions were also not clear before, adding adverse reactions including nausea, vomiting, abdominal pain, anaphylactic shock, general convulsion and so on Industry insiders said that this means that the state's regulation of Chinese patent medicines will be more stringent.