The General Administration of food and drug requires that the components of toxic decoction pieces be disclosed to calm the misunderstanding of Chinese patent medicine

The State Food and Drug Administration recently announced that the varieties of Chinese patent medicines containing toxic Chinese herbal pieces need to modify the instructions, and the warning words containing toxic Chinese herbal pieces must be added The varieties of Chinese patent medicines involving state secret technology cannot be spared This year, Yunnan Baiyao, Tongrentang Niuhuang Jiedu Pian, Niuhuang Qianjin San, China Resources Sanjiu Zhengtian Wan, Hansen pharmaceutical Simo Tang and other Chinese patent medicines have caused great waves in society due to the use of toxic pieces or some poisonous herbs Industry insiders pointed out that the State Administration of food and drug requires to modify the instructions of Chinese patent medicines containing toxic substances, which will help to calm the misunderstanding of Chinese patent medicines containing toxic substances in the international community on the one hand, and remind such enterprises to pay close attention to the adverse reactions of Chinese patent medicines containing toxic substances on the other hand Tongrentang, Yunnan Baiyao and Hansen pharmaceutical have been "shot" in succession because they produce Chinese patent medicines containing toxic decoction pieces, but did not tell the ingredients of the toxic decoction pieces Domestic well-known Chinese medicine enterprises have been shot in succession this year, and a variety of Chinese patent medicine products have been questioned The Hong Kong government laboratory recently found that Yunnan Baiyao samples contain the unidentified toxic substance aconitine alkaloids Although the relevant personnel of Yunnan Baiyao group said that the formula of Yunnan Baiyao does contain aconitine, the company has eliminated or weakened the toxicity of aconitine through its unique processing and production process, and Yunnan Baiyao series products are generally safe and reliable However, the Hong Kong Department of health and the Macao Health Bureau also issued a notice to stop recycling Tongrentang's drugs are treated the same way First, the Hong Kong Department of Health issued a notice that the mercury (mercury) content of "jianti wubu pill" exceeded the standard Then, the cinnabar content of Niuhuang Qianjin powder and Xiaoer Zhibao pill were 17.3% and 0.72%, respectively The former is beyond the domestic standard, while the latter is far beyond the Hong Kong standard Hansen pharmaceutical's flagship product for children's diseases, Simotang, has a single ingredient of areca, which was recognized as a primary carcinogen by the international cancer research center of the World Health Organization as early as 2003 It has been nearly 20 years since Hansen pharmaceutical produced Simotang, but it has never disclosed to patients that its pharmaceutical ingredients contain carcinogens Once the matter was made public by the media, it caused a lot of waves "This is the mistake of our traditional Chinese medicine enterprises, not all blame is the misunderstanding at home and abroad." Ji Shaoliang, a professor at Beijing University of traditional Chinese medicine, pointed out at an internal meeting of the China Association of traditional Chinese medicine that the biggest problem for Chinese patent medicine enterprises at present is that they do not have the courage to disclose their adverse reactions to the society After the occurrence of the above events, the Chinese Herbal Medicine Association held many internal meetings to discuss these issues Many experts suggested that Chinese patent medicine enterprises must disclose the toxic components and make clear their own treatment process of these toxic components The source told the economic information that the national regulatory authorities adopted the experts' suggestions The State Food and Drug Administration issued a notice in mid November, requiring that where the prescription contains 28 kinds of Chinese patent medicines (including toxic processed products) made of toxic herbs collected in the measures for the administration of toxic drugs for medical use (Order No 23 of the State Council), the relevant pharmaceutical manufacturers should indicate the name of the toxic Chinese herbal medicines in their instructions [ingredients], and increase the police at the corresponding positions This product contains X X X 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 The varieties of Chinese patent medicines involving state secret technology are no exception In addition, relevant drug manufacturers shall actively track the safety of drug clinical application, and timely supplement and improve the safety content such as instructions [precautions] according to the adverse reaction monitoring data and relevant safety information reported in the literature The revised contents of the manual shall be notified to the relevant medical institutions, pharmaceutical trading enterprises and other units in time, and the ex factory manual shall be replaced within 6 months after the supplementary application is filed According to the reporter of the economic reference, 28 kinds of toxic herbs include realgar, Pinellia ternata, goldenrod, Chuanwu, Caowu, tianxianzi, Croton, cinnabar, etc Li Lianda, an academician of the Chinese Academy of engineering, pointed out that toxic substances in drugs are not prohibited, which is the consensus of traditional Chinese medicine and Western medicine After formal and scientific processing methods and means, these herbs can be used as medicine safely, but the key is that enterprises need to continuously research and re evaluate the drugs "We found that many of the adverse reactions in the instructions of Western medicine were long and long, while the traditional Chinese medicine often marked" unclear " They are desperate to find, we are desperate to hide Ji Shaoliang said that for this difference, the industry should attach great importance to it Because as far as possible to find and fully explain adverse drug reactions, it is helpful for patients to use drugs safely According to song Minxian, a Chinese medicine expert who specializes in the careful use of toxic herbs for children, there are 82 pediatric Chinese patent medicine pills, 72 powders, 61 granules, 41 tablets, 35 oral liquids (mixtures), 34 diabetes agents, 18 capsules, 7 oral plasters and 6 injections There are 130 Chinese patent medicines that can contain toxic herbs, accounting for 34.75% of the total varieties; there are 59 Chinese patent medicines that contain two or more toxic herbs, accounting for 15.77% In the drug standard, there are 117 varieties of Chinese patent medicines for children, accounting for 31% of the total, which have not published prescription drugs and doses, or can not calculate the doses of each preparation unit (such as each tablet, gram, etc.) according to the drug standard There are 116 varieties without age dosage, accounting for 31% of the total number of Chinese patent medicines involved in infants, and there are no rules for those with age "The most important thing is that many Chinese patent medicines for children contain toxic herbs, and the adverse reactions of these ingredients are still unclear." Ma Rong, Dean of the First Affiliated Hospital of Tianjin University of traditional Chinese medicine, told reporters that there are 44 varieties of cinnabar, realgar, Polygonum multiflorum and areca in the Pharmacopoeia, and cinnabar is the most frequently used Most of them focus on the aspects of calming, calming, eliminating accumulation and tonifying, such as the treatment of infantile convulsion, epilepsy, accumulation stagnation, enuresis, cerebral palsy, etc According to Li Lianda, side effects will be the focus of pediatric Chinese patent medicine research and development in the future The safety research of children's medication, the common side effects, the prevention and treatment of side effects and sequelae that have an important impact on growth and development and long-term prognosis.