21st Century Business Herald reporter Lin Yunxiao Intern Zhang Chi Wang Yachi Beijing reported that recently, the mercury content of Beijing Tong Ren Tang drug caused controversy, and "Tong Ren Tang Ren Dan mercury content exceeded the standard by 50,000 times" once appeared on the Weibo hot search list. The incident stemmed from a popular science blogger who posted on multiple social media platforms that a reader had been found to have severe mercury poisoning after taking Beijing Tong Ren Tang's Ren Dan. After the reader sent Rendan for testing, the foreign test report showed that the mercury content was as high as 9729.985mg/kg.
The blogger also said that the content of heavy metals and harmful elements in many Chinese herbal medicines is stipulated: the mercury content shall not exceed 0.2mg/kg. In other words, the mercury content of this batch of Rendan, according to domestic standards, exceeds nearly 50,000 times.
In this regard, the 21st Century Business Herald reporter called the secretary of the board of directors of Tongrentang to learn about the relevant situation, and the other party said that it was inconvenient to be interviewed. Since then, the 21st Century Business Herald reporter consulted the customer service of Taobao and Jingdong's Tongrentang official flagship store as a consumer, and the other party said that the matter is still in the process of understanding and will take some time.
However, the other party said that the products have been strictly inspected and GMP certified, and are produced in accordance with standards and specifications, and further information is still being verified.
This incident is not the first time that Tong Ren Tang has been exposed to excessive mercury levels in drugs. As early as 2013, a proprietary Chinese medicine called "Jiansheng Wubu Pill" in Beijing Tong Ren Tang was ordered to be recalled by the Hong Kong health authority because the mercury content exceeded the upper limit by 5 times.
For the problem of excessive heavy metal content in traditional Chinese medicine, a research expert in the traditional Chinese medicine industry told the 21st Century Business Herald reporter that many classic Chinese patent medicine products contain mineral drugs, and many mineral sources of traditional Chinese medicine contain heavy metals. At the same time, the dosage information of the drug should also be refined, and the description of contraindications should be strengthened.
Excessive levels of mercury?
According to the above-mentioned blogger's post, Ms. Wang, who is in Germany, went to the hospital for examination last year because of long-term abdominal pain, and found that the mercury content in her body exceeded the standard, which is a serious mercury poisoning. In order to find the source of the mercury poisoning, Ms. Wang, together with her German doctor, carefully analyzed the drugs and foods she had recently taken, and finally selected two Chinese patent medicines and one ingredient that might be problematic and sent them to a professional institution for testing. The results showed that the mercury content in the Ren Dan produced by Tong Ren Tang was seriously exceeded. The mercury content is as high as 9729.985mg/kg.
According to modern medical research, the human body is damaged when the amount of mercury in the urine makes the creatinine value exceed 20 μg/g. In Ms. Wang's first physical examination, this value was as high as 925.3μg/g. The composition of Rendan is clearly marked as containing cinnabar, the main component of cinnabar is mercury sulfide, and also contains a small amount of free mercury (elemental mercury) and soluble inorganic mercury salts.
The blogger also revealed that in order to further confirm, he asked another well-known science blogger to also test another batch of similar products, and the results were still seriously exceeded.
According to him, in order to ensure the accuracy of the test, the testers tested Rendan in different bags three times, and the mercury content was 6.12%, 6.04% and 5.4% respectively, with an average value of 5.85%. Based on this, the blogger pointed out that the average mercury content of this batch of Ren Dan produced by Tong Ren Tang was 58,000 mg/kg, which was nearly 6 times that of the batch of Ren Dan tested in Germany, 580,000 times the EU standard, and 290,000 times the Chinese Pharmacopoeia standard for other Chinese herbal medicines.
In response to the above questions, the 21st Century Business Herald reporter contacted the secretary of the board of directors of Tong Ren Tang by phone many times to understand the relevant situation, and after the phone was connected, the other party said that it was not convenient to be interviewed.
After that, on April 17, 2024, the 21st Century Business Herald reporter consulted the customer service of Taobao and JD.com's Tongrentang official flagship store as a consumer about the above situation, and the other party said: "For this matter, we are still in the process of understanding it, and it will take some time." ”
At the same time, Tongrentang Taobao customer service also said that the production process of Rendan (approval number: Guoyao Zhun Zi Z11020497) meets the requirements of GMP, and the product quality meets the standards stipulated in the "Drug Standards of the Ministry of Health of the People's Republic of China (Traditional Chinese Medicine Prescription Preparations) Volume 5 WS3-B-0907-91".
Previously, according to media reports, on April 12, after Beijing Tong Ren Tang's product Ren Dan was suspected of exceeding the mercury content, Beijing Tong Ren Tang's many online official flagship stores once removed Ren Dan related products from the shelves, and they were put on the shelves again at 18 o'clock on the same day.
The 21st Century Business Herald asked its JD.com and Taobao customer service about the reason why Rendan products were removed from the shelves on April 12, and the other party said that it was because there was no stock at that time.
On April 17, the 21st Century Business Herald reporter searched for three e-commerce platforms, Taobao, Jingdong and Pinduoduo, as well as two online and external platforms of Meituan and Ele.me, and found that Beijing Tongrentang Rendan products can be purchased on the above platforms.
How to strengthen standardized supervision?
The 21st Century Business Herald reporter inquired about the instructions of Rendan's drugs, which showed that Rendan was produced by Beijing Tong Ren Tang Co., Ltd. Tong Ren Tang Pharmaceutical Factory, which was used for nausea, chest tightness, dizziness, motion sickness and seasickness caused by heatstroke. Dosage is 10-20 capsules with warm water or warm water.
Regarding the contraindications and adverse reactions of the drug, the drug instructions are not clear.
In terms of precautions for medicines, including light diet, it is not advisable to take tonic proprietary Chinese medicines at the same time during the period of taking medicine, and people with severe chronic diseases such as hypertension, heart disease, liver disease, diabetes, kidney disease, pregnant women or patients undergoing other treatments should take it under the guidance of a physician. There are no tips on mercury poisoning.
According to the Ministry of Health's standard Chinese medicine prescription book 5, Rendan's prescription includes tangerine peel, sandalwood, sand kernel, cardamom (peeled), licorice, wood, cloves, patchouli leaves, catechus, cinnamon, menthol, borneol and cinnabar. A total of 1260g of these materials are in the prescription, of which the content of cinnabar is 100g, while the specification of Rendan is 0.3g per 10 grains.
Regarding the controversial ingredient cinnabar in Rendan, according to the introduction of the Chinese Pharmacopoeia 2020 Edition (hereinafter referred to as the "Pharmacopoeia"), this product is a sulfide mineral cinnabar group cinnabar, which mainly contains mercury sulfide (HgS). After excavation, select the pure ones, use magnets to absorb iron-containing impurities, and then use water to remove miscellaneous stones and sediment.
In terms of inspection, the pharmacopoeia also introduced that this product contains bivalent mercury in mercury (Hg), not more than 0.10%. In terms of sexual taste and meridian attribution, it is sweet, slightly cold, and poisonous. Return to the Heart Sutra.
In addition, the pharmacopoeia also pointed out that this product is toxic, should not be taken in large quantities, and should not be taken in small quantities for a long time; pregnant women and people with liver and kidney insufficiency are prohibited.
The pharmacopoeia also stipulates the consistency limit guidance value of heavy metals and harmful elements, among which the mercury in medicinal materials and decoction pieces (plants) shall not exceed 0.2mg/kg.
It is understood that as early as 2013, Tongrentang was also exposed to excessive mercury content due to the presence of cinnabar in some drugs. In early May 2013, the Hong Kong Department of Health ordered the Hong Kong Department of Health (DH) to recall a proprietary Chinese medicine called "Healthy Five Tonic Pills" from Beijing Tong Ren Tang because the mercury content exceeded the upper limit by five times. The Hong Kong Department of Health (DH) said in the notice that the staff of the Department of Health found that the mercury content of the sample of "Healthy Five Supplements" (registration number: HKP-08760, batch code: 1033946) was about 5 times the upper limit during daily monitoring, so it ordered a recall.
Shortly after the recall, some industry insiders revealed to relevant media that nearly 40 drugs under Tong Ren Tang Group contained cinnabar (the main ingredient mercury sulfide), and pointed out for example that the cinnabar content of Niu Huang Qianjin Powder and Xiao'er Zhibao Pill was 17.3% and 0.72% respectively, the former exceeded the domestic standard, and the latter far exceeded the Hong Kong standard.
At that time, Jiang Erguo, deputy director of the Chinese herbal medicine information center of the China Association of Traditional Chinese Medicine, pointed out to the media that the hard standard requirements for heavy metal content have not started for a long time, although the country has corresponding requirements for heavy metal content, but due to the limitations of technology and equipment, many places are not in place, and are currently in the process of improvement.
Later, on May 22, 2013, Tong Ren Tang issued a statement on its official website to prove its innocence, stating that the Chinese patent medicines containing cinnabar produced by Tong Ren Tang are all national drug standards such as pharmacopoeia prescriptions. The statement also pointed out that Tong Ren Tang's Chinese patent medicines containing cinnabar are processed, produced and sold in strict accordance with national drug standards, and patients are safe and effective when taking them in accordance with the instructions of the doctors.
For the problem of excessive heavy metal content in traditional Chinese medicine, a research expert in the traditional Chinese medicine industry told the reporter of the 21st Century Business Herald that many classic Chinese patent medicine products contain mineral drugs, and traditional Chinese medicine from multiple mineral sources contain heavy metals, such as cinnabar, realgar, etc., which are an important part of the prescription. For these proprietary Chinese medicines, it is not suitable to discuss the issue of whether they exceed the standard or not, and the standardization of drug safety should be strengthened.
At the same time, the expert also pointed out that the dosage information of drugs should be refined, and the usage and dosage of multiple Chinese patent medicines, even those containing heavy metals, are vaguely described, such as "10-20 capsules at a time", etc., the dosage description is not accurate, and it is not clear how many times it should be taken. In addition, the description of contraindications should also be strengthened. For proprietary Chinese medicines containing heavy metals, sensitive groups such as infants and pregnant women should be marked with caution.
Deng Yong, a professor of health law at the Law Department of Beijing University of Chinese Medicine, also pointed out in an interview with the 21st Century Business Herald reporter that there is still a gap between the mainland and Europe, the United States and Japan in terms of the standardization of heavy metal elements in Chinese herbal medicines. First of all, in terms of testing technology and equipment, Europe, the United States and Japan are usually more advanced; in terms of regulations and policies, Europe, the United States and Japan have stricter regulations and standards; in information sharing and cooperation, information sharing and international cooperation between the above-mentioned countries may be more frequent; with regard to research and development, there may be relatively little domestic research in this area, resulting in limited standardization work; in terms of resources and funds, standardization work requires a lot of resources and financial support.
As for how to strengthen the supervision of heavy metal elements in Chinese herbal medicines, Deng Yong believes that first of all, it is necessary to strengthen regulations and policies, formulate stricter regulations and standards, secondly, to improve testing capabilities, invest in advanced testing equipment and technology, third, to strengthen information sharing, and share information and data with other countries and international organizations, in addition, it is public education and participation to improve the public's awareness of the quality of Chinese herbal medicines; finally, it is still strict quality control, from planting to processing, the whole process of strict quality control, and specific solutions require multi-faceted cooperation and long-term efforts。
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