Tongrentang, Kangmei and other well-known Chinese herbal pieces sampling aflatoxin exceeded the standard


Release time:

2017-08-23

Aflatoxins are classified as Class 1 carcinogens by the cancer research institute of the World Health Organization (WHO). Recently, the State Food and Drug Administration reported that 9 batches of Chinese herbal pieces produced by well-known Chinese medicine companies such as Beijing Tongrentang have detected this unqualified item.

Prior to this, the Shanghai Food and Drug Administration also found that the sampling of decoction pieces produced by six pharmaceutical companies, including Kangmei Pharmaceutical and Tianma Traditional Chinese Medicine, also had problems with aflatoxin and other items.

According to the reporter's statistics, since 2017, as of August 18, the State Food and Drug Administration has issued a total of 609 batches of unqualified Chinese herbal pieces.

Last week, the State Food and Drug Administration reported that Beijing Tongrentang (Bozhou) Decoction Pieces Co., Ltd., Henan Juren Traditional Chinese Medicine Decoction Pieces Co., Ltd., Bozhou Huqiao Pharmaceutical Co., Ltd., Jiangxi Bairen Traditional Chinese Medicine Decoction Pieces Co., Ltd., etc. The unqualified situation of 9 batches of Chinese herbal pieces produced by the company. The unqualified item is aflatoxin.

It is also the problem of aflatoxin. In the announcement on the quality of drug supervision and sampling inspection issued by Shanghai Food and Drug Administration in the fourth phase of 2017, seven decoction pieces produced by six pharmaceutical companies, including Kangmei Pharmaceutical, Jingui traditional Chinese Medicine and Tianma traditional Chinese Medicine, were unqualified. The unqualified items include content determination, character, processing, extract, aflatoxin, etc.

According to reports, because aflatoxins are extremely harmful to human health, in recent years, the "Chinese Pharmacopoeia" has continuously strengthened the control of aflatoxins and continuously improved the limit standards for aflatoxins.

On October 25, 2012, on the basis of the 2010 edition of the Chinese Pharmacopoeia, the State Pharmacopoeia Commission issued a draft limit standard for heavy metals, pesticide residues, aflatoxins and other substances in traditional Chinese medicine.

It stipulates that the "Aflatoxin" inspection item shall be added to the 14 medicinal materials and their decoction pieces included in the Chinese Pharmacopoeia, such as platycladus kernel, lotus seed, geizi, areca nut, malt, nutmeg, cassia seed, polygala, coix seed, jujube, dragon, centipede, leech, scorpion, etc., with the limit of "aflatoxin B1 not more than 5 μg/kg; the total amount of aflatoxin G2, aflatoxin G1 and aflatoxin B2 shall not exceed 10 μg/kg".

The 2015 edition of the "Chinese Pharmacopoeia" added the "aflatoxin" inspection of 14 medicinal materials and their decoction pieces, including platycladus seed, lotus seed, kozi, betel nut, malt, etc.

Aflatoxins are metabolites produced by Aspergillus flavus and Aspergillus parasiticus. When the decoction pieces are not dried in time and stored properly, they are often easily contaminated by Aspergillus flavus or Aspergillus parasiticus to produce such toxins.

Shi Lichen, founder of Max Conley, pointed out to the media that traditional Chinese medicine decoction pieces are drugs that do not account for the "proportion of drugs" at present, and sales can increase rapidly, and all traditional Chinese medicine enterprises have increased the layout of the market for traditional Chinese medicine decoction pieces.

For a long time, the Chinese herbal medicine industry is known for its disorder. In recent years, with the rapid growth of compound annual growth rate and the proportion of sales scale, it is urgent for the industry to further strengthen supervision.

As of August 18 this year, excluding the inspection notices of local drug administration on Chinese herbal pieces, only the State Administration of Drug Administration has notified 14 times and 609 batches of Chinese herbal pieces, with 1-2 notifications every month. The number of enterprises involved and the intensity of inspection and notification are rare.

"The country has increased its flight inspection efforts, and this market has gradually become standardized. However, the supply of high-quality products is relatively small, and the price will be relatively increased." An industry source told reporters that high quality and good price will become a major trend. In addition, the policy dividend will also promote the development and growth of Chinese medicine tablets. (Reporter Li Jie)