Japan's health ministry said that tests confirmed that the Kobayashi Pharmaceutical company containing monasaccharide ingredients in the raw material of the health care product was the cause of kidney dysfunction in consumers, and the other two "unexpected" substances did not have kidney toxicity.
Xinhua News Agency integrated Japan's Kyodo News Agency, Kansai TV and other media reported that animal experiments conducted by the National Research Institute of Japan showed that only rats ingested soft penicillitic acid (Patulin) had kidney dysfunction, while the other two "unexpected" substances did not have a negative impact on the kidneys of rats.
The Ministry of Health speculated that the plant that produces monascus raw materials mixed penicillium in the process of cultivating monascus and produced puberulinic acid. The other two "unexpected" substances may be monacolin K, the active ingredient of monascus health products, which is changed under the action of penicillium.
Earlier, the Health Ministry and the city of Osaka conducted an on-site inspection of Kobayashi Pharmaceutical's Osaka plant, which produces monascus raw materials, and extracted penicillium from the culture room and other places. In addition, a Kobayashi Pharmaceutical subsidiary plant in Wakayama Prefecture was also inspected.
Kobayashi Pharmaceutical announced in March this year that due to health problems such as kidney diseases after consumers took the company's monascus health products, the company's analysis of its monascus health products and the use of monascus raw materials found that there were "unexpected" ingredients in its own monascus raw materials, and decided to urgently recall all three of the company's monascus health products. Subsequent investigation confirmed the presence of puberulinic acid in these monascus raw materials. In addition to puberulinic acid, two other "unexpected" substances were detected.
According to the latest data released by the Ministry of Health, Labor and Welfare, 2,450 consumers have sought medical treatment after taking Kobayashi Pharmaceutical's health care products containing monaskoji, and the cause and effect of the incident is being investigated in 120 deaths.
Puberulinic acid is a secondary metabolite produced by a variety of molds, including penicillium, Aspergillus and Streptospora. This mycotoxin is toxic and is commonly found in rotten fruits, especially apples, and some fruit juices, jams and other fruit products. Since puberulinic acid is potentially harmful to the human body, especially it may cause digestive system problems, there is a strict limit standard for its content in food safety management to ensure that the health of consumers is protected.
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