I. Overview of aflatoxins
Aflatoxins are toxic metabolites of a class of fungi (Aspergillus flavus and Aspergillus parasiticus) that are highly carcinogenic and are found in medicinal materials, grains, nuts, cottonseed, and animal feed-related products. Toxicity is much higher than the toxicity of cyanide, arsenide and organic pesticides, and B1 is the most toxic. Acute poisoning, acute hepatitis, hemorrhagic necrosis, hepatic steatosis, and bile duct hyperplasia occur when a person consumes a large amount. When the trace is continuously ingested, it will cause chronic poisoning, growth disorders, and cause fibrous lesions, resulting in fibrous tissue hyperplasia.
The State Food and Drug Administration has requested to strengthen the safety of heavy metals and harmful elements, pesticide residues, aflatoxins, etc. in the notice on regulating the violation of laws and regulations in the production and management of Chinese medicines (Guo Food and Drug Administration [2012] No. 187) The detection and control of sexual indicators, to ensure the quality and safety of Chinese herbal medicines, and to require enterprises to have the inspection equipment and capabilities appropriate to the production varieties, strict quality inspection. "National Drug Safety "Twelfth Five-Year Plan", the plan clearly states "to carry out rapid drug testing technology research, build a testing technology sharing platform", "accelerate the application of rapid drug testing technology at the grassroots level, configure rapid testing equipment", Strengthen the requirements of county-level institutions for rapid inspection capacity building.
2. Chinese medicinal materials tested for aflatoxin and their national limit standards
The 2010 edition of the Chinese Pharmacopoeia stipulates five kinds of medicinal materials for aflatoxin examination: jujube kernel, silkworm, fat sea, dried tangerine peel, and peach kernel.
The current 2015 edition of the Chinese Pharmacopoeia stipulates that 19 kinds of Chinese herbal medicines for aflatoxin examination, compared with the 2010 edition of the Chinese Pharmacopoeia, added 14 varieties:
(1) Roots and rhizomes: Yuanzhi;
(2) Fruit seeds: jujube, nutmeg, cassia seed, malt, tangerine peel, gentian, baiziren, fat sea, lotus seed, peach kernel, betel nut, jujube kernel, coix seed;
(3) Animals: leeches, earthworms, cockroaches, cockroaches, silkworms.
The requirements of the Chinese Pharmacopoeia for the detection of aflatoxin not only highlight the characteristics of the overall quality control of traditional Chinese medicine, but also increase and improve the requirements for safety control.
Third, aflatoxin exceeded the standard frequency
1. On August 10, 2017, Shanghai Food and Drug Administration issued the 4th Announcement on the Quality of Drug Supervision and Inspection in 2017. According to the announcement, 7 pieces of decoction produced by 6 pharmaceutical companies were unqualified, and the unqualified items included content determination, traits, processing, leachate, aflatoxin and so on. Statistics show that the traits and processing of the batches that do not meet the standard are the most, with a total of 4 batches.
2. According to the EU Food and Feed Rapid Alert System (RASFF), on August 10, 2017, Spain notified RASFF that China's export of shelled peanuts was unqualified. The reason for the failure was that the aflatoxin exceeded the standard.
Some drugs and foods have been found to have aflatoxins exceeding the standard. Some problems are found in raw materials, and Others are not found in the self-inspection process, indicating that there are obvious defects in their production and quality control.
4. Rapid quantitative detection of aflatoxin B1 in Chinese herbal medicines in Shanghai Feizheng - accurate quantification in -8min
Based on the leading fluorescence quantitative FPOCT technology platform, Shanghai Festo Biotechnology can quickly and accurately detect the residual content of aflatoxin B1 in Chinese herbal medicines in 8 minutes. The accuracy is in line with the HPLC method and is suitable for all kinds of Chinese herbal medicine processing enterprises. Third-party testing agencies and government regulatory agencies.
4.1. Aflatoxin B1 Fluorescence Quantitative Rapid Detection System Performance
ïµ detection sensitivity: 0.5μg / kg;
ïµQuantitative linear range: 1.0μg/kg - 75.0μg/kg;
ïµ sample pretreatment time: 7min;
ïµ Detection time: 8min;
ïµAccuracy: recovery rate is 80%-125%;
ïµ specificity: no cross-reactivity with other mycotoxins at a concentration of 1000 μg/kg;
4.2. Sample preparation process
1. Crushing (pulverization and weighing of Chinese herbal medicine samples)
2. Oscillation extraction (5min);
3. Centrifugation (2min);
4.3. Detection operation process
1. Dilution;
2. Sample addition reaction (8 min);
3, reading, print test report;
4.4. Results interpretation and output
Reading with a portable aflatoxin B1 detector makes the test results more accurate and objective, avoiding human error.
The test result will be presented on the liquid crystal display of the fluorescence reader. At the same time, the paper test report can be obtained by pressing the print button. In addition, after the WIFI data upload function of the instrument is turned on, the relevant data information will be automatically uploaded to the “Food Safety Traceability Managementâ€. Cloud platform for easy traceability and quality management.
4.5. Shanghai fly test biomycotoxin series fluorescence quantitative test strip product advantages
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