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To investigate the microbial contamination in commercially available Angelicae Sinensis Radix decoction pieces and analyze the potential safety risks.
According to the General Principles of the Pharmacopoeia of the People’s Republic of China (referred to as the “Chinese Pharmacopoeia”) (2020 edition <1108 Microbial Limit Examination of Chinese Herbal Medicine>)，the total aerobic microbial count (TAMC)，total combined yeasts and molds count (TYMC)，heat-resistant bacterial count，control pathogens，and bile-tolerant gram-negative bacterial count were determined. High-throughput sequencing technology was utilized to analyze the dominant microbial species present in representative samples and identify potential objectionable microorganisms.
There was a high level of uncertainty regarding microbial contamination in commercially available Angelicae Sinensis Radix，and the dominant group in different types had significant differences. The TAMC ranged from 102 to 106 CFU·g-1，while a uneven contamination of bile-tolerant gram-negative bacteria，including potentially pathogenic species such as Acinetobacter baumannii，Klebsiella pneumoniae and Enterobacter cloacae，but Salmonella was not detected in any samples. The total combined yeasts and molds count ranged from 101 to 103 CFU·g-1.
The microbial contamination in Angelicae Sinensis Radix is severe and uneven. More data is needed to improve testing methods and evaluation standards for assessing the risk of microbial contamination in Chinese herbal medicine. High-throughput sequencing can provide a more accurate assessment of microbial risks in decoction samples of traditional Chinese herbal medicine.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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