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To study the whole chain microbial load in the production of a traditional Chinese medicine pill.
A type of traditional Chinese medicine pills prescription was selected as the research object，including the medicinal materials and their purified medicinal materials，intermediates (mixed powder，waiting for inner packaging pills)，and finished products. The microbial limit test method was established according to the 2020 edition of the Chinese Pharmacopoeia（ChP），to detect and analyze the microbial loads of all samples collected throughout the entire chain from medicinal materials to finished products of the traditional Chinese medicine pills.
The microbial content of different medicinal materials varies greatly，and the varieties with higer risk factors for microbial contamination in medicinal materials were Perillae Folium，Pogostemonis Herba，and Angelicae Dahuricae Radix. The production process of Perillae Folium and Pogostemonis Herba needed to be improved and adjusted from “medicinal material to pure medicinal material”. There was a positive correlation between the microbial load of medicinal materials and intermediate and finished products.
The study on the microbial load throughout the entire production chain of traditional Chinese patent medicines can help us to understand the transmission of microorganisms at each stage. This knowledge is crucial for identifying weak links in the production process and the key areas for process control, and has an important guiding significance for traditional Chinese patent medicines manufacturers to improve and explore their production process.
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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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