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To establish a microbial limit test method and quality standard conforms to the USP for compound Kushen extract and its related components.
Comparative analysis was conducted on the standards for traditional Chinese medicine preparations and decoction pieces in the USP and the Chinese Pharmacopoeia 2020 Edition to determine the microbial limit standards for compound Kushen extract and its related components. Then，guided by the General Principles of the USP<61> and <62>，a microbial limit test method suitable for compound Kushen extract and its related components was developed. The plate pouring method was used to perform a methodological applicability test on the total aerobic bacterial count，mold and yeast count of compound Kushen extract and its two components Sophorae Flavescentis Radix and Heterosmilacis Rhizoma. The method applicability test was conducted on the control bacteria using the direct inoculation method. Finally，the MALDI/TOF MS microbial identification method and bacterial 16S rRNA gene sequence alignment analysis method were comprehensively used to identify the bacterial species of the contaminated microorganisms in the sample，and further analysis was conducted on the distribution and harm of the contaminated microbial population.
As a result，microbial limit standards for compound Kushen extract and its related components were established in accordance with the requirements of the USP. The recoveries of the counting methods for compound Kushen extract and its two components，Sophorae Flavescentis Radix and Heterosmilacis Rhizoma，were between 0.5 and 2.0. The positive control strains in the control bacterial method suitability test were able to grow，meeting the requirements of the USP. According to the identification results，40 contaminated microorganisms involved 13 species and 5 genera，mainly covering different types of Bacillus genus (87.5%)，Enterobacterium genus (10%)，and Pseudomonas genus (2.5%). Polluting microorganisms were all less harmful conditional pathogenic bacteria.
Established a microbial limit test method and quality standard conforms to the USP for compound Kushen extract and its related components. Defined the distribution and harm analysis of the pollution microorganism poulation of the above products. Improved the microbial quality control of the Chinese medicine preparation and its components.
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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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