Full
Outline
To investigate the changes in the content of 4 kinds of andrographolide components in Andrographis herba decoction pieces before and after mold contamination, and analyze the impacts of different mold contamination degrees on the content of these 4 kinds of lactones.
According to the general principle 1108 microbial limit test for traditional Chinese medicine decoction pieces: Microbial enumeration tests in volume IV of the Chinese pharmacopoeia (2020 Edition), the method for enumeration of molds and yeasts was established and validated. The established method was used to count molds in Andrographis herba decoction pieces before and after mold contamination. High performance liquid chromatography was employed to determine the content of 4 kinds of andrographolide components in Andrographis herba decoction pieces before and after mold growth.
Andrographis herba decoction pieces showed weak inhibitory effects on Aspergillus niger and Candida albicans during the method suitability test. When the sample was diluted at 1:10, miscellaneous bacterial interference affected the detection. When the sample dilution reached 1:100, the interference was reduced, and the recovery ratios of the 2 kinds of test strains were both within the range of 0.5–2.0. Therefore, a sample dilution of 1:100 or higher could be used for the enumeration of molds and yeasts, with the plate pour plate method adopted for the test. In the high performance liquid chromatography determination of the 4 kinds of andrographolide components under the established chromatographic conditions, the 4 kinds of components exhibited good linearity in their respective concentration ranges (r>0.9999), with recoveries ranging from 95.31% to 104.14% and relative standard deviations less than 5% (n=6). After 20 batches of andrographolide slices were moulded, the content of dehydrated andrographolide was reduced by 62% on average, the content of new andrographolide was reduced by 69% on average, the content of andrographolide was reduced by 75% on average, and the content of deoxyandrographolide was reduced by 88% on average.
After mold contamination of Andrographis herba decoction pieces, the content of deoxyandrographolide decreases slightly, while the content of andrographolide, neoandrographolide and dehydroandrographolide decrease significantly. Therefore, regular monitoring during the storage of Andrographis herba decoction pieces is necessary to ensure they are free from microbial (mold) contamination and to guarantee the safety and effectiveness of medication. Meanwhile, this study on the impact of mold contamination on the content of active components in Andrographis herba decoction pieces provides a basis for establishing a more comprehensive quality standard for Andrographis herba decoction pieces.
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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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