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OBJECTIVE To establish a quality control method of human chain-activated immune cell preparations. METHODS The ability to secrete cytokines and in vitro cytotoxicity were detected by co-culture and flow cytometry analysis. Purity was determined by flow cytometry. The concentration of live cells and cell viability were determined by AO/PI dual fluorescence cell counter. The residual cytokines were determined by enzyme-linked immunosorbent assay. Mycoplasma nucleic acid was detected by probe real-time PCR.Other detection items were carried out according to the provisions of the 3rd part of Chinese Pharmacopoeia 2020. RESULTS The detection of human chain-activated immune cell preparations was carried out using the established method,and the results of biological activity research, physical and chemical characteristics research, and cytokine residual detection were normally distributed. The detection results were valid,and the coefficient of variation(CV) was less than 20%. All other indicators met the requirements of the Chinese Pharmacopoeia 2020. CONCLUSION A preliminary quality control method of human chain-activated immune cell preparations are established, which has the characteristics of ensuring the quality control lability, safety, and effectiveness of the cell preparations. It can be used for the quality control of the human chain-activated immune preparations.
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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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