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Outline
To verify the method of bacterial endotoxin test for octreotide acetate microspheres for injection.
According to the bacterial endotoxin test method of Chinese Pharmacopoeia (2020 edition), octreotide acetate microspheres for injection was dissolved by DMSO and diluted with water. Interference test and endotoxin recovery test were carried out with two manufacturers' gel limulus amebocyte lysate.
There was no interference between bacterial endotoxin and limulus reagent when the concentration of octreotide acetate microspheres for injection was diluted to 0.007 mg·mL-1. The recovery of bacterial endotoxin in DMSO solution was between 50% and 200%. DMSO can be used for dissolving octreotide acetate microsphere to perform bacterial endotoxin test.
Bacterial endotoxin test is suitable for the detection of octreotide acetate microspheres for injection.
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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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