To compare the rabbit method and dynamic turbidity method for pyrogen detection in heat-clearing Xingnaojing injection.
Three batches of heat-clearing type Chinese medicine injection, Xingnaojing injection, were selected as the research object. Animals were divided into seven groups, including endotoxin, 3 groups of endotoxin+endotoxin test samples, 3 groups of endotoxin test samples. Pyrogen was tested using rabbit pyrogen examination. At the same time, the endotoxin in Xingnaojing Injection was quantitatively detected by dynamic turbidimetry.
No pyrogen reaction was found in 3 batches of test sample groups by rabbit method. The body temperature of rabbits in endotoxin group increased by 0.6 ℃, and the pyrogen reaction occurred. Compared with the endotoxin group, the pyrogen test in endotoxin+test group was false negative. The contents of bacterial endotoxin in 3 batches of Xingnaojing Injection groups were determined by dynamic turbidimetric method, the content of endotoxin was <0.01 EU·mL-1.
Rabbit pyrogen test is easy to produce false negative results for pyrogen test of heat-clearing Xingnaojing Injection, and dynamic turbidimetry can quantitatively detect the contents of bacterial endotoxin.
| 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 |