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The comparison of pyrogen tests for heat-clearing Xingnaojing Injection
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Qun LIU1, Xin RUAN2, Jian RUAN1
Chinese Journal of New Drugs | 2021, 30(8) : 760 - 764
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收藏切换
Chinese Journal of New Drugs | 2021, 30(8): 760-764
The comparison of pyrogen tests for heat-clearing Xingnaojing Injection
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Qun LIU1, Xin RUAN2, Jian RUAN1
Affiliations
  • 1Yantai Center for Food and Drug Control and Test, Yantai 264670, China
  • 2Technology Center of Yantai Customs, Yantai 264000, China
Published: 2021-04-30
Outline
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Objective:

To compare the rabbit method and dynamic turbidity method for pyrogen detection in heat-clearing Xingnaojing injection.

Methods:

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.

Results:

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.

Conclusion:

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.

Xingnaojing injection  /  bacterial endotoxin  /  pyrogen test  /  dynamic turbidimetry
刘群, 阮新, 阮健. 清热类中药醒脑静注射液热原检测方法的比较. 中国新药杂志, 2021 , 30 (8) : 760 -764 .
Qun LIU, Xin RUAN, Jian RUAN. The comparison of pyrogen tests for heat-clearing Xingnaojing Injection[J]. Chinese Journal of New Drugs, 2021 , 30 (8) : 760 -764 .
Year 2021 volume 30 Issue 8
38
9
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  • Online Date:2026-10-28
  • Published:2021-04-30
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  • Accepted:2020-09-05
Affiliations
    1Yantai Center for Food and Drug Control and Test, Yantai 264670, China
    2Technology Center of Yantai Customs, Yantai 264000, China
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表12种不同金属材料的力学参数
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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