《Table 2–Results of empty micellar pyrogen test.》
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《LAL test and RPT for endotoxin detection of CPT-11/DSPE-mPEG_(2000) nanoformulation: What if traditional methods are not applicable》
Total temperature rise:0.74°C.
To test the interference of empty micelle to body temperature increase of rabbits，we performed a preliminary experiment.Empty micelle（batch 20150323EM）was diluted with 5%glucose injection solution to prepare a micelle solution of 12.0 mg/ml，which corresponds to a drug concentration of 2.8 mg/ml（maximum injection concentration）in drug-containing micelles.Each rabbit was injected with 10 ml of the solution per kg of body weight.All the procedures in this test followed the Chinese Pharmacopoeia（2015 edition，fourth part，1142 pyrogen test method）.The results are listed in Table 2.In three rabbits，the body temperature rise was lower than 0.6°C，and the total temperature rise of three rabbits was less than 1.3°C.It showed that the empty micelles did not increase the body temperature of rabbits，and proved that the excipients used in the formulation did not interfere with the pyrogen test.
| 图表编号 | XD00596000 严禁用于非法目的 |
|---|---|
| 绘制时间 | 2018.05.01 |
| 作者 | Yanan Jin、Juanjuan Jia、Chan Li、Jianqi Xue、Jiabei Sun、Kaiyuan Wang、Yaling Gan、Jing Xu、Yaqin Shi、Xingjie Liang |
| 绘制单位 | College of Chemistry & Environmental Science, Key Laboratory of Medicinal Chemistry and Molecular Diagnosis of the Ministry of Education, Hebei University、National Institutes for Food and Drug Control, No. 5, Huatuo Rd., Daxing District、Laboratory of Cont |
| 更多格式 | 高清、无水印（增值服务） |
