| 蛋白质补充液的细菌内毒素检测 |
| |
| 引用本文： | 陈丹丹,付步芳,付海洋,黄清泉.蛋白质补充液的细菌内毒素检测[J].中国药事,2013(8):838-841. |
| |
| 作者姓名： | 陈丹丹 付步芳 付海洋 黄清泉 |
| |
| 作者单位： | 中国食品药品检定研究院,北京100050 |
| |
| 摘 要： | 目的 考察蛋白质补充液的细菌内毒素检查方法的可行性.方法 依据《中华人民共和国药典》2010年版附录XIE细菌内毒素检查法和美国FDA的鲎试验应用指南,使用内毒素分散剂消除供试品的干扰作用,检测蛋白质补充液的细菌内毒素含量是否符合规定.结果 蛋白质补充液在使用内毒素分散剂稀释2倍后对细菌内毒素实验无干扰作用,其细菌内毒素限值符合规定.结论 该产品可以采用细菌内毒素检查法.
|
| 关 键 词： | 细菌内毒素 干扰试验 分散剂 |
Bacterium Endotoxin Test of Protein Supplement |
| |
| Chen Dandan,Fu Bufang,Fu Haiyang and Huang Qingquan.Bacterium Endotoxin Test of Protein Supplement[J].Chinese Pharmaceutical Affairs,2013(8):838-841. |
| |
| Authors: | Chen Dandan Fu Bufang Fu Haiyang and Huang Qingquan |
| |
| Affiliation: | (National Institute for the Control of food and Pharmaceutical Products, Beijing 100050) |
| |
| Abstract: | Objective To investigate the feasibility of bacterium endotoxin test for protein supplement. Methods According to the Chinese Pharmacopoeia Edited 2010 and the US FDA Guideline for LAI. test applications, endotoxin dispersing agent was used to overcome the inhibition, and the endotoxin limit value of sample was measured. Results There was no interference effect for bacterium endotoxin test when the protein supplement was diluted 2 folds by using endotoxin dispersing agent. Conclusion Bacterium endotoxin test could be used in this product. |
| |
| Keywords: | bacterium endotoxin interference test endotoxin dispersing agent |
| 本文献已被 维普 等数据库收录！ |
