| 注射用头孢呋辛钠细菌内毒素检查法研究 |
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| 引用本文： | 涂雪琼.注射用头孢呋辛钠细菌内毒素检查法研究[J].中国药业,2006,15(7):34-35. |
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| 作者姓名： | 涂雪琼 |
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| 作者单位： | 深圳市制药厂,广东,深圳,518029 |
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| 摘 要： | 目的 建立注射用头孢呋辛钠的细菌内毒素检查方法。方法 采用2000年版《中国药典（二部）》附录Ⅺ E细菌内毒素检查法和附录ⅪⅩF细菌内毒素检查法。结果 注射用头孢呋辛钠在6.68mg/mL稀释浓度时对细菌内毒素检查法无干扰作用，其细菌内毒素限值L=0.15EU/mg。结论 可采用细菌内毒素检查法代替家兔热原法对注射用头孢呋辛钠进行细菌内毒素检查。
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| 关 键 词： | 注射用头孢呋辛钠 细菌内毒素检查法 干扰试验 |
| 文章编号： | 1006-4931(2006)07-0034-02 |
| 收稿时间： | 02 13 2006 12:00AM |
| 修稿时间： | 2006年2月13日 |
Study of Bacterial Endotoxins Test in Cefuroxime Sodium for Injection |
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| Tu Xueqiong.Study of Bacterial Endotoxins Test in Cefuroxime Sodium for Injection[J].China Pharmaceuticals,2006,15(7):34-35. |
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| Authors: | Tu Xueqiong |
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| Institution: | Shenzhen Pharmaceutical Factory, Shenzhen, Guangdong, China 518029 |
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| Abstract: | Objective To study the bacterial endotoxins test in cefuroxime sodium for injection. Methods The bacterial endotoxins test and inhibition or enhancement test approved by Chinese Pharmacopoeia of 2000 edition were used. Results 6. 68 mg/mL solution of cefuroxime sodium for injection did not inhibit or enhance the test,L = 0. 15 EU/mg. Conclusion These results suggest that the bacterial endotoxins test can be used for the detection of endotoxin in cefuroxime sodium for injection instead of pyrogen test. |
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| Keywords: | cefuroxime sodium for injection bacterial endotoxins test inhibition and enhancement test |
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