葡萄糖酸钙注射液细菌内毒素检查法研究 |
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引用本文: | 张红宇,高菊珍,王璐.葡萄糖酸钙注射液细菌内毒素检查法研究[J].中国药品标准,2007,8(3):55-58. |
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作者姓名: | 张红宇 高菊珍 王璐 |
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作者单位: | 云南省药品检验所,昆明,650011 |
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摘 要: | 目的:对葡萄糖酸钙注射液进行细菌内毒素检查法研究,建立其细菌内毒素检查方法。方法:按《中国药典》2005年版二部附录XIE细菌内毒素检查法进行。结果:葡萄糖酸钙注射液在2.5mg/ml稀释浓度对细菌内毒素检查法无干扰作用,其细菌内毒素限值L为0.1E。/mg。结论:可采用细菌内毒素检查法替代家兔热原法对葡萄糖酸钙注射液进行细菌内毒素检查。
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关 键 词: | 葡萄糖酸钙注射液 细菌内毒素检查法 干扰试验 |
文章编号: | 1009-3656(2007)-3-55-4 |
Study on the Bacterial Endotoxins Test of Calcium Gluconate Injection |
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Authors: | Zhang Hongyu Gao Juzhen and Wang Lu |
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Institution: | Yunnan Institute for Drug Control ,Kunming 650011 |
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Abstract: | Objective:To study the Bacterial Endotoxins Test of Calcium Gluconate Injection.Methods:According to the Bacterial Endotoxins Test and inhibition or enhancement test approved by Chinese pharmacopoeia 2005 edition.Results:2.5mg/ml solution of Calcium Gluconate Injection don't inhibit or enhance the test,L=0.1Eu/mg.Conclusion:These results suggest that the Bacterial Endotoxins Test can be used for the detection of endotoxin in Calcium Gluconate Injection instead of pyrogen test. |
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Keywords: | Calcium Glueonate Injection Bacterial Endotoxins Test inhibition and enhancement test |
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