| 羟乙基淀粉40氯化钠注射液中细菌内毒素的检查方法 |
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| 引用本文： | 王瑶,刘洋,胡晨,孟长虹,史清水.羟乙基淀粉40氯化钠注射液中细菌内毒素的检查方法[J].江苏药学与临床研究,2019,27(3):193-196. |
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| 作者姓名： | 王瑶 刘洋 胡晨 孟长虹 史清水 |
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| 作者单位： | 南京医科大学公共卫生学院,江苏省食品药品监督检验研究院,无,南京医科大学公共卫生学院,南京医科大学公共卫生学院 |
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| 摘 要： | 目的：建立羟乙基淀粉40氯化钠注射液细菌内毒素的检查方法。方法：按《中国药典》2015年版四部通则1143细菌内毒素检查法及相关规定，对3批供试品分别用凝胶限度试验和动态浊度法进行干扰试验和细菌内毒素检查。结果：3批供试品的内毒素结果都符合规定。结论：羟乙基淀粉40氯化钠注射液可适用细菌内毒素检查法控制质量,其细菌内毒素限值确定为0.50 EU·mL-1。
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| 关 键 词： | 羟乙基淀粉40氯化钠注射液 细菌内毒素 凝胶限度试验 动态浊度法 |
| 收稿时间： | 2019/1/4 0:00:00 |
| 修稿时间： | 2019/6/19 0:00:00 |
Study on Bacterial Endotoxin Test of Hydroxyethyl Starch 40 Sodium Chloride Injections |
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| wangyao,LIU yang,huchen,mengchanghong and Shi qing shui.Study on Bacterial Endotoxin Test of Hydroxyethyl Starch 40 Sodium Chloride Injections[J].Jiangsu Pharmacertical and Clinical Research,2019,27(3):193-196. |
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| Authors: | wangyao LIU yang huchen mengchanghong and Shi qing shui |
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| Abstract: | Objective: To establish a method for the bacterial endotoxin test of Hydroxyethyl Starch 40 Sodium Chloride Injections. Methods: According to the general principles 1143 of Chinese Pharmacoposia 2015 edition (four), three batches of injections were tested by gel limit test and dynamic turbidimetric test, respectively, for bacterial endotoxin. Results: The endotoxin results of 3 batches of samples were in accordance with the regulations. Conclusion: The established method can be used for the bacterial endotoxin test of Hydroxyethyl Starch 40 Sodium Chloride Injections, and the limitation of bacterial endotoxin was 0.50 EU·mL-1. |
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| Keywords: | Hydroxyethyl starch 40 sodium chloride injection Bacterial endotoxin test Gel limit test Kinetic turbidimetric assay |
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