| 羟乙基淀粉200/0.5氯化钠注射液细菌内毒素检查的可行性研究 |
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| 引用本文： | 金曼,程春萍,周树美.羟乙基淀粉200/0.5氯化钠注射液细菌内毒素检查的可行性研究[J].齐鲁药事,2013(9):521-522,529. |
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| 作者姓名： | 金曼 程春萍 周树美 |
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| 作者单位： | 山东齐都药业有限公司,山东淄博255400 |
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| 摘 要： | 目的对羟乙基淀粉200/0.5氯化钠注射液进行凝胶法干扰试验,建立羟乙基淀粉200/0.5氯化钠注射液细菌内毒素的检查方法。方法按2010年版《中国药典》(二部)"细菌内毒素检查法",用不同厂家的鲎试剂对不同批号的羟乙基淀粉200/0.5氯化钠注射液分别进行干扰试验。结果羟乙基淀粉200/0.5氯化钠注射液进行2倍以上稀释的溶液对细菌内毒素检查无干扰作用。结论羟乙基淀粉200/0.5氯化钠注射液进行细菌内毒素检查是可行的。
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| 关 键 词： | 羟乙基淀粉200/0.5氯化钠注射液 细菌内毒素检查法 干扰试验 |
Study on the test method of bacterial endotoxin in Hydroxyethyl Starch 200/0.5 and Sodium Chloride Injection |
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| JIN Man,CHENG Chun-ping,ZHOU Shu-mei.Study on the test method of bacterial endotoxin in Hydroxyethyl Starch 200/0.5 and Sodium Chloride Injection[J].qilu pharmaceutical affairs,2013(9):521-522,529. |
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| Authors: | JIN Man CHENG Chun-ping ZHOU Shu-mei |
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| Institution: | ( Shandong Qidu Pharmaceutical Co. , Ltd. , Zibo 255400, China } |
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| Abstract: | Objective To establish a bacterial endotoxin test for Hydroxyethyl Starch 200/0.5 and Sodium Chloride Injection. Methods According to the bacterial endotoxin test in Chinese Pharmacopoeia 2010. Different batches of Hydroxyethyl Starch 200/0.5 and Sodium Chloride Injection from different TAL manufacturers were underwent the interfer- ence tests. Results There was no interference in the bacterial endotoxin test when the concentration of Hydroxyethyl Starch 200/0.5 was for more than 2 times diluted solution. Conclusion Carrying out the bacterial endotoxin test for Hydroxyethyl Starch 200/0.5 and Sodium Chloride Injection was feasible. |
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| Keywords: | Hydroxyethyl Starch 200/0 5 and Sodium Chloride Injection Bacterial endotoxin test Interference test |
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