| 玻璃酸钠注射液细菌内毒素检查法研究 |
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| 引用本文： | 张婷婷,姜素云,鲁军.玻璃酸钠注射液细菌内毒素检查法研究[J].中国药业,2013,22(11):40-41. |
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| 作者姓名： | 张婷婷 姜素云 鲁军 |
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| 作者单位： | 张婷婷(辽宁省大连市食品药品检验所,辽宁大连,116021)；姜素云(辽宁省大连市食品药品检验所,辽宁大连,116021)；鲁军(辽宁省大连市食品药品检验所,辽宁大连,116021)； |
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| 摘 要： | 目的建立玻璃酸钠注射液的细菌内毒素检查法。方法按2010年版《中国药典(二部)》附录ⅪE进行试验和结果判断。结果玻璃酸钠注射液质量浓度为1.25 g/L时对细菌内毒素检查法无干扰作用。结论玻璃酸钠注射液细菌内毒素检查法可行,其限值可定为0.05 EU/mg。
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| 关 键 词： | 玻璃酸钠注射液 细菌内毒素检查 干扰试验 |
Study on Method of Bacterial Endotoxin Test for Sodium Hyaluronate Injection |
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| Zhang Tingting,Jiang Suyun,Lu Jun.Study on Method of Bacterial Endotoxin Test for Sodium Hyaluronate Injection[J].China Pharmaceuticals,2013,22(11):40-41. |
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| Authors: | Zhang Tingting Jiang Suyun Lu Jun |
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| Institution: | (Dalian Municipal Institute for Drug and Food Control,Dalian,Liaoning,China 116021) |
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| Abstract: | Objective To establish the method of bacterial endotoxin test for Sodium Hyaluronate Injection.Methods To carry out the bacterial endotoxin test according to the Appendix ⅪE in the Chinese Pharmacopoeia（edition 2010,Vol.Ⅱ）.Results The test solution of Sodium Hyaluronate Injection in the mass concentration of 1.25 g/L had no interference effect on the bacterial endotoxin test.Conclusion The established method of the bacterial endotoxin test is applicable for Sodium Hyaluronate Injection and the endotoxin limit value may be set at 0.05 EU/mg. |
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| Keywords: | Sodium hyaluronate injection bacterial endotoxin test interfering test |
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