| 破伤风抗毒素渗透压的质量控制标准 |
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| 引用本文： | 段丽娟,梁桂香,杨俊杰,张金. 破伤风抗毒素渗透压的质量控制标准[J]. 微生物学免疫学进展, 2013, 0(5): 27-30 |
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| 作者姓名： | 段丽娟 梁桂香 杨俊杰 张金 |
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| 作者单位： | 兰州生物制品研究所有限责任公司甘肃省疫苗工程技术研究中心,兰州730046 |
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| 摘 要： | 目的：通过对不同厂家破伤风抗毒素产品的渗透压浓度的调查，了解国内该产品的渗透压浓度的波动范围，为生产过程中渗透压浓度质量控制提供依据。方法采用Advanced 3250型冰点渗透压仪检测破伤风抗毒素的渗透压浓度。结果不同厂家破伤风抗毒素制品的渗透压浓度均不低于240 mOsmol/L。结论破伤风抗毒素渗透压浓度波动范围均与国外同类制品基本一致，符合欧洲药典规定。
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| 关 键 词： | 破伤风抗毒素 渗透压 F（ah’）2 |
The standard for quality control of tetanus antitoxin osmotic pressure |
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| DUAN Li-juan,LIANG Gui-xiang YANG Jun-jie,ZHANG Jin. The standard for quality control of tetanus antitoxin osmotic pressure[J]. Progress In Microbiology and Immunology, 2013, 0(5): 27-30 |
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| Authors: | DUAN Li-juan LIANG Gui-xiang YANG Jun-jie ZHANG Jin |
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| Affiliation: | ( Lanzhou Institute of Biological Products Co. Ltd. , Center for Gansu Provincial Vaccine Engineering Research, Lanzhou 730046, China) |
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| Abstract: | Objce tive It is on the purpose to clarify the osmotic pressure fluctuation range of tetanus antitoxin in domestic market , and to provide data basis for the control of osmotic pressure in the manufacturing process. Methods Osmotic pressure of tetanus antitoxin produced by different manufacturers was detected by a freezing point osmometer .Results Os-motic pressure of tetanus antitoxin in domestic market was not less than 240mOsmol/L.Conclusion The fluctuation range for osmotic pressure of domestic tetanus antitoxin is basically same as that of the foreign products , and all meet the require-ment of the European Pharmacopoeia 7.0edition . |
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| Keywords: | Tetanus antitoxin（TAT） Osmotic pressure F（ ab＇） 2 |
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