破伤风抗毒素渗透压的质量控制标准  

The standard for quality control of tetanus antitoxin osmotic pressure

作　　者：段丽娟[1] 梁桂香[1] 杨俊杰[1] 张金[1] 

机构地区：[1]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

出　　处：《微生物学免疫学进展》2013年第5期27-30,共4页Progress In Microbiology and Immunology

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。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 .

关 键 词：破伤风抗毒素 渗透压 F(ab')2 

分 类 号：R927[医药卫生—药学]