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破伤风抗毒素渗透压的质量控制标准 被引量:1

The standard for quality control of tetanus antitoxin osmotic pressure
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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。 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 .
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
关键词 破伤风抗毒素 渗透压 F(ab')2 Tetanus antitoxin(TAT) Osmotic pressure F( ab') 2
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  • 1[2]U.S.Pharmacopoeia XX(1990):967
  • 2[3]Japanese Pharmacopoeia 12(1990):39
  • 3[4]British Pharmacopoeia 1993(Appendum 1994):A296
  • 4[8]U.S.Pharmacopoeia 29:General Chapters〈785〉
  • 5孙连升.药液的等渗与等张问题[J].临床误诊误治,1998,11(5):317-317. 被引量:3

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