微生物学免疫学进展
微生物學免疫學進展
미생물학면역학진전
PROGRESS IN MICROBIOLOGY AND IMMUNOLOGY
2013年
5期
27-30
,共4页
段丽娟%梁桂香%杨俊杰%张金
段麗娟%樑桂香%楊俊傑%張金
단려연%량계향%양준걸%장금
破伤风抗毒素%渗透压%F(ab')2
破傷風抗毒素%滲透壓%F(ab')2
파상풍항독소%삼투압%F(ab')2
Tetanus antitoxin ( TAT)%Osmotic pressure%F( ab') 2
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。
目的：通過對不同廠傢破傷風抗毒素產品的滲透壓濃度的調查，瞭解國內該產品的滲透壓濃度的波動範圍，為生產過程中滲透壓濃度質量控製提供依據。方法採用Advanced 3250型冰點滲透壓儀檢測破傷風抗毒素的滲透壓濃度。結果不同廠傢破傷風抗毒素製品的滲透壓濃度均不低于240 mOsmol/L。結論破傷風抗毒素滲透壓濃度波動範圍均與國外同類製品基本一緻，符閤歐洲藥典規定。
목적：통과대불동엄가파상풍항독소산품적삼투압농도적조사，료해국내해산품적삼투압농도적파동범위，위생산과정중삼투압농도질량공제제공의거。방법채용Advanced 3250형빙점삼투압의검측파상풍항독소적삼투압농도。결과불동엄가파상풍항독소제품적삼투압농도균불저우240 mOsmol/L。결론파상풍항독소삼투압농도파동범위균여국외동류제품기본일치，부합구주약전규정。
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 .
