摘要
目的 建立静注丙种球蛋白 (IVIG)制品Fc段生物学活性检测方法 ,了解国内不同生产工艺生产的IVIG制品Fc段生物学功能及IVIG制品的二级结构。方法 采用激活补体方法、抑制抗体依赖细胞介导细胞毒方法 (ADCC)检测国内 7种工艺生产的IVIG制品 ,用圆二色谱和傅里叶变换红外光谱法检测IVIG制品的二级结构。结果 在制品激活补体和抑制ADCC的活性方面 ,低pH制品平均高于中性IVIG制品 ,差异有极显著意义 (P<0 0 1) ;低 pH孵放与低 pH孵放加纳米膜过滤制品差异无显著意义 (P >0 0 5 )。 结论 低 pHIVIG制品在保持IVIGFc段生物学活性方面可能比中性IVIG制品有更好的稳定性 ;低 pH孵放法与低pH孵放加纳米膜过滤双重灭活 /去除病毒方法相比对IVIG制品的活性无影响 ;在低 pH孵放法病毒灭活工艺中 ,是否加入稳定剂对IVIG制品的活性无影响 ;有稳定剂条件下巴氏消毒加低 pH孵放双重病毒灭活方法对IVIG制品的生物学活性无影响 ;无稳定剂条件下进行巴氏消毒加低pH孵放双重法灭活病毒的某厂家生产的IVIG制品几乎没有Fc段生物学活性 ,圆二色谱和傅里叶变换红外光谱测定表明其制品的二级结构发生改变。
Objective To establish the test methods of biological activities of Fc fragment of intrtavenous immunoglobulin (IVIG) preparations so as to understand the biologic properties of Fc fragment of various domestic IVIG preparations produced by different technologies and the secondary structures of the IVIG preparations.Methods The domestic IVIG preparations produced by 7 technologies were tested by activating complement and inhibiting antibody dependent cell mediated cytotoxicity (ADCC),their secondery structuers were detected by circular dichroism(CD) and Fourier transform infra red(FT IR).Results In keeping biological activity of Fc fragment,the low pH IVIG preparations were averagely higher than the neutral preparations ,their difference was significant (P <0.01);there were no difference between the low pH incubations preparations and the low pH incubations plus nanomerer membrane filtrations ones (P >0.05).Conclusion The biologic activity of the Fc fragment may be preserved better in the low pH IVIG preparations than the neutral preparations.The biological activities of IVIG preparations are not different in low pH incubations compared to low pH incubations plus nanometer membrane filtrations.Low pH incubation with or without stabilizer does not affect biologic activities of IVIG preparations.Low pH incubation plus pasteurization with stabilizer does not affect the biologic activities of IVIG preparations.However,one of IVIG preparations produced by low pH incubation plus pasteurization without stabilizer results in near total loss of the biological activity.Further analysis shows that the secondary structure of the IVIG preparation detected by CD and FTIR has altered.
出处
《中国输血杂志》
CAS
CSCD
2001年第4期201-204,共4页
Chinese Journal of Blood Transfusion
