Micro-determination on activating complement in detecting biological properties of Fc fragment of IVIG
10.13303/j.cjbt.issn.1004-549x.2021.07.010
- VernacularTitle:微量法测定人免疫球蛋白制剂Fc段生物学活性
- Author:
Tingting LU
1
;
Jun ZHANG
1
;
Yuzhong SUN
1
;
Shunbo ZHOU
1
;
Yunhong WANG
1
;
Yaling DING
1
Author Information
1. Chengdu Rongsheng Pharmaceuticals Co., LTD, ChengDu 610041, China
- Publication Type:Journal Article
- Keywords:
properties of Fc fragment;
IVIG;
IgG
- From:
Chinese Journal of Blood Transfusion
2021;34(7):713-715
- CountryChina
- Language:Chinese
-
Abstract:
【Objective】 To improve method for determinating of biological potency of IgG Fc fragment in Chinese Pharmacopoeia and establish a method which is suitable for enzyme-labeled instrument. 【Methods】 The biological properties of FC fragment of IVIG in Chinese Pharmacopiea(General 3514) was adjusted, including sensitization process, sample treatment and dynamic curve parameters. Meanwhile, the kinetic curve of hemolysis was fitted with Origin, which made the method more suitable for enzyme plate. The biological properties of Fc fragment of IVIG was calculated by kinetics curve reaction of reference and sample. 【Results】 The method are stable, the RSD of repeatability and intermediate is 10%, also with significant improvement in efficiency. 【Conclusion】 The detection of properties of Fc fragment of IVIG is stable and efficient, it can be used for properties of Fc fragment of IVIG.
