Establishment of in-vitro model of complement activation and its application
10.16438/j.0513-4870.2016-1107
- VernacularTitle:补体活化的体外评价模型建立及应用
- Author:
Cai-xia FENG
1
;
Xian XIU
2
;
Wei TIAN
3
;
Yu-ling WANG
1
;
Hong-ye WANG
2
;
Ya-juan WANG
2
Author Information
1. The Fifth Hospital of Shijiazhuang, Shijiazhuang 050021, China
2. CSPC ZhongQi Pharmaceutical Technology (Shijiazhuang) Co., Ltd., Shijiazhuang 050035, China
3. Hebei University of Chinese Medicine, Shijiazhuang 050200, China
- Publication Type:ORIGINAL ARTICLES
- Keywords:
hypersensitivity reaction;
complement;
in-vitro model;
amphotericin B;
voriconazole
- From:
Acta Pharmaceutica Sinica
2017;52(5):722-728
- CountryChina
- Language:Chinese
-
Abstract:
Complement activation-related pseudo-allergic reactions (CARPA) may represent 77% of all immune-mediated immediate hypersensitivity reactions. Because of the universality of the CARPA response and correlation between it and drug properties, complement activity tests are recommended as one of the tests for immunotoxicity and bioequivalence of drugs. However, in-vivo tests of complement activation are complicated, and the immunological differences between different individuals and between human and animal, making it very necessary to establish a standard and sample evaluation model for testing the effects of drugs on complement activity. In this study, the standard reaction serum was prepared by pooling sera collected from 40 healthy blood donors; a standard positive control was prepared by incubation with a heat-agglutinated IgG and zymosan A; SC5b-9, C5a, C4d and Bb were chosen as the test targets and evaluation criteria of the results was defined, all of these constituted the in-vitro model. By using this in-vitro model, the immunological toxicity of the different prescription of antifungal drug amphotericin B, and voriconazole for injection, and the bioequivalence of amphotericin B liposome formulations were studied.
