Objective Complement activity test is commonly used to evaluate the consistency and immune toxicity of drugs. The aim of this study is to establish a sensitive, reliable and fast evaluation criterion for the physical and chemical properties of drugs and complement activation-related pseudo-allergy (CARPA).
Methods The standard reaction serum was prepared by pooling sera collected from 140 healthy blood donors in our hospital; 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 evaluation criterion, heterogeneous Amphotericin B and Voriconazole injection were employed to evaluate primarily their immune toxicity, imitation and consistent with commercially drugs.
Results The ability of AmBisome and d-AmB activating complement was strong in the prescription of AmB liposome (Ambisome), homemade AmB cholesterol sodium sulfate complex (ABCD) group and injectable amphotericin B (d-AmB) groups. Among them, AmBisome can activate both classical pathways (CP) and alternative pathways (AP), but d-AmB can only activate the alternative pathways (AP). The level of SC5b-9 in the RLD1, RLD2 and RLD3 amphotericin B liposome of serum was the same, the average level was (22.16±0.63)μg/ml; however, the fluctuation in the level of C5a was high, average was (571.32±106.12)ng/ml. The significant difference in the levels of SC5b-9 and C5a was found between the homemade Test1 and Test2 amphotericin B liposome and the RLD1, RLD2 and RLD3 amphotericin B liposome of serum.
Conclusion The evaluation criterion in vitro for immune complement activity regulation was preliminarily established by heterologous drugs.
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