Local and systemic safety of deproteinized calf blood extract injection: hypersensitivity, hemolysis, local tolerance, and acute intravenous toxicity in rodents and rabbits.

ABSTRACT:

Introduction

Deproteinized calf blood extract injection (DCBEI) is widely applied in neurology and wound care, but systematic preclinical safety data are scarce. Because it is administered parenterally, assessment of immunogenicity, hemocompatibility, local tolerance, and acute toxicity is essential to meet regulatory standards.

Methods

A focused safety package was developed, comprising: (i) active systemic anaphylaxis (ASA) in Hartley guinea pigs (n = 24, 4 groups); (ii) in-vitro hemolysis in rabbit erythrocytes, spectrophotometrically measured at 545 nm over 0.25-3 h; (iii) local tolerance in New Zealand White rabbits (n = 4 per regimen) after single or 6-day repeated intravenous (ear-vein) or intramuscular (quadriceps) dosing, assessed macroscopically and by histop

SUBMITTER: Qin G 

PROVIDER: S-EPMC12813156 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature