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Bai Y.-B.,Chengdu Rosen Pharmaceutical Co. | Zhang C.-M.,Chengdu Rosen Pharmaceutical Co. | Li Y.,Chengdu Rosen Pharmaceutical Co. | Liu R.-L.,Chengdu Rosen Pharmaceutical Co. | And 3 more authors.
Chinese Journal of Biologicals | Year: 2013

Objective: To investigate the acute toxicity of caprylic acid/caprylate residues in blood products under acidic condition. Methods: The 10% intravenous immunoglobulin (IVIG)(pH 4) solution at caprylate concentrations of 0.25, 2.5 and 10 mg/ml were prepared and injected i. v. into SD rats, 4.5 ml for each, using 0.9% sodium chloride solution as negative control. The rats were observed for physical and mental features, activity of limbs and behavioral pattern, and recorded for food intake, once a day for 14 d. The rats were weighed on days 3, 7 and 14 after injection, based on which the increasing rate of bodyweight was calculated. All the rats were dissected on day 14 after injection, and observed for pathological change of organs. Results: Obvious stress reaction, hemuresis and change of behavioral pattern were observed in the rats injected with IVIG at a caprylate concentration of 10 mg/ml, while the increasing rate of bodyweight decreased signi-ficantly (P < 0.01), and obviously pathological change was observed in lung. However, when the caprylate concentrations were 0.25 and 2.5 mg/ml, no obvious stress reaction or normal behavior was observed, the and result of pathological examination showed no significant difference with that in negative control group. Conclusion: The caprylic acid/caprylate residues at a concentration of 2.5 mg/ml in 10% IVIG (pH 4) caused no acute toxicity in rats, which provided an experimental basis for evaluation of safety of caprylic acid/caprylate residues in blood products at acidic condition, and a reference for determination of quantitative limit of caprylic acid/caprylate residues in 10% IVIG (pH 4).

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