Methodology Study on the Abnormal Toxicity Test and Sensitization Test of Cobratide Injection
Objective:To re-establish detection limits for"abnormal toxicity test"and"sensitization test"of Cobratide Injection,and provide reference for its safe use.Methods:Through the LD50,LD1 value and their confidence limits,determine the limit of abnormal toxicity test.By determining the non-toxic reaction doses after intraperitoneal(ip)and intravenous(iv)administration for guinea pigs to figure out the limits for sensitization ip and challenge iv of guinea pig sensitization test.Results:In the original quality standard,the limit of abnormal toxicity test was changed to"the product was prepared with sodium chloride injection into a solution containing 2 μg of Cobratide in 1 mL".The sensitization test limit was changed to 2 μg/mL,0.5 mL for sensitization dose,1.0 mL for challenge dose.Conclusion:In order to reduce the clinical ADR and feasibility of ensuring quality standard,the limits of abnormal toxicity and sensitization test for cobratide injection were set at 2 μg/mL and 2 μg/mL.
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