Objective  The sensitization detection method of direct peptide reactivity assay (DPRA) was established to evaluate the sensitization of troxerutin for injection with adverse drug reaction (ADR) aggregation signal.

Methods  To determine the consumption of cysteine polypeptide (Cys) and lysine polypeptide (Lys) in ADR batch and normal batch of troxerutin for injection by HPLC.

Results  There were no co-elution occurs neither Cys nor Lys in the ADR batch and normal batch preparations, the model of 1∶10 Cys and 1∶50 Lys was used. There was little difference in the data between batches. According to the model prediction, the sensitization of each batch was negative.

Conclusion  The prediction results of DPRA method for each batch of troxerutin for injection were negative. Based on the principle analysis of this method, it is preliminarily determined that the cause of clinical ADR aggregation signal of troxerutin for injection in ADR batch should be independent of small molecule hapten. At the same time, the feasibility of this method to predict whether the sensitizing component is small molecule hapten was discussed.

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