中药注射剂安全性评价及潜在致敏成分的虚拟筛查

Evaluation on safety of traditional Chinese medicine injection and virtual screening on potential allergen

探索中药注射剂不良反应事件的应对策略,为大规模中药致敏成分筛查提供指导依据。主要从中药安全风险信号的发现,"药物-不良反应事件"之间非预期蛋白的识别,潜在致敏物质的计算机虚拟筛查等角度进行阐述。结合国内外致敏物质识别领域的经验,提出建立符合中药注射剂特点的不良反应预警机制,参照证据等级分层次进行致敏物质的筛查。这些证据资料能有效融入到非临床安全性评价及上市前检测,防范高致敏风险的中药通过申请临床研究评审或在最后阶段流入市场。同时,致敏物质虚拟筛查的结果,将有助于中药注射剂过敏反应的进一步分析、验证及有效防控。

The purpose of this research was to investigate the coping strategies of adverse events of traditional Chinese medicine （TCM） injection in order to provide guidance for the large-scale screening on allergens in TCM. This paper elaborated from the three aspects as follows： the discovery of TCM security risk signal, identification of unexpected protein between drugs and adverse events, and computer virtual screening on potential allergen. To establish the early warning system of adverse events which accorded with the characteristic of TCM injections and perform screening on allergens hierarchically refer to the evidence level based on the experience in the field of allergens identification at home and abroad. The evidence data could effectively integrate into the non clinical safety evaluation and pre-market testing, which could prevent the TCM with risk of sensitization passing the evaluation of clinical research application and flowing into the market. Moreover, virtual screening results of allergens might contribute to further analysis, verification and effective prevention on allergic reaction of TCM injections.