目的 探索适用于中药注射剂类过敏反应的应急检验方法。方法 考察豚鼠一次性静脉注射注射用丹参和清开灵注射液后类过敏反应的发生情况 ，并观察清开灵注射液对RBL-2H3细胞中β-氨基己糖酶释放率的影响。结果 豚鼠一次性静脉注射中药注射液后，部分批次的中药注射液可观察到类过敏反应；清开灵注射液 体外可诱导RBL-2H3细胞发生非免疫性脱颗粒，刺激β-氨基己糖酶释放，且呈浓度依赖性。结论 豚鼠体内类过敏反应检查法和RBL-2H3细胞β-氨基己糖酶释放率检查法结合 ，可作为中药注射剂类过敏反应应急检验方法，用于药品质量控制。

Objective To study the emergency monitoring methods for anaphylactoid reaction caused by traditional Chinese medicine injection（TCMI）．Methods The anaphylactoid reaction was monitored in guinea pigs after injection of one-dose TCMI. In-vitro RBL-2H3 cells were cultured and treated with TCMI，and then the amount of releasing β-hexosaminidase was detected. Results After injection of one-dose TCMI in the guinea pigs，some batches of TCMI resulted into anaphylactoid reaction. Qingkailing injection induced non-immune degranulation in RBL-2H3 cells，and stimulated the releasing of β-hexosaminidase in a concentration-dependent manner. Conclusion Both in-vivo test of Guinea pigs anaphylactoid reaction and in-vitro test of β-hexosaminidase release in RBL-2H3 cells can be applied as the emergency monitoring methods for anaphylactoid reaction caused by TCMI，and can be used for the quality control of TCMI.

R284.1

广东省科技厅科技计划项目（2010B060500022）。