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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细胞中茁-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,刺激茁-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细胞茁-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 explore an emergency test method suitable for the allergic reaction of traditional Chinese medicine injection. Methods The incidence of anaphylactoid reactions after intravenous injection of Salvia miltiorrhiza and Qingkailing injection in guinea pigs were investigated. The effect of Qingkailing injection on the release rate of 茁 -aminocaprosinase in RBL-2H3 cells was observed. Results After a single intravenous injection of guinea pig injection of traditional Chinese medicine, some batches of Chinese medicine injection can be observed anaphylactoid reactions; Qingkailing injection can induce non-immune degranulation of RBL-2H3 cells in vitro stimulating 茁 -H-hexose Enzyme release, in a concentration-dependent manner. Conclusion The combination of in vivo hypersensitivity test in guinea pigs and the test of release rate of rhodo-hexosaminidase in RBL-2H3 cells can be used as an emergency test method for allergic reactions of traditional Chinese medicine injection for quality control of drugs.