BN大鼠和RBL-2H3细胞体内外实验评价丹红注射液致敏性风险OA

[Objective]This study aimed to evaluate the sensitization risk of Danhong Injection through in vivo and in vitro experiments.[Methods]The physicochemical properties of Danhong Injection were tested after compatibility with commonly used clinical solvents.For the in vitro experiment,RBL-2H3 cells were allocated to a negative control group,a positive control group(C48/80),and Danhong Injection groups(20,30 and 50 μL/mL).Cell viability,toluidine blue staining,and the levels of degranulation markers(immunoglobulin E(IgE),histamine(His),β-hexosaminidase(β-Hex),and tryptase(TPS))were assessed.A BN rat sensitization model was established,including normal saline control,ovalbumin positive control,Danhong Injection-sodium chloride injection compatibility,and Danhong Injection-glucose injection compatibility groups.Allergic reactions were observed following a double-challenge protocol.Blood and lung tissues were collected for histopathological analysis.[Results]Danhong Injection exhibited stable physicochemical properties after compatibility.In RBL-2H3 cells,the high dose(50 μL/mL)of Danhong Injection significantly increased histamine release(P<0.05).However,no significant allergic reactions were observed in BN rats in vivo.[Conclusion]Danhong Injection did not demonstrate significant sensitization risk at conventional clinical doses.