目的：比较评价绿原酸和双黄连粉针剂的潜在致敏性，并初步探索可疑致敏原绿原酸的致敏机制。方法：绿原酸与含等剂量绿原酸的双黄连粉针剂同时进行BN大鼠全身主动致敏实验（ASA），激发前取血测定抗体（IgE、IgG、IgA、IgM）、补体（C3、C4）、淋巴细胞免疫表型（CD3/4/8），记录激发后症状；单次静脉给予绿原酸与含等剂量绿原酸的双黄连粉针剂，测定给药前，给药后5、10、30、60、120、240min血浆中绿原酸浓度。结果：比较ASA激发后过敏反应发生率和发生程度，可知绿原酸过敏反应程度低于含等剂量绿原酸的双黄连粉针剂；绿原酸组和双黄连组抗体（IgE、IgG、IgA、IgM）、补体（C3、C4）各有不同程度升高，淋巴细胞免疫表型也有一定变化；单次静脉给药测定绿原酸血药浓度，给药后5、10、30、60min时，绿原酸组血浆中绿原酸浓度显著低于双黄连粉针剂组。结论：绿原酸对BN大鼠致敏性低于含等剂量绿原酸的双黄连粉针剂，原因可能是单体和复方绿原酸的代谢差异，也可能是因为绿原酸并非唯一致敏原。

This study aimed to evaluate and compare potential allergenicity of chlorogenic acid (CA) and Shuanghuanglian (SHL) Fenzhenji, and investigate mechanism of hypersensitivity reactions. Methods: Active systemic anaphylaxis (ASA) was used to determine the potential allergenicty of CA and SHL in BN rats. Symptoms of allergic response were observed. The level of immunoglobulins (Ig E, Ig G, Ig A and Ig M) and complements (C3 and C4) in the serum were detected. Ig E is detected by ELISA assay and other indexes are determined by Automatic Biochemical Analyzer. The surface expression of CD3/CD4/CD8 was also measured by flow cytometry. Then, BN rats were administered intravenously with CA and SHL, which contains equal amount of CA, respectively. The concentration of CA in plasma, which were taken before and 5, 10, 30, 60, 120, and 240 min after the injection, was determined by HPLC. Results: CA and SHL containing equal amount of CA, induce allergic response in BN rats. Responses of the latter were higher in the total incidence. For rats administrated with CA and SHL, the concentrations of immunoglobulins (Ig E, IgG, IgA and Ig M) and complements (C3 and C4) in serum increased on different levels compared with the control group. Besides, the surface expressions of CD3/CD4/CD8 were also varied. As concentrations of CA in plasma, the concentration of CA group was significantly lower than the SHL group. Conclusions: CA is less allergenicitive than SHL containing equal amount of CA. The reason may be related to different metabolism between CA and CA in SHL. It may also because that CA is not the only allergen in SHL. Further studies should be done to draw the final conclusion.

科学技术部“重大新药创制”科技重大专项（2008ZX09305）：创新药物研究开发技术平台建设，负责人：马璟。