目的 通過(guò)RBL-2H3肥大細(xì)胞脫顆粒模型考察注射用丹參多酚酸及丹參多酚酸B、D的致敏性。方法 RBL-2H3肥大細(xì)胞分為對(duì)照（PBS）組、C48/80 （陽(yáng)性對(duì)照，4 mg/mL）組和梯度濃度（0.025、0.050、0.100、0.200、0.400、0.800 mg/mL）的注射用丹參多酚酸、丹參多酚酸B、丹參多酚酸D組，孵育30 min后，通過(guò)中性紅染色試驗(yàn)觀察脫顆?，F(xiàn)象，化學(xué)熒光法測(cè)定組胺釋放率，酶聯(lián)免疫吸附（ELISA）法測(cè)定β-氨基己糖苷酶釋放率、類胰蛋白酶釋放量。結(jié)果 與對(duì)照組比較，陽(yáng)性藥C48/80組、質(zhì)量濃度≥0.2 mg/mL的丹參多酚酸B組、質(zhì)量濃度≥0.4 mg/mL的丹參多酚酸D組、質(zhì)量濃度為0.8 mg/mL的注射用丹參多酚酸組的細(xì)胞脫顆粒度顯著升高（P<0.01、0.05）；注射用丹參多酚酸沒(méi)有引起RBL-2H3細(xì)胞組胺釋放率增加，C48/80組、質(zhì)量濃度≥0.025 mg/mL的丹參多酚酸D組、0.8 mg/mL的丹參多酚酸B組組胺釋放率即顯著升高（P<0.001、0.05）；注射用丹參多酚酸和丹參多酚酸B組類胰蛋白酶釋放量無(wú)顯著性差異，質(zhì)量濃度≥0.025 mg/mL的丹參多酚酸D組類胰蛋白酶釋放量顯著增加（P<0.001）；注射用丹參多酚酸沒(méi)有引起β-氨基己糖苷酶釋放率增加，0.8 mg/mL的丹參多酚酸D組、質(zhì)量濃度≥0.1 mg/mL的丹參多酚酸B組的β-氨基己糖苷酶釋放率顯著增加（P<0.001）。結(jié)論 注射用丹參多酚酸在致敏性方面有較好的安全性。

Objective To study the sensitization of salvianolic acid B, D and Salvianolic Acid for Injection by RBL-2H3 mast cell degranulation model. Methods RBL-2H3 mast cells were divided into control group (PBS), C48/80 (positive control, 4 mg/mL) group and salvianolic acid, salvianolic acid B and salvianolic acid D groups at gradient concentrations (0.025, 0.050, 0.100, 0.200, 0.400, 0.800 mg/mL) for injection. After incubation for 30 min, degranulation was observed by neutral red staining test. The release rate of histamine was determined by chemofluorescence method, and the release rate of β -hexaminosidase was determined by enzyme linked immunosorbent assay (ELISA). Results Compared with control group, the cell degranulation degree of positive drug C48/80 group, salvianolic acid B group with mass concentration ≥ 0.2 mg/mL, salvianolic acid D group with mass concentration ≥ 0.4 mg/mL and Salvianolic Acid for Injection group of 0.8 mg/mL were significantly increased (P<0.01, 0.05). The histamine release rate of RBL-2H3 cells was not increased by Salvianolic Acid for Injection. The histamine release rate of C48/80 group, salvianolic acid D group with mass concentration ≥ 0.025 mg/mL and salvianolic acid B group of 0.8 mg/mL were significantly increased (P<0.001, 0.05). There was no significant difference in trypsinoid release between Salvianolic Acid for Injection and salvianolic acid B group, but the trypsinoid release of salvianolic acid D group with mass concentration ≥ 0.025 mg/mL was significantly increased (P<0.001). The release rate of β -hexaminosidase was not increased by Salvianolic Acid for Injection, but significantly increased by 0.8 mg/mL salvianolic acid D and with mass concentration ≥ 0.1 mg/mL salvianolic acid B (P<0.001). Conclusion Salvianolic Acid for Injection has good safety.

R965.3