目的 通过RBL-2H3肥大细胞脱颗粒模型考察注射用丹参多酚酸及丹参多酚酸B、D的致敏性。方法 RBL-2H3肥大细胞分为对照（PBS）组、C48/80 （阳性对照，4 mg/mL）组和梯度浓度（0.025、0.050、0.100、0.200、0.400、0.800 mg/mL）的注射用丹参多酚酸、丹参多酚酸B、丹参多酚酸D组，孵育30 min后，通过中性红染色试验观察脱颗粒现象，化学荧光法测定组胺释放率，酶联免疫吸附（ELISA）法测定β-氨基己糖苷酶释放率、类胰蛋白酶释放量。结果 与对照组比较，阳性药C48/80组、质量浓度≥0.2 mg/mL的丹参多酚酸B组、质量浓度≥0.4 mg/mL的丹参多酚酸D组、质量浓度为0.8 mg/mL的注射用丹参多酚酸组的细胞脱颗粒度显著升高（P<0.01、0.05）；注射用丹参多酚酸没有引起RBL-2H3细胞组胺释放率增加，C48/80组、质量浓度≥0.025 mg/mL的丹参多酚酸D组、0.8 mg/mL的丹参多酚酸B组组胺释放率即显著升高（P<0.001、0.05）；注射用丹参多酚酸和丹参多酚酸B组类胰蛋白酶释放量无显著性差异，质量浓度≥0.025 mg/mL的丹参多酚酸D组类胰蛋白酶释放量显著增加（P<0.001）；注射用丹参多酚酸没有引起β-氨基己糖苷酶释放率增加，0.8 mg/mL的丹参多酚酸D组、质量浓度≥0.1 mg/mL的丹参多酚酸B组的β-氨基己糖苷酶释放率显著增加（P<0.001）。结论 注射用丹参多酚酸在致敏性方面有较好的安全性。

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