[Study on safflower yellow for injection based on cell degranulation and acute anaphylactoid model]

Area of Science:

• Pharmacology
• Immunology
• Drug Safety

Background:

• Anaphylactoid reactions are a concern with injectable pharmaceuticals.
• Safflower yellow is used in injections, necessitating safety evaluations.
• Mast cell degranulation and histamine release are key indicators of anaphylactoid reactions.

Purpose of the Study:

• To establish and validate screening methods for anaphylactoid reactions caused by safflower yellow for injection.
• To evaluate potential hypersensitivity of different batches of safflower yellow for injection.
• To investigate the role of mast cell degranulation and histamine release in safflower yellow-induced reactions.

Main Methods:

• In vitro: RBL-2 H3 cell degranulation assay using neutral red staining to assess mast cell activation.
• In vivo: Acute anaphylactoid reaction model in mice, measuring plasma histamine levels via ELISA.
• Comparison of safflower yellow batches against positive (C48/80) and negative controls.

Main Results:

• Positive control C48/80 induced significant RBL-2 H3 cell degranulation and increased plasma histamine in mice.
• Safflower yellow for injection did not induce significant RBL-2 H3 cell degranulation in vitro.
• No significant increase in plasma histamine levels was observed in mice treated with safflower yellow for injection.

Conclusions:

• The established screening methods using RBL-2 H3 cells and mouse models are effective for detecting anaphylactoid reactions.
• Safflower yellow for injection, across tested batches, did not demonstrate significant potential to induce anaphylactoid reactions via mast cell degranulation and histamine release.
• Further investigation into the complex mechanisms of anaphylactoid reactions may be warranted.