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| Evaluation of the sensitization risk of Danhong Injection based on in vivo and in vitro experiments using BN rats and RBL-2H3 cells |
| Hits 105 Download times 18 Received:September 26, 2025 |
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| DOI
10.11656/j.issn.1673-9043.2026.03.08 |
| Key Words
Danhong Injection;pseudo-allergy;BN rat;degranulation |
| Author Name | Affiliation | E-mail | | RONG Xinyi | The Second Affiliated Hospital of Tianjin University of Chinese Medicine, Tianjin 300350, China
Tianjin University of Chinese Medicine, Tianjin 301617, China | | | WANG Yimin | Shandong BCI Pharmaceutical Co. LTD., Heze 274000, China | | | SUN Haili | Beijing Zhuoyue Future International Pharmaceutical Technology Development Co. LTD., Beijing 100176, China | | | LYU Chunxiao | The Second Affiliated Hospital of Tianjin University of Chinese Medicine, Tianjin 300350, China | lvchunxiao1989@163.com | | HUANG Yuhong | The Second Affiliated Hospital of Tianjin University of Chinese Medicine, Tianjin 300350, China | hyh101@126.com |
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| Abstract
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| [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. |
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