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| Limit determination of diester alkaloids in Wenyang Fuzheng ointment and experimental study on acute toxicity |
| Hits 122 Download times 31 Received:November 15, 2025 |
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| DOI
10.11656/j.issn.1673-9043.2026.02.09 |
| Key Words
aconite;diester alkaloids;limit test;acute toxicity experiments |
| Author Name | Affiliation | E-mail | | DENG Kai | Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan 430061, China
Hubei Shizhen Laboratory, Wuhan 430061, China
Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan 430061, China | | | SUN Wanjin | Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan 430061, China
Hubei Shizhen Laboratory, Wuhan 430061, China
Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan 430061, China | | | ZHANG Yingrong | Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan 430061, China
Hubei Shizhen Laboratory, Wuhan 430061, China
Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan 430061, China | | | HUANG Wei | Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan 430061, China
Hubei Shizhen Laboratory, Wuhan 430061, China
Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan 430061, China | huangwei@hbtcm.com |
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| Abstract
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| [Objective] In order to preliminarily explore the safety of external preparations containing aconite in clinical use，we established a limit test method for diester alkaloids in our hospital’s external preparation containing aconite，Wenyang Fuzheng Ointment. At the same time，we conducted single dose acute toxicity experiments，skin irritation experiments，and skin sensitization experiments. [Methods] An Agilent ZORBAX Extend C18 column（4.6× 250 mm，5 μm）was used，with acetonitrile-tetrahydrofuran（25∶15）as mobile phase A and 0.1 mol/L ammonium acetate solution as mobile phase B，for gradient elution；The flow rate was 1 mL/min，the column temperature was 25 ℃，the injection volume was 10 μL，and the detection wavelength was 235 nm. Using SD rats as experimental subjects，single dose acute toxicity experiments were conducted to observe and record the body weight，behavioral activity，and skin reactions of SD rats，and pathological examination was performed on the skin of each group of rats. Using guinea pigs as experimental subjects，skin irritation experiments and skin sensitization experiments were conducted to observe the local irritation reactions and sensitization effects of intact and damaged skin animals in contact with the test substance. [Results] The detection limits of three reference standards，namely aconitine，new aconitine，and secondary aconitine，were 5.73，5.92 and 5.56 μg/mL，respectively. No aconitine，new aconitine，or secondary aconitine was detected in the three batches of Wenyang Fuzheng Ointment samples and negative samples. The SD rats in the treatment group showed no toxic symptoms or toxic reactions，and pathological examination showed no obvious inflammatory lesions. There was no significant difference compared to the normal control group. The Wenyang Fuzheng Ointment showed no significant skin irritation reactions to guinea pigs with intact or damaged skin after single or multiple doses of medication administration. The Wenyang Fuzheng Ointment had no sensitizing effect on guinea pig skin after external contact. [Conclusion] This study preliminarily verified the safety of external preparations containing aconite from the aspects of limit test of diester alkaloids，single dose acute toxicity experiments，skin irritation experiments，and skin sensitization experiments，laying an experimental foundation for the clinical application and research and development of such external preparations containing aconite in the future. |
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