Chinese Journal of Pharmacovigilance ›› 2017, Vol. 14 ›› Issue (12): 730-736.

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Experimental Comparison Study on Acute Toxicity of Different Processing Methods of Psoraleae Fructus on Normal Mice

CAI Tao-tao1, HUANG Na-na2 ,WANG Liang1,3, SUN Xiao-qian4 , LI Xiao-yu1,3, SUN Rong5*   

  1. 1Shandong University of Traditional Chinese Medicine, Shandong Jinan 250355, China;
    2The Second Hospital of Shandong University, Shandong Jinan 250033, China;
    3Shandong Academy of Chinese Medicine, Shandong Jinan 250014, China;
    4School of Pharmaceutical Sciences of Shandong University, Shandong Jinan 250012, China;
    5Cheeloo College of Medicine, Shandong University, Shandong Jinan 250012, China
  • Received:2017-12-11 Revised:2018-01-19 Online:2017-12-20 Published:2018-01-19

Abstract: Objective To compare the acute toxicity of Psoraleae Fructus in normal mice prepared by different processing methods. Methods The method of preparing salt-processed Psoraleae Fructus was according to salt process of the Chinese Pharmacopoeia 2015. The water extracts of raw Psoraleae Fructus and salt-processed Psoraleae Fructus were prepared by extraction with 8 times the amount of water three times for 1 hour each. The all components of raw Psoraleae Fructus and salt-processed Psoraleae Fructus were prepared by crushing and making powder through 120 mesh sieve. HPLC method and the classical method of acute toxicity were used to determine the content of psoralen and isopsoralen and the acute toxicity in the above samples, and compare the content and the acute toxicity. Results The content of psoralen on the water extracts of raw Psoraleae Fructus and salt-processed Psoraleae Fructus was separately 0.0739%, 0.0727%, the content of psoralen on all components of raw Psoraleae Fructus and salt-processed Psoraleae Fructus was separately 0.3980%, 0.4813%, and the content of isopsoralen in the above samples was separately 0.0565%, 0.0511%, 0.3646%, 0.4541%. The LD50 and 95% confidence limit of water extraction components in raw Psoraleae Fructus and salt-processed Psoraleae Fructus are 49.212 g·kg-1·d-1(47.773~50.696 g·kg-1·d-1) and 56.028 g·kg-1·d-1(54.074~58.067 g·kg-1·d-1), which was respectively equal to 344.5 times and 392.2 times of the clinical daily dosage in 70 kg humans. The MFD of all components in raw Psoraleae Fructus and salt-processed Psoraleae Fructus was 40.032 g·kg-1·d-1 and 31.560 g·kg-1·d-1, which was respectively equal to 280.2 times and 220.9 times of the clinical daily dosage in 70 kg humans. The main acute toxicity symptoms and signs are poor spirit, negligent action, prostrate motionlessness, convulsions and unsteady walk. Conclusion The acute toxicity intensity in Psoraleae Fructus by different processing methods on normal mice is: water extraction components in raw Psoraleae Fructus > water extraction components in salt-processed Psoraleae Fructus > all components in salt-processed Psoraleae Fructus > all components in raw Psoraleae Fructus, The acute toxicity intensity of Psoraleae Fructus prepared by different processing methods in normal mice increases with increasing content of psoralen and isopsoralen, suggesting that there is a positive correlation between the toxicity and content of psoralen and isopsoralen, the toxic substances, toxicity characteristics and toxicity mechanism are all to be further studied.

Key words: Psoraleae Fructus, mice, acute toxicity

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