Study on abnormal toxicity test standard of asarone injection preparation
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    Abstract:

    Objective To measure the lethal dosage values (LD50) of i.v. asarone injection for mice and to establish a standard for abnormal toxicity test of asarone injection to potentially reduce the occurrence of adverse drug reaction. Methods To obtain the LD50 value, a weighted linear probit regression method (Bliss method) is employed. The limit of abnormal toxicity test is determined according to Appendix XI C in its 2010 edition of the Chinese pharmacopoeia. Results It is found that the LD50 of intravenously asarone injection in mice ranges from 51.9 to 153.1 mg/kg. The abnormal toxicity test should be added as an additional item in the standard. Conclusions Based on analyses in this study, an appropriate limit of abnormal toxicity test is 15 mg/kg, which is also in line with current medical standard in China.

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History
  • Received:
  • Revised:January 05,2015
  • Adopted:
  • Online: April 01,2016
  • Published: