中国比较医学杂志2016，Vol.26Issue(3)：35-39,5.DOI:10.3969.j.issn.1671-7856.2016.03.008
细辛脑注射制剂异常毒性检查标准研究
Study on abnormal toxicity test standard of asarone injection preparation
摘要
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.关键词
细辛脑/异常毒性/LD50/限值/标准Key words
Asarone/Abnormal toxicity/LD50/Limit value/Standard分类
医药卫生引用本文复制引用
邓莎,张德波,罗洁,郑娇娇,郑萍,蒲旭峰..细辛脑注射制剂异常毒性检查标准研究[J].中国比较医学杂志,2016,26(3):35-39,5.基金项目
中央补助地方经费项目(食药监办药化监[2014]61号). （食药监办药化监[2014]61号）
