Study on abnormal toxicity test standard of asarone injection preparation
10.3969.j.issn.1671-7856.2016.03.008
- VernacularTitle:细辛脑注射制剂异常毒性检查标准研究
- Author:
Sha DENG
;
Debo ZHANG
;
Jie LUO
;
Jiaojiao ZHENG
;
Ping ZHENG
;
Xufeng PU
- Publication Type:Journal Article
- Keywords:
Asarone;
Abnormal toxicity;
LD50;
Limit value;
Standard
- From:
Chinese Journal of Comparative Medicine
2016;26(3):35-39
- CountryChina
- Language:Chinese
-
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.
