Studies on the Acute Toxicity in Mice and Cytotoxicity of the Impurity in Ornithine
- VernacularTitle:鸟氨酸杂质的小鼠急性毒性和细胞毒性考察
- Author:
Wangping PAN
1
;
Xiaoling XU
;
Bei CAI
;
Xiaojun LÜ
;
Kaiyong HE
Author Information
1. 湖北省药品监督检验研究院 武汉430064
- Keywords:
Ornithine;
Impurity;
Acute toxicity in mice;
Cytotoxicity
- From:
China Pharmacist
2018;21(2):346-348
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To study the acute toxicity in mice and cytotoxicity of the impuritiy(3-amino-2-piperidinone hydrochloride) in ornithine. Methods:The mice were given the impurity by intravenous injection.The acute toxicity was observed and LD50in mice was calculated by Bliss method. According to the result of LD50,the mice were given the impurity respectively at high,medium and low dose. The changes of general condition and body weight were recorded,and the blood biochemical indices and histomorphology of organs and tissues were observed after 14 days. The cytotoxicity was measured on fibroblasts(L929) cells. Results:The LD50and 95% con-fidence limit of the impurity (intragastric administration) was 758.49-848.08 mg·kg-1.All the detected indices of the three groups (660,330 and 170 mg·kg-1) including general condition,weight change,biochemical indices,organ morphological and histological change were all within the normal ranges. The impurity significantly decreased the viability of L929 cells. The NOAEL value was 660 mg·kg-1in mice. Conclusion:The impurity has certain toxicity to mice and cells. The data can provide experimental basis for the quality standard establishment for ornithine and the safety improvement in clinic use.
