Evaluation on genotoxicities of raceanisodamine hydrochloride injection
10.12206/j.issn.2097-2024.202206035
- VernacularTitle:复方山莨菪碱注射液的遗传毒性评价
- Author:
Yijun TIAN
1
;
Wenjing SHI
1
;
Yachun DONG
1
;
Tianbao ZHANG
1
;
Yuping ZHU
2
Author Information
1. Department of Hygiene and Toxicology.
2. Department of Experimental Teaching Center of Basic Medicine, Naval Medical University, Shanghai 200433, China.
- Keywords:
raceanisodamine hydrochloride;
genetic toxicities;
bacterial reverse mutation test;
chromosomal aberration test;
micronucleus test
- From:
Journal of Pharmaceutical Practice
2023;41(1):50-55
- CountryChina
- Language:Chinese
-
Abstract:
Objective To study the genotoxicities of raceanisodamine hydrochloride injection. Methods Bacterial reverse mutation test, in vitro Chromosomal aberration test and in vivo Micronucleus test were performed to investigate the genotoxicities of raceanisodamine hydrochloride injection. Results The Ames test showed that raceanisodamine hydrochloride injection did not increase mutagenicity for TA1535, TA102, TA100, TA98 and TA97 strains at the dosage of 0.5, 5, 50, 500, 5000 μg per plate under two parallel system conditions (±S9). Results of CA test indicated that there was no statistical difference between raceanisodamine hydrochloride injection groups (doses of 58.75,117.5 and 235.0 μg/ml) and the solvent control group under two parallel system conditions (±S9). In MNT test, with doses of 7.5, 15.0 and 30.0 mg/kg respectively, the micronucleus induction rate of bone marrow of ICR mice was not statistically significant (P>0.05) when compared with that of vehicle control group in all dose groups. Conclusion Under the conditions of these study, the results indicated that raceanisodamine hydrochloride injection had no mutagenicity to Salmonella typhimurium, had no aberration effect on the chromosome of mammalian cultured cells, and had no effect on inducing micronucleus of bone marrow polychromatic erythrocytes in ICR mouse. All test results showed that raceanisodamine hydrochloride injection had no potential carcinogenicities and genetic toxicities under the test conditions.
