| 复方山莨菪碱注射液的遗传毒性评价 |
| 投稿时间：2022-06-09 修订日期：2022-09-21 点此下载全文 |
| 引用本文：田逸君,侍雯靖,董雅春,张天宝,朱玉平.复方山莨菪碱注射液的遗传毒性评价[J].药学实践杂志,2023,41(1):50~55 |
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| 中文摘要:目的 复方山莨菪碱注射液的遗传毒性研究。方法 采用细菌回复突变试验（bacterial reverse mutation test，简称Ames test），体外染色体畸变试验（chromosome aberration test， 简称CA）和体内微核试验（micronucleus test，简称MNT）3个标准试验组合，以评价复方山莨菪碱注射液的遗传毒性。结果 Ames试验表明在所有受试剂量为0.5、5、50、500、5 000 μg/皿，两种平行条件下，即有或没有S9代谢活化系统时，受试物对TA1535、TA102、TA100、TA98及TA97这5种细菌菌株，与溶媒对照组的突变菌落数进行比较，各剂量组的所诱发的回复突变菌落数均与其相近。CA试验中，受试物设3个剂量组，依次为58.75、117.5及235.0 μg/ml，所有剂量在两种平行的系统条件下（即有或没有S9代谢活化系统时），对中国仓鼠卵巢细胞（CHO细胞）的染色体畸变率均没有显著影响。MNT试验也设了3个剂量组，分别为7.5、15.0及30.0 mg/kg。所有剂量组与溶媒对照组的微核诱发率进行比较，对ICR小鼠骨髓的微核诱发率均无统计学意义（P>0.05）。结论 在本研究条件下,复方山莨菪碱注射液对细菌无致突变性，对哺乳动物细胞的染色体无致畸变作用，对啮齿类动物骨髓中的嗜多染红细胞无诱发微核的效应。所有试验结果都显示，复方山莨菪碱注射液在本受试条件下对人体不具有潜在致癌性及遗传毒性。 |
| 中文关键词:盐酸消旋山莨菪碱 遗传毒性 细菌回复突变试验 染色体畸变试验 微核试验 |
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| Evaluation on genotoxicities of raceanisodamine hydrochloride injection |
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| 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. |
| keywords:raceanisodamine hydrochloride genetic toxicities bacterial reverse mutation test chromosomal aberration test micronucleus test |
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