注射用右旋雷贝拉唑钠的遗传毒性评价

doi:10.19803/j.1672-8629.2020.09.03

中国药物警戒 ›› 2020, Vol. 17 ›› Issue (9): 559-563.
DOI: 10.19803/j.1672-8629.2020.09.03

注射用右旋雷贝拉唑钠的遗传毒性评价

高梅^1,2, 马会¹, 陈凯¹, 张岱州^1*

¹山东省药学科学院,山东省化学药物重点实验室,山东济南 250101;
²山东师范大学生命科学院,山东济南 250014

收稿日期:2020-08-17 修回日期:2020-08-17 出版日期:2020-09-15 发布日期:2020-08-17
通讯作者: ^*张岱州,女,主任药师,药学。E-mail:zhangdaizhou@163.com
作者简介:高梅,女,副主任药师,药物安全性评价。
基金资助:
中央引导地方科技发展专项“创新药物临床前评价公共服务平台”(CXLC161906)

Genotoxicity Evaluation of (R)-(+)-Rabeprazole Sodium for Injection

GAO Mei^1,2, MA Hui¹, CHEN Kai¹, ZHANG Daizhou^1*

¹Shandong Academy of Pharmaceutical Sciences, Shandong Provincial Key Laboratory of Chemical Drugs, Jinan Shandong 250101, China;
²College of Life Sciences, Shandong Normal University, Jinan Shandong 250014, China

Received:2020-08-17 Revised:2020-08-17 Online:2020-09-15 Published:2020-08-17

摘要/Abstract

摘要： 目的评价注射用右旋雷贝拉唑钠的遗传毒性,为临床合理用药提供参考。方法采用细菌回复突变试验、中国仓鼠肺细胞体外染色体畸变试验和小鼠体内微核试验3项试验组合,检测注射用右旋雷贝拉唑钠的遗传毒性。结果细菌回复突变试验结果显示,注射用右旋雷贝拉唑钠各剂量组回变菌落数与溶媒对照组比较,均无显著性升高;中国仓鼠肺细胞体外染色体畸变试验,各剂量组的染色体畸变率与溶媒对照组比较,差异无统计学意义;小鼠体内微核试验,各剂量组的微核率与溶媒对照组比较,差异无统计学意义;3项试验结果均为阴性。结论在本试验条件下,注射用右旋雷贝拉唑钠未见遗传毒性作用。

关键词: 注射用右旋雷贝拉唑钠, 遗传毒性, 细菌回复突变试验, 染色体畸变试验, 小鼠微核试验

Abstract: Objective To evaluate the genotoxicity of (R)-(+)-rabeprazole sodium for injection in order to provide reference for clinical rational drug use. Methods The genotoxicity of (R)-(+)-rabeprazole sodium for injection was evaluated via three experiments, including bacterial reverse mutation test, Chinese hamster lung cell (CHL) chromosome aberration test in vitro and mouse erythrocyte micronucleus test. Results The results of the bacterial reverse mutation test showed that the number of bacterial colonies in each dose group of (R)-(+)-rabeprazole sodium for injection did not increase significantly compared with the solvent control group. In the In vitro chromosome aberration test of CHL cells, the chromosome aberration rate of each dose group was not statistically significant compared with the solvent control group. The In vivo micronucleus test of mice suggested that the micronucleus rate of each dose group was not statistically significant compared with the solvent control group. All the three tests were negative. Conclusion Under the same conditions as in this study, no genotoxicity is detected in (R)-(+)-rabeprazole sodium for injection.

Key words: (R)-(+)-rabeprazole sodium for injection, genotoxicity, bacterial reverse mutation test, chromosome aberration assay, mouse micronucleus test

中图分类号:

R994.1
R975

高梅, 马会, 陈凯, 张岱州. 注射用右旋雷贝拉唑钠的遗传毒性评价[J]. 中国药物警戒, 2020, 17(9): 559-563.

GAO Mei, MA Hui, CHEN Kai, ZHANG Daizhou. Genotoxicity Evaluation of (R)-(+)-Rabeprazole Sodium for Injection[J]. Chinese Journal of Pharmacovigilance, 2020, 17(9): 559-563.

参考文献

[1] Maradey-Romero C, Fass R.New and future drug development for gastroesophageal reflux disease[J]. J Neurogastroenterol Motil, 2014, 20(1):6-16.
[2] Targownik L.Discontinuing Long-Term PPI Therapy: Why, With Whom, and How[J]. Am J Gastroenterol, 2018, 113(4):519-528.
[3] Bhargava A, Faiz SM, Srivastava MR, et al.Role of Proton Pump Inhibitors in Laryngopharyngeal Reflux: Clinical Evaluation in a North Indian Population[J].Indian J Otolaryngol Head Neck Surg, 2019, 71(3):371-377.
[4] Hunt RH, Xiao SD, Megraud F, et al.World Gastroenterology Organisation Global Guideline: Helicobacter pylori in developing countries[J]. J Clin Gastroenterol, 2011, 45(5):383-388.
[5] Park JH, Park H, Lee DH, et al.A randomized, double blinded, clinical trial to assess the efficacy and cost effectiveness of omeprazole compared to rabeprazole in the maintenance therapy of patients with gastroesophageal reflux disease[J]. J Neurogastroenterol Motil, 2013, 19(2):219-226.
[6] Hashimoto N.Rabeprazole is effective for bile reflux oesophagitis after total gastrectomy in a rat model[J]. World J Gastrointest Pathophysiol, 2015, 6(1):23-28.
[7] Gu L, Li S, He Y, et al.Bismuth, rabeprazole, amoxicillin, and doxycycline as first-line Helicobacter pylori therapy in clinical practice: A pilot study[J]. Helicobacter, 2019, 4(4):e12594.
[8] 林晓冬,刘娜,刘纯,等.右旋雷贝拉唑钠对大鼠消化性溃疡的药效研究[J].食品与药品,2018,20(5):362-366.
[9] 桂元,王砾,詹继东,等.右旋雷贝拉唑钠对反流性食管炎模型大鼠炎性因子及血管活性肠肽的影响[J]. 胃肠病学和肝病学杂志,2017,26(5):539-542.
[10] 国家食品药品监督管理局.药物遗传毒性研究技术指导原则[S].国家食品药品监督管理总局,2018:4,22-26,31-33.
[11] 中华人民共和国卫生部.保健食品检验与评价技术规范[S].2003:189-199.
[12] 袁伯俊,廖明阳,李波.药物毒理学实验方法与技术[M].北京:化学工业出版社,2007:268-271.
[13] Hori H, Takayanagi T, Kamada Y, et al.Genotoxicity evaluation of sesamin and episesamin[J]. Mutat Res, 2011, 719(1-2):21-28.
[14] Shimoyama T, Chinda D, Sawada Y, et al.Randomized Trial Comparing Esomeprazole and Rabeprazole in First-line Eradication Therapy for Helicobacter pylori Infection based on the Serum Levels of Pepsinogens[J]. Intern Med, 2017, 56(13):1621-1627.
[15] 戴晓莉,戴学栋,郭峰,等.注射用右旋雷贝拉唑钠大鼠13周重复给药毒性研究[J].中国药物警戒,2016,13(7):389-393.
[16] 刘翠玲,戴晓莉,马玉奎,等.注射用右旋雷贝拉唑钠Beagle犬13周重复给药毒性实验研究[J].中国药物警戒,2017,14(8):453-456.
[17] Gao YH, Xu JX, Su ZX, et al.The chiral bioconversion and preclinical pharmacokinetic analysis of (R)-(+)-rabeprazole in beagle dogs by HPLC and HPLC-MS/MS[J]. Biomed Chromatog, 2013, 27(11):1380-1386.
[18] Toda R, Shiramoto M, Komai E, et al.Pharmacokinetics and Pharmacodynamics of Azeloprazole Sodium, a Novel Proton Pump Inhibitor, in Healthy Japanese Volunteers[J]. J Clin Pharmacol, 2018, 58(4):425-433.
[19] Patel H, Desai N, Patel P, et al.Pharmacokinetic evaluation of differential drug release formulations of rabeprazole in dogs[J]. Drug Dev Ind Pharm, 2019, 45(9):1459-1467.
[20] 张海艇,齐霞.右旋雷贝拉唑钠对动物体内染色体损伤的影响实验研究[J].药学研究,2014,33(7):384-405.
[21] 苏军,齐霞,张海艇.右旋雷贝拉唑钠对CHL细胞染色体畸变的影响实验研究[J].中国药事, 2015,29(8):865-869.
[22] 贾庆文,英永,马会,等.体外染色体畸变试验染色体标本制备的质量控制[J].中国比较医学杂志. 2018,28(4):108-112.
[23] 刘泳廷,刘佳,高敏,等.贵州鲜铁皮石斛粉小鼠急性经口毒性和骨髓红细胞微核试验研究[J].中国卫生工程学, 2019,18(2):182-184.
[24] 彭双清,郝卫东.药物安全性评价关键计数[M].北京:军事医学科学出版社, 2013:236-237.

注射用右旋雷贝拉唑钠的遗传毒性评价

Genotoxicity Evaluation of (R)-(+)-Rabeprazole Sodium for Injection

PDF (PC)

可视化

摘要/Abstract

引用本文

使用本文

参考文献

相关文章 12

编辑推荐

Metrics

[1]	林铌, 叶倩, 耿兴超, 王雪, 靳洪涛, 文海若. 杂质5-羟甲基糠醛及其二聚体和代谢产物遗传毒性研究[J]. 中国药物警戒, 2023, 20(2): 157-162.
[2]	崔苗, 王涛, 宋延平, 杨彦平, 周欣. 注射用炎琥宁的遗传毒性研究[J]. 中国药物警戒, 2022, 19(9): 973-976.
[3]	叶倩, 汪祺, 于敏, 王雪, 耿兴超, 张乐帅, 文海若. 亚硝胺化合物致突变风险研究[J]. 中国药物警戒, 2022, 19(8): 881-888.
[4]	文海若, 叶倩, 杨颖, 宋捷, 汪祺, 王雪. 苯酚类化合物基因突变风险评价研究[J]. 中国药物警戒, 2022, 19(8): 868-872.
[5]	黄露, 刘博, 王岩, 范慧红, 张庆生. 核苷类抗病毒药物质量控制研究进展[J]. 中国药物警戒, 2022, 19(6): 692-696.
[6]	文海若, 王亚楠, 姜华, 王雪, 汪祺, 马双成. 大黄素体内遗传毒性风险评价[J]. 中国药物警戒, 2022, 19(6): 635-640.
[7]	文海若, 王亚楠, 杨莹, 赵婷婷, 马双成, 汪祺. 大黄素型单蒽酮基因突变风险评价[J]. 中国药物警戒, 2020, 17(8): 455-460.
[8]	王会萍, 王恩力, 徐娇艳, 姚景春. 通关散的遗传毒性研究[J]. 中国药物警戒, 2020, 17(12): 861-866.
[9]	刘翠玲, 戴晓莉, 马玉奎, 孙蓉, . 注射用右旋雷贝拉唑钠Beagle犬13周重复给药毒性实验研究[J]. 中国药物警戒, 2017, 14(8): 453-456.
[10]	戴晓莉, 戴学栋, 郭峰, 胡建庭, 马玉奎. 注射用右旋雷贝拉唑钠大鼠13周重复给药毒性研究[J]. 中国药物警戒, 2016, 13(7): 389-393.
[11]	吴彦, 邸莎, 李贤煜, 孔冉, 安婉丽, 李志华, 刘绍华, 黄东业, 田兆福, 杨鸿. 银菘香的急性毒性及致突变性研究[J]. 中国药物警戒, 2016, 13(6): 321-324.
[12]	吴彦, 杨鸿, 钟菊迎, 刘钊, 高尔宁, 王萍娟, 黄东业, 田兆福, 白家峰. 中药复方藿莲香Ⅰ号的遗传毒理学研究[J]. 中国药物警戒, 2014, 11(11): 649-651.