盐酸右美托咪定注射液与给药器具的相容性研究

Abstract
Figure/Table
References (19)
Related Citation (6)

Download: PDF (0 KB) HTML (1 KB)
Export: BibTeX | EndNote (RIS)

Abstract Objective To establish the content determination method of Dexmedetomidine Hydrochloride Injection,and study its compatibility with clinical syringes and infusion tubes,so as to provide basis for drug quality in in the process ofclinicaluse.Methods High performance liquid chromatography was used.The chromatographic column was kromasil entity-5-C18 column (250 mm×4.6 mm,5 m),the mobile phase was 0.01 mol/L sodium dihydrogen phosphate solution acetonitrile (60∶40),and the column temperature was 30℃.The detection wavelength is 210 nm.The compatibility of glass syringe,natural rubber piston syringe,synthetic rubber piston syringe,piston free syringe,infusion tube and Dexmedetomidine Hydrochloride Injection at different time points at room temperature was analyzed.Results The established content determination method was verified,and the change of its content could be determined accurately.The syringe of natural rubber had great adsorption on Dexmedetomidine Hydrochloride.The content of Dexmedetomidine Hydrochloride retained in the syringe for 24 h decreases to about 81%,and the compatibility was poor.The synthetic rubber syringe had a certain adsorption of dexmedetomidine hydrochloride.The content was retained in the syringe for 24 h,and the adsorption drops to about 93%,with general compatibility.The syringe and infusion tube without rubber plug had good compatibility with Dexmedetomidine Hydrochloride,and the content remained in the syringe or infusion tube for 24 h without adsorption (＜2%).Conclusion When Dexmedetomidine Hydrochloride Injection is used clinically,syringes without rubber stopper or syringes with synthetic rubber stopper should be preferred.

Key words： Dexmedetomidine Hydrochloride Injection Naturalrubber Syringe Infusion tube Compatibility

Received: 16 November 2021

	Service

	E-mail this article
	Add to my bookshelf
	Add to citation manager
	E-mail Alert
	RSS
	Articles by authors
	GUO Xiaopeng1 WEI Junling2

Cite this article:

GUO Xiaopeng1 WEI Junling2. Study on the compatibility of Dexmedetomidine Hydrochloride Injection with drug delivery equipment[J]. 中国当代医药, 2022, 29(17): 18-21.

URL:

https://www.dangdaiyiyao.com/EN/ OR https://www.dangdaiyiyao.com/EN/Y2022/V29/I17/18

[1]	李先福，李蒙，李龙，等.盐酸右美托咪定凝胶剂的原辅料相容性研究[J].国际药学研究杂，2019，46（11）：867-872.
[2]	徐斐，敖虎山.盐酸右美托咪定的临床应用[J].中国循环杂志，2015，30（4）：401-403.
[3]	林淑芳，李佩芬，刘济泳，等.盐酸右美托咪定的药理作用和临床应用价值[J].中国实用医药，2019，14（30）：89-91.
[4]	康凤娇，崔梦茹.盐酸右美托咪定的药理分析及临床应用研究[J].临床医药文献电子杂志，2020，7（33）：137-139.
[5]	耿志宇，王东信.右美托咪定用于术后急性疼痛的临床研究进展[J].中国新药杂志，2019，28（4）：438-441.
[6]	杨颖聪，刘康，周芳，等.盐酸右美托咪定对神经病理性疼痛的作用及其机制[J].医药导报，2017，36（3）：252-255.
[7]	向许进，耿智隆，唐毅，等.静脉泵注盐酸右美托咪定对腰骶丛神经阻滞作用时间的影响[J].临床药物治疗杂志，2020，18（6）：39-43.
[8]	徐斐，敖虎山.盐酸右美托咪定的临床应用[J].中国循环杂志，2015，30（4）：401-403.
[9]	牛洪顺.盐酸右美托咪定冻干粉针剂制备工艺研究[J].中国处方药，2016，14（11）：19-20.
[10]	盛照志，李清涛，孙峰京.盐酸右美托咪定注射液的稳定性研究[J].齐鲁药事，2010，29（2）：106-107.
[11]	舒成仁，黄露圆，葛苗苗，等.盐酸右美托咪定注射液在健康人体的药动学[J].医药导报，2011，30（12）：1555-1558.
[12]	裘福荣，高成璐，沈淑娇，等.中国健康志愿者静脉连续输注盐酸右美托咪定注射液的药动学[J].中国药学杂志，2014，49（22）：2014-2017.
[14]	国家药品监督管理局药品审评中心.化学药品注射剂与塑料包装材料相容性研究技术指导原则[Z].2012-09-07.
[16]	王永，王玮，龚晓英，等.RP-HPLC 法考察地佐辛和盐酸右美托咪定配伍稳定性[J].中国临床药理学杂志，2020，36（2）：197-199.
[17]	何光照，张晓璐，王玲娜，等.5-HT3RAs 与地塞米松磷酸钠注射液在注射器中的相容性[J].药学与临床研究，2020，28（1）：47-50.
[18]	吴新民，薛张纲，马虹，等.右美托咪定临床应用专家共识（2018）[J].临床麻醉学杂志，2018，34（8）：94-97.
[13]	国家药品监督管理局药品审评中心.化学药品注射剂生产所用的塑料组件系统相容性研究技术指南（试行）[Z].2020-10-21.
[15]	李鸿雁，张顺利，刘珍仁，等.HPLC 法测定盐酸右美托咪定有关物质[J].药物分析杂志，2015，35（12）：2193-2198.
[19]	国家药典委员会.中华人民共和国药典[S].4 部.北京：中国医药科技出版社，2020.