盐酸吗啡注射液输液稳定性研究
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摘要
目的探讨盐酸吗啡注射液在不同输液条件下的稳定性。方法模拟临床常用给药剂量,将盐酸吗啡注射液分别储存于自控镇痛泵、玻璃瓶、普通注射器中,分别于25℃和37℃放置0,1,2,3,5,7,9,11,13,15 d,采用高效液相色谱法测定盐酸吗啡的质量浓度,以pH复合电极测定p H。结果在25℃或37℃条件下,盐酸吗啡注射液在3种容器中放置15 d内,其外观及pH均无明显变化,盐酸吗啡注射液质量浓度基本平稳。结论无论是室温还是体温条件下,盐酸吗啡注射液置玻璃瓶、普通注射器、自控镇痛泵中15 d内均稳定。
Objective To investigate the stability of Morphine Hydrochloride Injection under different infusion conditions. Methods By simulating the dosage commonly used in the clinic, Morphine Hydrochloride Injection was stored in the patient-controlled analgesia pump, glass bottle and common syringe at 25 ℃ or 37 ℃ for 0, 1,2,3, 5,7, 9,11, 13, 15 d, respectively. The mass concentration of morphine hydrochloride was determined by HPLC,and the pH was determined by pH composite electrode. Results The appearance and pH of Morphine Hydrochloride Injection had no obvious change in the three containers within 15 d at 25 ℃ or 37 ℃,and the mass concentration of Morphine Hydrochloride Injection remained stable. Conclusion Whether at room temperature or body temperature,Morphine Hydrochloride Injection was stable in the glass bottle,common syringe and patient-controlled analgesia pump within 15 d.
Objective To investigate the stability of Morphine Hydrochloride Injection under different infusion conditions. Methods By simulating the dosage commonly used in the clinic, Morphine Hydrochloride Injection was stored in the patient-controlled analgesia pump, glass bottle and common syringe at 25 ℃ or 37 ℃ for 0, 1,2,3, 5,7, 9,11, 13, 15 d, respectively. The mass concentration of morphine hydrochloride was determined by HPLC,and the pH was determined by pH composite electrode. Results The appearance and pH of Morphine Hydrochloride Injection had no obvious change in the three containers within 15 d at 25 ℃ or 37 ℃,and the mass concentration of Morphine Hydrochloride Injection remained stable. Conclusion Whether at room temperature or body temperature,Morphine Hydrochloride Injection was stable in the glass bottle,common syringe and patient-controlled analgesia pump within 15 d.
引文
[1]杨振声.吗啡泵治疗重度癌痛的疗效分析[J].临床医学工程,2013,20(7):837-838.
[2]陈瑞杰,朱晓燕,徐优晓,等.生理盐水中盐酸吗啡注射液的稳定性考察[J].中国医院药学杂志,2007,27(12):1770-1771.
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[5]钟政,金华,李咏梅,等.湿度与特药吗啡含量测定关系研究[J].中国医药科学,2011,1(5):67.
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[8] HILDEBRAND KR,ELSBERRY DD,HASSENBUSCH SJ. Stability and Compatibility of Morphine-Clonidine Admixtures in an Implantable Infusion System[J]. J Pain Symptom Manage,2003,25(5):464-471.
[9]李鹏,陈富超,方宝霞,等.注射用氯诺昔康与盐酸吗啡注射液在0. 9%氯化钠注射液中的稳定性[J].医药导报,2012,31(4):518-521.
[10] DONNELLY RF,WONG K. Physical Compatibility of HighConcentration Bupivacaine with Hydromorphone,Morphine,and Fentanyl[J]. Can J Hosp Pharm,2010,63(2):154-155.
[2]陈瑞杰,朱晓燕,徐优晓,等.生理盐水中盐酸吗啡注射液的稳定性考察[J].中国医院药学杂志,2007,27(12):1770-1771.
[3]李玉莲.旋光法快速测定硫酸吗啡注射液的含量[J].中国药业,2004,13(9):35.
[4]曲恒燕,郝光涛,陈学义.高效液相色谱-质谱联用法测定人血浆中氢吗啡酮的浓度[J].中国临床药理学杂志,2015,31(3):216-218.
[5]钟政,金华,李咏梅,等.湿度与特药吗啡含量测定关系研究[J].中国医药科学,2011,1(5):67.
[6] LIN FS,LIN TF,YEH YC,et al. Compatibility and stability of ketorolac tromethamine and morphine hydrochloride in 0. 9%sodium chloride injection[J]. Pain Clinic,2013,19(3):99-103.
[7] NEGRO S,REYES R,AZUARA ML,et al. Morphine,haloperidol and hyoscine N-butyl bromide combined in s. c. infusion solutions:Compatibility and stability:Evaluation in terminal oncology patients[J]. Int J Pharm,2006,307(2):278-284.
[8] HILDEBRAND KR,ELSBERRY DD,HASSENBUSCH SJ. Stability and Compatibility of Morphine-Clonidine Admixtures in an Implantable Infusion System[J]. J Pain Symptom Manage,2003,25(5):464-471.
[9]李鹏,陈富超,方宝霞,等.注射用氯诺昔康与盐酸吗啡注射液在0. 9%氯化钠注射液中的稳定性[J].医药导报,2012,31(4):518-521.
[10] DONNELLY RF,WONG K. Physical Compatibility of HighConcentration Bupivacaine with Hydromorphone,Morphine,and Fentanyl[J]. Can J Hosp Pharm,2010,63(2):154-155.