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新型复方盐酸曲马多注射液(35毫克盐酸曲马多,45毫克盐酸异丙嗪)在中国健康受试者中的单剂量和多剂量药代动力学、安全性及耐受性研究

Pharmacokinetics, safety and tolerance of single- and multiple-dose of a novel compound tramadol hydrochloride injection (35 mg tramadol hydrochloride, 45 mgl promethazine hydrochloride) in Chinese healthy subjects.

作者信息

Liu Ping, Liang Sun, Wang Ben-Jie, Guo Rui-Chen

机构信息

Institute of Clinical Pharmacology, Qilu Hospital of Shandong University, Jinan 250012, China.

出版信息

Eur J Drug Metab Pharmacokinet. 2009 Jul-Sep;34(3-4):193-200. doi: 10.1007/BF03191173.

DOI:10.1007/BF03191173
PMID:20166438
Abstract

The pharmacokinetics of Tramadol and Promethazine after a single dose of 40, 80 and 120 mg intramuscular injecting CTHI was evaluated in healthy volunteers. Physical exam, vital signs, clinical laboratory tests and electrocardiogram measurements were monitored to assess the safety and tolerance of the drug. The plasma levels of Tramadol and Promethazine in serial samples were measured by a validated HPLC-MS method. No subject showed any drug-related clinically significant changes on physical examination, vital signs or laboratory tests.

摘要

在健康志愿者中评估了单次肌肉注射40、80和120毫克复方噻吩嘧啶后曲马多和异丙嗪的药代动力学。监测体格检查、生命体征、临床实验室检查和心电图测量,以评估药物的安全性和耐受性。通过经验证的高效液相色谱-质谱法测量系列样本中曲马多和异丙嗪的血浆水平。在体格检查、生命体征或实验室检查中,没有受试者出现任何与药物相关的具有临床意义的变化。

相似文献

1
Pharmacokinetics, safety and tolerance of single- and multiple-dose of a novel compound tramadol hydrochloride injection (35 mg tramadol hydrochloride, 45 mgl promethazine hydrochloride) in Chinese healthy subjects.新型复方盐酸曲马多注射液(35毫克盐酸曲马多,45毫克盐酸异丙嗪)在中国健康受试者中的单剂量和多剂量药代动力学、安全性及耐受性研究
Eur J Drug Metab Pharmacokinet. 2009 Jul-Sep;34(3-4):193-200. doi: 10.1007/BF03191173.
2
Development and validation of a sensitive LC-MS method for the determination of promethazine hydrochloride in human plasma and urine.一种用于测定人血浆和尿液中盐酸异丙嗪的灵敏液相色谱-质谱法的开发与验证。
Eur J Drug Metab Pharmacokinet. 2009 Jul-Sep;34(3-4):177-84. doi: 10.1007/BF03191171.
3
Development and validation of a sensitive LC-MS method for the determination of tramadol in human plasma and urine.一种用于测定人血浆和尿液中曲马多的灵敏液相色谱-质谱联用方法的开发与验证。
Eur J Drug Metab Pharmacokinet. 2009 Jul-Sep;34(3-4):185-92. doi: 10.1007/BF03191172.
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本文引用的文献

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Clinical pharmacology of tramadol.曲马多的临床药理学
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2
The analgesic efficacy of tramadol is impaired by concurrent administration of ondansetron.曲马多的镇痛效果会因与昂丹司琼同时给药而受到损害。
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The effects of tramadol on postoperative nausea, vomiting and headache after ENT surgery. A placebo-controlled comparison with equipotent doses of nalbuphine and pethidine.曲马多对耳鼻喉科手术后恶心、呕吐及头痛的影响。与等效剂量纳布啡和哌替啶的安慰剂对照比较。
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Increased nausea and dizziness when using tramadol for post-operative patient-controlled analgesia (PCA) compared with morphine after intraoperative loading with morphine.与术中负荷使用吗啡后使用吗啡相比,术后患者自控镇痛(PCA)使用曲马多会增加恶心和头晕的发生率。
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Pharmacokinetics of tramadol and bioavailability of enteral tramadol formulations. 2nd communication: drops with ethanol.曲马多的药代动力学及肠内曲马多制剂的生物利用度。第二次通讯:含乙醇滴剂
Arzneimittelforschung. 1998 May;48(5):436-45.
7
Comparison of tramadol and morphine via subcutaneous PCA following major orthopaedic surgery.骨科大手术后经皮下自控镇痛泵使用曲马多和吗啡的比较。
Can J Anaesth. 1998 May;45(5 Pt 1):435-42. doi: 10.1007/BF03012579.
8
Contribution of monoaminergic modulation to the analgesic effect of tramadol.单胺能调节对曲马多镇痛作用的贡献。
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