期刊文献+

药物制剂的合理性评价 被引量:2

Scientific Evaluation of Drug Preparations
下载PDF
导出
摘要 目的:分析部分药物制剂存在的问题,促进科学审批药物以及临床合理用药。方法:选择注射用头孢曲松钠/舒巴坦钠、非磺胺类药物/甲氧苄啶复方制剂、单硝酸异山梨酯注射液、转化糖注射液等多种不符合临床合理用药原则的药物制剂,对其合理性进行综合分析。结果及结论:这些药物制剂存在临床药理学与治疗学等方面的缺陷。药物审批必须遵循科学性、合理性原则。 Objective: To evaluate the unscientific characteristics of some drug preparations and promote the scientific approval and rational use of drugs. Method: Some drug preparations such as injection of ceftriaxone sodium/sulbactam sodium, combination of non-sulfonamide and rimethoprim, injection of isosorbide mononitrate, and injection of nimeisulide granules were analyzed according to scientific knowledge of pharmacology and pharmaceutics. Result: & Conclusion: Some pharmacological and therapeutic defects were found in these preparations. The approval of drugs should follow scientific principles strictly.
出处 《药物流行病学杂志》 CAS 2008年第6期411-413,共3页 Chinese Journal of Pharmacoepidemiology
关键词 药物制剂 合理用药 安全用药 Drug Preparation Rationality Scientific approval
  • 相关文献

参考文献18

  • 1国家食品药品监督管理局.关于印发β-内酰胺酶抑制剂抗生素复方制剂技术评价原则的通知[s].国食药监注[2006]44号.
  • 2Gobemado M. Fosfomycin[ J]. Rev Esp Quimioter, 2003,16(1 ) :15- 40.
  • 3戚文航.硝酸酯治疗新进展[J].岭南心血管病杂志,2002,8(2):82-84. 被引量:18
  • 4Chen J, Jiang XG, Cai L, Pharmacokinetics of three organic nitrates in Chinese healthy male volunteers [ J ]. Arzneimittelforschung, 2004, 54 ( 4 ) : 203-206.
  • 5吴宗贵,李舰南,樊民,尚玉琨,张亚文,白晶,丁茹,陈金明.静脉应用二硝酸异山梨酯和5-单硝酸异山梨酯抗心肌缺血起效时间的临床研究[J].上海医学,2003,26(9):625-627. 被引量:8
  • 6Wu ZG, Li JN, Fan M,et al. Comparison of the time to onset of action on myocardial ischaemia following intravenous administration of isosorbide dinitrate and 5-isosorbide mononitrate in Chinese patients [ J ]. Arzneimittelforschung,2004,54 ( 5 ) :275-279.
  • 7Sbeit W, Krivoy N, Shiller M, et al. Nimesulide-induced acute hepatitis[ J ]. Ann Pharmacother ,2001,35 (9) : 1049-1052.
  • 8Weiss P, Mouallem M, Bruck R, et al. Nimesulide-induced hepatitis and acute liver failure[ J]. lsr Med Assoc J,1999 ,1 (2) :89-91.
  • 9Rainsford KD. An analysis from clinico-epidemiological data of the principal adverse events from the COX-2 selective NSAID, nimesulide, with particular reference to hepatic injury [ J ]. Inflammopharmacology, 1998,6 ( 3 ) : 203 -221.
  • 10Schenkels LC, Veerman EC, Nieuw Amerongen AV. Biochemical composition of human saliva in relation to other mucosal fluids [ J ]. Crit Rev Oral Biol Med, 1995,6(2) :161-175.

二级参考文献13

  • 1雷莉,黄凤莉.临床药师与药物不良反应引发的药患纠纷[J].中国药师,2006,9(4):371-373. 被引量:12
  • 2王临旭,王九平,黄长形.尼美舒利致儿童急性重型肝炎死亡[J].药物不良反应杂志,2007,9(2):130-131. 被引量:22
  • 3Bergami A, Bemaseoni R, Caccia S, et al. Phannaeokinetics of isosorbide dinitrate in healthy volunteers alter 24-hour intravenous infusion.J Clin Pharmacol, 1997, 37: 828-833.
  • 4Schaumann W. Pharmacokinetics of isosorbide dinitrate and isosorbide-5-mononitrate. Int J Clin Pharmacol Ther Toxicol. 1989,27 : 445-453.
  • 5Parker JA. Organic nitrates: new formulations and their clinical advantages. Am J Cardiol, 1996, 77: C38-CA0.
  • 6Takehana K, Belier GA, Ruiz M, et al. Assessment of residual coronary stenoses using ^99m Tc-N-NOET vasodilator stress imaging to evaluate coronary flow reserve early after coronary reperfusion in a canine model of subendocardial infarction. J Nud Med, 2001,42:1388-1394.
  • 7Abshagen U, Betzien G, Endele R, et al. Pharmacokinetics of intravenous and oral isosorbide-5-mononitrate.Eur J Clin Pharmacol, 1981, 20: 269-275.
  • 8Lambert CR, Grady T, Hashimi W, et al. Hemodynamic and angiographic comparison of intravenous nitroglycerin and nicardipine mainly in subjects without coronary artery disease. Am J Cardiol,1993, 71: 420-423.
  • 9药品说明书和标签管理规定.中国药师,2006,9(4):349-350.
  • 10WHO pharmaceuticals newsletter:Nimesulide-containing products for oral use-marketing suspended in Ireland due to reports of liver failure[EB/OL].2007-05-21.[2007-08-13].http://www.who.int.

共引文献55

同被引文献14

  • 1陈敏,孙为民,杨继红,蒲玉花,杨琳.甘草酸二铵注射液与4种输液配伍的稳定性考察[J].中国药物与临床,2006,6(10):769-770. 被引量:5
  • 2无.慢性稳定性心绞痛诊断与治疗指南[J].中华心血管病杂志,2007,35(3):195-206. 被引量:2049
  • 3Hunt SA,Abraham WT,Chin MH,et al.ACC/AHA 2005 Guideline update for the Diagnosis and Management of Chronic Heart Failure in the Adult-Summary Article[J].Journal of the American College of Cardiology,2005,46:1116-1143.
  • 4Gori T,Parker JD.Long-term therapy with organic nitrates[J].Journal of the American College of Cardiology,2004,44:632-634.
  • 5Janota T.Widimsky J.Hypertensive crisis,emergent and urgent hypertensive situations-Current state of knowledge and guidelines for the management[J].Intervencni a Akutni Kardiologie,2010,9(4):198-202.
  • 6唐金陵,王彬译.临床证据[M].北京:北京大学医学出版社,2007.43-54.
  • 7Fox K,Garcia MA,Ardissino D,et al.Guidelines on the management of stable angina pectoris:executive summary:the Task Force on the Management of Stable Angina Pectoris of the European Society of cardiology[J].Europe Heart Journal,2006,27(11):1341-1381.
  • 8Thadani U.,Ripley T.L.Side effects of using nitrates to treat heart failure and the acute coronary syndromes,unstable angina and acute myocardial infarction[J].Expert Opinion on Drug Safety,2007,6(4):385-396.
  • 9Wu ZG,Li JN,Fan M,et al.Comparison of the time to onset of action on myocardial ischaemia following intravenous administration of isosorbide dinitrate and 5-isosorbide mononitrate in Chinese patientslJ].Arzneimittelforschung,2004,54(5):275-279.
  • 10任小贺,赵志刚.药源性疾病与合理用药[J].药品评价,2010(8):34-37. 被引量:8

引证文献2

二级引证文献7

相关作者

内容加载中请稍等...

相关机构

内容加载中请稍等...

相关主题

内容加载中请稍等...

浏览历史

内容加载中请稍等...
;
使用帮助 返回顶部