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利巴韦林气雾剂每揿主药含量的DUSA管法测定 被引量:4

Determination of the Content per Actuation of Ribavirin Aerosol by DUSA Method
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摘要 建立了DUSA管(单位剂量取样装置)法分析并测定利巴韦林气雾剂的每揿主药含量。利巴韦林气雾剂经适配器连接上DUSA管,通过真空泵控制空气流速为(28.3±1.5)L/min,采用高效液相色谱法测定3批样品的每揿主药含量,结果分别为(0.459 5 0.073 8)、(0.447 8 0.052 8)和(0.447 6 0.050 4)mg。并与法定标准测定结果比较,DUSA管法测得结果低约20%,更能反映出真正进入人体内的药物剂量。 A dosage unit sampling apparatus (DUSA) method was established for the determination of the content per actuation in ribavirin aerosol. The aerosol was connected with DUSA through an adaptor, and the flow rate was controlled at (28.3± 1.5) L/min by a vacuum pump. An HPLC method was utilized for the determination of ribavirin. The contents per actuation of 3 batches of samples were determined. The results were (0.459 5±0.073 8), (0.447 8±0.052 8) and (0.447 6±0.050 4) mg, respectively, which was approximately 20% less than the contents determined by the current official method. However, the results by DUSA method represented the actual dose administrated to patients.
出处 《中国医药工业杂志》 CAS CSCD 北大核心 2013年第10期1021-1024,共4页 Chinese Journal of Pharmaceuticals
基金 国家药典会气雾剂专项课题(2011-668)
关键词 利巴韦林气雾剂 每揿主药含量 DUSA管法 高效液相色谱 测定 ribavirin aerosol content per actuation DUSA method HPLC determination
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  • 1Westmeier R, Steckel H. Combination particles containing salmeterol xinafoate and fluticasone propionate: Formulation and aerodynamic assessment [J]. J Pharm Sci, 2008, 97 (6) : 2299-2310.
  • 2Murnane D, Martin GP, Marriott C. Validation of a reversephase high performance liquid chromatographic method for concurrent assay of a weak base (salmeterol xinafoate) and a pharmacologically active steroid (fluticasone propionate) [J]. JPharm Biomed Anal, 2006, 40 (5): 1149-1154.
  • 3Vo NV, Young KC, Lai MM. Mutagenic and inhibitory effects of ribavirin on hepatitis C virus RNA polymerase [J]. Biochemistry, 2003, 42 (35) : 10462-10471.
  • 4Witkowski JT, Robins RK, Sidwell RW, et al. Design, synthesis, and broad spectrum antiviral activity of 1-J3-D- ribofuranosyl-1,2,4-triazole-3-carboxamide and related nucleosides [J]. J Med Chem, 1972, 15 (11 ) : 1150-1154.
  • 5Fukui K, Kakeya N. Preparation of 1,2,4-triazole-3- carboxylic acid amide: JP, 59206367 [P]. 1984-11-22.
  • 6.ChP(中国药典).[S].,2005-Vo1Ⅱ(二部).Appendix(附录)IL.
  • 7FDA CDER: Guidance for Industry, Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products. Chemistry, Manufacturing, and Control Documentation [EB/OL]. http ://www. fda. gov/cder/guidance/index. htm. 1998 - 11 - 13.
  • 8LeBelle M, Pike RK, Graham SJ, et al. Metered -dose inhalers I:Drug content and particle size distribution of beelomethasone dipropionate. J Pharm Biomed Anal, 1996, 14:793
  • 9HOUHui—rain(侯惠民) WANGHao(王浩) ZHANGGuang—jie(张光杰).Application Technology of Pharmaceutical Excipilents(药用辅料应用技术)2nd Ed(第二版)[M].Beijins(北京):China Medieo—Pharmaceutical Science and Technology Publishing House(中国医药科技出版社),2002.160.
  • 10CenterfordrugevaluationSFDA SichuanMedcomSoftwareCo LTD(国家食品药品监督管理局药品审评中心 四川美康医药软件研究开发有限公司共同).MCDEX Clinical Drug Reference(MCDEX药物临床信息参考)[M].Chengdu (成都): Siehuan Science and Technology Publishing House (成都四川科学技术出版社),2004.495.

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