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溴吡斯的明注射液的制备及其含量测定

Preparation and assay of pyridostigmine bromide injection

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【作者】 王丽君王东凯黎玲邓硕杨秀丽孔俐文殷栋二

【Author】 WANG Li-jun1,WANG Dong-kai1,LI Ling1,DENG Shuo1,YANG Xiu-li1,KONG Li-wen1,YIN Dong-er2(1 Department of Pharmaceutics,Shenyang Pharmaceutical University,Shenyang 110016,China;2 Hainan Bikai Pharmaceutical Co.,Ltd.,Haikou 570216,China)

【机构】 沈阳药科大学药剂系海南碧凯药业有限公司 沈阳110016沈阳110016海口570216

【摘要】 目的:研究溴吡斯的明注射液的处方及制备工艺,并建立高效液相色谱法检测溴吡斯的明注射液的含量。方法:以稳定性为指标,筛选处方。采用十八烷基硅烷键合硅胶色谱法检测溴吡斯的明注射液的含量。结果:本品最适pH值为4.5~5.5。溴吡斯的明在150~350μg.mL-1范围内具有较好的线性关系,相关系数r=0.999 9,平均回收率为(99.79±0.69)%,精密度及稳定性均较好。制备的3批样品的含量分别为100.12%,99.98%和99.99%。结论:本品处方设计合理,工艺可行,质量稳定。所建立的高效液相色谱法可用于溴吡斯的明注射液含量的测定,且方法简便、准确。

【Abstract】 Objective:To develop an injection formulation and to establish the assay method of pyridostigmine bromide injection.Methods: The stability of the injection was used as an indicator for development of the formulation.Pyridostigmine bromide in injection was assayed using HPLC method.Results:The optimum pH for the injection formulation was 4.5~5.5 according to the stability.Linear range for measurement of pyridostigmine bromide was from 150 μg·mL-1 to 350 μg·mL1(r=0.999 9),and the average recovery was(99.79±0.69)%(n=6).The contents of three batches of pyridostigmine bromide were 100.12%,99.98% and 99.99% respectively.Conclusion:The developed injection formulation was stable and suitable for industrial production.The assay method is rapid,simple,and accurate.

  • 【文献出处】 中国新药杂志 ,Chinese Journal of New Drugs , 编辑部邮箱 ,2007年11期
  • 【分类号】R943;R927
  • 【被引频次】12
  • 【下载频次】211
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