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中药注射剂溶血检查的两种方法比较 被引量:7

The Comparison of Two Hemolysis Test methods of Traditional Chinese Medicine Injections
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摘要 目的:常规体外试管法与分光光度法在中药注射剂溶血检查中的应用比较。方法:通过吸收波长、离心转速及温育时间的研究,建立了分光光度法测定溶血率的方法,并与常规体外试管法进行了3种中药注射剂溶血试验的结果对比。结果:分光光度法可以定量地测定中药注射剂的溶血程度,较常规体外试管法更能准确地判断药品的质量。结论:建议对于中药注射剂应使用分光光度法评价其溶血程度。 Objective: To compare the application of routine test tube method in vitro and Spectrophotometric method in traditional Chinese medicine injections. Method: A spectrophotometrie method for hemolysis ratio of traditional Chinese medicine injections was established by the study of absorption wavelength, centrifugal speed and incubation time. Hemolysis ratio results of three traditional Chinese medicine injections were compared by the spectrophotometrie method and the routine test tube method in vitro. Results: The Hemolysis ratio can be determined quantitatively by the speetrophotometric method and the quality of drug can be estimated more accurate- ly than by the routine test tube method in vitro. Conclusion: Spectrophotometrie method should be used in evaluation of Hemolysis degree of traditional Chinese medicine injections.
作者 柯正方
出处 《中国药品标准》 CAS 2011年第3期216-219,共4页 Drug Standards of China
关键词 中药注射剂 常规体外试管法 分光光度法 溶血率 traditional Chinese medicine injections routine test tube method in vitro spectrophotometric method hemolysis ratio
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参考文献3

  • 1中国药典.2005年版.-部[S].2005:256.
  • 2GB/T14233.2-2005.医用输液、输血、注射器具检验方法.第2部分:生物试验方法[S].
  • 3国家食品药品监督管理局.药包材检验方法标准汇编[S].2003,10.

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