溶血率测定法用于有色注射剂的研究

    Study on the Mensuration of Hemolysis Ratio Used in Colored Injection

    • 摘要: 目的 比较用于有色注射液的溶血率测定方法,进一步完善溶血率测定法在药品质量控制中的应用。方法 以有色注射剂红茴香注射液为例,供试液加10%兔红细胞混悬液孵育后离心,常规溶血率法:对上清液进行吸光度值测定,并计算样品溶血率;改进后溶血率法:剩余红细胞加纯化水后,测定溶液吸光度值,并计算溶血率。结果 改进后溶血率法能更准确的反映有色注射液的溶血率。结论 溶血率测定法可用于对有色注射液的质量控制。

       

      Abstract: OBJECTIVE To compare methods in determining hemolysis of colored injection and further perfect the hemolysis determination in drug quality control. METHODS Took the red fennel injection for example. First mixed the test solution with 10% rabbit erythrocyte suspension, then incubated and centrifuged. Ordinary method: determined the absorbance value of supernatant and calculate the hemolysis. Improved method: determined the absorbance value of the remaining red blood cells with purified water and calculated the hemolysis. RESULTS The improved hemolysis determination could more accurately reflect the hemolysis of colored injection. CONCLUSION The mensuration of hemolysis can be used in drug quality control of colored injection.

       

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