人血白蛋白制品铝残留量的追踪研究

Tracing research of residual aluminum content of human albumin products made in China

目的:通过对我国人血白蛋白制品在执行2005年版中国药典前后的铝残留量状况的追踪分析,并与进口人血白蛋白比较,以提高国内人血白蛋白制品的质量。方法:采用原子吸收分光光度法检测人血白蛋白制品中的铝残留量。结果:国内压滤法生产的人血白蛋白制品合格率为98.6%以上,离心法为96.8%,比执行前的合格率平均提高了56.2%。结论:在执行2005年版中国药典仅仅一年的时间内,国内生产厂家通过对工艺的优化改进,人血白蛋白制品铝残留量的控制基本符合标准。

Objective：Improving the quality of human albumin products made in China by studying residual aluminum content of human albumin products after executing ChP 2005. Methods：Atom absorb spectrometry for residual aluminum content test. Result： Eligibility rates of human albumin products are 98.6% and 96.8% separately produced by compress filtrating and deposition. These rates increase 56.2% than executing ChP 2005 before. Conclusion： Residual aluminum content of human albumin products made in China is eligible by improving producing technics in one year after executing ChP 2005.