OBJECTIVE:To supplement and improve the hemolytic inspection methods of Chinese Pharmacopoeia,and to establish the method for the determination of hematolysis of hypotonic intravenous injection in vitro.METHODS:"Hematolysis and coagulation method" stated in appendix of Chinese Pharmacopoeia Ⅰ and Ⅱ were improved; the absorbance and hemolytic rate of 3 specifications of 8 batches of human serum albumin from 5 manufacturers were determined and calculated by spectrophotometry instead of visual method at 576 nm; the osmolality of samples were determined.RESULTS:The hemolytic rate of human serum albumin with low osmotic pressure was about 12％ (osmolality=191 mOsmol/kg)-60％ (osmolality＜100 mOsmol/kg).The correlation between hemolytic rate and osmolarity was not consistent among the products from different manufacturers.CONCLUSIONS:The method is suitable for the hemolysis of hypotonic intravenous infusion in vitro.%目的:补充完善《中国药典》中的溶血检查方法,并建立适用于低渗静脉输液的体外溶血测定方法.方法:对《中国药典》一部和二部附录中的“溶血与凝聚检查法”进行改进,将5个企业共3种规格8个批号的人血白蛋白样品的溶血情况结果判断由人工目视改为分光光度法测定.于576 nm波长处测定吸光度并计算溶血率,同时测定其渗透压摩尔浓度.结果:样品中低渗人血白蛋白的溶血率约在12％(渗透压摩尔浓度为191 mOsmol/kg)～60％(摩尔浓度＜100 mOsmol/kg);不同厂家样品的溶血率与渗透压摩尔浓度的相关性不一致.结论:建立的方法适用于低渗静脉输液的体外溶血情况考察.
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