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目的研究溶血率测定法在莪术油葡萄糖注射液安全性再评价中的应用,为提高莪术油葡萄糖注射液质量标准提供参考。方法用《中国药典》2010年版二部附录“溶血与凝聚检查法”和紫外分光光度测定溶血率法,对3家厂家生产的22批莪术油葡萄糖注射液进行溶血与凝聚检查和分光光度法测定溶血率,比较实验结果,并对检查样品进行安全性评价。结果溶血与凝聚检查试验和紫外分光光度法测定溶血率的试验结果有一定的相关性,部分批号莪术油葡萄糖注射液具溶血性,临床使用存在一定的风险。结论莪术油葡萄糖注射液应检查溶血与凝聚,紫外分光光度测定溶血率方法可用于莪术油葡萄糖注射液的质量控制。
Objective To study the application of hemolysis rate in the reevaluation of the safety of Curcuma oil glucose injection and provide reference for improving the quality standard of Curcuma oil glucose injection. Methods Twenty-two batches of zedoary turmeric oil dextrose injection produced by three manufacturers were checked for hemolysis and coagulation using the appendix of “Chinese Pharmacopoeia 2010”, “Hemolytic and Coagulation Test” and UV spectrophotometry. Method to measure the hemolysis rate, compare the experimental results, and evaluate the safety of the test samples. Results Hemolysis and agglutination test and UV spectrophotometry hemolysis rate test results have some relevance, part of the lotus root oil glucose injection with hemolytic, there is a certain clinical risk. Conclusion Curcuma oil glucose injection should check the hemolysis and agglutination, UV spectrophotometry hemolysis rate method can be used for the quality control of Curcuma oil glucose injection.