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[摘要]
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。
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[Abstract]
Objective To study the method for the determination of hemolysis on safety re-evaluation of Zedoary Turmeric Oil and Glucose Injection and make the references to improve the quality standards of Zedoary Turmeric Oil and Glucose Injection. Methods According to the appendix Ⅱ of Chinese Pharmacopoeia 2010, the test for hemolysis and agglomeration and the method for ultraviolet spectrophotometry to determine hemolytic rate were used to measure the 22 batches of Zedoary Turmeric Oil and Glucose Injection from three manufacturers. The experimental results were compared and a safety evaluation was made. Results There was a certain relevance between the results of the two methods, and some batches have hemolysis leading to a risk in clinical use. Conclusion Hemolysis and agglomeration should be tested in Zedoary Turmeric Oil and Glucose Injection and the method of ultraviolet spectrophotometry used to determine hemolytic rate can be used for the quality control of Zedoary Turmeric Oil and Glucose Injection.
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