目的 研究溶血率測(cè)定法在莪術(shù)油葡萄糖注射液安全性再評(píng)價(jià)中的應(yīng)用,為提高莪術(shù)油葡萄糖注射液質(zhì)量標(biāo)準(zhǔn)提供參考。方法 用《中國(guó)藥典》2010年版二部附錄“溶血與凝聚檢查法”和紫外分光光度測(cè)定溶血率法,對(duì)3家廠家生產(chǎn)的22批莪術(shù)油葡萄糖注射液進(jìn)行溶血與凝聚檢查和分光光度法測(cè)定溶血率,比較實(shí)驗(yàn)結(jié)果,并對(duì)檢查樣品進(jìn)行安全性評(píng)價(jià)。結(jié)果 溶血與凝聚檢查試驗(yàn)和紫外分光光度法測(cè)定溶血率的試驗(yàn)結(jié)果有一定的相關(guān)性,部分批號(hào)莪術(shù)油葡萄糖注射液具溶血性,臨床使用存在一定的風(fēng)險(xiǎn)。結(jié)論 莪術(shù)油葡萄糖注射液應(yīng)檢查溶血與凝聚,紫外分光光度測(cè)定溶血率方法可用于莪術(shù)油葡萄糖注射液的質(zhì)量控制。

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.