血塞通注射液溶血性考察与研究

Hemolysis of Xuesaitong Injection

目的对市场上流通使用的血塞通注射液在溶血性方面的状况进行考察与研究。方法按《中国药典》2005年版一部附录ⅩⅧB中药注射剂安全性检查法应用指导原则和中药、天然药物刺激性和溶血性研究的技术指导原则,对11个厂家共计27批血塞通注射液每批次样品制备4个浓度,进行溶血实验研究,并采用分光光度法(545λ/nm)测定计算溶血率,比较各批次样品的溶血率。结果不同厂家甚至同一厂家不同批次的血塞通注射液溶血率存在一定差异。结论在临床使用中应注意用量,过量使用可能导致溶血引起的不良反应;同时,应注意溶血引起的临床不良反应的观测。

Objective To explore the hemolysis of Xuesaitong injection. Methods According to the Guiding Principles of safety tests on traditional Chinese medicine injection in Annex ⅩⅧ B, Chinese Pharmacopoeia, 2005 Edition 1, and Technical Guidelines of studies on the irritability and hemolytic activity of traditional Chinese medicine and natural medicine, a total of 27 samples of Xuesaitong injections (each sample was diluted into four concentrations) produced by 11 manufacturers had been examined. Spectrophotometry (545 λ/nm) was used to calculate the hemolytic rate. Results There was a certain difference in the hemolytic rate among several samples of Xuesaitong injections produced by different manufacturers, or even different batches by the same manufacturer. Conclusion The dosage of Xuesaitong injections should be noted in clinical use. Excessive use may lead to adverse reactions caused by hemolysis; at the same time, clinical adverse reactions caused by hemolysis should be observed.