摘要
目的:运用改良溶血率测定方法评价丹参酮ⅡA磺酸钠注射液的体外溶血作用。方法:根据临床不同给药途径,采用体外试管法37℃温浴3 h后肉眼观察浓度分别为0.32,1.25和4.00 mg·m L^(-1)的供试品是否有溶血和红细胞凝集作用,同时增加一组相同供试品浓度不加红细胞悬液对照试管,用于改良法溶血率的计算。各试管离心后用Spectra Max I3多功能酶标仪在545 nm波长处测定上清液的吸光度,按照常规方法和改良方法计算溶血率,判定是否溶血。结果:体外试管法肉眼初步判定0.32和1.25 mg·m L^(-1)不发生溶血反应,4.00 mg·m L^(-1)肉眼难以法判断是否溶血;常规溶血率计算结果:1.25 mg·m L^(-1)剂量3~5号试管及4.00 mg·m L^(-1)剂量1~5号试管溶血率均>5%;改进溶血率计算结果:仅4.00 mg·m L^(-1)剂量3~5号试管溶血率>5%。结论:随着用药浓度的升高,丹参酮Ⅱ_A磺酸钠注射液可能出现溶血反应。当供试品溶液有颜色,可能干扰结果判断时,改良的溶血试验可更真实客观地评价供试品会否引起溶血反应。
Objective： To compare the improved calculation method of the sulfotanshinone sodium injection hemolysis rate versus the standard method in vitro. Methods： According to the different clinical pathway, the drug concentration was designed as 0.32, 1.25 and 4.00 mg·mL-1, the tube full of RBC suspension at 37℃ for 3 h was observed visually whether hemolysis and hemagglutination;while add a set of the same sample concentration control tubes without RBC suspension to improve method of hemolysis rate calculation. After all tubes＇ centrifugation, the absorbance of the supernatant was measured by Spectra Max I3 muhifunctional microplate reader at a wavelength of 545 nm to calculate the hemolysis rate in accordance with conventional method and improved method, it is determined whether hemolysis. Results： the 0. 32 and 1. 25 mg·mL-1 tubes to the naked eye initially were determined without hemolysis, and the 4.00 rag. mL-J tubes were difficult to determine whether hemolysis; the results of conventional hemolysis rate calculation： 3 - 5 tube＇s hemolysis rates of 1.25 mg·mL-1 dose and 1 - 5 tube＇s hemolysis rates of 4.00 mg·mL-1 dose were higher than 5% ; the results of improved hemolysis rate calculation： 3 -5 tube＇s hemolysis rates of 4.00 mg·mL-1 dose were higher than 5%. Conclusion： Along with the increase of drug concentration, sulfotanshinone sodium injection hemolytic reaction may arise. When the sample solution＇s color may interfere with the judgment for hemolysis, the improved calculation methed can be real and feasible to evaluate the hemolytic reaction of the test.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2016年第17期1990-1993,共4页
Chinese Journal of New Drugs
基金
山东省自主创新及成果转化专项基金资助项目(2014ZZCX02104)
关键词
丹参酮ⅡA磺酸钠
溶血
溶血率
sulfotanshinone sodium
hemolytic
hemolytic rate
