摘要
目的建立注射用益气复脉(冻干)(YQFM)对H9C2心肌细胞损伤的保护作用,并对30批样品进行测定。方法筛选H2O2对H9C2心肌细胞损伤的造模时间(0.5、1.0、1.5 h)、造模剂量(0.1、0.2、0.3、0.4、0.5、0.6 mmol/L),确定最佳造模方式;并进行线性、精密度和耐用性方法学考察;以YQFM随行样品作为对照,以细胞存活率作为衡量其保护作用的指标。结果造模时间为0.5 h,H2O2造模剂量为0.2 mmol/L时,细胞存活率为60%左右,造模效果相对稳定;浓度为5 mg/mL的30批YQFM,使H2O2所致的损伤H9C2细胞的存活率为84.4%~96.8%,具有较好的细胞保护作用。结论所建方法适用于YQFM对H9C2细胞损伤的保护作用研究,可作为初步评价YQFM生物学质量标准。
Objective Establish a protective effect of YiqiFumai Lyophilized Injection for injection on H9C2 cardiomyocyte injury.Determine the protective effect of 30 batches of samples on myocardial cell injury.Methods Study the modeling time(0.5,1.0,and1.5 h)and the modeling dosage(0.1,0.2,0.3,0.4,0.5,and 0.6 mmol/L)of H2O2 on H9C2 cardiomyocyte injury.Determine the best modeling method,and carry out linear,reproducible,precision and stability methodological investigation.Use the accompanying sample as a control.Use the percentage of CCK-8 cell viability as an index to measure its relative protection.Results When the modeling time was 0.5 h,the dose of H2O2 was 0.2 mM,the degree of cell damage was about 60%,and the modeling effect was relatively stable.The concentration of YiqiFumai(lyophilized)in 30 batches was 5 mg/mL.Its protective effect on H9C2 cardiomyocyte injury induced by H2O2 is between 84.4%—96.8%,which has a good cytoprotective effect.Conclusion The established method is suitable for the protective effect of YiqiFumai Lyophilized Injection for injection on H9C2 cell injury.It can be used as a preliminary evaluation of the biological quality standard of YiqiFumai Lyophilized Injection for injection.
作者
李晓凡
王秀丹
万梅绪
李智
李德坤
张彦文
鞠爱春
LI Xiaofan;WANG Xiudan;WAN Meixu;LI Zhi;LI Dekun;ZHANG Yanwen;JU Aichun(Tianjin Medical University,Pharmacy,Tianjin 300070,China;Tianjin University of Traditional Chinese Medicine,Graduate School,Tianjin 300193,China;TianjinTasly Pride Pharmaceutical Co.,Ltd.,Tianjin 300410,China;Tianjin Key Laboratory of Safety Evaluation of TCM Injections,Tianjin 300410,China;Tianjin Medical College,Tianjin 300222,China)
出处
《药物评价研究》
CAS
2020年第8期1510-1514,共5页
Drug Evaluation Research
基金
天津市科技计划项目(18YFCZZC00430)。