目的 建立注射用益氣復(fù)脈（凍干）（YQFM）對(duì)H9C2心肌細(xì)胞損傷的保護(hù)作用，并對(duì)30批樣品進(jìn)行測(cè)定。方法 篩選H₂O₂對(duì)H9C2心肌細(xì)胞損傷的造模時(shí)間（0.5、1.0、1.5 h）、造模劑量（0.1、0.2、0.3、0.4、0.5、0.6 mmol/L），確定最佳造模方式；并進(jìn)行線性、精密度和耐用性方法學(xué)考察；以YQFM隨行樣品作為對(duì)照，以細(xì)胞存活率作為衡量其保護(hù)作用的指標(biāo)。結(jié)果 造模時(shí)間為0.5 h，H₂O₂造模劑量為0.2 mmol/L時(shí)，細(xì)胞存活率為60%左右，造模效果相對(duì)穩(wěn)定；濃度為5 mg/mL的30批YQFM，使H₂O₂所致的損傷H9C2細(xì)胞的存活率為84.4%~96.8%，具有較好的細(xì)胞保護(hù)作用。結(jié)論 所建方法適用于YQFM對(duì)H9C2細(xì)胞損傷的保護(hù)作用研究，可作為初步評(píng)價(jià)YQFM生物學(xué)質(zhì)量標(biāo)準(zhǔn)。

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, and 1.5 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 0.2mM, 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.

R965

天津市科技計(jì)劃項(xiàng)目（18YFCZZC00430）