目的 建立注射用益氣復(fù)脈（凍干）（YQFM）對H9C2心肌細胞損傷的保護作用，并對30批樣品進行測定。方法 篩選H₂O₂對H9C2心肌細胞損傷的造模時間（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隨行樣品作為對照，以細胞存活率作為衡量其保護作用的指標(biāo)。結(jié)果 造模時間為0.5 h，H₂O₂造模劑量為0.2 mmol/L時，細胞存活率為60%左右，造模效果相對穩(wěn)定；濃度為5 mg/mL的30批YQFM，使H₂O₂所致的損傷H9C2細胞的存活率為84.4%~96.8%，具有較好的細胞保護作用。結(jié)論 所建方法適用于YQFM對H9C2細胞損傷的保護作用研究，可作為初步評價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

天津市科技計劃項目（18YFCZZC00430）