论文部分内容阅读
目的:考察柴胡注射液体外细胞毒性并初步探索其原因,为中药注射剂安全性评价提供参考。方法:将柴胡注射液倍比稀释后与L929细胞接触培养,通过倒置显微镜观察其形态,采用MTT(四唑盐)法量化细胞毒性,计算相对增殖率(RGR),并对其细胞毒性与聚山梨酯80含量相关性进行研究。结果:6个不同厂家32批柴胡注射液中,聚山梨酯80含量大于2mg.mL-1的25批样品,无明显细胞毒性的稀释倍数为4～16倍以上;聚山梨酯80含量小于1mg·mL-1的7批样品,无明显细胞毒性的稀释倍数为2～8倍。结论:柴胡注射液体外细胞毒性与聚山梨酯80含量呈正相关。
OBJECTIVE: To investigate the cytotoxicity of Bupleurum chinense injection and explore its causes, so as to provide reference for the safety evaluation of traditional Chinese medicine injections. METHODS: The Bupleurum injection was diluted to contact with L929 cells and the morphology was observed by inverted microscope. MTT (tetrazolium salt) method was used to quantify the cytotoxicity, the relative proliferation rate (RGR) was calculated, and the cytotoxicity was evaluated. The correlation of polysorbate 80 content was studied. RESULTS: Among 25 samples of 32 Bupleurum injections from 6 different manufacturers, 25 samples with a polysorbate 80 content greater than 2 mg.mL-1 had a 4-fold to 16-fold dilution without significant cytotoxicity; the polysorbate 80 content was less than In 7 batches of 1 mg·mL-1, the dilution factor without significant cytotoxicity was 2-8 times. Conclusion: The external cytotoxicity of Bupleurum chinense injection was positively correlated with polysorbate 80 content.