柴胡注射液体外细胞毒性研究

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2 mg·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1 mg·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 in vitro of Radix Bupleuri injection and explore the principle in order to provide references for the security evaluation of traditional Chinese medicine injection. Methods: L929 cells were incubated with Radix Bupleuri injection of various concentrations,and cell form was observed by inverted phase contrast microscope.Cytotoxicity was examined by MTT test and RGR was calcutated to study the correlation between the cytotoxicity and the concentration of Polysorbate 80. Results: No obvious cytotoxcity exsited in Radix Bupleuri injection diluted 4 to 16 times when the concentration of Polysorbate 80 was above 2 mg·mL^-1 in 32 groups from 6 factories.When the the concentration of Polysorbate 80 was below 1 mg·mL^-1,only 7 groups injection diluted 2 to 8 times had no cytotoxcity. Conclusion: Direct correlation exsited between the cytotoxicity in vitro of Radix Bupleuri injection and the concentration of Polysorbate 80.