不同来源灯盏花素注射液体外细胞毒性比较研究

目的: 比较不同来源灯盏花素注射液体外细胞毒性的差别,遴选优质药品。 方法: 将不同来源灯盏花素注射液原液以及稀释液,与L929 细胞接触培养,通过倒置相差显微镜观察其形态,采用四甲基偶氮唑盐比色法(MTT法)量化细胞毒性,计算相对增值率,并进行细胞毒性评价。 结果: 10个厂家生产的灯盏花素注射液原液的细胞毒性分级均为4级。样品D和F无细胞毒性反应的浓度较其他样品低,显示其有较强的细胞毒性;而样品A无细胞毒性反应的浓度较其他样品高,说明其细胞毒性较其他样品低。在不同来源的灯盏花素注射液所添加的辅料中,吐温-80的细胞毒性分级为4级。将吐温-80稀释1024倍时,其细胞毒性分级为1级,基本无细胞毒性。 结论: 不同厂家生产的灯盏花素注射液由于生产条件不同、处方不同等原因,其细胞毒性存在较大的差别。吐温-80作为中药注射剂的辅料,可再适当降低其浓度,以提高药品的安全性。

Objective: To compare the cellular toxic response with respect to different Breviscapine injections produced by different factories and evaluate the qualities of them. Methods: Different Breviscapine injections were incubated into serum-supplemented minimum essential medium for different doses.L929 cells were used.The cellular morphology was observed by phase contrast inverted microscopy and proliferation of the cells was examined using mitochondrial function Methyl thiazolyl tetrazolium(MTT)assay.Relative growth rate(RGR)was calculated and the biological reactivity was described. Results: The observed responses to different Breviscapine Injections produced by different factories were all grade 4.However,the concentrations of sample D and F which did not show cytotoxicity was lower then other samples.The concentration of sample A which did not show cytotoxicity was higher then other samples.One of adjuvants in Breviscapine injections is tween-80.The observed response to tween-80 was grade 4.However,The biological reactivity was grade 1 when tween-80 was diluted 1024 times. Conclusion: It showed the responses to Breviscapine injections produced by different factories were different.Tween-80 may link with advers effects of Breviscapine injections.