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目的:探讨斑马鱼神经元损伤模型在养血清脑颗粒质量控制应用的可行性,为该制剂提供一种新型生物活性质量控制方法。方法:以养血清脑颗粒为例,采用吗替麦考酚酯诱导的斑马鱼神经元损伤药效模型对养血清脑颗粒进行神经细胞保护生物活性评价和质量稳定性检测。结果:斑马鱼神经元损伤模型作为神经细胞保护药物生物活性质控方法具有较好的精密度,日内RSD 2.2%~3.7%,日间RSD 1.2%;重复性(RSD 8.4%)和稳定性(RSD 4.9%)良好;在0.10~1.00 g·L-1内养血清脑颗粒对神经细胞保护率成良好的线性关系,方法学考察符合生物活性测定指导原则的要求。结论:采用斑马鱼神经元损伤模型评价养血清脑颗粒神经细胞保护作用的方法快速、稳定可靠,可作为现有质量控制方法的有效补充,为中药的生物活性质量控制研究提供一定的技术参考。
Objective: To investigate the feasibility of zebrafish neuron injury model in the quality control of Yangxue Qingnao Granules, and to provide a new bioactive quality control method for this preparation. Methods: Taking Yangxue Qingnao Granule as an example, the mycophenolate mofetil-induced neuronal damage model of zebrafish neurons was used to evaluate the biological activity and the quality stability of Yangxue Qingnao Granules. Results: The zebrafish neuron injury model had good precision as a quality control method for neuroprotective drugs. The daily RSD was 2.2% ~ 3.7%, daytime RSD was 1.2%, repeatability (RSD 8.4%) and stability RSD 4.9%) was good. In the range of 0.10-1.00 g · L-1, Xuexue Qingnao Granule had a good linear relationship with the neuroprotective rate. The methodological study accorded with the requirements of bioassay guidelines. Conclusion: The method of zebrafish neuron injury model to evaluate the neuroprotective effects of Yangxue Qingnao granule is fast, stable and reliable, and can be used as an effective supplement to the existing quality control methods. It can provide some technical references for the study of biological active quality control of traditional Chinese medicine.