斑马鱼高血脂模型在山青之片质量控制中的应用研究

Zebrafish-Based Biological Quality Control for Lipid Lowering Shanqingzhi Tablets

目的:探讨斑马鱼高血脂模型在山青之片质量控制中的应用。方法:用高脂肪饮食诱导的斑马鱼高血脂模型对山青之片进行生物活性评价和质量稳定性检测。结果:斑马鱼高血脂模型作为降血脂药物生物学质量内控检测方法具有较好的可重复性(RSD为3.5%)及稳定性(RSD为3.6%);不同批号山青之片具有较好的质量稳定性,其血脂降低率平均值为60.8%(P<0.001),RSD为1.9%;同批次山青之片供试品溶液室温放置8 h以内质量稳定,血脂降低率平均值为60.5%(P<0.001),RSD为3.1%。结论:用斑马鱼高血脂模型评价中药山青之片的降血脂效果,方法快速、稳定可靠;应用斑马鱼模型建立中药的生物学质量标准有助于推动中药的现代化,值得尝试和推广。

Objective： To establish larval zebrafish-based biologically quality control standard for lipid lowering traditional chinese medicine shanqingzhi tablets. Methods ： Biological activity / pharmaceutical effect and stability of shanqingzhi tablets were quantitative- ly assessed in a well-validated larval zebrafish hyperlipidemia model induced by feeding standardized high-fat food. Results： Larval ze-brafish hyperlipidemia model as a biological quality control standard for lipid lowering shanqingzhi tablets exhibited excellent reproduc- ibility （ RSD = 3.5% ） and stability （ RSD = 3.6% ）. The preparations from a variety of batches demonstrated similar pharmaceutical activity that reduced blood lipid in larval zebrafish by 60. 8% （ RSD = 1.9% , P 〈 0. 001 ） after 40 hrs of drug treatment. The same batch of preparations were all stable for at least 8 hrs in room temperature and decreased zebrafish blood lipid by 60. 5% （ RSD = 3. 1%, P 〈 0. 001 ）. Conclusion： Zebrafish hyperlipidemia model-based biological quality control for lipid lowering shanqingzhi tablets is a rapid, reliable, stable and reproducible method. Developing biological quality control standards for natural products may contribute to the modernization of the traditional chinese medicines.