【摘要】 目的 对比分析酒丹参配方颗粒与标准汤剂的主要化学成分，并系统评价两者在脑缺血再灌注损伤模型中的神经保护作用及药效学差异。方法 采用超高效液相色谱-飞行时间串联质谱（UPLC-Q-TOF-MS/MS）技术鉴定酒丹参配方颗粒与标准汤剂的化学成分。建立大脑中动脉闭塞/再灌注（MCAO/R）小鼠模型，随机分为假手术组、模型组、尼莫地平组、酒丹参配方颗粒低/高剂量组、酒丹参标准汤剂低/高剂量组（n=14）。连续灌胃给药7 d后，通过神经功能评分、脑梗死体积（TTC染色）、脑组织病理形态（HE染色）以及超氧化物歧化酶（SOD）、丙二醛（MDA）和谷胱甘肽（GSH）水平进行药效学评价。结果 酒丹参配方颗粒与标准汤剂均含有丹参酮IIA、丹酚酸B等核心药效成分，化学成分组成基本一致。在MCAO/R模型小鼠中，两种制剂均能显著改善神经功能缺损、减轻脑梗死体积、缓解脑组织病理损伤，并有效提高SOD活性和GSH含量、降低MDA含量（P<0.05）。同等剂量下，两者的各项药效学指标均无统计学差异（P>0.05）。结论 酒丹参配方颗粒与标准汤剂在化学物质基础上高度相似，在脑缺血再灌注损伤模型中表现出相近的神经保护作用，提示二者药效学等效性，为酒丹参配方颗粒的临床标准化应用提供了实验依据。更多还原

【Abstract】 Objective To compare and analyze the main chemical components of Jiudanshen formula granules and standard decoction, and systematically evaluate their neuroprotective effects and pharmacodynamic differences in cerebral ischemia-reperfusion injury model. Methods UPLC-Q-TOF-MS/MS was used to identify the chemical constituents of Jiudanshen formula granules and standard decoction. A middle cerebral artery occlusion/reperfusion(MCAO/R) mouse model was established and randomly divided into sham operation group, model group, positive drug group, low/high dose group of Danshen formula granules and low/high dose group of Danshen standard decoction(n=14). After 7 days of continuous gavage, the pharmacodynamics were evaluated by neurological function score, cerebral infarction volume(TTC staining), pathological morphology of brain tissue(HE staining) and oxidative stress indexes(SOD, GSH, MDA). Results Both Jiudanshen formula granules and standard decoction contain core effective components such as tanshinone Ⅱ A and salvianolic acid b, and their chemical composition is highly consistent. In MCAO/R model mice, both preparations can significantly improve the neurological deficit, reduce the volume of cerebral infarction, alleviate the pathological damage of brain tissue, effectively increase the activities of SOD and GSH, and reduce the content of MDA(P<0.05). At the same dose, there was no statistical difference in each pharmacodynamic index between them(P>0.05). Conclusion Jiudanshen Formula Granules are highly similar to the standard decoction on the basis of chemical substances, showing similar neuroprotective effect in the model of cerebral ischemia-reperfusion injury, and its pharmacodynamic equivalence has been confirmed, which provides experimental basis for the clinical standardized application of Jiudanshen Formula Granule.更多还原