世界中医药

目的：探讨复方蛭龙胶囊（FFZLC）对缺血性脑卒中大鼠的治疗作用及分析其的活性成分与相关机制。方法：采用永久性双侧颈总动脉结扎法建立缺血性脑卒中大鼠模型。将SD大鼠随机分为模型组、假手术组，阳性对照组（0.09 g/kg），FFZJC大剂量组（0.9 g/kg）、FFZJC小剂量组（0.3 g/kg），每组10只，灌胃1次/d，连续8周。采用酶联免疫吸附测定（ELISA）检测血清与脑组织的炎症介质肿瘤坏死因子-α（TNF-α）、C反应蛋白（CRP）、白细胞介素-6（IL-6）、白细胞介素-8（IL-8）；测定脑组织含水量；建立高效液相色谱法（HPLC）测定FFZJC中尿嘧啶、次黄嘌呤、黄嘌呤、尿苷、羟基红花黄色素、丹酚酸B的含量。结果：与假手术组比较，模型组大鼠的脑组织含水量、大鼠的脑组织与血清中CRP、IL-6、IL-8、TNF-α明显增加（P<0.05或P<0.01）；与模型组比较，FFZJC大剂量组、FFZJC小剂量组、阳性对照组能明显降低缺血性脑卒中大鼠脑组织的含水量、大鼠的血清与脑组织中CRP、IL-6、IL-8、TNF-α的表达（P<0.05或P<0.01）；建立了FFZJC的HPLC分析方法，各成分在相应浓度范围内，线性关系良好；各成分平均回收率在97%～99%之间，相对标准偏差（RSD）小于2%；3批制剂中尿嘧啶、次黄嘌呤、黄嘌呤、尿苷、羟基红花黄色素、丹酚酸B的平均含量分别为0.588 4 mg/g、0.668 1 mg/g、1.272 8 mg/g、0.361 5 mg/g、3.485 2 mg/g和7.508 6 mg/g，其对应的RSD均小于2%。结论：FFZJC对大鼠缺血性脑卒中有保护作用，本研究建立的FFZJC活性成分HPLC分析方法可作为该制剂的质量控制方法。

English Summary:

To study Fufangzhilong capsules(FFZLCs) against ischemic stroke in rats and to analyze the active components and the relative mechanism.Methods:The rat model of ischemic stroke was established by permanent bilateral common carotid artery ligation.SD rats were randomLy divided into a model group(MG),a sham operation group(SHAMG),a positive control group(PCG,0.09 g/kg),and FFZLC high and low-dose groups(0.9 and 0.3 g/kg),with 10 rats in each group.The corresponding drugs were given once a day by gavage for 8 weeks.Tumor necrosis factor-α(TNF-α),C-reaction protein(CRP),interleukin-6(IL-6),and interleukin-8(IL-8) in the serum and brain tissues of rats were determined by enzyme-linked immunosorbent assay(ELISA),and the water content in brain tissues was measured.The content of uracil,hypoxanthine,xanthine,uridine,hydroxysafflor yellow A,and salvianolic acid B in FFZLCs was determined by high-performance liquid chromatography HPLC.Results:As compared with the SHAMG,the water content in brain tissues and the expression of CRP,IL-6,IL-8,and TNF-α in the serum and brain tissues of the MG were significantly increased(P<0.05 or P<0.01).Compared with the MG,the FFZLC high and low-dose FFZLC groups,and the PCG significantly reduced the water content in brain tissues and the expression of CRP,IL-6,IL-8,and TNF-α in the serum and brain tissues of rats(P<0.05 or P<0.01).The HPLC analysis method of FFZLC was established.The linear relationship between the components in the corresponding concentration range was good.The average recovery of each component was between 97%～99%,and the relative standard deviation(RSD) was less than 2%.The average content of uracil,hypoxanthine,xanthine,uridine,hydroxysafflor yellow A,and salvianolic acid B(mg/g) in 3 batches of preparations were 0.588 4,0.668 1,1.272 8,0.361 5,3.485 2,and 7.508 6 mg/g,respectively,and the corresponding RSD was less than 2%.Conclusion:FFZLCs have a protective effect on rats with ischemic stroke,and the HPLC method of FFZLC can be used for the quality control of the preparation.

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