银青抗感口服液指纹图谱及解热镇痛抗炎药效研究

Fingerprint of Yinqing Kanggan Oral Liquid and Its Antipyretic,Analgesic,and Anti-Inflammatory Efficacy

目的:基于指纹图谱及解热镇痛抗炎实验对银青抗感口服液进行质量控制及药效学评估。方法:采用SunfireTM-C_(18)色谱柱,乙腈-0.1%磷酸溶液为流动相,梯度洗脱,检测波长分别为327、245、202 nm,建立银青抗感口服液的指纹图谱并确定共有峰,通过与对照品相对保留时间及紫外光谱吸收进行色谱峰对应化合物的指认,确定共有峰的归属;观察银青抗感口服液对干酵母致热大鼠、二甲苯致小鼠耳肿胀及醋酸所致小鼠扭体的影响,进行药效学评估。结果:建立了银青抗感口服液的HPLC特征图谱,共标定了16个共有峰,并通过对照品指认了其中的10个成分,各批次样品的相似度均>0.9。与模型组相比,发热大鼠给药组体温明显下降(P<0.01),血清中肿瘤坏死因子-α(TNF-α)、白细胞介素-1β(IL-1β)、白细胞介素-6(IL-6)含量明显下降(P<0.01);给药组白细胞计数明显下降(P<0.01),小鼠耳组织纤维排列紊乱、水肿及充血的情况有所改善,小鼠扭体次数明显减少(P<0.01)。结论:银青抗感口服液能有效发挥解热镇痛抗炎的药效作用。本研究所建立的HPLC方法灵敏,结果准确,重复性好,可全面有效地评价该制剂的质量。

Objective:To conduct quality control and pharmacodynamic evaluation of Yinqing Kanggan(YK)oral liquid based on fingerprint and antipyretic,analgesic and anti-inflammatory experiments.Method:SunfireTM-C18 was taken as chromatographic column,acetonitrile 0.1%phosphoric acid solution was used as the mobile phase to conduct gradient elution.The detection wavelengths were 327 nm,245 nm,and 202 nm respectively,the fingerprint of YK oral liquid was established,and common peaks were determined.According to the relative retention time and ultraviolet absorption,the corresponding compounds of chromatographic peaks were identified and the attribution of common peaks were recognized.The effects of YK oral liquid on dry yeast induced fever in rats,ear swelling in mice induced by xylene,and body twisting in mice induced by acetic acid were observed and evaluated pharmacodynamically.Results:HPLC characteristic spectrum of YK oral liquid was established,a total of 16 common peaks were calibrated,and ten of the components were identified through the control material.The similarity of each batch of the samples was greater than 0.9.Compared with model group,the rat′s body temperature of fever medication group decreased significantly(P<0.01),and the content of TNF-α,IL-1β,and IL-6 in serum decreased significantly(P<0.01).The white blood cell count decreased significantly in the medicine administration group(P<0.01).The disorder of fiber arrangement,edema,and congestion of the mice ear tissue were improved,and the number of body twisting of mice significantly decreased(P<0.01).Conclusion:Yinqing Kanggan oral liquid can effectively exert its antipyretic,analgesic,and anti-inflammatory effects.The HPLC method established by this study is sensitive,accurate,and reproducible,which can comprehensively and effectively evaluate the quality of this preparation.