正骨紫金丸HPLC指纹图谱及活血化瘀作用谱效关系研究

Zhenggu Zijin Pills(正骨紫金丸):HPLC Fingerprint and Its Relationship with Huoxuehuayu(活血化瘀)Effect

目的:建立正骨紫金丸的HPLC指纹图谱,通过谱效关系探究正骨紫金丸活血化瘀的主要药效成分,为提升其质量控制标准提供实验依据。方法:收集10批次正骨紫金丸,采用HPLC法建立指纹图谱,通过相似度分析评价不同批次产品的质量差异性;建立大鼠局部急性软组织损伤模型,以大鼠腿部肿胀度、血液黏度为正骨紫金丸活血化瘀的药效指标,采用PLSR、灰色关联度分析法进行指纹图谱与活血化瘀的谱效学关系研究。结果:正骨紫金丸HPLC指纹图谱共标定15个共有峰,采用对照品指认出7个成分,分别为5号峰(甘草苷)、8号峰(丹皮酚)、9号峰(丁香酚)、10号峰(芦荟大黄素)、12号峰(大黄素)、14号峰(大黄酚)、15号峰(大黄素甲醚);正骨紫金丸具有较强的活血化瘀作用,谱效相关性分析结果显示,正骨紫金丸指纹图谱中4、6、8、15号峰是与消肿作用关联较大的正相关峰,1、2、3、12、13、14号峰是与血液黏度关联较大的负相关峰(利于活血化瘀)。结论:不同批次的正骨紫金丸产品质量及药效稳定,通过谱效相关性分析初步阐明了正骨紫金丸活血化瘀的主要药效物质成分,可为其质量标准提升提供有益参考。

Objective:To establish the HPLC fingerprint of Zhenggu Zijin Pills(正骨紫金丸),and explore the main pharmacodynamic components for the Huoxuehuayu(活血化瘀)effect based on the fingerprint-effect relationship,so as to provide experimental evidence for improving the quality control standard of Zhenggu Zijin Pills.Methods:HPLC fingerprints were established for 10 batches of Zhenggu Zijin Pills,and then the quality differences among different batches of samples were evaluated by similarity analysis.The rat model of local acute soft tissue injury was established,with which the Huoxuehuayu effect of Zhenggu Zijin Pills was evaluated based on leg swelling degree and blood viscosity.Partial least squares regression(PLSR)and grey relational analysis were employed to analyze the relationship between fingerprint and Huoxuehuayu effect.Results:A total of 15 common peaks were identified in the HPLC fingerprints of different batches of Zhenggu Zijin Pills.Compared with the reference substances,7 components were identified,including peak 5(liquiritin),peak 8(paeonol),peak 9(eugenol),peak 10(aloe-emodin),peak 12(emodin),peak 14(chrysophanol),and peak 15(physcion).Zhenggu Zijin Pills demonstrated definite Huoxuehuayu effect.The results of the fingerprint-effect relationship analysis showed that peaks 4,6,8,and 15 in the fingerprints of Zhenggu Zijin Pills were positively correlated with the detumescence effect,while peaks 1,2,3,12,13,and 14 were negatively correlated with blood viscosity,facilitating Huoxuehuayu.Conclusion:Different batches of Zhenggu Zijin Pills showed stable quality and efficacy.This study preliminarily identified the main active ingredients of Zhenggu Zijin Pills for Huoxuehuayu by fingerprint-effect relationship analysis,providing references for improving the quality standard of Zhenggu Zijin Pills.