壮腰健肾片的物质基础及质量标准提升研究

Study on the Material Basis and Quality Standard Improvement of Zhuangyao Jianshen Tablets

中文关键词:壮腰健肾片  超高效液相色谱－四极杆飞行时间质谱联用  物质基础  质量标准  指纹图谱  含量测定

Key Words:Zhuangyao Jianshen tablets  UPLC－Q－TOF MSE  material basis  quality standard  fingerprint  content determination

中文摘要:应用超高效液相色谱－四极杆飞行时间质谱联用（UPLC－Q－TOF MSE）技术及UNIFI软件分析和识别壮腰健肾片的化学成分，运用ADMETlab、TCMSP数据库预测和筛选活性成分，共筛选出55个潜在活性成分。在活性成分分析的基础上，结合与壮腰健肾片功能主治相关的药理活性文献报道进行综合评估，确认以没食子酸、原儿茶酸和原儿茶醛为含量测定指标。建立了壮腰健肾片中上述3种成分含量的高效液相色谱（HPLC）测定方法，并对15批次样品进行测定，测得没食子酸、原儿茶酸、原儿茶醛的含量分别为0.135 3 ~ 0.344 8、0.430 8 ~ 0.946 3、0.042 4 ~ 0.107 7 mg/g。进一步建立了壮腰健肾片的HPLC指纹图谱，确定15个共有峰并归属至处方药味，15批样品的相似度为0.988 ~ 1.000，批次间的成分一致性较高。该研究新建立的分析指标较原标准能更全面地表征及评价壮腰健肾片的质量，可为该制剂的药效物质基础分析和质量标准提高提供科学依据，对提高产品的质量可控性具有重要意义。

Abstract:An ultrahigh performance liquid chromatography－quadrupole time-of-flight mass spectrometry（UPLC－Q－TOF MSE） with UNIFI software analysis was used to analyze the chemical components in Zhuangyao Jianshen tablets．The active components were screened by ADMETlab and TCMSP database，of which 55 potential active components were found．The galic acid，protocatechuic acid and protocatechuic aldehyde were determined as the content determination index，based on the comprehensive evaluation of active components and the pharmacological activity literature related to the function of Zhuangyao Jianshen tablets．Meanwhile，a high performance liquid chromatography（HPLC） method was established to detect the contents of galic acid，protocatechuic acid，protocatechuic aldehyde in 15 batches of samples，which were 0.135 3－0.344 8 mg/g，0.430 8－0.946 3 mg/g and 0.042 4－0.107 7 mg/g，respectively．The HPLC fingerprints for 15 batches of Zhuangyao Jianshen tablets were established，15 common peaks were calibrated and attributed to the Chinese medicine of the prescription with their similarities between 0.988 and 1.000，which showed that the inter-batch consistency of ingredients were high．Compared with those in the original standard，the newly established analytical indexes in this paper could more comprehensively characterize and evaluate the quality of Zhuangyao Jianshen tablets，and provide a scientific basis for the effective material analysis and the improvement of the quality standard．It is of great significance to improve the quality controllability of the product.