基于鱼腥草挥发性成分动态性的中药制剂“印迹模板”一致性分析
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摘要
目的:通过阐明不同批次鱼腥草挥发性成分种类与含量的动态变化规律,揭示中药复方制剂"印迹模板"的均一性规律,为有效地控制中药复方制剂的质量提供实验依据。方法:采用水蒸气蒸馏法提取鱼腥草挥发油,采用GC-MS检测(电子轰击离子源,离子源温度230℃,检测范围m/z 40～500),并结合文献及Chemical Book数据库分析11批鱼腥草的挥发性成分,以面积归一化法计算各成分的相对质量分数,并对指纹图谱进行总量统计矩分析。结果:在11批鱼腥草挥发油中,共有成分仅15个,占成分总数的3. 35%,总相对质量分数平均值73. 94%;而非共有成分却有433个,占总数的96. 65%。GC-MS指纹图谱总量一阶矩的RSD 6. 8%,总量二阶矩的RSD 14. 8%(标准差RSD 7. 4%),总量统计矩相似度的RSD 3. 8%。鱼腥草挥发性成分在种类和含量上具有不均一性,而其GC-MS指纹图谱的色谱学行为却呈现出均一性,"印迹模板"整体相似。结论:中药指纹图谱总量统计矩(相似度)法适用于动态中药质量控制,可促进古代经典名方物质基准及复方制剂均一性和稳定性的研究。
Objective: The homogeneity regularity of " imprinting templates" of compound preparation of traditional Chinese medicine( TCM) was revealed,which provided the basis for effectively controlling the quality of compound preparation of TCM, by clarifying the dynamic changeability in number and content of volatile ingredients in different batches of Houttuyniae Herba. Method: The volatile oil of Houttuyniae Herba was extracted by steam distillation. The volatile components in 11 batches of Houttuyniae Herba were determined by GC-MS( electron ionization,ion source temperature of 230 ℃,detection range of m/z 40-500) combined with literature and ChemicalBook database. The relative content of each component was calculated by peak area normalization method and analyzed by the total quantum statistical moments of fingerprint. Result: There were only15 common ingredients in the volatile oil from 11 batches of Houttuyniae Herba,accounting for 3. 35% of total number and 73. 94% of total content, while the number of non-common ingredients was 433, accounting for96. 65% of total number. However,the RSD of total quantum first moment of GC-MS fingerprint was 6. 8%,the RSD of total quantum second moment was 14. 8%( RSD of standard deviation was 7. 4%),and the RSD of similarity of total quantum statistical moment was 3. 8%. The type and content of volatile ingredients in Houttuyniae Herba were heterogeneous,but their chromatographic behavior of GC-MS fingerprint was uniform,the whole " imprinting templates" was similar. Conclusion: The total quantum statistical moment( similarity) of TCM fingerprint is applicable to quality control of dynamic Chinese medicines,which will play a breakthrough role in the study of homogeneity and stability of material reference and compound preparation for ancient classical formulas.
Objective: The homogeneity regularity of " imprinting templates" of compound preparation of traditional Chinese medicine( TCM) was revealed,which provided the basis for effectively controlling the quality of compound preparation of TCM, by clarifying the dynamic changeability in number and content of volatile ingredients in different batches of Houttuyniae Herba. Method: The volatile oil of Houttuyniae Herba was extracted by steam distillation. The volatile components in 11 batches of Houttuyniae Herba were determined by GC-MS( electron ionization,ion source temperature of 230 ℃,detection range of m/z 40-500) combined with literature and ChemicalBook database. The relative content of each component was calculated by peak area normalization method and analyzed by the total quantum statistical moments of fingerprint. Result: There were only15 common ingredients in the volatile oil from 11 batches of Houttuyniae Herba,accounting for 3. 35% of total number and 73. 94% of total content, while the number of non-common ingredients was 433, accounting for96. 65% of total number. However,the RSD of total quantum first moment of GC-MS fingerprint was 6. 8%,the RSD of total quantum second moment was 14. 8%( RSD of standard deviation was 7. 4%),and the RSD of similarity of total quantum statistical moment was 3. 8%. The type and content of volatile ingredients in Houttuyniae Herba were heterogeneous,but their chromatographic behavior of GC-MS fingerprint was uniform,the whole " imprinting templates" was similar. Conclusion: The total quantum statistical moment( similarity) of TCM fingerprint is applicable to quality control of dynamic Chinese medicines,which will play a breakthrough role in the study of homogeneity and stability of material reference and compound preparation for ancient classical formulas.
引文
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[2]刘昌孝,陈士林,肖小河,等.中药质量标志物(QMarker):中药产品质量控制的新概念[J].中草药,2016,47(9):1443-1457.
[3]贺福元,贺红,邓凯文,等.超分子“印迹模板”(药素)特征的中药药理学研究方法探索[J].中国中药杂志,2015,40(21):4313-4318.
[4]赵新先.中药注射剂学[M].广州:广东科学技术出版社,2000:564-708.
[5]李双虎,秦侃,范鲁雁.中药注射剂临床安全性评价研究进展[J].安徽医药,2014,18(2):221-224.
[6]袁艺,龙子江,刘伟,等.鱼腥草野生苗与组培苗挥发油抗炎作用的比较[J].中国实验方剂学杂志,2008,14(9):41-43.
[7]邓凯文,贺福元,石继连,等.鱼腥草挥发油与甲基正壬酮在大鼠体内代谢产物“网通性”的研究[J].中国中药杂志,2011,36(15):2076-2083.
[8]杨文凡,陈勇,程翼宇.鱼腥草不同部位挥发油成分的研究[J].中草药,2006,37(8):1149-1151.
[9]贺福元,周宏灏,邓凯文,等.指纹图谱的一种定性定量研究新方法:总量统计矩分析法[J].药学学报,2008,43(2):195-201.
[10]贺福元,邓凯文,黄胜,等.总量统计矩标准相似度数学模型的建立及应用研究[J].药学学报,2013,48(9):1453-1458.
[11]贺福元,周逸群,邓凯文,等.超分子化学对中医药理论的特殊影响[J].中国中药杂志,2014,39(8):1534-1543.
[12]江峰.量化参数在色谱定量结构-保留关系研究中的应用[D].杭州:浙江工业大学,2004.
[13]杨岩涛,吴春英,刘文龙,等.不同相似度法对当归补血汤指纹图谱分析的比较研究[J].中华中医药杂志,2013,28(5):1431-1435.
[14]贺福元,邓凯文,黄胜,等.中药群体指纹图谱信息量和一次投料量数学模型的建立及对大黄和鱼腥草实验研究[J].中成药,2011,33(8):1292-1298.
[15]贺福元,邓凯文,刘文龙,等.中药复方对人体作用本质:“网通虹势”的多重遗传谱效动力学[J].中国实验方剂学杂志,2011,17(2):240-247.