一测多评法在含皂苷类成分中药质量控制中的应用
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摘要
因中药多成分、多靶点的特征,采用关联中药药效活性的多指标成分定性定量较单一指标更能合理表征中药质量,同时由于对照品不稳定、昂贵不易获得等特点也使多指标评控模式难以普及。皂苷是苷元为三萜或螺旋甾烷类化合物的一类糖苷,其广泛分布于植物界并是许多中药的主要活性成分,具有抗肿瘤、免疫调节、抗病毒、防治心血管疾病等作用。如何对含皂苷类成分的中药进行合理有效的质量控制,对于保证此类中药的临床安全有效性具有重要意义。一测多评(quantitative analysis of multi-components by single marker,QAMS)法是只用一种对照品来实现对中药中多个成分的同步监控,能有效避免多指标评控模式存在的问题,该方法自提出至今十多年已经在中药质量控制和评价中得到较好的发展和验证,并在含皂苷类成分中药的质量控制中应用广泛。该文在阐述QAMS法原理的基础上结合近10年文献,对QAMS法在含三萜皂苷和甾体皂苷类成分中药及其制剂中的质控研究进行系统梳理及论述,并对可能存在的问题进行分析阐释,以期为该方法在中药质控领域的持续深入发展提供参考。
Due to the multi-component and multi-target features of Chinese medicinal materials( CMMs),multiple active components could be more reasonably represent the quality of CMMs compared with the singlecomponent QC mode. However, it is still difficult to apply the multi-component QC mode because of the instability,high cost and inaccessibility of reference substances of CMMs. Saponins are glycosides with aglycones of triterpene or spirostane and widely distributed in plants. Saponins are also the major active constituents of many CMMs,with multi-effects of inhibiting tumors,regulating the immune system,inhibiting virus,preventing and treating cardiovascular diseases. Therefore, rational and effective control of the quality of CMMs containing saponins is of great significance for ensuring the clinical safety and efficacy of such CMMs and related products.The quantitative analysis of multi-components by single marker( QAMS) can use only one reference substance to achieve the simultaneous monitoring of multiple components in CMMs, and make up the weaknesses of multicomponent QC mode,and has been well developed and validated in the QC and evaluation of CMMs for more than ten years since it was put forward. And now it has been widely used in the QC of CMMs containing saponins. Based on the investigation of QAMS theory and literatures in the past decade,studies on the QC of CMMs and related preparations containing triterpenoid saponins and steroidal saponins by QAMS were summarized and discussed systematically. In addition,some possible problems were analyzed and interpreted,in order to provide reliable basis for more QC of CMMs and reference for the continuous use and in-depth development of this method in the research of CMMs.
Due to the multi-component and multi-target features of Chinese medicinal materials( CMMs),multiple active components could be more reasonably represent the quality of CMMs compared with the singlecomponent QC mode. However, it is still difficult to apply the multi-component QC mode because of the instability,high cost and inaccessibility of reference substances of CMMs. Saponins are glycosides with aglycones of triterpene or spirostane and widely distributed in plants. Saponins are also the major active constituents of many CMMs,with multi-effects of inhibiting tumors,regulating the immune system,inhibiting virus,preventing and treating cardiovascular diseases. Therefore, rational and effective control of the quality of CMMs containing saponins is of great significance for ensuring the clinical safety and efficacy of such CMMs and related products.The quantitative analysis of multi-components by single marker( QAMS) can use only one reference substance to achieve the simultaneous monitoring of multiple components in CMMs, and make up the weaknesses of multicomponent QC mode,and has been well developed and validated in the QC and evaluation of CMMs for more than ten years since it was put forward. And now it has been widely used in the QC of CMMs containing saponins. Based on the investigation of QAMS theory and literatures in the past decade,studies on the QC of CMMs and related preparations containing triterpenoid saponins and steroidal saponins by QAMS were summarized and discussed systematically. In addition,some possible problems were analyzed and interpreted,in order to provide reliable basis for more QC of CMMs and reference for the continuous use and in-depth development of this method in the research of CMMs.
引文
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[11]张佳佳,巫军.黑乳海参皂苷nobilisideⅠ和nobilisideⅡ的体外抗真菌及抗肿瘤活性[J].中药材,2011,34(9):1420-1423.
[12]崔雨晴,张继全,吴飞,等. HPLC同时测定不同产地假马齿苋中的5个三萜皂苷类成分[J].药物分析杂志,2017,37(2):230-236.
[13]祖先鹏,林璋,谢海胜,等.假马齿苋的化学成分和药理活性研究进展[J].中草药,2017,48(18):3847-3863.
[14]梁军,夏永刚,郭信东,等.超高效液相色谱-高分辨质谱法同时测定类叶牡丹中9种三萜皂苷类成分[J].中草药,2017,48(20):4323-4327.
[15]郑义,陈晓兰,丁宁,等.金银花和山银花有效成分测定及比较分析[J].甘肃农业大学学报,2015,50(4):170-174,180.
[16]王芳,高松.金银花、山银花药理学研究现状[J].辽宁中医药大学学报,2013,15(4):237-239.
[17]邱麒.酸枣仁总皂苷化学成分及药理活性初探[J].海峡药学,2013,25(12):48-49.
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