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采用系统量化指纹法结合抗氧化活性对丹参片进行 HPLC 和 UV 指纹综合评价的质量控制。

Integrated evaluation of HPLC and UV fingerprints for the quality control of Danshen tablet by systematic quantified fingerprint method combined with antioxidant activity.

机构信息

College of Pharmacy, Shenyang Pharmaceutical University, Benxi, P. R. China.

出版信息

J Sep Sci. 2017 May;40(9):1942-1952. doi: 10.1002/jssc.201601330. Epub 2017 Apr 18.

Abstract

Danshen tablet, which consists of Salviae Miltiorrhizae Radix et Rhizoma, Notoginseng Radix et Rhizoma and Borneolum syntheticum, has been widely used in the therapy of cardiovascular disease. The aim of this study was to develop comprehensive evaluation methods for the quality control of Danshen tablet. First, five-wavelength fusion fingerprint was established to avoid one-sidedness of a single wavelength. Then, the ultraviolet spectrum fingerprint was applied to reflect the information of unsaturated bond and conjugated system of chemical substances in Danshen tablet. The similarity analyses of these two fingerprints were performed by systematic quantified fingerprint method in terms of qualitative and quantitative aspects. After that, the evaluation results of high-performance liquid chromatography and ultraviolet fingerprints were integrated by the mean algorithm, which could reduce the error caused by single method. The integrated evaluation results showed that 30 batches of samples were classified into seven grades. Finally, the fingerprint-efficacy relationship was established using an on-line antioxidant system and partial least-squares model to explore the connection between chemical components and antioxidant activities. The methods established in this paper were found suitable for the analysis of Danshen tablet.

摘要

丹参片由丹参、三七和冰片组成,已广泛用于心血管疾病的治疗。本研究旨在建立丹参片质量控制的综合评价方法。首先,建立了五波长融合指纹,以避免单一波长的片面性。然后,紫外光谱指纹用于反映丹参片中化学物质的不饱和键和共轭体系的信息。通过系统量化指纹法从定性和定量两方面对这两种指纹进行了相似性分析。之后,采用均值算法对高效液相色谱和紫外指纹的评价结果进行了综合,可减少单一方法造成的误差。综合评价结果表明,30 批样品分为 7 个等级。最后,建立了指纹-功效关系,使用在线抗氧化系统和偏最小二乘模型来探讨化学成分与抗氧化活性之间的关系。本文建立的方法适用于丹参片的分析。

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