首页> 外文期刊>Journal of Pharmaceutical and Biomedical Analysis: An International Journal on All Drug-Related Topics in Pharmaceutical, Biomedical and Clinical Analysis >Chemical fingerprint and metabolic fingerprint analysis of Danshen injection by HPLC-UV and HPLC-MS methods.
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Chemical fingerprint and metabolic fingerprint analysis of Danshen injection by HPLC-UV and HPLC-MS methods.

机译:HPLC-UV和HPLC-MS法分析丹参注射液的化学指纹图谱和代谢指纹图谱。

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HPLC-UV and HPLC-MS techniques were used in fingerprint analysis of Danshen injection and its raw materials (roots and rhizoma of Salvia miltiorrhiza). HPLC profiles of Danshen injections from a Chinese pharmaceutical factory and their raw materials were established as their characteristic fingerprint and employed to assess their consistency and difference. To develop the representative fingerprint of Danshen injection, 10 batches of samples were analyzed under the same HPLC conditions. The results showed that 10 batches of Danshen injections had very similar HPLC fingerprints. To characterize the major constituents of Danshen injection for quality control, 11 major chromatographic peaks were characterized by their MS spectra and comparison with the reference standards. Through comparison of the HPLC profiles of Danshen injection with its raw material, it was found that they are greatly different, which indicated the changes of major constituents in the course of preparation procedure. In addition, therat's plasma was analyzed by HPLC-MS technique after intravenous administration of Danshen injection at different time intervals to explore the in vivo metabolism of the major active constituents. Except for protocatechuic aldehyde, the major phenolic acids in Danshen injection appeared in rat's plasma after intravenous administration, but quantity of each phenolic acids was very different from that in Danshen injection. With the administration time prolonged danshensu and salvianolic acid B disappeared quickly, salvianolic D, lithospermic acid and salvianolic A slowly decreased and maintained relatively high concentration after 30min of intravenous administration. This indicated that polyphenolic acids were significant for biological acitivity of Danshen injection. It might be concluded that chemical fingerprint combined with metabolic fingerprint is a useful means to control the quality and to clarify the possible mechanism of action of herbal products.
机译:HPLC-UV和HPLC-MS技术用于丹参注射液及其原料(丹参的根和根)的指纹分析。建立了一家中国制药厂的丹参注射液及其原料的HPLC图谱,作为其特征指纹图谱,并用于评估其一致性和差异。为了建立丹参注射液的代表性指纹图谱,在相同的HPLC条件下分析了10批样品。结果表明,十批丹参注射液的HPLC指纹图谱非常相似。为了表征丹参注射液的主要成分以进行质量控制,通过11个主要色谱峰的MS质谱图表征并与参考标准品进行了比较。通过比较丹参注射液与其原料的HPLC图谱,发现它们之间存在很大差异,表明制备过程中主要成分的变化。此外,在不同时间间隔静脉注射丹参注射液后,通过HPLC-MS技术分析大鼠血浆,以探讨主要活性成分的体内代谢。除原儿茶醛外,丹参注射液中的主要酚酸在静脉内给药后均在大鼠血浆中出现,但每种酚酸的量与丹参注射液中的差异很大。随着时间的延长丹参素和丹酚酸B迅速消失,丹酚酸D,精子酸和丹酚酸A缓慢下降,并在静脉注射30分钟后保持相对较高的浓度。这表明多酚酸对于丹参注射液的生物活性具有重要意义。可以得出结论,化学指纹与代谢指纹相结合是控制质量和阐明草药产品可能作用机理的有用手段。

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