Zhang Jin-lan, Cui Ming, He Yun, Yu Hai-lan, Guo De-an
School of Pharmaceutical Sciences and Modern Research Center for Traditional Chinese Medicine, Peking University, Xueyuan Road 38, Beijing 100083, PR China.
J Pharm Biomed Anal. 2005 Jan 4;36(5):1029-35. doi: 10.1016/j.jpba.2004.09.009.
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, the rat'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 30 min of intravenous administration. This indicated that polyphenolic acids were significant for biological activity 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.
采用高效液相色谱-紫外检测（HPLC-UV）和高效液相色谱-质谱联用（HPLC-MS）技术对丹参注射液及其原料（丹参根及根茎）进行指纹图谱分析。建立了某中药厂丹参注射液及其原料的HPLC图谱作为其特征指纹图谱，用于评价它们的一致性和差异。为建立丹参注射液的代表性指纹图谱，在相同的HPLC条件下对10批样品进行了分析。结果表明，10批丹参注射液的HPLC指纹图谱非常相似。为表征丹参注射液用于质量控制的主要成分，通过质谱分析并与对照品比较对11个主要色谱峰进行了表征。通过比较丹参注射液及其原料的HPLC图谱，发现二者有很大差异，这表明在制备过程中主要成分发生了变化。此外，在不同时间间隔静脉注射丹参注射液后，采用HPLC-MS技术分析大鼠血浆，以探索主要活性成分的体内代谢情况。除原儿茶醛外，丹参注射液中的主要酚酸在静脉注射后均出现在大鼠血浆中，但各酚酸的含量与丹参注射液中的含量有很大差异。随着给药时间延长，丹酚酸B和丹参素迅速消失，丹酚酸D、紫草酸和丹酚酸A缓慢下降，静脉注射30分钟后仍维持较高浓度。这表明多酚酸对丹参注射液的生物活性具有重要意义。可以得出结论，化学指纹图谱与代谢指纹图谱相结合是控制草药产品质量和阐明其可能作用机制的一种有用方法。
