Study On Quality Control Of Cortex Moutan And Pharmacokinetic Of Activity Ingredient In Cortex Moutan

Chinese Traditional Herbal Medicine (CTHM) is a typical complex system, and the quality control of TCM is one of the bottlenecks of coming true its modernization. The quality control of TCM should present the holistic and dialectical features. Most TCM have more than one activity ingredient, therefore it is necessary to determine content of all the activity ingredients. Fingerprint is a powerful tool for the comprehensive assessment of TCM quality, in which the spectrum peaks represent the compounds contained in TCM. Furthermore, rapid identification of the compounds contained in TCM by modern analytical instruments, such as HPLC-TOF/MS, is also benefit for us to comprehend the mechanism of TCM effects and find out the activity ingredients. Pharmacokinetic study of TCM provides a new view angle to exhibit the principals of prescription and pharmacology mechanism of TCM.A reliable HPLC-DAD method was developed and validated for the determination of gallic acid, paeoniflorin and paeonol, three major activity ingredients in Cortex Moutan. Extract solvents, extract time and extract times were optimized to improve the extract effect. Finally, Cortex Moutan was extracted by ultrasonic wave for 20min. The method was successfully applied on determination of 16 batches of Cortex Moutan. Chromatographic fingerprint profile of the 16 batches of Cortex Moutan was established and 17 common peaks were picked up for similarity analysis. The results indicated that the quality difference was not obvious among the 16 batches of Cortex Moutan. It is more comprehensive and reliable when multi-compounds quantitative and fingerprint were combined for the quality control of Cortex Moutan. Then, principal component analysis and cluster analysis were used for the further study of quality distinction among Cortex Moutan, expecting to find out the factors which affect the quality of Cortex Moutan. Principal component analysis and cluster analysis were both applied in order to enhance the reliability of results. According to the results, 16 batches of Cortex Moutan were classified in four categories.HPLC-TOF/MS and GC-MS were used for the rapid identification of constituents in Cortex Moutan. The mass response of Cortex Moutan extraction was evaluated in both positive and negative ionization mode. After searching against the formula database established by ourselves, 21 compounds were identified by HPLC-TOF/MS, including two pairs of isomerides were identified. Meanwhile, 14 common peaks in Cortex Moutan fingerprint were recognized. 32 compounds were identified by GC-MS after searching against the formula database supplied by GC-MS instrument. A simple, rapid and reliable liquid chromatographic-tandem mass spectrometry (LC-MS) method was developed and validated for the quantification of paeoniflorin in rat plasma. In summary, statistically significant differences (P < 0.5) in pharmacokinetic parameters of paeoniflorin including AUC0-t, AUC0-∞and MRT were obtained among the rats orally administered paeoniflorin and extract of Cortex Moutan, as well as paeoniflorin and extract of Cortex Moutan combined with Radix Salviae miltiorrhizae. In contrast, the pharmacokinetic parameters of ke and T1/2 of paeoniflorin has no significant changes. Meanwhile, there were no significant differences in pharmacokinetic parameters of AUC_0-t, AUC_0-∞, MRT, k_e and T_1/2 of paeoniflorin between two decoctions (extract of Cortex Moutan and extract of Cortex Moutan combined with Radix Salviae miltiorrhizae). The pharmacokinetic results are useful for the further study of the clinical applications of paeoniflorin and Cortex Moutan.