Résumé
Quality marker(Q-marker) is a new concept and pattern for quality control of traditional Chinese medicine(TCM),which will lead the development direction for quality control of TCM.Among them,how to characterize the overall quality attribute of TCM and its biological effect,is a critical scientific problem in the study of Q-marker.In this paper,integrated pharmacology is utilized to screen out and confirm the Q-marker from the complex system of TCM,so as to solve the critical scientific problem.System biology in vivo is firstly applied to establish the correlation of chemical fingerprints of TCM,their metabolic fingerprints,network targets,biological effects and efficacy of TCM,which is used to preliminary screen out Q-marker of TCM.Following that,a pharmacological method in vitro,including intestinal absorption in vitro coupled with bioactivity assessment,is employed to simultaneously determine the absorbed doses of TCM and evaluate their biological activity.Furthermore,data mining is utilized to establish the exact quantitative mathematic model between Q-marker of TCM and bioactivity.Meanwhile,two representative examples,including Yuanhu Zhitong tablets,Xinsuning capsules,are introduced to identify Q-marker of TCM and establish their quality standards related with bioactivity,which will be beneficial to improve the level of quality control of TCM and ensure the effectiveness and safety of clinical applications.
Résumé
Objective:To establish a method for the content determination of tetrahydropalmatine and imperatorin in Yuanhu Zhi-tong tablets by HPLC. Methods:An AKZONOBEL Kromasil 100-5 C18 column (250 mm × 4. 6 mm , 5μm) was used and the mobile phase consisted of methanol and 0. 1% phosphoric acid (52∶48) (adjusting pH to 6. 5 with triethylamine),the flow rate was 1. 0 ml· min-1 at the column temperature of 40℃, the detection wavelength was at 284 nm, and the injection volume was 10 μl. Results:The linear range of tetrahydropalmatine was 0.004 2-0.084 0 mg·ml-1(r=1.000 0). The average recovery was 97.72% with RSD of 1.10%(n=6). The linear range of imperatorin was 0.003 6-0.072 0 mg·ml-1(r=0.999 7). The average recovery was 97.99%with RSD of 0. 96%(n=6). The measurement results of 10 batches were stable and reliable. Conclusion:The method is simple and accurate, which can be used to improve the quality standard.