TCM Recipe Therapeutic Drug Monitoring (Ⅱ)

Since 1960's, Therapeutic drug monitoring (TDM) has been widely used to monitor the body fluid's drug concentration of patients. TDM studied the relationship between the concentration and effect after the administration of drug to men and adjusted individual dosage regimen so as to get the best therapeutic effectiveness as well as decrease the toxicity and side-effect of that drug [1] However, TDM has little or never used to the clinical treatment of Traditional Chinese Medicine (TCM) so far. On the basis of study on the relationship between TCM Syndrome (terminology on traditional Chinese medicine) and pharmacokinetics(PK) for a long time[2,3], Professor Huang Xi put forward the idea about Recipe TDM [4] recently. Recipe means a terminology about pharmacology of traditional Chinese medical formulae. Recipe TDM consist of Pharmaceutics (PKT), pharmacokinetics (PK), pharmacodynamics and therapeutics monitoring. By monitoring these contents, it helps to develop the standard of quality controlling of Traditional Chinese Recipe(TCR) and elucidate the scientific mechanism of TCR. It is also adjusted individual dosage regimen so as to increase the therapeutic effectiveness as well as decrease the toxicity andside-effect of that recipe.This experiment primely monitor the pharmaceutics of Salvia Miltiorrhiza Bge prescription and develop the improved methodology of detecting ferulic acid serum concentration after oral administration of Coronary Heart No II Decoction to healthy human. Above results help to further study recipe TDM. ObjectiveTo initially explore the PKT and PK methodology of recipe TDM , This work select the Salvia Miltiorrhiza Bge and one of it's prescription Coronary Heart No II dcoction as the research tool, Which accumulated many evidences in phytochemistry, pharmacology and clinical medicine. On the basis of PKT monitoring of Salvia Miltiorrhiza Bge prescription, develop the improved RP-HPLC method for the determination of Ferulic Acid concentration in human serum.Methods and results1. Danshensu and Protocatechuic Aidehyde contents of Salvia Miltiorrhiza Bge and Coronary Heart No II Decoction in Different Decocting Methods are Quantitatively determined by HPLC respectively.(1) MethodsrChromatographic conditions including Kromasil column (250mm X 4 6mm,5nm), the mobile phase consists of acetonitrile and 0.01 moL ·L-1 potassium dihydrogen phosphate (9:91,adjusted to pH 2.8 with phosphoric acid), the UV detector was set at 280 nm and the flow rate was 1.0 mL·min-1.(2) Results:The result showed that the standard curve of Danshensu was linear over the range of 0.245~5.880ug(r=0.9998); Protocatechuic Aidehyde was linear over the range of 0.011 ~0.504μg(r=0.9996).(3) Conclusion: Both amount of water added and decocting duration required had an influence on the output of the concents of TCM by decocting. At the same decocting duration required, When added 12 times water, the output of the Danshensu or Protocatechuic Aidehyde by decocting are higher than that of added 8 times water. The decocting duration required longer, the output of Danshensu or Protocatechuic Aidehyde by decocting higher. When the five crude drugs of Coronary Heart No II decoction boiling together, whichever amount of water added or decocting duration required, the output of the Danshensu or Protocatechuic Aidehyde by decocting are awalys higher than that of Salvia Miltiorrhiza Bge's dcoction.2. Danshensu and Protocatechuic Aidehyde contents of Salvia Miltiorrhiza Bge in five place of production are Quantitatively determined by HPLC respectively.(1) MethodsrChromatographic conditions including Kromasil column (250mm X 4 6mm,5nm), the mobile phase consists of methanol and 1% Acetic acid (20:80), the UV detector was set at 280 run and the flow rate was 1.0 mL· min-1.(2) Results: The result showed that the standard curve of Danshensu was linear over the range of 4.2~33.6#g·mL-1, Protocate Chualdehyde was linear over the range of 0.36~1.8#g·mL-1'.(3) Conclusion: The quant...