Study On The Therapeutic Basis Of Traditional Chinese Medicinal Preparation Nao-Deshen Pill

In this paper, the present situation and development about the therapeutic basis of Traditional Chinese Medicine prescription and the methods which were used to study the constituents of Chinese medicine were summaried. The significance of the therapeutic basis of traditional Chinese medicine prescription in novel drug developments was mentioned. As the crucial chemical constituents and pharmacological activities, contained in Nao-Deshen pill, were discussed in recent researches. Under the direction of theroy and clinical practice of Traditional Chinese Medicine, this study scheme was designed to trace the therapeutic part as the core of Chinese medicine. Resorted to the extraction technology of macroporous adsorbing resin to purify Nao-Deshen pill, while the effective fraction was screened by the pharmacodynamic trial and its quality control method was established by suitable means.In Nao-Deshen prescription, there were some effective constituents, such as saponins, flavones, ferulaic acid, puerarin, isoflavones and hydroxysafflor yellow A (HSYA), which could be as evaluationt factors in the technology of extraction and purificaiton. Given the previous study, Nao-Deshen prescription was divided into two parts:: Part one contained Notoginseng, Szechwan Lovage Rhizome and Hawthorn Fruit; Part two included Kudzuvine Root and Safflower. The extractions were opimized by orthogonal design trial as follow: The extracting solvent of part one was 80% ethanol cunsumed ten times the amount of material in the volume, and two times for one hour each time, then the merged extracting liquid was dried by decompression as sampleⅠ; The extracting solvent of part two was 40% ethanol cunsumed twelve times the amount of material in the volume, and two times for three quarters forty five minutes each time, then the merged extracting liquid was dried by decompression as sampleⅡ. Then, A, a kind of Mqacroporous adsorbing resin, was selected as the packing material to purify two extracts (sampleⅠandⅡ) in the purification technology. For sampleⅠandⅡ, the same column in diameter/high was H1, and the ratio of loading capatity to resin volume was N, but the adsorbing concentrations, differently, were C1 and Ca respectively. After adsorbed, both sampleⅠand sampleⅠwere eluted by water with five times of the resin volume, and then eluted by certain concentration of ethanol respectively. As that, the column of sampleⅠwas eluted by M% ethanol with five times of the resin volume and t he column of sampleⅡwas eluted by N% ethanol with six times of the resin volume. Merging M% and N% elutiions, dried by decompression, pulverized and mixed well, and then the purified sample of Nao-Deshen pill was made. While a model of the rat global brain ischemia was made to screen and verify the effective fraction of Nao-Deshen by the nervous symptom, the oedema of brain , and the infarct size of brain.By analytical methods of High Performance Liquid Chromatography (HPLC) and Thin Layer Chromatography (TLC), the quality assessment method on the therapeutic part of Nao-Deshen pill was established. The contents of saponins, flavones, ferulaic acid, isoflavones and HSYA were 12.52%～12.71%, 11.53%～11.75%,0.226%～0.229%, 35.43%～36.07% and 2.14%-2.21% respectively. Therefore, the total content of five fractions was more than 60%. And the transferring rates of saponins, flavones, ferulaic acid, isoflavones and HSYA were 89.14%～90.81%,79.33%～81.13%,81.89%～84.25%,84.47%～85.72% and 71.21%～73.38% respectively. These met demands of the novel medicine development, showing that the technology on the study of Nao-Deshen were reasonable and feasible.This thesis preliminarily illuminated that the therapeutic substances of Nao-Deshen maybe be saponins from Notoginseng, flavones from Hawthorn Fruit, ferulaic acid, isoflavones and HYSA, which should provide a good foundation for further development of Nao-Deshen pill.