Study On The Purification Process Of Each Effective Fraction, The Quality Standard And Fingerprint Of The Ganershu Intermediate

Ganershu sustained-releasing capsule, consisting of the total flavonoids, saponins, total alkaloids and total organic acids, belongs to the sixth new Chinese traditional drug. In this dissertation, according to the provision of the sixth new Chinese traditional drug, we have determined the best purification process parameter by optimizing purification process of all effective fraction of Ganershu; We have basically made the draft quality standards of the Ganershu intermediate by studying on quality standards of the Ganershu intermediate; We have established the quality control process by studying on fingerprint of the Ganershu Intermediates, these laid the foundation for the research of new medicines of Ganershu sustained-releasing capsule. The methods and results are as following:Study on the purification process of the intermediate (1) The macroporous resin:the baldediameter lenth ratio was 1:13, the flow rates of adsorption and elution were 4BV/h and 3BV/h, respectively, the eluant is 90% ethanol with 10BV, these were used to enrich the total flavonoids and saponins; (2) The cation exchange resin: the baldediameter lenth ratio was 1:6, the concentration of the sample solution is pH2.6, the flow rates of adsorption and elution were 4BV/h and 5BV/h, respectively, the eluant is 5% aqua ammonia of 60% ethanol with 18BV, these were used to enrich the total alkaloids; (3) The antionexchange resin:the baldediameter lenth ratio was 1:16, the concentration of the sample solution is pH10, the flow rates of adsorption and elution were 4BV/h and 5BV/h, respectively, the eluant is 50% ethanol with 12BV, these were used to enrich the total organic acids.Study on the quality standards of the intermediate The TLC method was used to identify hesperidin, paeoniflorin and tetrahydropalmatine etc. target components; The HPLC method was used to determine quercetin, kaempferol, isohamnetin, paeoniforin, gallic acid, palmatine in the intermediate, in the end, we have basically made the draft quality standards of the Ganershu intermediate.Study on the fingerprint of the intermediate The fingerprint quality control methods of the Ganershu intermediate has been established by HPLC and UV.23 fingerprint peaks have been got by studying the fingerprint of different batches sample, combined with informations of tangerine, citrus aurantium and capillary wormwood in the prescription, the main chromatographic peaks of 3 target components that hesperidin, naringin and chlorogenic acid were confirmed finalily.