Pharmacetic Studies On Kangdu Mixture

Objective: The research project mainly study the preparation procedure, qualitystandards, fingerprint and stability of Kangdu Mixture, so as to establish relativelycomplete, stable, feasible quality standard system. Through the investigation on thepreparation process, to set up the best preparation method. The thin layerchromatograpHy (TLC) method was used to identify in quality Honeysuckle,forsythia, radix puerariae and folium isatidis. To establish a TLC identificationmethod of high sensitivity, strong specificity, good repeatability;By using the methodof HPLC to determine the content of chlorogenic acid and luteolin in honeysuckle,pHillyrin in forsythia, puerarin in radix puerariae. Study on HPLC fingerprint ofdifferent batches of Kangdu Mixture, to establish fingerprint by HPLC, wereevaluated based on the overall quality of Kangdu Mixture;The preliminaryinvestigation on the stability of Kangdu Mixture,easy to determine the stability of theprepatation process is reasonable and intrinsic quality.Methods: Chlorogenic acid and the extract rate of the comprehensive score ofindicators, on the basis of the original technology of the extraction time, the Kangdumixture water volume, extraction times are investigated, and the orthogonal tabledesign of3factors and3levels, according to the comprehensive score and to optimizethe best extraction process, with the content of chlorogenic acid as index, to determinethe the best alcohol precipitation process; select honeysuckle, forsythia, RadixPuerariae and Folium Isatidis were identified, mainly study the extracting method ofsample, the choice of developing agent, sample weight, to build simple operation,strong specificity and good repeatability identification method; through the HPLCmethod for quantitative study of honeysuckle, forsythia, radix puerariae; chlorogenicacid, luteolin, forsythin, Ge Gensu as the quantitative indicators, Resistance toKangdu mixture of different batch number for HPLC fingerprint study, and throughthe analysis of similarity, establish Kangdu mixture of HPLC fingerprint and qualityevaluation method; the three batch of Chinese sample room temperature sampleobserving and long-term acceleration test thus, character identification, relativedensity, pH value and the content of chlorogenic acid as index, the preliminarystability against antoxic agentsResults: The preparation process by screening system, the optimum extractionprocess for the extraction of3hours, the amount of water for10times,2times ofextraction; when the relative density is1.15(80℃) and alcohol precipitation with 95%ethanol in alcohol, the alcohol content of60%, as the best alcohol sinkingprocess; through the thin layer chromatograpHy identification method of honeysuckle,forsythia, radix puerariae, in Folium Isatidis; content and HPLC method fordetermination of chlorogenic acid, forsythin, galuteolin, Ge Gensu, the linear rangeand the correlation coefficients were chlorogenic acid: Y=11.263X+1.4858（r=0.9998）;wood X glucoside: Y=1.6627X+0.1715（r=0.9998）; Forsythia in: Y=1.9177X-0.2363(r=1); Ge Gensu: Y=138.63X-58.954(r=0.9998); Quality standards for the proposedmethod has the characteristics of strong specificity, repeatability is good, has providedthe safeguard for resistance to poison mixture quality control; Quality standards forthe proposed method has the characteristics of strong specificity, repeatability is good,has provided the safeguard for resistance to Kangdu mixture quality control;acquisition of10batches of Kangdu mixture, obtaining HPLC fingerprints, and thethe similarity analysis, through the analysis of the HPLC fingerprints, thesemi-finished product to finished18peaks,19peaks, and confirm the chlorogenicacid, forsythin, puerarin on peak; The three batch of Chinese sample roomtemperature sample observing and long-term accelerated test, showed that the qualityof preparation is stable, controllable.Conclusion: this experiment on Kangdu mixture preparation technology, qualitystandard, stability, fingerprint into deeper research. In the preparation process byorthogonal test to determine the optimum water extraction and alcohol precipitationprocess, and the pilot plant test; in the quality standard of honeysuckle, forsythia,kudzu, Folium Isatidis were identified by TLC, the chlorogenic acid, luteolin, evenAlice glycosides and Puerarin Content Determination by HPLC method, to ensure thequality of this product; Kangdu mixture of HPLC fingerprint was set up; thepreliminary stability laid a foundation for the quality control of Kangdu mixture andclinical safety.