Study On The Preparation System Of Chitosan And Its Application

Kalii Dehydrograpolidi Succina(KDS) is obtained by structural modification of diterpene esters that is extracted from the leaves of Acanthus Andrographis. It has a strong antipyretic, anti-inflammatory effect, which has been widely used in clinical acute pneumonia, upper respiratory tract infection, acute enteritis and others, the main forms were used of injections in recent years. But its low solubility in water, poor stability, adverse reactions. Self-emulsifying drug delivery system(SEDDS) as a carrier of insoluble drugs can improve its oral absorption and drug safety.To research KDS self-emulsifying drug delivery system has its practical significance.This paper examines the KDS saturation solubility in different materials by orthogonal compatibility test and drawing pseudo-ternary phase diagrams, with the appearance of the emulsion, the emulsion time, particle size and self-emulsifying an area as an index to determine the best self emulsifiable concentrate essential formulation of oil component phase (MCT), surfactants (Tween-20) and co-surfactant (glycerol). Various materials are mixed in different proportions compatibility, using pseudo-ternary phase diagrams, BBD-RSM and D-optimization combination formulation optimization was performed by analysis of variance and response surface analysis to determine the optimum proportion of prescriptions:MCT-Tween-20-glycerin= 12:45:50.And using dissolution method study prescription drug loading, the emulsion has lower drug loading of 15mg/g.The paper compares KDS in aqueous solution and micro-emulsion dissociation constant by ultraviolet spectrophotometry and A-pH method, the results show that its micro-emulsion solution dissociation constant pKa1 relatively large, pKa2 basically the same. Compare similar molecular structure Andrographolide and KDS at different pH buffer solution changes the ultraviolet spectrum and micro-emulsion particle size. The results show that under alkaline conditions wear KDS new absorption peak at 190nm, carboxyl dissociate particle size increases, affecting the stability of the emulsion. SEDDS was established method for the determination rather wear amber for KDS SEDDS preliminary evaluation. The results showed that after KDS SEDDS diluted with water to form a clear, transparent and with a light blue opalescent. emulsion, emulsification time of 31.27 s, particle size is 67.1±0.06 nm, Zeta potential is-17.4 mV.Finally, the study of soluble curing liquid SEDDS adsorbent adsorption capacity, UV method for the determination of adsorption material KDS saturation solubility, To product the large adsorption capacity, strong drug cured adsorbent.select the appearance and properties of the particles, forming the rate of re-dispersion and particle size distribution, dissolution as an indicator, the final choice of adsorbent PEG6000 curing SEDDS, and to optimize the amount of proportion, the KDS self-emulsifying granules was obtained according to the 4:1 (m/m). Compare KDS materials, KDS and PEG6000 mixture, KDS since emulsion, KDS self-emulsified granules 60min cumulative percentage release, the results show that the self-emulsifying granules within 10min release of up to 95%, which significantly higher than the others. KDS HPLC method was established, KDS of self-emulsifying granules quality was evaluated by TLC, inspection, determination, self-emulsifying ability, the results were in line with regulations.This paper confirms that self-emulsifying drug delivery system can stability of poorly soluble drugs and improve the solubility, made the emulsifying agents can effectively improve the drug loading after adding solid sorbent and dissolution rate of dissolution.