Study On The Preparation Technology Of Asparagus Chewable Tablets And Establishment Of Quality Standards

Objective: By studying prescribing properties of dry extract powder and particle of asparagus before,determined dosage forms for chewable tablets.Prepared the asparagus chewable tablets,optimize the prescription,and build the quality standards for asparagus chewable tablets.It was beneficial for the majority of obese patients and the promotion of asparagus industry development and resource utilization,creating considerable economic benefits.Methods: 1.The contents of gallic acid and total phenolic acid in asparagus extract were determined by HPLC and UV respectively.2.prescribing research: on the basis of the density,Angle of repose,hygroscopicity of asparagus extract dry paticles and particle,determined the dosage forms,provided prescription optimization theory and methodology.3.the optimization of prescription : adopted single factor experiment,used the paticle comprehensive evaluation method and tablet comprehensive evaluation method to screen appropriate excipients and dosage;used the wet legal system method of tableting prepared asparagus chewable tablets;Sensory score as the evaluation indicator,adopted the CCD-RSM to optimized the prescription of asparagus chewable tablets.4.The establishment of quality standard: used high performance liquid chromatography(HPLC)method for identify the gallic acid in asparagus total phenolic acids,combined with HPLC and UV for content determination of the preparation of the gallic acid and total phenolic acid in in asparagus total phenolic acids.In accordance with the "Chinese pharmacopoeia"(2015)to inspect on the formulation,formulated the total phenolic acids asparagus chewable tablets quality standard.Results:1.the asparagus chewable tablets content of gallic acid in sample was 5.909mg/g,12.17 mg/g.2.the main consideration of the formulation was given priority to oral,according to the asparagus dry paticles and particle properties,determined dosage forms was chewable tablets.3.adopted single factor experiment,used the paticle comprehensive evaluation method and tablet comprehensive evaluation method to choose lactose as the filler,5% PVP-ethanol for adhesive,citrate for taste masking agent,PEG-4000 as the lubricant.Sensory score as the evaluation indicator,adopted the CCD-RSM to optimized the prescription of asparagus total phenolic acids chewable tablets:drugs and lactose ratio was 1.8:1,dosage of citrate was 0.82%,the dosage of lubricant is 3.39%.4.Quality standards(1)identification: adopted HPLC.(2)inspection:adopted "Chinese pharmacopoeia"(2015)of the general principles of the four appendices preparation ID chewable tablet under relevant regulations.(3)the content of asparagus chewable tablets of every piece was that gallic acid and total phenolic acids respectively shall be not less than 5.6 mg/piece and 11.06 mg/piece.Conclusion: The study prepared the asparagus total phenolic acids chewable tablets with stable and controllable quality.The prescription and preparation technology was reasonable,simple and feasible.It was available for HPLC and UV to detect the effective component,this method was stable,convenient and accurate.