Study Of Donepezil Hydrochloride Dispersible Tablets

Objective: Because of the use of donepezil in tablets of different accessories,the disintegration and dissolution are also different.First,the optimal prescription screening.Refer to a large number of relevant literature,screening of scientific and reasonable preparation method,using the single factor investigation,roughly determine the usage and dosage of various kinds of accessories,the orthogonal experiment design method,the compound preparations of donepezil HCL dispersible tablet to filter and trial of donepezil HCL dispersible tablet production process is optimized,Especially for donepezil HCL scattered in the main application of several kinds of supplementary material about addition touch simply experiment was carried out for many times,according to the reasonable application of proportion between main drug and excipients,according to the dispersion of donepezil HCL dispersible tablet time limit,according to the accumulation of donepezil HCL dispersible tablet dissolution percentage and according to the content of donepezil HCL tablets uniformity as examining index,such asVarious comprehensive evaluation to commercial mouth slides as reference standard,carefully,trial and error,ultimately selected homemade formulation the optimal prescription.This one-sided bright and beautiful,dispersing uniformity and dissolution in vitro after repeated experiments are fine.Methods: the quality control of donepezil HCL dispersible tablet is important testing steps.Repeatedly groped for high-performance liquid chromatography(HPLC)conditions,trial and error,ensure accurate,sensitive,simple operation,easy,and the homemade donepezil HCL dispersible tablet preparation for quality control.Finally,the stability of donepezil HCL tablets for inspection.Dosage of several kinds of supplementary material in how much work out the optimum process and the optimal prescription and separately factors affecting experiment including illumination experiment,high humidity and high temperature test,accelerated test including 0,1,2,3 and 6 months of test,and the long-term test examination including 0,3,6 months,for the rationality of the design of prescription,prescription design science,making craft of donepezil HCL dispersible tablet of feasibility,homemade preparation quality control,convenient in the packing and shipping,and storage conditions of scientific selection to provide the necessary information.Above research plan as homemade preparation of donepezil HCL dispersible tablet,for the evaluation of new drugs high standard quality and to guide clinical rational application of donepezil HCL tablets provide scientific reasonable rigorous basis.Early groping test for many times,and fully confirmed this test has operability and feasibility of the experimental process only need regular general instruments in the laboratory,suitable for general laboratory and clinical monitoring application.Results: the prescription design: donepezil HCL API 5 mg,microcrystalline cellulose(MCC)45 mg,crosslinking povidone(PVPP)9 mg,mannitol(Mannitosel)60 mg Lactose(Lactose)20 mg.As detection wavelength at 315 nm,found that the chromatographic peak of main drugs in the peak shape is better after many experiments,and its good reproducibility,after many experiments after repeated experiments to prove its accessories without interference,so choose 315 nm,the final as the best detection wavelength to test more nai pp together;In methanol-water-trifluoroacetic acid system(V(methanol): V(water):V(trifluoroacetic acid)= 75:25:0.2)as mobile phase,through repeated experiments found donepezil HCL main fengfeng shape in symmetry is very good,after many experiments found many nai pp qi dispersible tablet accessories to the main medicine in the determination of basic without interference.Conclusion: donepezil HCL as model drug preparation of donepezil HCL dispersed tablet,screening the right prescription craft,the establishment of a reliable quality control method,and carries on the stability test,completed the tablets of the basic work.Based on the screening of prescription when using the single factor experiment investigation,by investigating the dispersion uniformity pharmacopoeia department requires all through the sieve,2 content uniformity conform to the requirement of pharmacopoeia department 2,accumulated dissolution percentage 15 min basic releases completely,and evaluation index such as the growth of the relevant material,according to the experiment design method,mainly studies the comprehensive analysis of factors,including high temperature and high humidity light of nai pp’s main drug and its test results of several materials,optimizing the donepezil HCL optimum prescription craft of dispersible tablets.