Study Of The Nifedipine Dispersible Talblets

Objective:Nifedipine belongs to the first generation of calcium antagonists,widely used in clinical treatment of hypertension,angina pectoris and cardiac arrhythmia.At present,the commercial preparations are ordinary tablets,slow-release and controlled release preparations,and nifedipine dispersible tablets are not reported.This experiment was to prepare nifedipine dispersible tablets which can rapidly disintegrating and rapidly drug releasing.It belongs to available drug,can be used for the clinical first aid to quickly reduce the patient's blood pressure.Central composite design-Response surface methodology was used to get the final optimal prescription of nifedipine dispersible tablets.And establish the accurate and reliable quality control method to control the quality of homemade preparation and its stability.Methods:Single factor test in screening optimization prescription study,the star point-response surface method and orthogonal experimental design optimization method.Single factor experiment investigated to determine the types of materials used and the approximate amount of experimental design,system analysis emphasis on the factors that impact on the test results.Using solid dispersion technique to improve insolubility of nifedipine.The dispersible uniformity and 10 min cumulative dissolution as evaluation indexes,the central composite design-response surface optimization method to optimize the amount of accessories.As well as the nifedipine dispersible tablets accurate and reliable quality control methods.HPLC and UV were used to create a homemade tablet method for the determination method of determination of related substances.With reference to the guiding principles of the chemical stability technical study guidelines,combined with the actual situation of the stability test,according to the optimal prescription,impact factor test,accelerated and long-term experiments,formulation design,process improvement,quality of research,packaging,transportation,storage and other necessary information.Results:Testing to determine the final prescription as:the compositions of the nifedipine solid dispersions are nifedipine 10 mg,PEG4000 40 mg and talcum powder 10 mg.Add MCC of 30 mg,CMS-Na of 12 mg,CCNa of 12 mg in the granules,plus PVPP is 30 mg,L-HPC is 6 mg.The test established by ultraviolet spectrophotometry and high performance liquid chromatography determination of content and related substances determination method to prepare reliable.Mobile phase was a mixsture of methanol and water(65:35),detection wavelength was 237 nm,flow rate was 0.8 mL/min,5?35 ?g/mL concentration range good linearity,high accuracy,good precision.The measurement method is accurate,specific,effective determination of the content of the sample is simple.Methods to determine the related substances is accurate and effective,the measure of related substances of the sample meet the requirement.The nifedipine bulk drug and formulations are unstable to strong acids,alkalis and strong oxidizing.The influencing factors results showed that:high temperature,high humidity conditions and bright light affected on the nifedipine dispersible tablets,therefore,suggesting that the tablets should be sealed packaging,dark cool and dry place;long-term trials to six months,during this period,the preparation of the items of the indexes are in line with the requirements,the basic stability.The expiration period is to be tested further to complete.Conclusion:The subject screening nifedipine dispersible tablets with commercial preparations optimized preparation prescription homemade tablets traits well,uniformity of content,related substances test qualified compared with the control formulation similar to the dissolution behavior.High performance liquid chromatography specific,easy to use,can be used for the determination of nifedipine and related substances.