Preparation And Quality Research Of Fenofibrate Capsules

Fenofibrate is a kind of dedicated drug for high blood lipids,which can effectively regulate blood levels of triglyceride and cholesterol.As the third generation of phenoxybenzoic acid lipid-lowering drugs,its research is very important for patients,families and society.In this topic,fenofibrate capsules were prepared by drug micronization technology,and the formulation and prescription of fenofibrate capsules were determined.Quality and preliminary stability were investigated.Micronizing Fenofibrate capsule prescription process was studied using single factor method,and determined the prescription and process:in 1000,fenofibrate 100 g,starch 80 g,5%P 188?to drugs?and 2%silicon dioxide?to drugs?,mixed evenly,mixture of drugs to airflow pulverization at one time,20 mesh granulating,drying,20 mesh arranging particles,adding talcum powder into particles mixture,filling capsules.In addition,the methodology of the dissolution,content and related substances of fenofibrate capsules were investigated.The high performance liquid chromatography?HPLC?analysis method for the related substances and the content of fenofibrate were established.The HPLC column was Thermo BDS C18?4.6×250 mm,5?m?.The column temperature was 25°C.The mobile phase was a mixture of acetonitrile and pH 2.5 water?V/V=70/30?.The injected sample volume was 10?L.The flow rate was 1.0 mL·min^-1.The detection wavelength was 286 nm.Results showed that the separation of fenofibrate peak and impurities peaks were more than 1.5,which the blank solvent and excipients didn't interfere the determination of related substances.Good linearity,specificity,precision,durability and high degree of accuracy were detected in the test.Paddle method was also developed for quality control of the dissolution.Dissolution medium wasdistilled water phosphate buffer,pH 6.8,pH 4.5 acetate buffer,pH 1.2 hydrochloric acid solution.The temperature was 37.0±0.5?.The rotated speed was 75.The detection wavelength was 289 nm.These results showed that blank excipients and media didn't interfere the determination of fenofibrate.In four mediums,the fenofibrate's linearity was all good.The RSD of precision,accuracy,stability and durability testing were less than 2.0%.The dissolution of the three batches of self-made fenofibrate capsules were measured by the above-mentioned conditions,and the results met the Chinese Pharmacopoeia and were higher than the original ones.The dissolution curves were similar to those of the reference ones.The appearances,the weight deviation,related subtances and content of the three batches of self-made Fenofibrate capsules were checked,and the results were in accordance with the Chinese Pharmacopoeia.Finally,the stability of fenofibrate capsules was investigated.These results showed that there was a same trend between reference drugs and custom sample on appearances,dissolution,content and the related substances of the three batches of fenofibrate capsules.It met with the Chinese Pharmacopoeia.The long-term experiment of the fenofibrate capsules for 6 months is investigated,and the long-term retention of the capsule is needed to provide reference data for the future expiration date.