The Study Of Dipyridamole Sustained-release Tablets And Compound Dipyridamole Sustained-release Tablets

ObjectiveDipyridamole is commonly used in clinical coronary artery dilatation and anti-platelet aggregation. It is mainly used for thrombosis prevention and treatment of diseases. Dipyridamole tablet is administrated three times one day, because its half time is short. Dipyridamole sustained-release tablets and Compound dipyridamole sustained-release tablets (aspirin and dipyridamole) were prepared. Both of the tablets can extend the drug action time and effect. At the same time they are more convenient to take for the patients.MethodsOrthogonal designs were used to modify the formulations of Dipyridamole sustained-release tablet and Compound Dipyridamole sustained-release tablet. UV method was developed for the releasing of Dipyridamole sustained-release tablet. They were released in HCL solution (9→1000), using rotating basket at speed 100. Detection wavelength was set at 283nm. Dual wavelength UV method was developed for the Compound Dipyridamole sustained-release tablet releasing. They were released in the same condition. But the detection wavelength was set at 226 and 396nm. HPLC method was established for the related substances determination of the drugs. HPLC method was also established for the drugs content determination. Dipyridamole sustained-release tablet determination was used methanol-water-phosphoric acid-diethylamine (275:225:0.3:0.1) as the mobile phase; Eclipse XDB-C18 (4.6×150mm,5μm) as chromatography column. The wavelength was set at 283nm. Compound dipyridamole sustained-release tablet was determined at the same condition. But the wavelength was set at 225nm. The salicylic acid detect wavelength was set at 300nm.ResultsThe formulations of Dipyridamole sustained-release tablet and Compound dipyridamole sustained-release tablet were modified. They can control the tablet releasing speed. From the results of the dipyridamole sustained-release tablet determination we knew that they had a good liner relationship between 2-16μg/ml (R2=0.9997), and the average recovery was 99.55%. The content determination had a good liner relationship between 0.16-1.6μg (R2=0.9991), and the average recovery was 100.63%. The results of Compound dipyridamole sustained-release tablet release and content determination were accurate. The aspirin had a good liner between 2.06-8.24μg/ml (R2=0.9995) and the average recovery was 99.9%. Dipyridamole (226nm) and dipyridamole (396nm) had a good liner between 4.03-16.12μg/ml (R2=0.9992) and 5.01-50.05μg/ml (R2=0.9995); the average recovery was 99.9% and 100.6%. In the content determination, the aspirin had a good linearity between 6.72-15.68μg/ml (R2=0.9999) and the average recovery was 100.0%. Dipyridamole had a good liner relationship between 50.53-117.89μg/ml (R2=0.9995) and the average recovery was 100.3%.ConclusionThe formulation and the preparation methods of Dipyridamole sustained-release tablet and Compound dipyridamole sustained-release tablet were simple and accurate. They are more convenient to take for the patients. The methods of quality control were simple, accurate and reproductive.