Study On Pulsatile Release Tablets Of Tetramethylpyrazine Phosphate Prepatated By Compression Coating

Based on the ancient Chinese academic thought of" correspondence between man and nature " and "Chrono-medication", combined with the study of modern Chronopharmaco-logy, The research shows that the Acute myocardial infarction caused by the coronary artery’occlusion; blood flow was blocked; part of the myocardium were in Local necrosis caused by Persistent and Serious ischemia has obvious circadian-rhythm. Acute myocardial infarction occurred frequently in the 2:00-5:00, this time need to have a reliable effect of drug peak plasma concentration.The patients can take medicine at the leisure time ahead of schedule according to the incidence of disease’s circadian-rhythm.Pulsatile drug delivery formulations can make the medicine have a lag time to match the disease attack period between the medicine was taken and release. The disease can be prevented,and drug adverse effect can be diminished.Tolerance was not to bring about,and the compliance of the patients enhance. In this paper, pulsatile release tablets of tetramethylpyrazine phosphate were prepatated by compression coating,and the prescription screening, preparation, in vitro release, quality standard and stability were studied.Tablet core prescription was determined by the single factor experiment based on the disintegration time, swelling capacity, release curve, appearance and other indicators. The coating layer’s prescription are optimized by the orthogonal test on the basis of single factor experiments. The test indicates the factors influence was MCC:Lactose> coating weight> dosage of HPMC.So the coating layer’s prescription composes with 35%EC, 45%HPMC, MCC:Lactose=3:1 and coating weight was 250mg. Pressure coating process inspection test showed that coating was bright, clean and beautiful under the condition of pressure readings of 2.5 and filling ratio as a 1:1. The authors measured the cumulative release of the tablet in nine hours, and draw the release curve. The release of tablet has reached the expected effect, the lag time was 4h.The method of Model fitting was used for the preliminary study on the mechanism of drug release. The data of accumulative dissolution rate within 9 hours of the drug in pulsatile release tablets which was preparated by optimal prescription was fitted by six kinds of mathematical model.The software of DDSolver was used for statistical analysis. The fitting results of release period indicated Korsmeyer-Peppas model fitting was best which indicated that the best explaination of the release mechanism may be the comprehen-sive results of dissolution and diffusion.About the material and content of pulsatile release tablets of tetramethylpyrazine phosphate were determined by high performance liquid chromatography. System suitability test shows that method was stable and reliable. At the same time the quality standards of tetramethylpyrazine phosphate was set up. Stress test prompted the preparation Should be sealed tightly, keep in a dry, shady, cool place.