Study On Technology Of Sustained-release Nifedipine Tablets

In order to offer commercial opportunity through intellectual property to national pharmaceutical factory, we study the formulation of the sustained-release Nifedipine tablets. We attempt to obtain a sustained-release tablet that can be administered in a single daily administration.On the one hand this dosage form makes it easier for the Hypertension patients to use,and enables better compliance with the treatment. On the other hand domestical Nifedipine tablet can be used by more people because of it is cheaper than the other factories,We attempt to design a formulation to prolong Nifedipine in vitro release. We select HPMC as hydrophilic matrix system. The best situation is the lest powder,1.5%HPMC and 0.7%magnesium stearate,making this mixture into granula. According to the ChP2005, we confirm the quality standard of the sustained-release Nifedipine tablet and investigate the tablets stability of 3 lots product. The result as following: (1) the sustained-release Nifedipine tablets have stability quality after accelerat test and long-term test. (2) At last the study advance the mechanism of the drug release.The drug is released by diffusion and corrosion mechanism.This research studied the quality standard for sustained-release Nifedipine tablets, compared the ultraviolet spectrophotometry method with the HPLC method, and advanced the HPLC method.