Trimetazidine hydrochloride sustained release tablet taking glyceryl behenate as framework material and preparation method of trimetazidine hydrochloride sustained release tablet
2013
The invention belongs to the field of sustained-release drug preparations, and particularly relates to a trimetazidine hydrochloride sustained release tablet taking glyceryl behenate as a framework material and a preparation method of the trimetazidine hydrochloride sustained release tablet. According to the main technical scheme disclosed by the invention, a sustained-release preparation is prepared from trimetazidine hydrochloride as an effective component, only glyceryl behenate as a sustained-release framework material and auxiliary materials such as a small amount of release speed regulator. According to the trimetazidine hydrochloride sustained release tablet provided by the invention, an in vitro release rate experiment shows that the drug release is not affected by the pH environment, compared with commercially available 'vasorel' (trimetazidine dihydrochloride tablet), the trimetazidine hydrochloride sustained release tablet has good similarity (f2 is greater than 65); and the Beagle pharmacokinetic experiment in dogs shows that the trimetazidine hydrochloride sustained release tablet has bioequivalence in comparison with 'vasorel'. One trimetazidine hydrochloride sustained release tablet provided by the invention is taken twice a day, and the trimetazidine hydrochloride sustained release tablet is convenient to take, has good medicine compliance in patients, and is capable of keeping steady state plasma concentration for a long period of time. The preparation method disclosed by the invention is simple and stable in process, and is easily put into volume production.
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