Azelnidipine preparation with combination of two disintegrating agents and preparation method of azelnidipine preparation

Abstract

The invention provides an azelnidipine preparation with combination of two disintegrating agents. The azelnidipine preparation is prepared from azelnidipine, two combined disintegrating agents in different proportions and other pharmaceutic adjuvants, wherein the combined disintegrating agents are prepared from calcium carboxymethyl celluloses and low-substituted hydroxypropyl celluloses; the adding amount of the calcium carboxymethyl celluloses accounts for 13% to 120% of that of the low-substituted hydroxypropyl celluloses; the other pharmaceutic adjuvants contain one or multiple types of filling agents, adhesives or lubricants. The azelnidipine preparation is simple in preparation method and controllable in quality, and has the high fitting degree with the in-vitro stripping curve of a product prepared by a specified pharmaceutical factory while having the bioequivalence at the same time. Thus, the efficacy and safety of the azelnidipine preparation in clinical applications are ensured.

Description

technical field [0001] The invention relates to a pharmaceutical dosage form of a dihydropyridine calcium ion antagonist, in particular to an azendipine preparation and its preparation. Background technique [0002] Azelnidipine, whose English name is Azelnidipine, has the following structural formula. [0003] [0004] Azedipine is a dihydropyridine calcium channel blocker, which was jointly developed by Sankyo Company and Ube Company of Japan and was first listed in Japan in 2003. The trade name is It is widely used because of its reliable antihypertensive effect. It is clinically used for the treatment of mild to moderate hypertension. It is characterized by a long duration of action and mild action. [0005] In the research and application of oral preparations of azeldipine, it is found that its bioavailability is relatively low, and one of the important reasons is that its dissolution is slow and incomplete. commercially available Surfactant Tween-80 was added t...

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