Topiramate medicine composition

Abstract

The invention relates to a topiramate medicine composition. In the composition, pregelatinized starch is added, the stability of the active components of topiramate is increased, and therefore the quality and security of the composition can be ensured. In the composition, the pregelatinized starch also plays a role of a dry binder, the hardness and the friability of the composition are ensured, the amounts of auxiliary materials are decreased, and the cost is saved. The invention also relates to a preparation method for the topiramate medicine composition. The preparation method comprises a dry granulation technology. The preparation method has simple technology. The finished products after granulation are epigranular, which is convenient for storage and transportation. The topiramate medicine composition is suitable for industrialized production.

Description

[0001] technical field [0002] The invention relates to a topiramate pharmaceutical composition and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0003] Epilepsy is a neurological disease, usually brain dysfunction caused by sudden abnormal excessive discharge of brain cells caused by brain lesions. It is estimated that the incidence of epilepsy in different populations around the world is about 0.3% to 0.5%, and the prevalence is about With 5 to 10 people in every 1000 people, epilepsy seriously threatens people's health and affects people's daily life. [0004] Topiramate, a new type of antiepileptic drug that replaces monosaccharides with sulfamic acid esters, was developed by Johnson & Johnson in the United States and was launched in the UK under the trade name Topamax in 1995. In the electrophysiological and biochemical studies on neurons cultured in vitro, it was found that there are three mechanisms for t...

AI Technical Summary

Problems solved by technology

[0008] In order to improve the stability of the topiramate preparation and prevent the degradation of the topiramate active ingredient, WO01 / 89445 discloses a topiramate blister pack without a desiccant, which includes a disc-shaped sheet for placing a pre-dried topiramate chamber and a sealing The cover plate of the disk-shaped flakes, most of the topiramate tablets currently on the market are packed in the described blister packs, but these packs are relatively expensive and the operation process is loaded down with trivial details; CN1726011 discloses a dual or multi-phase tablet containing topiramate and its preparation method, one phase of the tablet contains topiramate, and the other phase contains a hygroscopic gum material selected from alginate, gum arabic or xanthan gum. The preparation method of this tablet is cumbersome, easy to separate, and has low dissolution rate; WO2006 / 097946 discloses a topiramate tablet containing 5%-35% topiramate and 25%-70% spray-dried mannitol granules in a weight ratio. The tablet is prepared by a direct compression method, and the tablet prepared by this method is prone to splitting, poor content uniformity

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