Valproate semisodium tablet and its preparation method

A technology of semi-sodium valproate and coated tablets, which is applied in the fields of pill delivery, pharmaceutical formulations, and medical preparations of non-active ingredients. It can solve the problems of unqualified tablet appearance and poor particle fluidity, and achieve appearance maintenance. Intact, stable content, stable quality effect
CN102895201AActive Publication Date: 2013-01-30NEW FOUNDER HLDG DEV LLC +2
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Patent Information

Authority / Receiving Office
CN · China
Current Assignee / Owner
NEW FOUNDER HLDG DEV LLC
Publication Date
2013-01-30

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Abstract

The invention provides a valproate semisodium tablet and its preparation method. The common valproate semisodium tablet comprises 50-67wt% of valproate semisodium, 25-35wt% of a microcrystalline cellulose, 5-9wt% of lactose, 1-3wt% of sodium carboxymethyl starch, 0.2-2wt% of magnesium stearate, and 1-10wt% of silica and / or talcum powder. The valproate semisodium tablet has the advantages of stable quality, no fractured, cracked or crushed tablets, and realization of the enteric-coated tablet release degree according with requirements of Chinese Pharmacopoeia 2005. The preparation method obviously overcomes the disadvantages comprising bad particle fluidity, sticking, tablet breaking and tablet appearance disqualification in present production technologies, has no special requirements on the production environment, enables the qualification rate of products to reach above 95%, and is suitable for large-scale industrialized production.
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Description

Technical field

[0001] The invention belongs to the field of pharmacy, and specifically relates to a half-sodium valproate tablet and a preparation method thereof. Background technique

[0002] U.S. Patent Documents US4,988,731 and US5,212,326 disclose semi-sodium valproate (also known as divalproex sodium, the International Non-Patent Drug Name (INN) is: Valproate semisodium, CAS: 76584-70-8, United States The drug name (USAN) is: divalproex sodium, the molecular formula is shown in the following formula I), which is a low-molecular polymer composed of equimolar valproic acid and sodium valproate. Valproate hemi-sodium is an anticonvulsant and mood stabilizing drug, mainly used for the treatment of epilepsy and bipolar disorder, but also for the treatment of migraine and schizophrenia. Valproate semi-sodium is used to control absence seizures, tonic-clonic seizures (grand seizures), complex partial seizures, and seizures associated with Lennox-Gastaut syndrome in patients with ...

Claims

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