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Divalproex sodium enteric-coated tablet core as well as preparation method and application thereof

A technology of divalproex sodium and enteric-coated tablets, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, active ingredients of anhydride/acid/halide, etc., which can solve the problem of unfavorable pressure granulation and unqualified product quality , high tablet content, etc., to achieve the effects of improving bioavailability in vivo, reducing hygroscopicity, and improving fluidity

Active Publication Date: 2013-08-07
BEIJING SIHUAN PHARMA +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

During the dry granulation process, divalproex sodium easily absorbs moisture in the air and becomes oily when exposed to the air, which is not conducive to strong pressure granulation, and is easily hydrolyzed into valproic acid and sodium valproate to form tablets The content of related substances is too high, and the product quality is unqualified

Method used

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  • Divalproex sodium enteric-coated tablet core as well as preparation method and application thereof
  • Divalproex sodium enteric-coated tablet core as well as preparation method and application thereof
  • Divalproex sodium enteric-coated tablet core as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-3

[0056] The composition of divalproex sodium enteric-coated tablet cores in Examples 1-3 is shown in Table 1.

[0057] Table 1 (composition of tablet core)

[0058]

[0059] The preparation method of divalproex sodium enteric-coated tablet core in embodiment 1-3, comprises the following steps:

[0060] 1) Granulation: Divalproex sodium, fillers, disintegrants and 80% (w / w), 20% (w / w), 50% (w / w) of the total anti-adhesive agent After the adhesive is mixed evenly, it is put into a dry-compressed granulator for granulation; the obtained dry-compressed tablet is pulverized by a one-way pulverizer, passed through a 10-20 mesh sieve, and the obtained granules are granulated through a 20-40 mesh sieve;

[0061] 2) Blending and tableting: mix the sized granules with 20% (w / w), 80% (w / w), 50% (w / w) of anti-sticking agent, talcum powder, stearic acid After the magnesium is evenly mixed, it is pressed into tablets.

[0062] The process parameter of embodiment 1-3 is shown in table ...

Embodiment 4-6

[0066] The preparation process of embodiment 4 is the same as embodiment 1; the preparation process of embodiment 5 is the same as embodiment 2; the preparation process of embodiment 6 is the same as embodiment 3.

[0067] The process parameter of embodiment 4-6 is shown in table 3.

[0068] table 3

[0069]

[0070] test case 1 Determination of Dissolution Profile of Divalproex Sodium Enteric-coated Tablets

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Abstract

The invention relates to a divalproex sodium enteric-coated tablet core as well as a preparation method and an application thereof. The divalproex sodium enteric-coated tablet core is used for dry granulation. The divalproex sodium enteric-coated tablet core comprises the following components: 20-70 percent of divalproex sodium, 10-70 percent of filling agent, 0.5-20 percent of disintegrating agent, 5-20 percent of antisticking agent, 0.5-10 percent of talcum powder and 0.5-5 percent of magnesium stearate, wherein the antisticking agent is selected from one or a combination of silicon dioxide, superfine silica powder and silicon dioxide precipitate. The divalproex sodium enteric-coated tablet core prepared by using the preparation method is complete in release in vitro, higher in in-vitro dissolution speed and release rate and high in quality and has better safety and safety. The dry granulation method has the advantages of simple, convenient and feasible process, low cost, easiness in mass production, environmental friendliness and the like.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a sodium dipvalerate enteric-coated tablet core, a preparation method thereof and an application thereof. Background technique [0002] The World Health Organization (WHO) defines epilepsy as a chronic brain disease characterized by abnormal electrical discharges and recurrent seizures. There are 50 million people with epilepsy worldwide. There are more than 8 million epilepsy patients in my country, with a lifetime prevalence rate of 0.7%, and about 400,000 new cases each year. [0003] Since phenobarbitone became the first epilepsy drug in 1912, about 17 drugs have been used to treat epilepsy. Among them, valproate has better safety, does not need to monitor blood drug concentration, has low side effects, and is better tolerated by patients, so it has become the main drug in mood stabilizers. At present, enteric-coated tablets of divalproex so...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61P25/18A61K47/04A61P25/08A61P25/24A61K9/28A61K31/19A61P25/06
Inventor 霍彩霞黄晓霞屈英薇张洋
Owner BEIJING SIHUAN PHARMA
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