Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

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

Active Publication Date: 2013-01-30
NEW FOUNDER HLDG DEV LLC +2
View PDF8 Cites 4 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In order to solve the problems in the above-mentioned prior art, an object of the present invention is to provide a common tablet of hemisodium valproate, which overcomes the problems of poor particle fluidity, sticky punching, lobes, and chips in the existing production process. Disadvantages of unqualified appearance of the agent

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Valproate semisodium tablet and its preparation method
  • Valproate semisodium tablet and its preparation method
  • Valproate semisodium tablet and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0082] Example 1 (Valproic acid half-sodium ordinary tablets, 500mg / tablet based on valproic acid)

[0083] prescription:

[0084]

[0085] Preparation:

[0086] Weigh 270g semi-sodium valproate, 161g microcrystalline cellulose, 3.2g sodium carboxymethyl starch, and 35.6g lactose, respectively pass through a 100-mesh sieve, and mix them; use absolute ethanol as a wetting agent to prepare the above-mentioned mixed fine powder Become a soft material, pass a 20-mesh sieve to make granules, dry, sizing, and dry; weigh the remaining 4.8 g of sodium carboxymethyl starch, 6.4 g of magnesium stearate, 15 g of talcum powder, and 13 g of silicon dioxide into the above granules In the middle, mix well; compress tablets at a rotation speed of 25-50r / min.

[0087] Friability check

[0088] According to the requirements of Appendix XG of the Second Part of Chinese Pharmacopoeia 2005, the friability of the tablets of Example 1 was checked, and the weight loss was 0.31%, and there were no broken, cra...

Embodiment 2

[0089] Example 2 (Valproic acid half-sodium ordinary tablets, 250mg / tablet based on valproic acid)

[0090] prescription:

[0091]

[0092] Preparation:

[0093] Weigh 270g semi-sodium valproate, 126.9g microcrystalline cellulose, 4.6g sodium carboxymethyl starch, and 36.4g lactose, respectively pass through a 100-mesh sieve, and mix them; use 95% ethanol aqueous solution as a wetting agent to mix the above The powder is made into soft material, passed through a 20-mesh sieve to make granules, dried, granulated, and dried; weigh the remaining 5.7g of sodium carboxymethyl starch, 7.2g of magnesium stearate and 31.2g of silicon dioxide and add them to the above granules , Mix well; compress tablets at a speed of 25-50r / min.

[0094] Friability check

[0095] According to the requirements of Appendix XG of the Second Part of Chinese Pharmacopoeia 2005, the friability of the tablets of Example 2 was checked, the weight loss was 0.28%, and there were no broken, cracked or crushed tablets. ...

Embodiment 3

[0096] Example 3 (Semi-sodium valproic acid enteric-coated tablets, 250 mg / tablet based on valproic acid)

[0097] prescription:

[0098]

[0099] Preparation:

[0100] (A) Preparation of tablet core

[0101] Weigh 270g semi-sodium valproate and 155g microcrystalline cellulose, 3.8g sodium carboxymethyl starch, and 34.5g lactose, respectively pass through a 100-mesh sieve, and mix them; use 95% ethanol aqueous solution as a wetting agent to mix the above fine powder Make soft material, sieved through 20 mesh to make granules, dried, sized and dried; weigh the remaining amount of sodium carboxymethyl starch 4.7g, magnesium stearate 7g, and silicon dioxide 30g into the above granules and mix well ; Compress tablets at a speed of 25-50r / min;

[0102] (B) Preparation of enteric-coated tablets

[0103] The 1000 tablet cores obtained in (A) above were fluidized in a fluidized bed coating device and sprayed with OY-P-7171 to obtain semi-sodium valproate enteric-coated tablets (the weight gain...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

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.

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

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
IPC IPC(8): A61K9/20A61K9/28A61K31/20A61K47/38A61P25/06A61P25/08A61P25/18A61P25/24
Inventor 孟宏涛丁继军谢小飞王振国任爱国易崇勤
Owner NEW FOUNDER HLDG DEV LLC
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com