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Divalproex sodium medicine composition with improved oral absorptivity

The technology of sodium divalproex and composition is applied in the field of sodium divalproex pharmaceutical composition and preparation thereof, which can solve the problems of poor particle fluidity, low release degree, stickiness and the like, and achieves improved bioavailability The effect of improving the release degree in vitro and simple operation

Inactive Publication Date: 2010-04-14
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] The conventional preparation method in the prior art prepares divalproex sodium preparations. Due to the physical and chemical properties of divalproex sodium materials, it is easy to cause the particles in the prepared tablets to have poor fluidity, sticky punching, unqualified tablet appearance, and low release rate.
Cannot be mass-produced
[0011] In order to improve product quality and overcome the problem of incapable of industrialized production, we have carried out a lot of design and research on technical solutions, selected the optimal prescription and process, and solved the above technical defects

Method used

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  • Divalproex sodium medicine composition with improved oral absorptivity
  • Divalproex sodium medicine composition with improved oral absorptivity
  • Divalproex sodium medicine composition with improved oral absorptivity

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0089] Embodiment 1 (prior art)

[0090] (1) Prescription

[0091] Chip composition

[0092] Divalproex Sodium 250g

[0093] Croscarmellose Sodium 30g

[0094] Microcrystalline Cellulose 150g

[0095] Lactose 90g

[0096] 120g pregelatinized starch

[0097] Talc powder 10g

[0098] Magnesium Stearate 10g

[0099] 5% povidone absolute ethanol appropriate amount

[0100] Coating Composition

[0101] Coating powder (enteric-coated type) 72.8g

[0102] 80% ethanol solution 728ml

[0103]

[0104] Makes 1000 pieces

[0105] (2) Preparation method

[0106] 1) Pulverize divalproex sodium, sieve, and set aside; sieve microcrystalline cellulose, lactose, croscarmellose sodium, pregelatinized starch, magnesium stearate, and talcum powder, respectively, and set aside;

[0107] 2) Weigh the raw and auxiliary materials according to the prescription amount respectively, and set aside;

[0108] 3) The uniformly mixed raw and auxiliary m...

Embodiment 2

[0112] (1) Prescription

[0113] Composition 1

[0114] Divalproex Sodium 250g

[0115] Beta Cyclodextrin 125g

[0116] Composition 2

[0117] Croscarmellose Sodium 20g

[0118] Microcrystalline Cellulose 100g

[0119] Lactose 120g

[0120] 40g pregelatinized starch

[0121] Talc powder 10g

[0122] Magnesium Stearate 10g

[0123] 5% povidone absolute ethanol solution appropriate amount

[0124] Coating Composition

[0125] Coating powder (enteric-coated type) 81g

[0126] 80% ethanol solution 810ml

[0127] (2) Preparation method

[0128] 6) Put divalproex sodium and beta-cyclodextrin in a mortar, add a small amount of water to grind into a paste, dry below 50°C, grind into 80-100 mesh fine powder, and set aside;

[0129] 7) Sieve microcrystalline cellulose, lactose, croscarmellose sodium, pregelatinized starch, talcum powder, and magnesium stearate respectively, and set aside;

[0130] 8) Add the excipient 2) of the prescription amount into 1), mix evenly, and ...

Embodiment 3

[0134] (1) Prescription

[0135] Composition 1

[0136] Divalproex Sodium 250g

[0137] Beta Cyclodextrin 250g

[0138] Composition 2

[0139] Croscarmellose Sodium 30g

[0140] Microcrystalline Cellulose 60g

[0141] Lactose 80g

[0142] 30g pregelatinized starch

[0143] Talc powder 10g

[0144] Magnesium Stearate 10g

[0145] 5% povidone absolute ethanol solution appropriate amount

[0146] Coating Composition

[0147] Coating powder (enteric-coated type) 79.2g

[0148] 80% ethanol solution 792ml

[0149] (2) Preparation method

[0150] 1) Put divalproex sodium and beta-cyclodextrin in a mortar, add a small amount of water and grind them into a paste, dry below 50°C, grind them into 80-100 mesh fine powder, and set aside;

[0151] 2) Sieve microcrystalline cellulose, lactose, croscarmellose sodium, pregelatinized starch, talcum powder, and magnesium stearate respectively, and set aside;

[0152] 3) Add the excipient 2) of the prescription amount into 1), mix e...

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Abstract

The invention relates to a medicine composition containing divalproex sodium, which can be applied to patients safely, not only can improve the wettability and the flowability of the divalproex sodium, but also can improve the absorptivity of the divalproex sodium in gastrointestinal tracts. Particularly, the invention relates to a medicine composition containing amorphous divalproex sodium and betacyclodextrin. The preparation method of the medicine composition comprises the following steps: grinding, drying and pulverizing the divalproex sodium and the betacyclodextrin to obtain fine powder of 80-100 meshes; mixing with proper assistant materials and making into granules, and then tabletting and coating to obtain the medicine composition. The divalproex sodium medicine composition not only can improve release in vitro to a greater degree, thereby improving bioavailability, but can effectively treat epilepsia and vesania and prevent cephalagra; in addition, the divalproex sodium medicine composition can be taken orally and conveniently, can cover odor, and can be disintegrated and absorbed quickly and carried conveniently.

Description

technical field [0001] The invention relates to a medicinal composition of divalproex sodium and a preparation method thereof. Dispersing divalproex sodium in beta-cyclodextrin can greatly increase the release rate in vitro, thereby improving the bioavailability. Background technique [0002] Epilepsy is one of the oldest human diseases. The World Health Organization (WHO) definition of epilepsy: Epilepsy is a chronic disease with recurrent seizures, protracted disease course, and sudden brain dysfunction. It is characterized by sudden abnormal high-frequency discharge of brain neurons and spreading to the surroundings. Due to the different locations of abnormal discharge neurons, the clinical manifestations are different symptoms of motor, sensory, consciousness and autonomic dysfunction. The types of seizures are also divided into partial seizures, generalized seizures, and generalized tonic-clonic seizures. The seizure classification of a small number of patients is not...

Claims

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Application Information

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IPC IPC(8): A61K47/48A61K31/19A61K9/28A61P25/08A61P25/18A61P25/06A61K47/40A61K47/38A61K47/36A61K47/26A61K47/12A61K47/02A61K47/69
Inventor 严洁黄欣
Owner TIANJIN HANKANG PHARMA BIOTECH
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