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Oral preparation containing amisulpride

A technology for oral preparations of amisulpride, applied in the field of pharmaceutical preparations, can solve the problems of large specifications, difficulty in orally dispersible tablets, difficulty in achieving rapid dissolution and rapid onset of effect, etc., to improve water solubility, facilitate rapid dissolution, improve The effect of bioavailability

Active Publication Date: 2014-05-14
QILU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The amisulpride pharmaceutical composition prepared by this method is to wrap the particles containing amisulpride, and the size is very large, it is very difficult to make it into an orally dispersible tablet, and it is difficult to achieve the effect of rapid dissolution and rapid onset of action

Method used

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  • Oral preparation containing amisulpride
  • Oral preparation containing amisulpride
  • Oral preparation containing amisulpride

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] Embodiment 1: amisulpride oral preparation prescription:

[0064] Raw material name dosage

[0065] Amisulpride 100g,

[0066] β-cyclodextrin 350g,

[0067] Microcrystalline Cellulose 63g,

[0068] Crospovidone 18g,

[0069] Polyvinylpyrrolidone 16g is made into 10wt% polyvinylpyrrolidone aqueous solution and added,

[0070] Magnesium Stearate 6g,

[0071] Silica 3g,

[0072] A total of 1000 units were made.

[0073] Preparation Process:

[0074] 1) Prepare 50°C saturated aqueous solution by weighing 350g of β-cyclodextrin, then place it in a high-speed mixer, start stirring at a speed of 1000 rpm; dissolve 100g of amisulpride in 3000ml of ethanol, and then add it dropwise to In the stirred saturated aqueous solution of β-cyclodextrin, the dropping rate is 2ml / min, and stirred at constant temperature for 1 hour; stop heating and continue stirring to room temperature, stop stirring after 3 hours, and spray dry to obtain β-cyclodextrin inclusion compound ;

[00...

Embodiment 2

[0078] Embodiment 2: amisulpride oral preparation prescription:

[0079] Raw material name dosage

[0080] Amisulpride 100g,

[0081] β-cyclodextrin 250g,

[0082] Lactose 199g,

[0083] Croscarmellose Sodium 21g,

[0084] Hydroxypropyl methylcellulose 3g, made into 2wt% hydroxypropyl methylcellulose aqueous solution and added,

[0085] Talcum powder 30g,

[0086] A total of 1000 units were made.

[0087] Preparation Process

[0088] 1) Weigh β-cyclodextrin according to the prescription amount to make a 50°C saturated aqueous solution, then put it in a high-speed mixer, start stirring at a speed of 1500 rpm; dissolve the prescription amount of amisulpride in 3000ml of ethanol, and then Add dropwise into the stirred saturated aqueous solution of β-cyclodextrin at a speed of 2 ml / min, and stir at constant temperature for 30 minutes. Stop heating and continue stirring to room temperature, stop stirring after 2.5 hours, and spray dry to obtain β-cyclodextrin inclusion comp...

Embodiment 3

[0091] Embodiment 3: raw material name consumption

[0092] Amisulpride 100g,

[0093] α-Cyclodextrin 200g,

[0094] Pregelatinized starch 240g,

[0095] Sodium carboxymethyl starch 30g,

[0096] Hydroxypropyl cellulose 5g is made into the solution containing 5wt% hydroxypropyl cellulose with the ethanol of concentration 75wt% and adds,

[0097] Talcum powder 30g,

[0098] A total of 1000 units were made.

[0099] Preparation Process

[0100] 1) Weigh α-cyclodextrin according to the prescription amount, add appropriate amount of water and grind it into a paste, pour it into the colloid mill, and turn on the machine; dissolve the prescription amount of amisulpride in 3000ml of ethanol, and then add it dropwise to the ground In the pasty α-cyclodextrin, the speed is 3ml / min, continue to grind for 30 minutes, and spray dry to obtain the α-cyclodextrin inclusion compound;

[0101] 2) Pass the prepared α-cyclodextrin inclusion compound through a 100-mesh sieve, then mix it e...

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Abstract

The invention relates to an oral preparation containing amisulpride. The amisulpride which is active medicine is prepared into cyclodextrin inclusion compound, is sieved, is uniformly mixed with pharmaceutically acceptable auxiliary materials, and is granulated by a wet method or a dry method, obtained granules are squashed to form tablets, filled into capsules to form a capsule preparation or is directly separately packaged to obtain a granule preparation. The water solubility and the stability of the oral preparation containing the amisulpride can be strengthened, bitter taste of the amisulpride is covered, medication compliances of patients are improved, and bioavailability of the oral preparation is improved to a great extent.

Description

technical field [0001] The invention relates to an oral preparation containing amisulpride, which belongs to the technical field of pharmaceutical preparations. Background technique [0002] Amisulpride is an atypical antipsychotic drug indicated for the treatment of paranoid progressive schizophrenia, acute delusional psychosis, and also for the treatment of deficit states in schizophrenia, residual psychotic evolution, and accompanying There is a sluggish inhibition state. Amisulpride is commonly used orally in the form of tablets with doses of 100, 200 and 400 mg per tablet (Vidal, edition 2003, Solianmonograph, pp. 1736 and 1738). However, oral daily doses of amisulpride are frequently increased during acute psychotic episodes, reaching up to 1200 mg / day. Therefore, patients treated with amisulpride must swallow several tablets per day. [0003] Due to the special pathological state of the patient, and the taste of the active ingredient amisulpride is very bitter, it ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/40A61K47/40A61P25/18
Inventor 王晶翼于艳玲杨清敏张明会
Owner QILU PHARMA CO LTD
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