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Amisulpride tablet and method for preparing same

A technology of amisulpride tablets and tablets, which is applied in the direction of pill delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc., can solve the problems of improving taste, rapid onset of effect, poor solubility of amisulpride, Problems such as poor fluidity and formability can achieve the effect of improving drug compliance, improving dissolution rate and reducing possibility

Active Publication Date: 2017-09-05
HEBEI LONGHAI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Amisulpride has poor solubility, is almost insoluble in water, and has poor fluidity and formability. However, it is clinically required that the drug be dissolved quickly and take effect quickly, which requires the use of appropriate prescriptions and processes in the production of preparations to improve the dissolution rate of the drug.
[0006] CN1842331A discloses a solid pharmaceutical composition of amisulpride, which wraps the granules containing amisulpride to make orally dispersible tablets. Due to the large size, it is difficult to achieve the effect of improving the taste and acting quickly

Method used

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  • Amisulpride tablet and method for preparing same
  • Amisulpride tablet and method for preparing same
  • Amisulpride tablet and method for preparing same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Components of film-coated tablets (mass unit: mg), each tablet contains 200 mg of amisulpride:

[0042] Amisulpride 200.0g

[0043] Lactose 53.6g

[0044] Microcrystalline Cellulose 107.2g

[0045] Sodium carboxymethyl starch 4.0g

[0046] Pregelatinized starch 32.0g

[0047] Magnesium Stearate 3.2g

[0048] Film coating premix:

[0049] Opadry Gastric Film Coating Powder 48.5g

[0050] Aspartame 0.25g

[0051] Sodium chloride 1.0g

[0052] Peach Flavor Essence 0.25g

[0053] Film-coated tablet preparation process:

[0054] (1) Weigh the raw materials in proportion, pass the amisulpride, filler, disintegrant and binder through a 60-mesh sieve and mix evenly;

[0055] (2) Add an appropriate amount of wetting agent water 200g to the mixture mixed in the previous step, pass through a 20-mesh sieve to granulate, dry the prepared granules in an oven at 50-60°C, pass through a 20-mesh sieve for granulation;

[0056] (3) Add the lubricant magnesium stearate to the g...

Embodiment 2

[0061] Composition of amisulpride film-coated tablet (mass unit: mg), each tablet contains 200mg of amisulpride:

[0062] Amisulpride 200.0g

[0063] Lactose 200.0g

[0064] Sodium carboxymethyl starch 46.0g

[0065] Povidone k30 50.0g

[0066] Magnesium Stearate 4.0g

[0067] Film coating premix:

[0068] Opadry Gastric Film Coating Powder 49.0g

[0069] Acesulfame K 0.10g

[0070] Sodium chloride 0.75g

[0071] Cherry Flavor 0.15g

[0072] Film-coated tablet preparation process:

[0073] (1) Weigh the raw materials in proportion, pass the amisulpride, filler, disintegrant and binder through a 60-mesh sieve and mix evenly;

[0074] (2) Add an appropriate amount of wetting agent water 200g to the mixture mixed in the previous step, pass through a 20-mesh sieve to granulate, dry the prepared granules in an oven at 50-60°C, pass through a 20-mesh sieve for granulation;

[0075] (3) Add lubricant talcum powder to the granules prepared in the previous step, and mix well; ...

Embodiment 3

[0080] Composition of amisulpride film-coated tablet (mass unit: mg), each tablet contains 100mg of amisulpride:

[0081] Amisulpride 100.0g

[0082] Lactose 75.0g

[0083] Microcrystalline Cellulose 200.0g

[0084] Mannitol 75.0g

[0085] Croscarmellose Sodium 12.0g

[0086] Pregelatinized starch 35.0g

[0087] Talc powder 3.0g

[0088] Film coating premix:

[0089] Opadry Gastric Film Coating Powder 49.5g

[0090] Aspartame 0.15g

[0091] Sodium chloride 0.30g

[0092] Strawberry Peach Flavor 0.05g

[0093] Film-coated tablet preparation process:

[0094] (1) Weigh the raw materials in proportion, pass the amisulpride, filler, disintegrant and binder through a 60-mesh sieve and mix evenly;

[0095] (2) Add an appropriate amount of wetting agent water 200g to the mixture mixed in the previous step, pass through a 20-mesh sieve to granulate, dry the prepared granules in an oven at 50-60°C, pass through a 20-mesh sieve for granulation;

[0096] (3) Add the lubricant...

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Abstract

The invention discloses an amisulpride tablet and a method for preparing the same. The amisulpride tablet comprises raw materials and excipients, and is characterized in that film coating is carried out on the surfaces of the amisulpride tablet by the aid of film coating premixes; the film coating premixes comprise opadry gastric-soluble coating powder and flavoring agents; the flavoring agents comprise sweeteners, taste masking agents and aromatizers; the sweeteners are selected from a type of aspartame and acesulfame potassium; each taste masking agent is sodium chloride; the aromatizers are selected from a type of cherry flavor essence, apple flavor essence, honey peach flavor essence, sweet orange flavor essence, strawberry flavor essence and mint flavor essence. The amisulpride tablet and the method have the advantages that film coating is carried out on the amisulpride tablet, accordingly, bitter taste of amisulpride can be masked to a certain extent while the stability of the amisulpride tablet which is a medicine is improved, the medication compliance of patients can be improved, and medicine taking pretending possibility of the patients can be reduced to a certain extent; usage of lubricants is controlled, accordingly, the dissolution of the medicine can be greatly improved, and the medicine can be stably and quickly released in bodies.

Description

technical field [0001] The invention relates to an amisulpride tablet and a preparation method thereof, and relates to the technical field of amisulpride medicines. Background technique [0002] Amisulpride is an atypical antipsychotic drug, mainly used in the treatment of psychosis, specifically for the treatment of paranoid progressive schizophrenia, acute delirium psychosis, and also for the treatment of schizophrenic deficits state, residual psychotic evolution, and suppressed state with bluntness, can also be used in the treatment of prominent primary negative symptoms as well as psychotic depression. [0003] Amisulpride is usually administered orally in the form of tablets with a dose of 100, 200 or 400 mg per tablet (Vidal, edition 2003, Solian monograph, pages 1736 and 1738). However, during acute psychotic episodes, the daily oral dose of amisulpride is frequently increased, up to 1200 mg / day. Therefore, patients treated with amisulpride must swallow several tabl...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K47/38A61K47/10A61K47/02A61K31/40A61P25/18A61P25/24
CPCA61K9/2009A61K9/2013A61K9/2866A61K31/40
Inventor 张月红盖树常杨亚青王薇薇刘雅倩
Owner HEBEI LONGHAI PHARMA
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