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Sulpiride tablet and preparation method thereof

A technology of sulpiride tablets and tablets, which is applied in the direction of pharmaceutical formulas, medical preparations of non-active ingredients, pill delivery, etc., can solve problems such as unsatisfactory dissolution rate of sulpiride tablets, and improve bioavailability and compressibility Good, saving consumption and cost effect

Active Publication Date: 2015-04-22
常州康普药业有限公司
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  • Abstract
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AI Technical Summary

Problems solved by technology

[0004] The present invention aims to solve the technical problem of unsatisfactory dissolution rate of ordinary sulpiride tablets, adopts PVPk30 and PEG4000 as carriers to prepare sulpiride solid dispersion, adds lactose, microcrystalline cellulose and other auxiliary agents, and then prepares solid dispersion type tablets, and the obtained sulpiride Tablet dissolution can reach more than 90% of the labeled amount

Method used

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  • Sulpiride tablet and preparation method thereof
  • Sulpiride tablet and preparation method thereof
  • Sulpiride tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] (1) The preparation of solid dispersion carrier, PEG4000 300g, PVPk30 20g are joined in the 95% (ml / ml) ethanol of formula quantity 2 / 3, heat and stir until PEG4000 and PVPk30 dissolve completely, get adjuvant solution; 1000g sulpiride is dissolved in the 95% (ml / ml) ethanol of recipe quantity (remainder) 1 / 3 to obtain main drug solution; Described adjuvant solution and described main drug solution are mixed uniformly to obtain mixed solution; The solution was vacuum-dried for 12 hours (vacuum degree less than 10Pa), the drying temperature was 35°C, and the moisture content was controlled to be less than 1% (mass percentage);

[0018] (2) Tablet preparation, pulverize the material obtained in step (1), and pass through a 100-mesh standard sieve to obtain a solid dispersion powder; put the gained solid dispersion powder, 200 g of lactose, and 300 g of microcrystalline cellulose into a granulator, and dry mix 5min, add 40% (ml / ml) ethanol of 150g as binding agent, set the...

Embodiment 2

[0023] (1) The preparation of solid dispersion carrier, PEG4000 300g, PVPk30 30g are joined in the 95% (ml / ml) ethanol of formula quantity 2 / 3, heat and stir until PEG4000 and PVPk30 dissolve completely, get adjuvant solution; 1000g sulpiride is dissolved in the 95% (ml / ml) ethanol of recipe quantity (remainder) 1 / 3 to obtain main drug solution; Described adjuvant solution and described main drug solution are mixed uniformly to obtain mixed solution; The solution was vacuum-dried for 24 hours (vacuum degree less than 10Pa), the drying temperature was 55°C, and the moisture content was controlled to be less than 1% (mass percentage);

[0024] (2) Tablet preparation, pulverize the material obtained in step (1), and pass through a 120-mesh standard sieve to obtain a solid dispersion powder; put the gained solid dispersion powder, 200 g of lactose, and 300 g of microcrystalline cellulose into a granulator, and dry mix 10min, add the 45% (ml / ml) ethanol of 200g as binding agent, se...

Embodiment 3

[0026] Tablet Quality Check

[0027] 1. Appearance: The surface of the sulpiride tablet prepared in Examples 1 and 2 is smooth, and it is brighter and whiter than the tablet prepared by traditional techniques.

[0028] 2. Dissolution rate:

[0029] Embodiment 1, 2 gained sulpiride tablet respectively gets 6, checks dissolution rate according to Chinese Pharmacopoeia 2010 edition two appendix XC, the dissolution amount of the tablet prepared in embodiment 1, 2 is all more than 85% in 30 minutes (according to labeling meter).

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Abstract

The invention belongs to the technical field of pharmaceutical preparation and particularly relates to a sulpiride tablet and a preparation method thereof. The preparation method comprises the following steps: weighing 300g of PEG 4000 and 20-30g of PVPk30, dissolving 95% ethanol to obtain an additive solution; dissolving 1000g of sulpiride in 95% ethanol to obtain a main medicine solution; uniformly mixing the additive solution with the main medicine solution to obtain a mixed solution; carrying out vacuum drying on the mixed solution; crushing the obtained solid material, shearing 300g of microcrystalline cellulose and 200g of lactose in a granulator for granulation, and drying the granules in a boiling dryer; trimming the dry granules in a 20-30-mesh sieve, mixing the obtained granules with a lubricating agent in the prescription and tabletting.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a sulpiride tablet and a preparation method thereof. Background technique [0002] Sulpiride is a commonly used drug for the treatment of schizophrenia. It belongs to benzamide antipsychotics. Its action is characterized by selectively blocking dopamine receptors in the mesolimbic system, and has little effect on other transmitters. Its anticholinergic effect is relatively mild. It has no obvious sedative and anti-excitatory and restless effects, and this product also has strong antiemetic and inhibitory effects on gastric juice secretion. [0003] The dissolution rate is measured by the first method of Appendix XC of the Chinese Pharmacopoeia. Since the raw material of sulpiride is almost insoluble in water, the dissolution rate of sulpiride tablets prepared by ordinary processes is generally about 80%, although it meets the provisions of the Phar...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/34A61K47/26A61K47/38A61K47/32A61K31/40
Inventor 王苏南汤金春
Owner 常州康普药业有限公司
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