Dexamethasone acetate tablet and preparation method thereof

A technology of dexamethasone acetate and corn starch, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., and can solve the problems of inability to absorb and lower drug properties of dexamethasone acetate raw materials, etc. problem, to achieve the effect of improving dissolution rate, complete and smooth appearance, and improving solubility

Inactive Publication Date: 2020-02-04
安徽金太阳生化药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] Aiming at the deficiencies in the prior art, the object of the present invention is to provide a kind of dexamethasone acetate tablet and preparation method thereof, which solves the problem that the drug properties of dexamethasone a

Method used

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  • Dexamethasone acetate tablet and preparation method thereof

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Embodiment 1

[0030] The present embodiment provides a kind of dexamethasone acetate tablet, comprises the composition by weight of following raw material: dexamethasone acetate 5kg, cornstarch 552kg, sucrose 240kg, carboxymethyl starch sodium 8kg, magnesium stearate 6kg, lauryl sulfate Sodium 0.7kg.

[0031] The quality parameters of the dexamethasone acetate tablet are: moisture ≤ 4.0%, content = 93.0%, friability ≤ 0.8%, and the dissolution limit is 75% of the labeled amount.

[0032] The preparation method of dexamethasone acetate sheet, comprises the following steps:

[0033] S1. Weigh the raw materials of each component in the weighing workshop in parts by weight.

[0034] S2, take by weight 5kg of dexamethasone acetate, 8kg of sodium starch glycolate, and 250kg of cornstarch and mix them first, and place them in a two-dimensional mixer for mixing and stirring for 10 minutes (the mixture is added to the two-dimensional mixer several times) Mixing, after mixing, suction into the blen...

Embodiment 2

[0041] The present embodiment provides a kind of dexamethasone acetate tablet, comprises the composition by weight of following raw material: dexamethasone acetate 7.5kg, cornstarch 828kg, sucrose 360kg, carboxymethyl starch sodium 12kg, magnesium stearate 9kg, lauryl Sodium sulfate 1.05kg.

[0042] The quality parameters of dexamethasone acetate tablets are: moisture≤4.0%, content=107.0% (due to the existence of certain errors in the total mass of dexamethasone acetate tablets during tablet compression, the active ingredients in dexamethasone acetate tablets will also exist deviation, resulting in some active ingredient content greater than 100%), friability ≤ 0.8%, and the limit of dissolution is 75% of the labeled amount.

[0043] The preparation method of dexamethasone acetate sheet, comprises the following steps:

[0044] S1. Weigh the raw materials of each component in the weighing workshop in parts by weight.

[0045] S2, take by weight 7.5kg of dexamethasone acetate,...

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Abstract

The invention discloses a dexamethasone acetate tablet and a preparation method thereof. The dexamethasone acetate tablet is prepared from the following raw materials in percentage by weight: 0.62% ofdexamethasone acetate, 68.00% of corn starch, 29.56% of sucrose, 0.99% of carboxymethyl starch sodium, 0.74% of magnesium stearate, and 0.09% of lauryl sodium sulfate. The preparation method of the dexamethasone acetate tablet includes the following steps that micronization treatment of the dexamethasone acetate is realized firstly through the wall breaking of the raw materials, the obtained dexamethasone acetate is fully mixed with the corn starch raw materials to improve dissolution of the tablet, at the same time, when the dexamethasone acetate is integrated with the corn starch during preparation, an overall shape is protected, overall efficacy being not prone to being losing is protected, it is ensured that the appearance of the tablet is complete and smooth with uniform color, moisture content is less than or equal to 5.0%, the content is 93.0-107.0%, and brittleness is less than or equal to 0.8%.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical processing, and in particular relates to a dexamethasone acetate tablet and a preparation method thereof. Background technique [0002] Dexamethasone acetate is a kind of adrenal cortex hormone drug, its anti-inflammatory, anti-allergic, anti-shock effect is more significant than prednisone, but it has a slight effect on water and sodium retention and promotion of potassium excretion, and has a stronger inhibitory effect on pituitary-adrenal gland. powerful. It is white or off-white crystal or crystalline powder; odorless, slightly bitter taste. Soluble in acetone, soluble in methanol or ethanol, slightly soluble in ethanol or chloroform, slightly soluble in ether, insoluble in water. [0003] The anti-inflammatory effect and immunosuppressive effect of dexamethasone acetate can significantly improve its application value in the market. However, it is not easily soluble in water. In the ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/36A61K31/573A61P29/00A61P37/08A61P9/02A61P37/06
CPCA61K9/2059A61K9/2095A61K31/573A61P9/02A61P29/00A61P37/06A61P37/08
Inventor 张强李安
Owner 安徽金太阳生化药业有限公司
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