Prednisone acetate tablets and preparation method thereof

A technology of prednisone acetate tablets and prednisone acetate, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., which can solve the problems of difficult absorption of tablets, and achieve the appearance Complete and smooth, convenient process steps, rapid dissolution effect

Inactive Publication Date: 2020-02-28
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] In view of the deficiencies in the prior art, the object of the present invention is to provide a prednisone acetate tablet and a preparation method ther

Method used

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  • Prednisone acetate tablets and preparation method thereof

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Embodiment 1

[0031] The embodiment of the present invention provides a kind of prednisone acetate tablet, comprises following composition by weight: prednisone acetate 30kg, cornstarch 459kg, sucrose 202.8kg, sodium starch glycolate 10kg, sodium lauryl sulfate 4.8kg, stearic acid Magnesium 5kg.

[0032] The quality parameter of prednisone acetate tablet is: moisture≤5.0%, content=107.0% (because there is certain error in the total mass of prednisone acetate tablet in the tablet process, cause the active ingredient in the prednisone acetate tablet to also exist Deviation, causing the content of some active ingredients to be greater than 100%), friability ≤ 0.8%, dissolution rate limited to 75% of the labeled amount, complete and smooth appearance, and uniform color.

[0033] The preparation method of prednisone acetate sheet, comprises the following steps:

[0034] S1. Weigh the raw materials of each component in the weighing workshop in parts by weight.

[0035] S2. Weigh 30kg of prednis...

Embodiment 2

[0042] The embodiment of the present invention provides a kind of prednisone acetate tablet, comprises following composition by weight percentage: prednisone acetate 45kg, cornstarch 688.5kg, sucrose 300kg, sodium starch glycolate 15kg, sodium lauryl sulfate 7.2kg, stearin Magnesium acid 7.5kg.

[0043] The quality parameters of the prednisone acetate tablet are: moisture≤5.0%, content=93%, friability≤0.8%, the dissolution rate is limited to 75% of the marked amount, the appearance is complete and smooth, and the color is uniform.

[0044] The preparation method of prednisone acetate sheet, comprises the following steps:

[0045] S1. Weigh the raw materials of each component in the weighing workshop in parts by weight.

[0046] S2. Weigh 45kg of prednisone acetate, 15kg of carboxymethyl starch sodium, and 300kg of cornstarch by weight, and place them in a two-dimensional mixer for mixing and stirring for 30min while controlling the environmental conditions: temperature 16-28°...

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Abstract

The invention discloses prednisone acetate tablets and a preparation method thereof, which comprises, by weight, 4.22% of prednisone acetate, 64.50% of corn starch, 28.50% of sucrose, 1.41% of sodiumcarboxymethyl starch, 0.67% of sodium lauryl sulfate, and 0.70% of magnesium stearate; quality parameters of the prednisone acetate tablets include moisture of </=5.0%, content of 93.0-107.0% and friability of </=0.8%. According to the preparation method, micronization of prednisone acetate is implemented first, so that the dissolution rate of the prednisone acetate tablets is effectively improved; the prednisone acetate is fully mixed with the corn starch material; the quality is stable, the impurity content is low, the moisture is low, and the prednisone acetate tablet scan be directly absorbed and digested by a human body after being taken by the human body.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical processing, and in particular relates to a prednisone acetate tablet and a preparation method thereof. Background technique [0002] With the continuous development of science and technology, prednisone is an adrenocortical hormone drug, mainly used for allergic and inflammatory diseases. It is a commonly used oral glucocorticoid clinically, and it is the most important drug in the treatment of autoimmune diseases such as systemic lupus erythematosus, rheumatism, and nephrotic syndrome. At the same time, prednisone acetate has anti-inflammatory and anti-allergic effects, can inhibit the proliferation of connective tissue, reduce the permeability of capillary walls and cell membranes, reduce inflammatory exudation, and inhibit the formation and release of histamine and other toxic substances . [0003] However, prednisone acetate, as the active ingredient of medicine, is not easily absorbe...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/573A61K47/36A61K47/26A61P5/44
CPCA61K9/2018A61K9/2059A61K31/573A61P5/44
Inventor 陈宝乾陈永恒
Owner 安徽金太阳生化药业有限公司
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