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Prednisone acetate micro-tablet and preparation method thereof

A technology of prednisone acetate and microtablets, which is applied in the direction of medical formulas, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc., and can solve the problems of slow dissolution of prednisone acetate tablets, relatively large dose differences, Problems such as difficulty in medication for patients, to achieve the effect of solving the slow dissolution rate of tablets, reducing the loss of raw materials, and strong controllability of the method

Pending Publication Date: 2021-08-27
CISEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] First of all, the content of the tablet is relatively fixed, and the weight of the tablet is relatively large. Prednisone acetate is a hormone drug applicable to a wide range of diseases, and the dose of prednisone acetate required for different diseases varies greatly, and the sodium prednisone acetate tablet is Taking medicine for a long time will gradually reduce or increase the dosage according to the condition of the medicine. The content of the currently produced tablets is relatively fixed and the weight of the tablet is relatively large, which brings certain difficulties to the patient. For example, in order to prevent organ transplantation Abnormal reactions, 100mg per day is required before the operation. According to the 5mg specification, 20 tablets are required to be taken per day. If the tablet is heavy, it will bring great challenges to the patient’s medication
[0007] The dissolution of prednisone acetate tablets is slow. Prednisone acetate is a fat-soluble drug. Only by dissolving quickly in water can it be well absorbed in the stomach. The biggest difficulty in research and development is to speed up the dissolution rate.

Method used

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  • Prednisone acetate micro-tablet and preparation method thereof
  • Prednisone acetate micro-tablet and preparation method thereof
  • Prednisone acetate micro-tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Composition of prednisone acetate microtablets:

[0034]

[0035] The preparation method of prednisone acetate microchips:

[0036] (1) Pretreatment of raw and auxiliary materials: mix prednisone acetate and starch at a ratio of 1:2 and then pulverize. Starch and other auxiliary materials are passed through a 40-mesh sieve, and auxiliary materials that cannot be sieved are crushed and sieved;

[0037] (2) Pre-mixing: put the pre-treated mixed powder in the prescribed amount, the remaining starch and the prescribed amount of crospovidone and mannitol in a mixer and mix for 20 minutes;

[0038] (3) Granulation: use an appropriate amount of 50% ethanol solution to obtain a soft material with suitable hardness, use a 20-mesh sieve to granulate, dry at 60°C, and measure the moisture to be 5.1%;

[0039] (4) Total blending: the obtained granules were mixed with colloidal silicon dioxide for 3 minutes, then the prescription amount of magnesium stearate was added and mixed...

Embodiment 2

[0042] Composition of prednisone acetate microtablets:

[0043]

[0044] The preparation method of prednisone acetate microchips:

[0045] (1) Pretreatment of raw and auxiliary materials: mix prednisone acetate and sucrose at a ratio of 1:2 and then pulverize. Starch and other auxiliary materials are passed through a 40-mesh sieve, and auxiliary materials that cannot be sieved are crushed and sieved;

[0046] (2) Premixing: put the pretreated obtained recipe amount mixed powder, recipe amount croscarmellose sodium, and microcrystalline cellulose in a mixer and mix for 20 minutes;

[0047] (3) Granulation: use an appropriate amount of 50% ethanol solution to obtain a soft material with suitable hardness, use a 20-mesh sieve to granulate, dry at 60°C, and the measured moisture content is 5.4%;

[0048] (4) Total blending: the obtained granules were mixed with colloidal silicon dioxide for 3 minutes, then the prescription amount of magnesium stearate was added and mixed for ...

Embodiment 3

[0051] Composition of prednisone acetate microtablets:

[0052]

[0053]Preparation Process:

[0054] (1) Pretreatment of raw and auxiliary materials: mix prednisone acetate and starch at a ratio of 1:1 and then pulverize. Starch and other auxiliary materials are passed through a 40-mesh sieve, and auxiliary materials that cannot be sieved are crushed and sieved;

[0055] (2) Pre-mixing: put the pretreated mixed powder in the prescribed amount, the remaining starch, the prescribed amount of croscarmellose sodium, and dextrin in a mixer and mix for 30 minutes;

[0056] (3) Granulation: use an appropriate amount of 50% ethanol solution to obtain a soft material with suitable hardness, use a 20-mesh sieve to granulate, dry at 60°C, and measure the water content to be 4.6%;

[0057] (4) Total blending: the obtained granules are mixed with colloidal silicon dioxide for 2 minutes, then the prescription amount of magnesium stearate is added and mixed for 2 minutes;

[0058] (5)...

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Abstract

The invention discloses a prednisone acetate micro-tablet and a preparation method thereof. The micro-tablet comprises prednisone acetate serving as an active component and pharmaceutic adjuvants, the mass percentage of the active ingredient prednisone acetate in the micro-tablet is 2%-20%. The preparation method of the prednisone acetate micro-tablet comprises the following steps: pretreating the raw and auxiliary materials, premixing, performing wet granulation, totally mixing, and tabletting to obtain the prednisone acetate micro-tablet. The raw materials and the auxiliary materials are mixed according to a set proportion and then crushed, and the particle size of the crushed mixed powder is controlled, so that the production process is improved, the loss of the raw materials is reduced, and the problem that the dissolution speed of the tablet is relatively low is solved.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a prednisone acetate microtablet and a preparation method thereof. Background technique [0002] Glucocorticoid (Glucocorticoid, GC) is a class of steroid hormones secreted by the zona fasciculus of the adrenal cortex. Poison and anti-shock effects. Because of their powerful anti-inflammatory and immunosuppressive effects, glucocorticoids have become commonly used drugs in the clinical treatment of autoimmune and acute and chronic inflammatory diseases. [0003] Prednisone acetate is an adrenal cortex hormone drug, which belongs to the national essential drug, and its chemical name is 17α, 21-dihydroxypregna-1,4-diene-3,11,20-trione-21-acetate, The molecular formula is C23H28O6, the molecular weight is 400.47, and it is a white or off-white crystalline powder at room temperature. It is mainly used for allergic and autoimmune inflammatory diseases. It is sui...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/573A61K47/04A61P37/08A61P37/02A61P29/00A61P11/06A61P21/00A61P17/00A61P9/14A61P35/02A61P35/00
CPCA61K31/573A61K9/2095A61K9/2009A61P37/08A61P37/02A61P29/00A61P11/06A61P21/00A61P17/00A61P9/14A61P35/02A61P35/00
Inventor 李中井薛晓霞李圣陶孙守飞
Owner CISEN PHARMA
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