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Metformin hydrochloride medicinal composition preparation and preparation method thereof

A technology of metformin hydrochloride and metformin, which is applied in the direction of drug combination, pharmaceutical formula, pill delivery, etc., can solve the problems of inability to achieve rapid dissolution, low dissolution rate of preparations, increased labor intensity, etc., and achieve remarkable therapeutic effect, remarkable drug effect, The effect of enhancing the potency

Active Publication Date: 2018-08-21
重庆希尔安药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] In the prior art, the preparation method of general metformin hydrochloride preparation all adopts the mode of mixing and granulating raw materials and auxiliary materials, and the granules prepared by this method are mixed with magnesium stearate, and the mixture will cause rapid There will be a large area of ​​lobes during dehydration and tabletting. Although water spraying and wet-making methods can be used, the labor intensity will be increased invisibly, and unqualified products will have to be reworked, resulting in low production efficiency. , and does not comply with GMP management regulations. In addition, the dissolution rate of the preparation prepared by this method is not high, and the dissolution process is relatively slow, and rapid dissolution cannot be achieved.

Method used

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  • Metformin hydrochloride medicinal composition preparation and preparation method thereof

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preparation example Construction

[0030] According to one aspect of the present invention, a kind of preparation method of the pharmaceutical composition of metformin hydrochloride comprises the steps:

[0031] (A) adding metformin to an aqueous binder solution for granulation;

[0032] (B) The stirring speed of granulation is between 200-400rpm, and the granulation time is 90-180s;

[0033] (C) The method of gradient temperature change is used for drying, and the temperature of each gradient is controlled between 20-40°C, and the temperature of the previous gradient and the subsequent gradient tend to alternate back and forth, and the difference between the two adjacent gradients 4-5°C, after drying, add cornstarch and mannitol to pre-mix for 3-5 minutes, then add magnesium stearate and mix for 3-5 minutes, press into tablets, and coat.

[0034] In this preparation method, magnesium stearate is added after drying, which is added separately from other previously added substances. This method of operation can ...

Embodiment 1

[0048] 1) According to the production requirements, the materials such as metformin, mannitol, corn starch and magnesium stearate are weighed;

[0049] 2) Adhesive preparation: Weigh the hypromellose of the adhesive prepared in the prescription amount, add an appropriate amount of boiling water to disperse and dissolve, and cool to room temperature to obtain an aqueous hypromellose solution;

[0050] 3) Mixing and granulation: add metformin to the hypromellose aqueous solution, start stirring and shearing, the stirring rate is 200rpm, and the granulation time is controlled within 90s;

[0051] 4) Pour all the wet granules into the boiling drying granulator, and perform variable temperature drying operation. The variable temperature drying interval is three intervals. The temperature of the first gradient is set at 35°C, the temperature of the second gradient is set at 40°C, and the third gradient The temperature of the gradient is set at 35°C, and after drying to a moisture co...

Embodiment 2

[0056] 1) According to the production requirements, the materials such as metformin, mannitol, corn starch and magnesium stearate were weighed, the D90 index of metformin was controlled at 90 μm, the mesh particle size of corn starch was 60 mesh, and the mesh particle size of mannitol was 80 mesh;

[0057] 2) Adhesive preparation: Weigh the hypromellose of the adhesive prepared in the prescription amount, add an appropriate amount of boiling water to disperse and dissolve, and cool to room temperature to obtain a 5% (w / w) hypromellose aqueous solution;

[0058] 3) Mixing and granulation: add metformin to the hypromellose aqueous solution, start stirring and shearing, the stirring rate is 400rpm, and the granulation time is controlled within 180s;

[0059] 4) Pour all the wet granules into the boiling drying granulator, and carry out variable temperature drying operation. The variable temperature drying interval is four intervals. The temperature of the first gradient is set at ...

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Abstract

The invention provides a metformin hydrochloride medicinal composition preparation and a preparation method thereof. The preparation method comprises the following steps: (A) pelletizing melbine withan adhesive solution; (B) pelletizing at a stirring speed within 200-400rpm for 90-180 seconds; (C) drying by using a gradient temperature variation method, after drying, adding corn starch and mannitol, premixing for 3-5 minutes, further mixing with magnesium stearate for 3-5 minutes, tabletting, and coating, thereby obtaining the metformin hydrochloride medicinal composition preparation, whereineach gradient of temperatures is controlled within 20-40 DEG C, drying, the temperatures are changed in a tendency that temperatures of a former gradient and a later gradient are alternatively changed, and the temperatures of two adjacent gradients are 4-5 DEG C different. The preparation method of the metformin hydrochloride medicinal composition preparation provided by the embodiment of the invention is simple in operation step and gentle in operation condition, and effective components in the preparation prepared by using the preparation method can be rapidly dissolved, and the dissolutionrate can be increased.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a metformin hydrochloride pharmaceutical composition preparation and a preparation method thereof. Background technique [0002] Metformin hydrochloride is a biguanide hypoglycemic drug used to treat non-insulin-dependent type Ⅱ diabetes patients, especially those with obesity and hyperinsulinemia. It is characterized by not promoting the secretion of insulin, but promoting the uptake of glucose by tissues ; Using this drug not only has the effect of lowering blood sugar, but also has the effect of reducing body weight and hyperinsulinemia. It can be used in combination with sulfonylurea hypoglycemic agents, small intestinal glycosidase inhibitors or thiazolidinedione hypoglycemic agents, and the effect is better than those used alone. It can also be used in patients on insulin therapy to reduce the dosage of insulin. In addition, it can also significantly lower blood pressure and blood...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/155A61K9/50A61K9/28A61K47/36A61K47/26A61P3/10A61P1/16A61P9/12
CPCA61K9/28A61K9/5015A61K9/5036A61K31/155A61P1/16A61P3/10A61P9/12
Inventor 梅勇罗磊杨莉陈云龙涛袁开超周年华陈小红陈晓雪刘勇
Owner 重庆希尔安药业有限公司
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