Metformin hydrochloride enteric-coated tablet

A metformin hydrochloride enteric and tablet-dissolving technology, which is applied to medical preparations of non-active ingredients, metabolic diseases, organic active ingredients, etc., can solve the problems of unguaranteed curative effect and complicated preparation process, and achieve saving of enteric coating materials and preparation The effect of process simplification, raw material cost and production cost reduction

Inactive Publication Date: 2012-02-22
HEBEI JAMESHILL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The metformin hydrochloride enteric-coated tablet not only has a complicated preparation process, but also can only be released in a narrow range of intestinal fluid with a pH value of 6.6 to 6.8, and basically does not release after the pH value is lower than 6.4. Therefore, for patients with a pH value of intestinal fluid lower than 6.4 In terms of taking such medicines, there is no guarantee of curative effect

Method used

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  • Metformin hydrochloride enteric-coated tablet
  • Metformin hydrochloride enteric-coated tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026]The specification is 0.25g, based on 10,000 tablets, the tablet core is made of 2500g of metformin hydrochloride, 3075g of povidone K30, 300g of 75% ethanol aqueous solution containing 10% of povidone K30, and 25g of magnesium stearate; The coating layer is made of Eudragit L30D-55250g, 37.5g of talcum powder, 7.5g of PEG4000, 12.5g of 4% sodium hydroxide solution, and 250g of purified water. 150g of enteric coating liquid is used for coating every 1kg of tablet core.

[0027] Described metformin hydrochloride enteric-coated tablet is made according to the following steps:

[0028] (1) weighing each raw material in proportion;

[0029] (2) Tablet core preparation: after metformin hydrochloride is pulverized, put in the high-efficiency wet mixing granulator, add the internally added povidone K30 of recipe quantity, after stirring and mixing evenly, add containing povidone K30 to be 10% (wt) %) of 75% (wt%) ethanol aqueous solution is prepared into a suitable soft materi...

Embodiment 2

[0033] Based on 5000 tablets, the specification is 0.5g, and the tablet core is made of 2500g of metformin hydrochloride, 125g of povidone K30, 200g of 75% ethanol aqueous solution with binder 10% of povidone K30, and 12.5g of magnesium stearate; The enteric coating layer is made of Eudragit L30D-55250g, talcum powder 25g, PEG40005g, 4% sodium hydroxide solution 15g and purified water 300g. 170g of enteric coating liquid is used for coating every 1kg of tablet core.

[0034] Preparation:

[0035] (1) weighing each raw material in proportion;

[0036] (2) Tablet core preparation: after metformin hydrochloride is pulverized, put in the high-efficiency wet mixing granulator, add the internally added povidone K30 of recipe quantity, after stirring and mixing evenly, add containing povidone K30 to be 10% (wt) %) of 75% (wt%) ethanol aqueous solution is prepared into a suitable soft material, prepared into granules through a nylon sieve, mixed evenly with magnesium stearate after ...

Embodiment 3

[0040] In terms of making 10000 tablets, the specification is 0.85g, and the tablet core is made of 8500g of metformin hydrochloride, 340g of povidone K30, 850g of 75% ethanol aqueous solution with binder 10% of povidone K30, and 68g of magnesium stearate; The enteric coating layer is made of Eudragit L30D-55250g, talcum powder 75g, PEG400010g, 4% sodium hydroxide solution 10g, purified water 200g. 158g of enteric coating solution is used for coating every 1kg tablet core.

[0041] Preparation:

[0042] (1) weighing each raw material in proportion;

[0043] (2) Tablet core preparation: after metformin hydrochloride is pulverized, put in the high-efficiency wet mixing granulator, add the internally added povidone K30 of recipe quantity, after stirring and mixing evenly, add containing povidone K30 to be 10% (wt) %) of 75% (wt%) ethanol aqueous solution is prepared into a suitable soft material, prepared into granules through a nylon sieve, mixed evenly with magnesium stearate...

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Abstract

The invention discloses a metformin hydrochloride enteric-coated tablet, which comprises a tablet core and an enteric-coated layer. The tablet core is prepared by the following raw materials by weight: 100 parts of metformin hydrochloride, 3-5 parts of povidone K30, 8-12 parts of 75% ethanol water containing 10% povidone K30 and 0.5-1.0 part of magnesium stearate. The enteric-coated layer is prepared by the following raw materials by weight: 100 parts of eudragit L30D-55, 10-30 parts of talcum powder, 2-4 parts of polyethylene glycol 4000, 4-6 parts of 4% sodium hydroxide solution and 80-120 parts of purified water. The preparation process includes the steps of weighing all raw materials according to proportion, preparing the tablet core, preparing enteric-coated solution and then obtaining the metformin hydrochloride enteric-coated tablet. The metformin hydrochloride enteric-coated tablet simplifies preparation technology, effectively reducing manufacture cost, can simultaneously control releasing speed, and effectively guarantees clinical effects of products.

Description

technical field [0001] The invention relates to the technical field of medicine preparation, in particular to a metformin hydrochloride enteric-coated tablet and a preparation process thereof. Background technique [0002] Metformin hydrochloride is mainly absorbed in the stomach and duodenum and jejunum in the middle and upper parts of the small intestine, but hardly absorbed in the lower part of the small intestine and the colon. Since metformin hydrochloride has a strong irritant to the stomach, the preparation of metformin hydrochloride enteric-coated tablets can effectively solve the irritant effect of metformin hydrochloride on the stomach. However, the pH value of the duodenum and jejunum is mainly between 5.0-7.0. In order to ensure that metformin hydrochloride enteric-coated tablets can be effectively released in patients with different pH values ​​of small intestinal fluid, metformin hydrochloride enteric-coated tablets should be released in a wider range. Effecti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/32A61K31/155A61K47/32A61P3/10
Inventor 李占谋田兰张文双范围杰孙文健李亚松孙懿辉史春东
Owner HEBEI JAMESHILL PHARMA
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