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Preparation method of compound preparation containing metformin hydrochloride and vildagliptin

A technology of metformin hydrochloride and compound preparations, which is applied to medical preparations containing active ingredients, pill delivery, and pharmaceutical formulations, etc., which can solve problems such as uneven content, achieve low energy consumption, low production equipment costs, and solve tablet content. uneven effect

Active Publication Date: 2020-04-28
NANJING YOKO PHARMA +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Aiming at the problems existing in the prior art, the purpose of the present invention is to provide a preparation method for a compound preparation containing vildagliptin and metformin hydrochloride, which solves the problem of uneven content, and the tablet has good compressibility and fluidity, and is brittle. The hardness and hardness meet the quality standards of Pharmacopoeia, and the stability is consistent with the commercial ones

Method used

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  • Preparation method of compound preparation containing metformin hydrochloride and vildagliptin
  • Preparation method of compound preparation containing metformin hydrochloride and vildagliptin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] components Dosage (mg / tablet) Vildagliptin 50 Metformin Hydrochloride 1000 Hydroxypropyl Cellulose 80.5 Magnesium stearate 12 Sheet weight 1142.5

[0049] (1) Weigh vildagliptin (1000g) and hydroxypropyl cellulose (the weight of hydroxypropyl cellulose is 1% of vildagliptin, 10g), mix uniformly in equal increments, add 95% ethanol to prepare soft material, granulated through a 20-mesh sieve, dried at 40°C, and granulated through a 20-mesh sieve.

[0050](2) Take by weighing metformin hydrochloride (1000g) and hydroxypropyl cellulose (the weight of hydroxypropyl cellulose is 8% of vildagliptin, 80g), equal increase and mix uniformly, add water to prepare soft material, cross 20 Granulate with a mesh sieve, dry at 60°C, pass through a 20-mesh sieve for granulation.

[0051] (3) Take by weighing one-twentieth (50.5g) of the granule weight in step (1), mix it with the granule obtained in step (2) and magnesium stearate (12g), an...

Embodiment 2

[0053] components Dosage (mg / tablet) Vildagliptin 50 Metformin Hydrochloride 850 Hydroxypropyl Cellulose 100 Magnesium stearate 12 Sheet weight 1012

[0054] (1) Weigh vildagliptin (500g) and hydroxypropyl cellulose (the weight of hydroxypropyl cellulose is 2% of vildagliptin, 10g), mix uniformly in equal increments, add 95% ethanol to prepare soft material, granulated through a 24-mesh sieve, dried at 40°C, and granulated through a 24-mesh sieve.

[0055] (2) Take by weighing metformin hydrochloride (850g) and hydroxypropyl cellulose (the weight of hydroxypropyl cellulose is 11.6% of vildagliptin, 99g), equal increase and mix uniformly, add water to prepare soft material, pass 24 Granulate with a mesh sieve, dry at 60°C, pass through a 24-mesh sieve for granulation.

[0056] (3) Take by weighing one-tenth (51g) of the granule weight in step (1), mix it with the granule obtained in step (2) and magnesium stearate (12g), and press i...

Embodiment 3

[0058] components Dosage (mg / tablet) Vildagliptin 50 Metformin Hydrochloride 1000 Hydroxypropyl Cellulose 120 Magnesium stearate 12 Sheet weight 1182

[0059] (1) Weigh vildagliptin (1000g) and hydroxypropyl cellulose (the weight of hydroxypropyl cellulose is 4% of vildagliptin, 40g), mix uniformly in equal increments, add 95% ethanol to prepare soft material, granulated through a 30-mesh sieve, dried at 40°C, and granulated through a 30-mesh sieve.

[0060] (2) Take by weighing metformin hydrochloride (1000g) and hydroxypropyl cellulose (the weight of hydroxypropyl cellulose is 11.8% of vildagliptin, 118g), equal increase and mix uniformly, add water to prepare soft material, cross 30 Granulate with a mesh sieve, dry at 60°C, pass through a 30-mesh sieve for granulation.

[0061] (3) Take by weighing one-twentieth (52g) of the granule weight in step (1), mix it with the granule obtained in step (2) and magnesium stearate (12g), an...

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Abstract

The invention discloses a preparation method of a compound preparation containing metformin hydrochloride and vildagliptin. The method comprises the following steps: respectively carrying out wet granulation on the metformin hydrochloride and vildagliptin, sieving the granulated metformin hydrochloride and vildagliptin by sieves with the same mesh, and mixing and tablettig the obtained granules and magnesium stearate to prepare the compound preparation. The method solves the problem of non-uniform content of the vildagliptin, and the above obtained tablet has the advantages of good tablettability, good fluidity, realization of the friability and the rigidity meeting pharmacopeia quality standards, realization of the stability same to that of commercial preparations, simplicity in operation, and suitableness for industrial production.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a preparation method of a compound preparation of metformin hydrochloride and vildagliptin. Background technique [0002] In my country, more than 90% of the cases are type II diabetes, which manifests as progressive failure of pancreatic beta cells, which leads to insufficient insulin secretion after sugar load and damages the response of incretins to sugar. Chronic hyperglycemia will lead to serious microvascular and macrovascular complications. [0003] Metformin hydrochloride vildagliptin tablets, trade name Eucreas, was approved in the European Union on November 14, 2007 for the treatment of type II diabetes. Vildagliptin regulates blood sugar by increasing the level of active GLP-1. Compared with oral hypoglycemic drugs such as sulfonylureas and thiazolidinediones, adding vildagliptin on the basis of metformin hydrochloride treatment can effectively reduce blood ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/155A61K31/40A61K9/20A61P3/10
CPCA61K9/2013A61K31/155A61K31/40A61K2300/00
Inventor 张峰钟元元朱素华薛峪泉
Owner NANJING YOKO PHARMA
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