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Repaglinide-metformin hydrochloride tablet and preparing method thereof

A metformin hydrochloride tablet and specification technology, which is applied in pill delivery, metabolic diseases, sugar-coated pills, etc., can solve the problems of cumbersome preparation process, many excipient ingredients, and high preparation cost, and achieve the effect of simple preparation process

Inactive Publication Date: 2015-02-11
JIANGSU CAREFREE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Although repaglinide-metformin hydrochloride ordinary tablets are already on the market in foreign countries, the preparation process is too cumbersome, there are too many excipients, and the preparation cost is relatively high

Method used

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  • Repaglinide-metformin hydrochloride tablet and preparing method thereof
  • Repaglinide-metformin hydrochloride tablet and preparing method thereof
  • Repaglinide-metformin hydrochloride tablet and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0065] Embodiment 1, screening of repaglinide-metformin hydrochloride tablet prescription

[0066] In the early trial production process, wet granulation was considered after mixing raw materials and excipients. Because the dissolution rate did not meet the requirements, I often fumbled later. Now repaglinide, meglumine, poloxamer 188, and a small amount of PVPk30 Added together in the form of a solid dispersion aqueous solution binder, its dissolution rate can reach more than 98%, and the related substances are completely qualified.

[0067] Selection of packaging materials

[0068] Repaglinide-Metformin Hydrochloride Tablets are very sensitive to light, high temperature, and high humidity environments, so when selecting inner packaging materials, single-aluminum colored blister packaging is recommended. The biggest advantage of blister packaging is that it is easy to carry, which can reduce the pollution caused by the medicine during carrying and taking, and the blister pac...

Embodiment 2

[0069] Embodiment 2, one of preparation technology of repaglinide-metformin hydrochloride tablet

[0070] Each 10,000-tablet specification 500mg / 2mg repaglinide-metformin hydrochloride tablet contains:

[0071]

[0072] The preparation method of the repaglinide-metformin hydrochloride tablet described in the present embodiment comprises the following steps:

[0073] (1) Weigh 5000g of metformin hydrochloride, 620g of microcrystalline cellulose, 100g of sorbitol, 200g of PVPk30, 280g of crospovidone, 20g of repaglinide, 18840g of poloxamer, 20g of meglumine, 305g of PVPk, dioxide Silicon 35g;

[0074] (2) microcrystalline cellulose, sorbitol, crospovidone, and PVPk30 are respectively passed through an 80-mesh sieve, and mixed uniformly;

[0075] (3) Metformin hydrochloride is passed through a 100-mesh sieve, the mixture obtained by step polymerization (2) is diffused in metformin hydrochloride in stages, put into a wet mixing granulator, and stirred for 10 to 20 minutes; ...

Embodiment 3

[0104] Embodiment 3, repaglinide-metformin hydrochloride tablet preparation process two

[0105] Each 10,000 tablets of 500mg / 2mg Compound Repaglinide-Metformin Hydrochloride Tablets contains:

[0106]

[0107] The preparation method of the repaglinide-metformin hydrochloride tablet described in the present embodiment comprises the following steps:

[0108] (1) Weigh 5000g of metformin hydrochloride, 620g of microcrystalline cellulose, 100g of sorbitol, 200g of PVPk30, 280g of crospovidone, 20g of repaglinide, 18840g of poloxamer, 20g of meglumine, 305g of PVPk, dioxide Silicon 35g;

[0109] (2) microcrystalline cellulose, sorbitol, crospovidone, and PVPk30 are respectively passed through an 80-mesh sieve, and mixed uniformly;

[0110] (3) Metformin hydrochloride is passed through a 100-mesh sieve, and the mixture obtained by step polymerization (2) is uniformly mixed with metformin hydrochloride in an equal increment method, put into a wet mixing granulator, and stirred ...

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Abstract

The invention discloses a prescription of a repaglinide-metformin hydrochloride tablet and a preparation technology thereof. In particular, a solid dispersion water solution technology is used; the problem that repaglinide is insoluble in water can be solved only through common wet granulations; dissolved objects and related matter are both superior to those of foreign objects. Microcrystalline celluloses and sorbitol serve as fillers; polyvinylpolypyrrolidone serves as disintegrating agents; PVPk30 serves as bonding agents; silicon dioxide serves as lubricating agents; meglumine serves as saltiness agents; and poloxamer 188 serves as solubilizers. The repaglinide-metformin hydrochloride tablet prepared with the technology is fewer in use auxiliary material; the high dissolving performance and the high stability can be kept; the preparation technology is simple; the technology cost is lower; and the repaglinide-metformin hydrochloride tablet is suitable for industrial production.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a repaglinide-metformin hydrochloride tablet prescription and a preparation process thereof, belonging to the technical field of medicine. Background technique [0002] Diabetes is an endocrine and metabolic disease characterized by hyperglycemia, which often leads to damage, functional defects and failure of various tissues in the human body, especially the eyes, kidneys, nerves, heart and blood vessels. With the improvement of people's living standards, the incidence of diabetes is also on the rise. At present, the pathogenesis of diabetes is not very clear, but it can be divided into two types according to the pathological characteristics displayed by patients: type I diabetes, namely insulin-dependent (IDDM), must rely on exogenous insulin to maintain life activities, and type II diabetes Diabetes mellitus, that is, non-insulin-dependent (NIDDM), patients with diabetes do not need to...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/451A61K9/28A61K47/38A61P3/10A61K31/155
Inventor 秦引林史善文
Owner JIANGSU CAREFREE PHARM CO LTD
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