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Preparation method of alogliptin benzoate tablet high in bioavailability

A technology of alogliptin tablets and benzoic acid, which is applied in the field of preparation of alogliptin benzoate tablets, can solve the problems of affecting human absorption, slow disintegration, and lowering the level of hemoglobin Alc, so as to speed up the disintegration speed and speed up Absorption, bioavailability enhancement effect

Inactive Publication Date: 2017-07-04
CISEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The efficacy of alogliptin combined with sulfonylureas, metformin, thiazolidinediones and insulin and other current clinical standard hypoglycemic drugs shows that this product can significantly reduce the level of hemoglobin Alc, and all of them have reached the main index, tolerance Good, no significant effect on patient weight, no increase in incidence of hypoglycemia compared with placebo
Due to its slow disintegration during taking, it affects the absorption of human body after taking

Method used

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  • Preparation method of alogliptin benzoate tablet high in bioavailability
  • Preparation method of alogliptin benzoate tablet high in bioavailability
  • Preparation method of alogliptin benzoate tablet high in bioavailability

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Alogliptin Benzoate Tablets (Specification: 12.5mg (calculated as alogliptin), 10,000 tablets in total)

[0027]

[0028] Preparation method:

[0029] (1) Weigh the raw material of alogliptin benzoate through micronization and pass through a 120 mesh sieve, mannitol, microcrystalline cellulose, hypromellose, cross-linked carmellose sodium pass through a 80 mesh sieve, stearin Magnesium acid is passed through a 40-mesh sieve for subsequent use.

[0030] (2) Take alogliptin benzoate, mannitol, microcrystalline cellulose, and croscarmellose sodium in the prescribed amount by weighing and mix them evenly, then add the adhesive soft material in the prescribed amount, and pass through a 20-mesh sieve. grain. The prepared wet granules are air-dried at 50-60°C.

[0031] (3) The dry granules are passed through an 18-mesh sieve for granulation, and the prescription amount of magnesium stearate is added and mixed evenly to obtain mixed granules.

[0032] (4) Determining the...

Embodiment 2

[0035] Alogliptin Benzoate Tablets (Specification: 12.5mg (calculated as alogliptin), 10,000 tablets in total)

[0036]

[0037] The preparation method is the same as in Example 1, and 10,000 alogliptin benzoate tablets can be obtained.

Embodiment 3

[0039] Alogliptin Benzoate Tablets (Specification: 12.5mg (calculated as alogliptin), 10,000 tablets in total)

[0040]

[0041] The croscarmellose sodium was premixed with the new glucoside P1, and the other preparation methods were the same as in Example 1, and 10,000 alogliptin benzoate tablets could be prepared.

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Abstract

The invention belongs to the technical field of drug preparation, and more specifically relates to a preparation method of alogliptin benzoate tablet high in bioavailability. The preparation method comprises following steps: alogliptin benzoate raw material is subjected to micronization treatment; prescription dosages of alogliptin benzoate, a filling material, and a disintegrating agent are weighed, and are uniformly mixed, a prescription dosage of an adhesive solution is added so as to obtain a soft material, the soft material is sieved using a sieve of 20 meshes, and is subjected to drying and size stabilization, and a prescription dosage of a lubricant is added for uniform mixing so as to obtain mixed particles; the mixed particles are subjected to tabletting using a tablet machine; and coating is carried out so as to obtain finished products. Compared with the prior art, the preparation method comprises following advantages: raw material micronization is adopted so as to increase disintegrating speed; and the particle size is reduced, so that absorption by human body is accelerated, and the bioavailability of alogliptin benzoate is increased.

Description

technical field [0001] The invention belongs to the technical field of medicine preparation, and in particular relates to a preparation method of alogliptin benzoate tablets with high bioavailability. Background technique [0002] Diabetes mellitus is a metabolic disease characterized by elevated blood sugar caused by defects in insulin secretion and (or) action. Diabetic patients with long-term poor blood sugar control may be accompanied by various organs, especially eye, heart, blood vessel, kidney, nerve damage or organ insufficiency or failure, resulting in disability or premature death. Diabetes is a worldwide epidemic disease, and its prevalence is increasing day by day. According to WHO estimates, there are currently about 175 million diabetic patients in the world, and it will reach 300 million by 2025. The prevalence of diabetes in China is also increasing sharply, increasing by 4-5 times from the 1980s to the mid-1990s. It is estimated that there are now 30 to 40 ...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K31/513A61K47/38A61P3/10
CPCA61K31/513A61K9/2054A61K9/2866
Inventor 王静石井岗成瑞明袁洪雨
Owner CISEN PHARMA
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