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Preparation method for gliclazide tablet composition

A special tablet and composition technology, applied in the field of gliclazide tablet composition, can solve the problems of poor reproducibility, low disintegrant dosage, low process controllability, etc., and achieve process controllability The effect of high performance, uniform product properties, and operable process

Inactive Publication Date: 2015-07-22
NANJING REAL PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] There are many problems in the prescription of gliclazide tablet composition in the prior art, for example, the prescription contains waxy materials or contains fats with low melting point, easy to stick during the tableting process, and it is difficult to realize large-scale industrial production; for example, it contains disintegrating Disintegrant, the controllability of the process is not high, and the amount of disintegrating agent is small, it is difficult to accurately grasp the dosage, resulting in the problem of sudden or difficult release of the finished drug, and high cost
At the same time, the properties of the product are uniform, poor stability, large batch-to-batch variation, and poor reproducibility

Method used

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  • Preparation method for gliclazide tablet composition
  • Preparation method for gliclazide tablet composition
  • Preparation method for gliclazide tablet composition

Examples

Experimental program
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Embodiment Construction

[0019] (Example 1) Weigh each main and auxiliary material according to the following proportioning, with a total amount of 200 grams:

[0020]

[0021] (1) Granulation: Weigh hypromellose and put it in a stainless steel bucket, add the calculated amount of 95% ethanol and purified water of the same weight, stir evenly to make a 3% hydroxypropyl methylcellulose ethanol solution as a binder agent. Weigh the prescribed amount of gliclazide, hydroxypropyl cellulose, and microcrystalline cellulose, add them to the wet granulator and stir for 5 minutes, then add the binder, stir for 3-4 minutes and discharge, and use a 16-mesh nylon sieve to shake Granulation on the type granulator;

[0022] (2) Drying: Dry the wet granules in a hot air circulation oven, the temperature is controlled at 75°C, dried for 3.5 hours, and the moisture content of the granules is controlled at 2.0%;

[0023] (3) Granulation and blending: the granules are sized on a swing granulator with a 16-mesh stai...

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Abstract

The invention relates to a preparation method for gliclazide tablet composition. The preparation method comprises the steps of 1, granulation, 2, drying, 3, whole granule total blending, 4, tableting and 5, packaging, wherein before preferable feeding, characters of original auxiliary materials are inspected, and blocking and foreign matter phenomena should not exist; if the phenomena exist, raw materials and internally-added auxiliary materials are screened by 80-mesh stainless steel meshes, and externally-added auxiliary materials are screened by 20-mesh stainless steel meshes. The preparation method is simple in technology, operable, high in technological controllability, and suitable for industrial mass production; meanwhile, due to the fact that the gliclazide raw materials with the fineness below 80 meshes are selected, it can be ensured that products are uniformly and stably released, meanwhile, the products are uniform in quality and good in stability, differences between batches are small, and the reproducibility is good.

Description

technical field [0001] The invention relates to a medical preparation containing organic active ingredients, in particular to a gliclazide tablet composition. Background technique [0002] Gliclazide (Gliclazide), molecular formula: C15H21N3O3S Drug category: pancreatic hormone and other drugs that affect blood sugar. Gliclazide is mainly used for mild to moderate diabetes mellitus that is ineffective in adulthood and has no tendency to ketosis. It can also improve diabetic fundus lesions and disorders of metabolism and vascular function. It can be used in combination with biguanide oral hypoglycemic agents for patients who cannot be controlled by single use, and it can be used in combination with insulin to treat insulin-dependent diabetes, which can reduce the dosage of insulin. [0003] Gliclazide is an oral sulfonylurea drug for treating diabetes, and its structure contains a nitrogen heterocycle, so it has characteristics different from other sulfonylurea drugs. It l...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61J3/10A61K9/20A61K31/64A61P5/50
Inventor 时文祥赵允华王贞
Owner NANJING REAL PHARMA
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