Metformin hydrochloride sustained-release tablet and preparation method thereof

A technology for metformin hydrochloride and sustained-release tablets, which can be applied to pharmaceutical formulations, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc., and can solve problems such as unstable release of metformin hydrochloride sustained-release tablets and complex production processes , to achieve the effect of stable release curve, good reproducibility and stable release curve

Active Publication Date: 2020-08-28
恒昌(广州)新药研究有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The problem to be solved by the present invention is that the metformin hydrochloride sustained-release tablets in the prior art are unstable in release, there may be sudden release, and technical problems such as complex production process

Method used

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  • Metformin hydrochloride sustained-release tablet and preparation method thereof
  • Metformin hydrochloride sustained-release tablet and preparation method thereof
  • Metformin hydrochloride sustained-release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] 1) Crush and sieve

[0057] Metformin hydrochloride and sodium carboxymethylcellulose were crushed through 80-mesh sieve before feeding into production; hydroxypropyl methylcellulose K100M, microcrystalline cellulose, and hydroxypropyl methylcellulose E5 were passed through 60-mesh sieve, and the remaining materials Weigh directly for use.

[0058] 2) Granulation

[0059] Mixing: add the sieved metformin hydrochloride and carmellose sodium into the boiling drying granulator, set the fan at 35Hz, turn off the heating, and mix for 10 minutes.

[0060] Granulation: set the fan frequency to 35Hz, the air inlet temperature to 80.0°C, set the atomization pressure to 0.35MPa in the inner layer and 0.30MPa in the outer layer (or the inner layer is 0.05MPa larger than the outer layer, but the outer layer is not less than 0.2MPa), set the supply The liquid speed is 300r / min. When the temperature of the material reaches 45°C±5°C, it starts to spray water and granulate, and it in...

Embodiment 2-4

[0074] Using the same method as in Example 1, Metformin Hydrochloride Sustained-release Tablets were prepared. The types and dosages of the various raw materials are shown in Table 1, and 250,000 Metformin Hydrochloride Sustained-release Tablets were prepared, which are denoted as S2-S4.

Embodiment 5

[0076] The type and amount of raw materials are the same as S1, the difference is that in the preparation method, the hydroxypropyl methylcellulose K100M is not added in stages, but in step 3) the total mixing stage, all the hydroxypropyl methylcellulose K100M is added . The types and dosages of the various raw materials are shown in Table 1, and 250,000 metformin hydrochloride sustained-release tablets were prepared, which were denoted as S5.

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Abstract

The invention discloses a metformin hydrochloride sustained-release tablet and a preparation method thereof, and belongs to the technical field of pharmaceutical preparations. The metformin hydrochloride sustained-release tablet comprises metformin hydrochloride, a sustained-release agent, an adhesive, filler, a flow aid, a lubricant and other components, wherein the sustained-release agent comprises sodium carboxymethyl cellulose and hydroxypropyl methyl cellulose K100M, the adhesive is hydroxypropyl methyl cellulose E5, and the ratio of the metformin hydrochloride to the sustained-release agent is 125:(80-120); and the ratio of the metformin hydrochloride to the adhesive is 125:(1.5-3.0), and the preparation process comprises the steps: spraying water, mixing the metformin hydrochloridewith sodium carboxymethyl cellulose, performing granulation so as to obtain particles, performing secondary water spraying, and adding hydroxypropyl methyl cellulose K100M at twice. The method is suitable for industrial production, the product quality is stable, and the obtained metformin hydrochloride sustained-release tablet has uniform and stable release.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a metformin hydrochloride sustained-release tablet and a preparation method thereof. Background technique [0002] Metformin hydrochloride is a biguanide oral hypoglycemic agent, which can be used for the treatment of non-insulin-dependent diabetes mellitus. Or type 2 diabetes, this product is combined with insulin, which can increase the hypoglycemic effect of insulin, reduce the amount of insulin, and prevent hypoglycemia. This product can also be used in combination with sulfonylurea oral hypoglycemic agents, which has a synergistic effect. [0003] According to literature reports, this product is a hypoglycemic drug. This product can reduce fasting and postprandial hyperglycemia in patients with type Ⅱ diabetes mellitus, and HbAlc can decrease by 1%-2%. use. 2. Increase the utilization of glucose by non-insulin-dependent tissues, such as br...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/155A61K47/38A61P3/10
CPCA61K9/2054A61K31/155A61P3/10
Inventor 张用杰
Owner 恒昌(广州)新药研究有限公司
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