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Peroral solid preparation of metformin hydrochloride and preparation method

A technology of metformin hydrochloride and solid preparation, which is applied in pharmaceutical formulations, medical preparations containing active ingredients, metabolic diseases, etc., can solve problems such as delayed action, and achieve the effects of rapid disintegration and dispersion, uniform appearance and uniform distribution

Inactive Publication Date: 2006-07-05
RADIOLOGY INST ACAD OF MILITARY MEDICINE SCI PLA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] —In order to overcome the gastrointestinal irritation of ordinary tablets, enteric-coated tablets, sustained-release tablets, and sustained-release capsules have been developed, but enteric-coated tablets delay the action of the drug; in addition, it is known that postprandial hyperglycemia is a characteristic of type II diabetes One of them is also the difficulty of blood sugar control. Therefore, controlling postprandial hyperglycemia is of great significance to the blood sugar control and stability of diabetic patients in a day. Although enteric-coated tablets, sustained-release tablets and sustained-release capsules can maintain blood drug concentration at A relatively stable level, which overcomes the local stimulating effect of drugs, but cannot well meet the clinical needs of rapidly controlling blood sugar levels after meals

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Embodiment 1. Oral solid preparation 1 containing 250mg metformin hydrochloride and its preparation method

[0032] The oral solid formulation 1 of the unit dose consists of the following:

[0033] components

[0034] Preparation method: first crush metformin hydrochloride and pass through a 80-mesh standard sieve, and other auxiliary materials are also respectively passed through an 80-mesh standard sieve; weigh all the raw materials respectively, and then grind and mix them in equal increments. The mixing sequence is: metformin hydrochloride and micro-powder Grind and mix with silica gel, then grind and mix with pregelatinized starch, then mix with microcrystalline cellulose, and finally add sodium carboxymethyl starch. The resulting mixture was uniformly mixed with a 40-mesh sieve to obtain a free-flowing powder. The powder is directly compressed into tablets. During operation, the ambient humidity should be controlled below 60%.

Embodiment 2

[0035] Embodiment 2. Oral solid preparation 2 containing 250mg metformin hydrochloride and its preparation method

[0036] components

[0037] According to the preparation method of Example 1, only the disintegrant was replaced with cross-linked polyvinylpyrrolidone. The resulting mixture had satisfactory powder flowability and was compacted without difficulty.

Embodiment 3

[0038] Embodiment 3. Oral solid preparation 3 containing 250mg metformin hydrochloride and its preparation method

[0039] components

[0040] Preparation method: First, crush metformin hydrochloride and pass through a 80-mesh standard sieve, and other auxiliary materials are also respectively passed through an 80-mesh standard sieve. Then, mix metformin hydrochloride, micropowder silica gel, starch, microcrystalline cellulose, and polyvinylpolypyrrolidone in an amount of 2 / 3, and use 10% polyvinylpyrrolidone aqueous solution as a binder to prepare a soft material, which is passed through a 30-mesh sieve. Granules, dried at 70°C for about 2 hours, sieved with a 26-mesh standard sieve, added the remaining 1 / 3 of polyvinylpolypyrrolidone and magnesium stearate, mixed evenly, and pressed into tablets.

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PUM

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Abstract

An orally taken solid medicine for treating the insulin independent diabetics is prepared from meguan, disintegrant, filler, swelling additive, flowing aid, and other medicinal auxiliary or carrier.

Description

technical field [0001] The invention relates to an oral solid preparation of metformin hydrochloride and a preparation method thereof. Background technique [0002] Metformin hydrochloride, namely 1,1-dimethylbiguanide hydrochloride (1,1-Dimethylbiguanidehydrochloride), is a commonly used drug for treating non-insulin-dependent (type II) diabetes. The commonly used dosage forms of metformin hydrochloride administration are ordinary tablets and recently reported enteric-coated tablets, sustained-release tablets, and sustained-release capsules. [0003] The administration of tablets and capsules has the following limitations and disadvantages: [0004] - In terms of patient administration, the limiting factor is that some patients have difficulty swallowing tablets and capsules; [0005] —Metformin hydrochloride is a water-soluble drug, and the drug concentration in the local area is likely to be too high after the ordinary tablet is taken orally, thus easily causing digesti...

Claims

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Application Information

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IPC IPC(8): A61K31/155A61K9/00A61P3/10
Inventor 王秀冬吴祖泽孙仲诒
Owner RADIOLOGY INST ACAD OF MILITARY MEDICINE SCI PLA
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