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Metformin hydrochloride sustained-release capsule and its preparation method

A technology of metformin hydrochloride and metformin hydrochloride, applied in the field of medicine, can solve the problems of poor penetrability of the lower small intestine and large intestine, easy to cause adverse reactions, and large fluctuations in blood drug concentration, so as to avoid adverse reactions, facilitate swallowing, The effect of avoiding pollution

Inactive Publication Date: 2013-08-14
BOSEN BIO PHARMA SHANXI PROVINCE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, metformin absorbs quickly, and the action time is only 2 to 4 hours. It needs to be taken 2 to 3 times a day, resulting in large fluctuations in blood drug concentration in the body, and is more likely to cause adverse reactions. The ability is very poor, and the absorption site is mainly concentrated in the upper part of the small intestine

Method used

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  • Metformin hydrochloride sustained-release capsule and its preparation method
  • Metformin hydrochloride sustained-release capsule and its preparation method
  • Metformin hydrochloride sustained-release capsule and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Cystic Heart Prescription:

[0021]

[0022] Coating prescription:

[0023] Eudragit NE30D 35g

[0024] Talc powder (1250 mesh) 6.3g

[0025] water 35ml

[0026] Concrete preparation process comprises the following steps:

[0027] (1) Preparation of micropills: preparation of drug-containing pellet cores by extrusion spheronization

[0028] In the present invention, after fully mixing the active ingredients and the diluent, the soft material is prepared with water. Select a 0.8mm sieve plate, operate at an extrusion frequency of 30rpm, a spheronization frequency of 50rpm, and a spheronization time of 5min, sieve the prepared pellets, and select 24-32 mesh particles.

[0029] (2) Sustained-release coating: coating by fluidized bed coating method

[0030] The film-forming material acrylic resin polymer material (Eudragit NE30D), talcum powder and water are uniformly mixed as a coating solution. Get the pellets equivalent to 250mg of metformin hydrochloride, put ...

Embodiment 2

[0034] Cystic Heart Prescription:

[0035]

[0036] Coating prescription:

[0037]

[0038] Concrete preparation process comprises the following steps:

[0039] (1) Preparation of micropills: preparation of drug-containing pellet cores by extrusion spheronization

[0040] In the present invention, after fully mixing the active ingredients and the diluent, the soft material is prepared with water. Select a 0.8mm sieve plate, operate at an extrusion frequency of 35rpm, a spheronization frequency of 55rpm, and a spheronization time of 5min, sieve the prepared pellets, and select 24-32 mesh particles.

[0041] (2) Sustained-release coating: coating by fluidized bed coating method

[0042] The film-forming material acrylic resin polymer material (Eudragit NE30D), talcum powder and water are uniformly mixed as a coating solution. Get the micropills equivalent to metformin hydrochloride 250mg, drop in the fluidized bed coating machine, with air volume 14L / min, spray speed 2...

Embodiment 3

[0046] Cystic Heart Prescription:

[0047]

[0048] Coating prescription:

[0049]

[0050] Concrete preparation process comprises the following steps:

[0051] (1) Preparation of micropills: preparation of drug-containing pellet cores by extrusion spheronization

[0052]In the present invention, after fully mixing the active ingredients and the diluent, the soft material is prepared with water. Select a 0.8mm sieve plate, operate at an extrusion frequency of 30rpm, a spheronization frequency of 50rpm, and a spheronization time of 5min, sieve the prepared pellets, and select 24-32 mesh particles.

[0053] (2) Sustained-release coating: coating by fluidized bed coating method

[0054] The film-forming material acrylic resin polymer material (Eudragit NE30D), talcum powder and water are uniformly mixed as a coating solution. Get the micropills equivalent to metformin hydrochloride 250mg, drop in the fluidized bed coating machine, with air volume 13L / min, spray speed 28...

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Abstract

The invention relates to a metformin hydrochloride sustained-release capsule and its preparation method. The metformin hydrochloride sustained-release capsule is prepared by steps of coating a metformin hydrochloride granule sustained-release material and putting into an enteric capsule. In comparison with the prior art, sustained-release granules and enteric capsule filling technology are combined together to prepare the new dosage form of metformin hydrochloride sustained-release (enteric-coated) capsule. As the sustained-release granule coating and enteric capsule filing technology is adopted, metformin hydrochloride will not be disintegrated and will not stimulates gastric mucosa, and adverse reactions such as nausea, stomachache, diarrhoea and the like caused by medication can be avoided. Meanwhile, metformin hydrochloride will not be damaged by gastric juice, and bioavailability of metformin hydrochloride is raised. In addition, the product provided by the invention is also a sustained-release enteric-coated preparation. The medicine can be stably released in a body, effective plasma concentration is maintained for a long time, and toxic and side effect which might be caused by higher plasma concentration within a short time are avoided. The frequency for taking the medicine is reduced, and patient compliance is also raised.

Description

technical field [0001] The invention relates to a metformin hydrochloride sustained-release capsule preparation and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Metformin Hydrochloride (Metformin Hydrochloride) is currently recognized as the preferred oral treatment for diabetes. It is a biguanide compound that can inhibit the absorption of glucose from the intestinal tract, inhibit liver gluconeogenesis, reduce the output of hepatic glucose, and increase the anaerobic response of peripheral tissues to glucose. Glycolysis, increase the number of insulin receptors in target cells and the affinity between receptors and insulin, improve insulin sensitivity, increase glucose uptake and aerobic oxidation in peripheral tissues, and also reduce triglycerides, cholesterol, and extremely low density It has good long-term effects on diabetic patients, and rarely causes hypoglycemia and lactic acidosis. Obese patients are mo...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K31/155A61P3/10
Inventor 王英刘艳玲胥清泉
Owner BOSEN BIO PHARMA SHANXI PROVINCE
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