Metformin hydrochloride enteric-coated tablets and preparation method thereof

A metformin hydrochloride enteric and metformin hydrochloride technology are applied in the field of metformin hydrochloride enteric-coated tablets and the preparation thereof, and can solve the problems such as the need for further improvement, and achieve the effects of reducing the increase of related substances and high bioavailability

Active Publication Date: 2011-02-23
BEIJING JINGFENG PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Metformin hydrochloride is mainly absorbed in the small intestine. After oral administration of enteric-coated tablets, it is not released in the upper gastrointestinal tract but in the small intestine, avoiding enzymatic hydrolysis in the stomach, thus avoiding the enzyme barrier, improving local drug concentration and bioavailability, and at the same time It avoids adverse stimulation to the gastrointestinal tract, and is safer and more reliable. Currently, enteric-coated tablets are generally coated with an enteric coating outside the tablet core, but there is still room for further improvement in the stability of the preparation.

Method used

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  • Metformin hydrochloride enteric-coated tablets and preparation method thereof
  • Metformin hydrochloride enteric-coated tablets and preparation method thereof
  • Metformin hydrochloride enteric-coated tablets and preparation method thereof

Examples

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Comparison scheme
Effect test

Embodiment 1

[0022] Embodiment 1. Metformin hydrochloride enteric-coated tablets

[0023] Tablet core prescription (10000 tablets)

[0024] Name of raw material Amount (g)

[0025] Metformin Hydrochloride 2500

[0026] Dextrin 500

[0027] Hypromellose 30 (additional)

[0028] Hypromellose 30 (additional)

[0029] Magnesium Stearate 15

[0030] Talc powder 30

[0031] 4% hypromellose 15% ethanol aqueous solution appropriate amount

[0032] Isolation gown coating solution prescription

[0033] Raw material name dosage

[0034] Opadry (stomach-soluble film-coated pre-suspension) 90g

[0035] Purified water 500g

[0036] Enteric Coating Solution Prescription

[0037] Raw material name dosage

[0038] Opadry (enteric-coated film-coated pre-suspension) 300g

[0039] Purified water 1200g

[0040] Preparation:

[0041] 1. The raw materials are crushed and passed through an 80-mesh sieve, and the dextrin, hydroxypropyl cellulose, magnesium stearate, and talcum powder are passed thro...

Embodiment 2

[0050] Embodiment 2. Metformin hydrochloride enteric-coated tablets

[0051] Tablet core prescription (10000 tablets)

[0052] Name of raw material Amount (g)

[0053] Metformin Hydrochloride 2500

[0054] Dextrin 450

[0055] Hypromellose 25 (additional)

[0056]Hypromellose 25 (additional)

[0057] Magnesium Stearate 12

[0058] Talc powder 25

[0059] 4% hypromellose 15% ethanol aqueous solution appropriate amount

[0060] Isolation gown coating solution prescription

[0061] Raw material name dosage

[0062] Opadry (stomach-soluble film-coated pre-suspension) 85g

[0063] Purified water 450g

[0064] Enteric Coating Solution Prescription

[0065] Raw material name dosage

[0066] Opadry (enteric-coated film-coated pre-suspension) 250g

[0067] Purified water 1100g

[0068] Prepare with reference to embodiment 1 method

Embodiment 3

[0069] Embodiment 3. Metformin hydrochloride enteric-coated tablets

[0070] Tablet core prescription (10000 tablets)

[0071] Name of raw material Amount (g)

[0072] Metformin Hydrochloride 2500

[0073] Dextrin 550

[0074] Hypromellose 35 (additional)

[0075] Hypromellose 35 (additional)

[0076] Magnesium Stearate 17

[0077] Talc 305

[0078] 4% hypromellose 15% ethanol aqueous solution appropriate amount

[0079] Isolation gown coating solution prescription

[0080] Raw material name dosage

[0081] Opadry (stomach-soluble film-coated pre-suspension) 95g

[0082] Purified water 550g

[0083] Enteric Coating Solution Prescription

[0084] Raw material name dosage

[0085] Opadry (enteric-coated film-coated pre-suspension) 350g

[0086] Purified water 1300g

[0087] Prepare with reference to embodiment 1 method

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Abstract

The invention belongs to the technical field of medicinal preparations, in particular relates to metformin hydrochloride enteric-coated tablets and a preparation method thereof, and provides stable metformin hydrochloride enteric-coated tablets. Each metformin hydrochloride enteric-coated tablet comprises a tablet core, an insulation coating and an enteric coating, wherein the tablet core is prepared from metformin hydrochloride, dextrin, hyprolose, magnesium stearate and talcpowder by adopting the ethanol aqueous solution of hypromellose as an adhesive; the insulation coating is prepared from a gastric soluble film coating premixed suspension agent and purified water; and the enteric coating is prepared from an enteric film coating premixed suspension agent and the purified water.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a metformin hydrochloride enteric-coated tablet and a preparation method thereof. Background technique [0002] Metformin Hydrochloride (Metformin Hydrochloride), whose chemical name is 1,1-dimethylbiguanide hydrochloride, is a biguanide hypoglycemic agent, used for type 2 diabetic patients who are not satisfied with simple diet control, especially obesity and hyperinsulinemia For patients with hyperinsulinemia, this drug not only has the effect of lowering blood sugar, but also has the effect of reducing body weight and hyperinsulinemia. It can be effective for some patients with poor curative effect of sulfonylureas, such as combined with sulfonylurea hypoglycemic agents, small intestinal glycosidase inhibitors or thiazolidinedione hypoglycemic agents, the effect is better than that of each alone. It can also be used in patients on insulin therapy to reduce the d...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/155A61P3/10A61K9/36
Inventor 陈成龙张洪范辉张信中
Owner BEIJING JINGFENG PHARMA GRP
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