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A kind of metformin hydrochloride pharmaceutical composition and its preparation method and application

A technology of metformin hydrochloride and a composition, applied in the field of medicine, can solve problems such as affecting the quality of life of patients, and achieve the effects of being beneficial to long-term treatment, promoting gastrointestinal motility, and promoting digestion and absorption

Active Publication Date: 2021-03-23
HARBIN ZHENBAO PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

In addition, it seriously affects the quality of life of patients

Method used

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  • A kind of metformin hydrochloride pharmaceutical composition and its preparation method and application
  • A kind of metformin hydrochloride pharmaceutical composition and its preparation method and application

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preparation example Construction

[0038] In the second aspect, the embodiment of the present invention also provides a preparation method of metformin hydrochloride pharmaceutical composition, which comprises the following steps:

[0039] S1. Mix metformin hydrochloride, pregelatinized starch and mannitol evenly, add water to granulate.

[0040] Specifically include: first crush metformin hydrochloride to 100-120 mesh, then put metformin hydrochloride, mannitol, and pregelatinized starch in a wet granulator, mix for 5-6 minutes, add an appropriate amount of purified water, and granulate for 1-2 minutes . Wet sizing is carried out with a oscillating granulator, and the mesh number of the sieve is 12-14 mesh. Wet granules are placed in a high-efficiency boiling dryer, preheated at an inlet air temperature of 60-70°C for 10 minutes, and dried at room temperature to control the moisture content of the granules between 1.5% and 6.5%. The dried granules are sized in a swing granulator, and the mesh size of the sie...

Embodiment 1

[0050] The present embodiment provides a kind of metformin hydrochloride pharmaceutical composition, and its preparation method is as follows:

[0051] S1, material preparation: metformin hydrochloride 130g, pregelatinized starch 8g, mannitol 8g and magnesium stearate 4g;

[0052] S2. Granulation: Grind metformin hydrochloride to 120 mesh; then place metformin hydrochloride, pregelatinized starch and mannitol in a wet granulator, mix for 5 minutes, add an appropriate amount of purified water, and granulate for 2 minutes. Wet sizing is carried out with a oscillating granulator, and the mesh number of the sieve is 12 mesh. Wet granules are placed in a high-efficiency fluidized dryer, and the dryer is preheated for 10 minutes with wind at a temperature of 70°C, and then dried at room temperature. Control particle moisture between 1.5% and 6.5%. The dried granules are sized in a swing granulator, and the mesh number of the sieve is 16 mesh. After granulation, store in the trans...

Embodiment 2

[0054] The present embodiment provides a kind of metformin hydrochloride pharmaceutical composition, and its preparation method is as follows:

[0055] S1. Preparation of materials: 110 g of metformin hydrochloride, 6 g of pregelatinized starch, 6 g of mannitol, 2 g of magnesium stearate, and 2 g of gastric-soluble film coating premix.

[0056] S2. Granulation: crush metformin hydrochloride to 100 mesh; then put metformin hydrochloride, pregelatinized starch and mannitol in a wet granulator, mix for 6 minutes, add an appropriate amount of purified water, and granulate for 1 minute. Wet sizing is carried out with a oscillating granulator, and the mesh number of the sieve is 14 mesh. Wet granules are placed in a high-efficiency fluidized dryer, and the dryer is preheated for 15 minutes with wind at a temperature of 60°C, and then dried at room temperature. Control particle moisture between 1.5% and 6.5%. The dried granules are sized in a swing granulator, and the mesh size of ...

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Abstract

The invention relates to the technical field of medicines and provides a metformin hydrochloride medicine composition as well as a preparation method and application thereof. The metformin hydrochloride medicine composition comprises the following components in parts by weight: 100-150 parts of metformin hydrochloride, 5-10 parts of pregelatinized starch, 5-10 parts of mannitol and 1-5 parts of magnesium stearate. The preparation method comprises the following steps: uniformly mixing the metformin hydrochloride, the pregelatinized starch and the mannitol, adding water to pelletize, further adding the magnesium stearate, and uniformly mixing, thereby obtaining capsules or tablets. According to the embodiment of the invention, contents of the metformin hydrochloride, the pregelatinized starch and the mannitol are limited, medicines are slowly released in bodies, direct irritation of the metformin hydrochloride to gastrointestinal tracts can be alleviated, side effects, particularly serious gastrointestinal tract reactions, can be reduced, an effective blood concentration can be maintained, the compliance and the security of medicine taking can be improved for patients, the patients can tolerate the composition, and long-term treatment can be facilitated.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a metformin hydrochloride pharmaceutical composition and a preparation method and application thereof. Background technique [0002] Metformin hydrochloride acts as a hypoglycemic drug, but very large doses of metformin hydrochloride can cause diarrhea in individual patients. When diarrhea exceeds 5 times a day or bloody diarrhea occurs, it is generally necessary to reduce the dose of the drug or stop the chemical drug immediately and treat it in time. Generally, after the drug is stopped, the treatment will be difficult to proceed smoothly, thereby affecting the curative effect of the treatment. [0003] The main cause of diarrhea in patients receiving chemical drugs is due to the direct inhibition or destruction of intestinal mucosal cells by the drugs, and it is also related to many other factors such as secondary infection of the intestinal tract and emotional stress. Cont...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48A61K9/28A61K47/06A61K47/26A61K47/12A61K31/155A61K38/01A61P3/10
CPCA61K9/1617A61K9/1623A61K9/1652A61K9/2013A61K9/2018A61K9/2059A61K9/28A61K31/155A61K38/011A61P3/10A61K2300/00
Inventor 方同华韩冰崔玉海周艳谋
Owner HARBIN ZHENBAO PHARMA
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