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Metronidazole tablet composition with stable quality and preparation method thereof

A technique for metronidazole tablet and stable quality, applied in the field of metronidazole tablet composition and its preparation, capable of solving the problems of slow dissolution and large influence of dissolution rate and particle size, achieving definite curative effect, consistent quality and curative effect , the effect of stable quality

Active Publication Date: 2020-12-01
河北君临药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] After research, we unexpectedly found that the dissolution rate of metronidazole preparations is greatly affected by the composition of excipients and the particle size of the granules before tableting. We found unexpected effects by controlling the composition of excipients and the particle size of the granules before tableting. It solves the problem of slow dissolution, and the method of the present invention is simple in process operation, and can be consistent with the dissolution curve of the reference preparation in four media in vitro, ensuring the curative effect of the product

Method used

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  • Metronidazole tablet composition with stable quality and preparation method thereof
  • Metronidazole tablet composition with stable quality and preparation method thereof
  • Metronidazole tablet composition with stable quality and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Embodiment 1: Metronidazole tablet composition

[0050] Prescription composition:

[0051]

[0052] Preparation:

[0053] (1) Preparation of raw and auxiliary materials: Metronidazole is passed through a 100-mesh sieve, white sugar is passed through a 80-mesh sieve, dextrin is passed through a 120-mesh sieve, and a 2% aqueous solution of hydroxypropyl methylcellulose is prepared. The apparent viscosity is, The viscosity is 6mPa•s;

[0054] (2) Mixing and preparation of soft materials:

[0055] ①Put metronidazole, white sugar, and dextrin in a tank mixer and dry mix for 10 minutes at a stirring rate of 200rpm and a shear rate of 800rpm;

[0056] ② The stirring rate is 200rpm, the shear rate is 800rpm, and the binder is added within 6 minutes;

[0057] ③ The stirring rate is 200rpm, the shear rate is 800rpm, stirring for 14 minutes to make a suitable soft material and then discharging;

[0058] (3) Granulation: Granulate with a 18-mesh nylon sieve swinging granula...

Embodiment 2

[0066] Embodiment 2: Metronidazole tablet composition

[0067] Prescription composition:

[0068]

[0069] Preparation:

[0070] (1) Preparation of raw and auxiliary materials: Metronidazole is passed through a 100-mesh sieve, white sugar is passed through a 80-mesh sieve, dextrin is passed through a 120-mesh sieve, and a 2% aqueous solution of hydroxypropyl methylcellulose is prepared. The apparent viscosity is, The viscosity is 6mPa•s;

[0071] (2) Mixing and preparation of soft materials:

[0072] ①Put metronidazole, white sugar, and dextrin in a tank mixer and dry mix for 10 minutes at a stirring rate of 200rpm and a shear rate of 800rpm;

[0073] ② The stirring rate is 200rpm, the shear rate is 800rpm, and the binder is added within 6 minutes;

[0074] ③ The stirring rate is 200rpm, the shear rate is 800rpm, stirring for 14 minutes to make a suitable soft material and then discharging;

[0075] (3) Granulation: Granulate with a 18-mesh nylon sieve swinging granula...

Embodiment 3

[0083] Embodiment 3: Metronidazole tablet composition

[0084] Prescription composition:

[0085]

[0086] Preparation:

[0087] (1) Preparation of raw and auxiliary materials: Metronidazole is passed through a 100-mesh sieve, white sugar is passed through a 80-mesh sieve, dextrin is passed through a 120-mesh sieve, and a 2% aqueous solution of hydroxypropyl methylcellulose is prepared. The apparent viscosity is, The viscosity is 6mPa•s;

[0088] (2) Mixing and preparation of soft materials:

[0089] ①Put metronidazole, white sugar, and dextrin in a tank mixer and dry mix for 10 minutes at a stirring rate of 200rpm and a shear rate of 800rpm;

[0090] ② The stirring rate is 200rpm, the shear rate is 800rpm, and the binder is added within 6 minutes;

[0091] ③ The stirring rate is 200rpm, the shear rate is 800rpm, stirring for 14 minutes to make a suitable soft material and then discharging;

[0092] (3) Granulation: Granulate with a 18-mesh nylon sieve swinging granula...

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Abstract

The invention provides a metronidazole tablet composition with stable quality. A preparation method comprises the following steps: (1) preparation of raw materials and auxiliary materials; (2) mixingto prepare a soft material; (3) granulating; (4) drying; (5) size stabilization; (6) total mixing; and (7) tableting. The metronidazole tablet composition disclosed by the invention is definite in curative effect and stable in quality, and is consistent with reference listed drugs in quality and curative effects, and generic drugs can well replace the reference listed drugs; and the production process is simple, and the process tolerance is good.

Description

technical field [0001] The technical field of pharmaceutical preparations of the present invention, more specifically, relates to a metronidazole tablet composition with improved dissolution rate and a preparation method thereof. Background technique [0002] Metronidazole is mainly used to treat or prevent systemic or local infections caused by the above-mentioned anaerobic bacteria, such as anaerobic bacterial infections in the abdominal cavity, digestive tract, female reproductive system, lower respiratory tract, skin and soft tissues, bones and joints, etc. , endocarditis, meningeal infection, and colitis caused by antibiotics are also effective. Tetanus is often treated with tetanus antitoxin (TAT). It can also be used for oral anaerobic infection. [0003] Metronidazole can be rapidly and completely absorbed after oral administration, with a protein binding rate of <20%. After absorption, it is widely distributed in various tissues and body fluids, and can pass th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4164A61K47/38A61K47/36A61K47/26A61P31/04
CPCA61K9/2059A61K9/2054A61K9/2018A61K9/2095A61K31/4164A61P31/04Y02A50/30
Inventor 李新联尉杰李伟
Owner 河北君临药业有限公司
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