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Ornidazole orally disintegrating tablet and preparation method thereof

A technology of ornidazole mouth and ornidazole, which is applied in the field of pharmaceutical preparations, can solve the problems of strong irritation, great harm to human body, and adverse reactions, and achieve the effect of rapid disintegration, reliable curative effect, and no gritty feeling

Inactive Publication Date: 2019-01-29
武汉长联来福制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

(2) Ornidazole injection contains organic solvents, which are directly injected into blood vessels, which are highly irritating and will cause a series of adverse reactions, which are more harmful to the human body

Method used

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  • Ornidazole orally disintegrating tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] A kind of ornidazole orally disintegrating tablet adopts wet granulation and is made of components comprising the following weight percentages:

[0050] Ornidazole 250g (50%),

[0051] Crospovidone 150g (30%),

[0052] Sodium carboxymethylcellulose 5g (1%),

[0053] Sodium saccharin 40g (8%),

[0054] Mannitol 45g (9%),

[0055] Calcium stearate 10g (2%);

[0056] The preparation method of ornidazole orally disintegrating tablet in the present embodiment, comprises the steps:

[0057] (1) Pass ornidazole through a 60-mesh sieve, and grind the rest of the auxiliary materials through a 100-mesh sieve.

[0058] (2) after ornidazole, sodium saccharin, mannitol, crospovidone of 15% in the proportioning of raw materials are sieved and mixed uniformly, add the concentration of sodium carboxymethylcellulose that is 25% in the proportioning of raw materials Aqueous solution to prepare soft materials;

[0059] (3) pass through a 20-mesh sieve to granulate, dry in an oven a...

Embodiment 2

[0063] An ornidazole orally disintegrating tablet, which is dry granulated, is made of components comprising the following weight percentages:

[0064] Ornidazole 250g (50%),

[0065] Low-substituted hydroxypropyl cellulose 140g (28%),

[0066] Sodium saccharin 55g (11%),

[0067] Xylitol 30g (6%),

[0068] Calcium stearate 15g (3%),

[0069] Stearic acid 10g (2%);

[0070] The preparation method of ornidazole orally disintegrating tablet in the present embodiment, comprises the steps:

[0071] (1) Pass ornidazole through a 60-mesh sieve, and grind the rest of the auxiliary materials through a 100-mesh sieve.

[0072] (2) After mixing the ornidazole raw material and the internally added material evenly, dry granulation to prepare 20-mesh granules.

[0073] (3) After the uniformity of mixing and the content are tested to be qualified, it can be obtained by pressing into tablets, and the theoretical quantity is 1000 tablets.

Embodiment 3

[0075] An ornidazole orally disintegrating tablet adopts powder direct compression and is made of components comprising the following weight percentages:

[0076] Ornidazole 250g (50%),

[0077] Crospovidone 90g (18%),

[0078] Mannitol 150g (30%),

[0079] Calcium stearate 2.5g (0.5%),

[0080] Anhydrous colloidal silicon dioxide 7.5g (1.5%);

[0081] The preparation method of ornidazole orally disintegrating tablet in the present embodiment, comprises the steps:

[0082] (1) Pass ornidazole through a 60-mesh sieve, and grind the rest of the auxiliary materials through a 100-mesh sieve.

[0083] (2) Mix the ornidazole raw material and the internally added material evenly.

[0084] (3) After the uniformity of mixing and the content are tested to be qualified, it can be obtained by pressing into tablets, and the theoretical quantity is 1000 tablets.

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Abstract

The invention belongs to the technical field of medicine preparations, and in particular relates to an ornidazole orally disintegrating tablet preparation and a preparation method of the ornidazole orally disintegrating tablet preparation. The ornidazole orally disintegrating tablet is prepared from the following ingredients in percentage by weight: 50-80 % of ornidazole, and 20-50 % of an excipient, wherein the excipient comprises one or more of a disintegrating agent, an adhesive, a corrigent, a lubricant and a glidant. The ornidazole orally disintegrating tablet provided by the invention has the advantages that the disintegrating is rapid, the mouthfeel is excellent, no gritty sense exists, no discomfort exists, the stability is stable, the curative effects are reliable, the effect is timely, the absorption is rapid, the bioavailability is greatly increased, the demands of patients are conformed, in addition, the preparation process is simple, and is suitable for large-scale production, etc.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to an ornidazole orally disintegrating tablet and a preparation method thereof. Background technique [0002] Anaerobic infection is one of the common bacterial infections in clinical treatment, and the affected population is wide. The detection rate of anaerobic bacteria in surgical infection is more than 50%, among which the detection rate in abdominal infection is 60.67%, and the detection rate in appendix abscess and incision suppuration after appendectomy reaches 70.58%. In my country, with the continuous growth of population and accelerated aging, the incidence of anaerobic infection is on the rise. Since 2010, the amount of nitroimidazole preparations in my country has generally been on the rise, from 5.581 billion yuan in 2010 to 8 billion yuan in 2016. Ornidazole occupied 55.63% of the nitroimidazole drug market in 2014, occupying an absolute advantage i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4164A61P31/04
CPCA61K9/0056A61K9/2095A61K31/4164A61P31/04
Inventor 郭文胜刘大鹏向卫卫吴莹王晓星赵秀林
Owner 武汉长联来福制药股份有限公司
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