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Tinidazole tablet and preparation method thereof

A technology of tinidazole tablets and nidazole tablets, which is applied in the direction of pharmaceutical formulas, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc., can solve the problem of poor smoothness of tinidazole tablet compression process and easy occurrence of Grinding, low production efficiency and other problems, to avoid the growth of genotoxic impurities, reduce production costs and energy consumption, and overcome the effects of poor process fluidity

Pending Publication Date: 2021-08-10
LIVZON GROUP LIVZON PHARMA FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Secondly, the tableting process of tinidazole tablets is poor in smoothness, resulting in low production efficiency: the main drug specification of tinidazole tablets is 0.5g, which is large in size, and the compressibility and fluidity of tinidazole raw materials are poor, resulting in low production efficiency. The smoothness of the tablet process is poor, and the hardness is low and the friability is too high. During the coating process, the surface is prone to grinding and the coating film is incomplete, which seriously affects the production efficiency.
At the same time, the existing tinidazole tablets are generally prepared by wet granulation process, and the high temperature of wet granulation will cause the increase of nitrous acid, which will increase the content of nitrite impurities in tinidazole tablets

Method used

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  • Tinidazole tablet and preparation method thereof
  • Tinidazole tablet and preparation method thereof
  • Tinidazole tablet and preparation method thereof

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preparation example Construction

[0029] Tinidazole tablet of the present invention adopts dry granulation process to prepare, and its preparation method specifically comprises the following steps:

[0030] S1. Weigh raw materials: Weigh raw materials and auxiliary materials according to the prescription.

[0031] S2. Premixing: Put the prescribed amount of tinidazole, filler, part of the disintegrant, glidant, and part of the binder into the mixer and mix for 20-40 minutes, and mix evenly.

[0032] S3. Granulation: adopt dry granulation process to granulate, the conveyor speed is 80-200rpm, the spacing between the pressing wheels is 0.2mm, the rotating speed of the pressing wheels is 20-40rpm, and the sizing screen is 18 mesh.

[0033] S4. Total mixing: The granules are mixed with the remaining disintegrant, remaining binder and lubricant, and the mixing time is 10-20 minutes.

[0034] S5. Feed the total mixed granules into the tablet press, control the hardness to 8.0-17.0kg, the tablet weight difference is...

Embodiment 1～6

[0047] The formula of embodiment 1~6 is as shown in table 3:

[0048] The formula of table 3 embodiment 1~6

[0049]

[0050]

[0051] Wherein, the preparation method of embodiment 1~6 is as follows:

[0052] S1. Weigh raw materials: Weigh raw materials and auxiliary materials according to the prescription.

[0053] S2. Premixing: Put the prescribed amount of tinidazole, filler, povidone, colloidal silicon dioxide, and crospovidone (internal addition) into the mixer and mix for 20-40 minutes, and mix well.

[0054] S3. Granulation: Dry granulation process is used for granulation, and the specific process parameters are as follows: conveyor speed 80-200rpm, pressure wheel spacing 0.2mm, pressure wheel speed 20-40rpm, granulation screen 18 mesh.

[0055]S4, total blending: the granules after granulation and crospovidone (additional), silicified microcrystalline cellulose (additional) and magnesium stearate are put into the mixer and mixed, the mixing speed is 10rpm, and ...

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Abstract

The invention discloses a tinidazole tablet and a preparation method thereof, and belongs to the technical field of pharmaceutical preparations. The tinidazole tablet disclosed by the invention is prepared by controlling the dosage and the particle size of the raw materials and the auxiliary materials and adopting a dry granulation process. The tinidazole tablet prepared by the preparation method can effectively improve the dissolution rate, disintegration time limit, hardness and friability of the medicine tablet, effectively overcomes the problem that the nitrite content is increased due to high temperature and high humidity in the existing wet granulation process, and is good in production compliance and high in production efficiency.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a tinidazole tablet and a preparation method thereof. Background technique [0002] Tinidazole is a class of nitroimidazole derivatives developed in the late 1960s. It is suitable for various anaerobic infections, such as sepsis, osteomyelitis, abdominal infection, pelvic infection, lung and bronchial infection, pneumonia, sinusitis, skin cellulite Histitis, periodontal infection, postoperative wound infection, etc.; and preoperative prophylaxis for colorectal surgery, gynecological surgery, and oral surgery; in addition, it is also used for intestinal and extraintestinal amoebiasis, vaginal Treatment of trichomoniasis, giardiasis, Gardnerella vaginitis, etc. [0003] Tinidazole has been prepared into various dosage forms and widely used in clinic, such as injection, effervescent tablet, suppository, gargle, tablet and capsule, etc. Among them, the tablet ha...

Claims

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Application Information

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IPC IPC(8): A61K9/30A61K31/4164A61K47/32A61K47/38A61K47/04A61K47/12A61P15/02A61P31/04A61P33/02A61P41/00
CPCA61K31/4164A61K9/282A61K9/2027A61K9/2009A61K9/2054A61K9/2013A61P31/04A61P41/00A61P15/02A61P33/02
Inventor 范文峰覃开芳钟贞李玥颖曹珺王亚龙徐凯郑晓斌蓝美英
Owner LIVZON GROUP LIVZON PHARMA FACTORY
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