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Tinidazole tablet and preparation method thereof

A technology for 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 tablet compression process of tinidazole tablets and poor raw material availability. Poor compressibility and fluidity, poor smoothness of the tableting process, etc., to achieve the effects of shortening the disintegration time limit, good compressibility, and improving the disintegration time limit and dissolution rate

Active Publication Date: 2020-01-21
SUZHOU KELUN PHARMA RES CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Li Houtao et al. (Li Houtao, Zhou Meili, Song Junmei. Screening of Tinidazole Adhesive [J], Qilu Pharmaceutical Affairs, 2006, (25)) studied the adhesive in order to optimize the dissolution rate of Tinidazole Tablets, It is found that 2% hydroxypropyl cellulose can improve the compressibility of the tablet, promote the dissolution and disintegration of the drug, and the average dissolution rate can reach 98%. However, the disintegration time limit is 11 minutes, and the disintegration is still not ideal
[0006] Secondly, the smoothness of the tableting process of tinidazole tablets is poor, and the production efficiency is low
The proportion of raw materials is relatively high, and the compressibility and fluidity of raw materials are poor, resulting in poor smoothness of the tableting process, and low hardness and high brittleness. During the coating process, it is easy to grind the surface and the film is incomplete. , seriously affecting production efficiency

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1～6

[0045] Embodiments 1-6 were prepared using the following wet one-step granulation process:

[0046] 1) Weighing ingredients: Weighing each raw material and auxiliary material according to the mass ratio;

[0047] 2) Preparation of adhesive solution: take pregelatinized starch and evenly disperse it in purified water, place it in a steam interlayer heating pot, heat and stir continuously to make it gelatinize to 90-95°C, and then it is ready; unless otherwise specified, the example The binder solution is prepared by dispersing pregelatinized starch as binder in purified water.

[0048] 3) Premixing: mix tinidazole, diluent, and 30%-70% disintegrant (internal addition) in the formulation amount in a mixer;

[0049] 4) Granulation: Turn on the boiling drying granulator, spray the binder solution prepared in step 2) for granulation, control the inlet air temperature, fan frequency, binder injection speed, atomization pressure, material temperature, etc. parameters, complete gran...

Embodiment 1

[0060] The formula is shown in Table 1.

[0061] Table 1

[0062]

[0063]

[0064] In the granulation process, step 2) prepares the binder solution: take the pregelatinized starch and disperse it evenly in purified water to make the concentration 6.5 (weight) %, place it in a steam interlayer heating pot, heat and continuously stir to make it paste Heat it up to 90-95°C to get it.

[0065] Prepare tinidazole tablets according to the aforementioned wet one-step granulation process, and detect the powder properties of the intermediate after step 5) granulation, and the disintegration time limit, hardness, friability and dissolution rate of the tablet, and detect The results are shown in Table 2.

[0066] Table 2

[0067]

Embodiment 2

[0069] The recipe is shown in Table 3.

[0070] table 3

[0071]

[0072] In the granulation process, step 2) prepares the binder solution: take the pregelatinized starch and disperse it evenly in purified water to make the concentration 7.5% by weight, place it in a steam interlayer heating pot, heat and continuously stir to make it paste Heat it up to 90-95°C to get it.

[0073] Tinidazole tablets were prepared according to the aforementioned wet one-step granulation process, and the powder properties of the intermediate, the disintegration time limit, hardness, friability and dissolution rate of the tablet were tested. The test results are shown in Table 4.

[0074] Table 4

[0075]

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Abstract

The invention discloses a tinidazole tablet and a preparation method thereof. The tinidazole tablet comprises a tablet core and a coating, wherein the tablet core comprises tinidazole, a diluent, an adhesive, a disintegrating agent and a lubricant. The preparation method disclosed by the invention comprises a step of preparing the tinidazole tablet by using a wet-method one-step pelletizing process. The disintegrating agent is added in different steps by external and external addition modes respectively, so that the time can be shortened, and the production efficiency can be improved; and witha prescription, the dissolution and hardness of the product can be improved, the powder properties of raw materials are improved, the smoothness of a tablet pressing process can be improved, the appearance can be improved, and the product quality can be effectively improved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates 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 ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K47/38A61K47/36A61K31/4164A61P33/02A61P31/04
CPCA61K9/28A61K9/2095A61K9/2059A61K9/2054A61K31/4164A61P33/02A61P31/04
Inventor 李玲罗月危军吴灵静王琦王利春王晶翼
Owner SUZHOU KELUN PHARMA RES CO LTD
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