Oral solid tablet containing metronidazole and preparation method thereof

A technology containing metronidazole and metronidazole, which is applied in pill delivery, pharmaceutical formulations, coatings, etc., can solve the problems of increasing solubility, and no improvement in the intra-batch variation of dissolution curves, etc., to achieve definite curative effect, good uniformity, The effect of simple production process

Inactive Publication Date: 2019-04-16
WUHAN TONGJI MODERN PHARMA TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Within 20 minutes, both the pH6.8 and the dissolution uniformity within the water batch are still greater than 10%, which cannot achieve the similarity of the in vitro dissolution with the reference preparation
The preparation is an orally disintegrating tablet. In order to provide bioavailability, the method of adding solubilizer sodium lauryl sulfate or Tween 80 is used in the prescription. This method can increase the solubility, but it has no effect on the intra-assay variation of the dissolution curve.

Method used

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  • Oral solid tablet containing metronidazole and preparation method thereof
  • Oral solid tablet containing metronidazole and preparation method thereof
  • Oral solid tablet containing metronidazole and preparation method thereof

Examples

Experimental program
Comparison scheme
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Embodiment 1

[0043] A metronidazole-containing oral solid tablet of the present embodiment comprises a drug tablet core and a coating layer, wherein: the drug tablet core is composed of the following component raw materials:

[0044]

[0045]Wherein: the filler is composed of 94g cornstarch and 24g calcium hydrogen phosphate; the particle size of the metronidazole is D50≤40μm, D90≤90μm; the particle size distribution of each component raw material of the drug tablet core after total mixing As follows: 20-60 mesh particles account for 50-70%, 60-100 mesh particles account for 10-30%, and fine powder below 100 mesh accounts for 5-20% (see Table 1 and Table 2 for specific particle size distribution) .

[0046] The coating layer consists of:

[0047] Opadry Gastric Film Coating Premix: 10g.

[0048] The preparation method of the above-mentioned oral tablet containing metronidazole is as follows: the metronidazole is crushed to a particle size of D50≤40 μm, D90≤90 μm; then mixed with corn ...

Embodiment 2

[0050] A metronidazole-containing oral tablet of the present embodiment includes a drug tablet core and a coating layer, wherein: the drug tablet core is composed of the following component raw materials:

[0051]

[0052] Wherein: the metronidazole particle size is D50≤40μm, D90≤90μm; the particle size distribution of the raw materials of the various components of the drug tablet core is mixed as follows: 20-60 mesh particles account for 50-70%, 60 ~100 mesh particles accounted for 10~30%, and fine powder below 100 mesh accounted for 5~20% (see Table 1 and Table 2 for specific particle size distribution).

[0053] The coating layer consists of:

[0054] Opadry Gastric Film Coating Premix: 10g.

[0055] The preparation method of the above-mentioned oral tablet containing metronidazole is as follows: the metronidazole is pulverized to a particle size of D50≤40 μm, D90≤90 μm; After mixing Ketone K30, add purified water to granulate, dry, and granulate into granules with a p...

Embodiment 3

[0057] A metronidazole-containing oral tablet of the present embodiment includes a drug tablet core and a coating layer, wherein: the drug tablet core is composed of the following component raw materials:

[0058]

[0059] Wherein: the metronidazole particle size is D50≤40μm, D90≤90μm; the particle size distribution of the raw materials of the various components of the drug tablet core is mixed as follows: 20-60 mesh particles account for 50-70%, 60 ~100 mesh particles accounted for 10~30%, and fine powder below 100 mesh accounted for 5~20% (see Table 1 and Table 2 for specific particle size distribution).

[0060] The coating layer consists of:

[0061] Opadry Gastric Film Coating Premix: 10g.

[0062] The preparation method of the above-mentioned oral tablet containing metronidazole is as follows: the metronidazole is crushed to a particle size of D50≤40 μm, D90≤90 μm; then mixed with pregelatinized starch, microcrystalline cellulose, croscarmell Sodium cellulose and hi...

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Abstract

The invention discloses an oral solid tablet containing metronidazole and a preparation method thereof, and relates to the field of drug preparations. The oral solid tablet containing the metronidazole comprises a drug tablet core and a coating layer, wherein drug tablet core tableting particles are composed of the metronidazole, a filler, a disintegrating agent, a binder and a lubricant. The particle diameter of a metronidazole raw material is preferably D50<=60[mu]m, and D90<=120[mu]m; the particles with the particle size of 20-60 meshes account for 50-70%, the particles with the particle size of 60-100 meshes account for 10-30%, and fine powder of 100 meshes or less accounts for 5-20%. The oral preparation containing the metronidazole and metronidazole tablet reference preparation produced by Famar Health Care Services Madrid, S.A.U are consistent in dissolution in vitro.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to an oral solid tablet containing metronidazole and a preparation method thereof. Background technique [0002] Metronidazole is mainly used in the treatment of intestinal and parenteral amoebiasis (such as amebic liver abscess, pleural amoebiasis, etc.). It can also be used to treat vaginal trichomoniasis, cylindrosis, skin leishmaniasis, and guinea worm infection. It is also widely used in the treatment of anaerobic infection. , [0003] The molecular formula of metronidazole is C 6 h 9 N 3 o 3 , the structural formula is shown in Formula 1: [0004] [0005] At present, the preparations of metronidazole in China are mainly film-coated oral tablets and injections, and the common specification of oral tablets is 200 mg. [0006] Metronidazole can be rapidly and completely absorbed after oral or rectal administration, and the protein bindi...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K31/4164A61K47/36A61K47/38A61P31/04A61P33/02A61P33/10
CPCA61K9/2059A61K9/2866A61K31/4164A61P31/04A61P33/02A61P33/10
Inventor 李亦武
Owner WUHAN TONGJI MODERN PHARMA TECH CO LTD
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