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Ornidazole oral preparation and preparation method thereof

An oral preparation, ornidazole technology, applied in the field of pharmaceutical preparations, can solve problems such as complex prescriptions, and achieve the effects of simple prescriptions, controllable process, and low price

Active Publication Date: 2013-06-12
河北凯盛医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

CN102688208 discloses an ornidazole tablet and a preparation method thereof, comprising ornidazole, lactose, microcrystalline cellulose, soluble starch, sodium carboxymethyl starch, pregelatinized starch, magnesium stearate, binder (hydroxypropyl ethanol solution of methyl cellulose), using wet granulation process, but the formulation is relatively complicated, and disintegrants still need to be added to ensure the dissolution rate of ornidazole

Method used

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  • Ornidazole oral preparation and preparation method thereof
  • Ornidazole oral preparation and preparation method thereof
  • Ornidazole oral preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0086] Prescription composition:

[0087] Ornidazole 5.0kg starch 0.4kg microcrystalline cellulose 0.8kg Adhesive 5% ( w / w ) Hydroxypropylmethylcellulose E5 aqueous solution Magnesium stearate 0.03kg production 10000 pieces

[0088] Preparation:

[0089] 1) Mix 5.0kg of ornidazole, 0.4kg of starch, and 0.8kg of microcrystalline cellulose, and add 5% of binder ( w / w ) 1.2-1.3 kg of hydroxypropyl methylcellulose E5 aqueous solution to prepare soft materials;

[0090] 2) Granulate with a 16-mesh screen, dry at 50-60°C for 10-30 minutes, use a stainless steel 16-mesh screen, granulate with a swinging granulator, and control the moisture content to ≤2%;

[0091] 3) Add lubricant magnesium stearate 0.5% and mix uniformly in a three-dimensional mixer;

[0092] 4) Detection content of intermediates;

[0093] 5) According to the results of the intermediate, calculate the weight of the tablet, and press the tablet to obtain the orn...

Embodiment 2

[0095] Prescription composition:

[0096] Ornidazole 5.0kg starch 0.3kg microcrystalline cellulose 0.9kg Adhesive 5% ( w / w ) Hydroxypropylmethylcellulose E5 aqueous solution Magnesium stearate 0.03kg production 10000 pieces

[0097] Preparation:

[0098] 1) Mix 5.0kg of ornidazole, 0.3kg of starch, and 0.9kg of microcrystalline cellulose evenly, and add 5% of binder ( w / w ) 1.2-1.3 kg of hydroxypropyl methylcellulose E5 aqueous solution to prepare soft materials;

[0099] 2) Granulate with a 16-mesh screen, dry at 50-60°C for 10-30 minutes, use a stainless steel 16-mesh screen, granulate with a swinging granulator, and control the moisture content to ≤2%;

[0100] 3) Add lubricant magnesium stearate 0.5% and mix uniformly in a three-dimensional mixer;

[0101] 4) Detection content of intermediates;

[0102] 5) According to the result of the intermediate, calculate the loading weight, put it into a hard gelatin capsule she...

Embodiment 3

[0104] Prescription composition:

[0105] Ornidazole 5.0kg starch 0.4kg microcrystalline cellulose 0.6kg Adhesive 5% ( w / w ) Hydroxypropylmethylcellulose E5 aqueous solution Magnesium stearate 0.03kg production 10000 pieces

[0106] Preparation:

[0107] 1) Mix 5.0kg of ornidazole, 0.4kg of starch, and 0.6kg of microcrystalline cellulose evenly, and add 1.2-1.3kg of 5% hydroxypropylmethylcellulose E5 aqueous solution of the binder to prepare a soft material;

[0108] 2) Granulate with a 16-mesh screen, dry at 50-60°C for 10-30 minutes, use a stainless steel 16-mesh screen, granulate with a swinging granulator, and control the moisture content to ≤2%;

[0109] 3) Add lubricant magnesium stearate 0.5% and mix uniformly in a three-dimensional mixer;

[0110] 4) Detection content of intermediates;

[0111] 5) According to the result of the intermediate, calculate the loading amount and put it into an aluminum-plastic bag to ob...

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Abstract

The invention discloses an ornidazole oral preparation and a preparation method thereof. The prescription of the oral preparation comprises ornidazole, filler, an adhesive and a lubricant, and also can contain film coating powder. According to the preparation method, a disintegrating agent is not required to be added, and the problem of low dissolution rate of the ornidazole oral preparation can be solved by selecting a proper adhesive (hydroxypropyl methyl cellulose E5 aqueous solution or alcohol solution). The ornidazole oral preparation is simple in prescription, low in cost and high in dissolution rate, and is easy to industrialize.

Description

technical field [0001] The invention relates to an oral preparation of ornidazole and a preparation method thereof, which mainly uses a binder to improve the dissolution rate of the oral preparation of ornidazole, and belongs to the field of pharmaceutical preparations. Background technique [0002] Ornidazole (Ornidazole, ONZ), chemical name 1-(3-chloro-2-hydroxypropyl)-2-methyl-5-nitroimidazole, molecular formula: C 7 h 10 ClN 3 o 3 ;Molecular weight: 219.63. Chemical Structure: [0003] [0004] Its properties are white or slightly yellow crystalline powder; odorless, bitter taste; color gradually turns yellow when exposed to light. This product is easily soluble in ethanol, slightly soluble in water, and soluble in 0.1mol / L hydrochloric acid. Dissociation constant pKa: 2.4±0.1. [0005] Ornidazole was listed by the Swiss company Roche in the 1970s with a trade name of Tiberal, which was recorded in the Czech Pharmacopoeia (1991 edition). Since 2002, my country...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K9/48A61K9/20A61K9/28A61K31/4164A61K47/38A61P31/04A61P31/10A61P33/02
Inventor 赵凯李新苑洪忠张乐解兵亮
Owner 河北凯盛医药科技有限公司
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