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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 prescription, and achieve the effects of simple prescription, controllable process and low price

Active Publication Date: 2018-06-26
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

[0085] Composition of prescription:

[0086] Ornidazole

5.0kg

starch

0.4kg

Microcrystalline cellulose

0.8kg

Adhesive

5%( w / w ) Hydroxypropyl methylcellulose E5 aqueous solution

Magnesium stearate

0.03kg

production

10000 pieces

[0087] Preparation:

[0088] 1) Mix 5.0kg of ornidazole, 0.4kg of starch, 0.8kg of microcrystalline cellulose, and add 5% ( w / w ) 1.2-1.3 kg of hydroxypropyl methylcellulose E5 aqueous solution to prepare soft materials;

[0089] 2) Granulate with 16 mesh screen, dry at 50~60℃ for 10~30min, adopt stainless steel 16 mesh screen, swing granulator to granulate, control moisture content ≤2%;

[0090] 3) Add 0.5% magnesium stearate lubricant and mix well in a three-dimensional mixer;

[0091] 4) Detection content of intermediates;

[0092] 5) According to the intermediate results, calculate the tablet weight and press the tablet to obtain the ornidazole tablet.

Embodiment 2

[0094] Composition of prescription:

[0095] Ornidazole

5.0kg

starch

0.3kg

Microcrystalline cellulose

0.9kg

Adhesive

5%( w / w ) Hydroxypropyl methylcellulose E5 aqueous solution

Magnesium stearate

0.03kg

production

10000 pieces

[0096] Preparation:

[0097] 1) Mix 5.0kg of ornidazole, 0.3kg of starch, 0.9kg of microcrystalline cellulose, and add binder 5% ( w / w ) 1.2-1.3 kg of hydroxypropyl methylcellulose E5 aqueous solution to prepare soft materials;

[0098] 2) Granulate with 16 mesh screen, dry at 50~60℃ for 10~30min, adopt stainless steel 16 mesh screen, swing granulator to granulate, control moisture content ≤2%;

[0099] 3) Add 0.5% magnesium stearate lubricant and mix well in a three-dimensional mixer;

[0100] 4) Detection content of intermediates;

[0101] 5) According to the intermediate results, calculate the packing weight and pack it into the hard rubber capsule to obtain the ornidazole capsule.

Embodiment 3

[0103] Composition of prescription:

[0104] Ornidazole

5.0kg

starch

0.4kg

Microcrystalline cellulose

0.6kg

Adhesive

5%( w / w ) Hydroxypropyl methylcellulose E5 aqueous solution

Magnesium stearate

0.03kg

production

10000 pieces

[0105] Preparation:

[0106] 1) Mix 5.0 kg of ornidazole, 0.4 kg of starch, and 0.6 kg of microcrystalline cellulose, and add 1.2 to 1.3 kg of 5% hydroxypropyl methylcellulose E5 aqueous solution as a binder to prepare soft materials;

[0107] 2) Granulate with 16 mesh screen, dry at 50~60℃ for 10~30min, adopt stainless steel 16 mesh screen, swing granulator to granulate, control moisture content ≤2%;

[0108] 3) Add 0.5% magnesium stearate lubricant and mix well in a three-dimensional mixer;

[0109] 4) Detection content of intermediates;

[0110] 5) According to the result of the intermediate, calculate the filling quantity and put it into an aluminum-plastic bag to obtain ornidazole particles.

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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, and mainly uses a binder to improve the dissolution of the oral preparation of ornidazole, and belongs to the field of pharmaceutical preparations. Background technique [0002] Ornidazole (ONZ), chemical name is 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 light yellow crystalline powder; it is odorless, bitter in taste; it turns yellow when exposed to light. This product is 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, and its trade name, Tiberal, was included in the Czech Pharmacopoeia (1991 edition). Since 2002, my country has successively approved the production of ornida...

Claims

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Application Information

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Patent Type & Authority Patents(China)
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