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A kind of darfinacine sustained-release preparation and preparation method thereof

A technology of darfinacine and sustained-release tablets, which is applied in the directions of non-active ingredients medical preparations, pharmaceutical formulas, and medical preparations containing active ingredients, etc., and can solve problems such as slow onset of action

Active Publication Date: 2016-08-10
COSCI MED TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Imipramine, a central nervous system drug, not only has anticholinergic sympathomimetic effects, but also centrally inhibits the voiding reflex. It is recommended for mixed urgency-stress urinary incontinence. Disadvantages: slow onset, take for several weeks only after

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Embodiment 1: Darfinacine Sustained-release Tablets

[0024] Darfenacin

75.0g

sodium alginate

80.0g

Calcium hydrogen phosphate

37.0g

Povidone K30

7.0g

water

Appropriate amount

[0025] Magnesium stearate

1.0g

Co-made

1000 pieces

[0026] Preparation:

[0027] Mix the main ingredients in the prescription, sodium alginate, calcium hydrogen phosphate, and povidone K30, add water as a wetting agent, granulate, dry at 50°C, granulate with a 20-mesh sieve, add magnesium stearate, and compress into tablets.

Embodiment 2

[0028] Embodiment 2: Darfinacine Sustained-release Tablets

[0029] Darfenacin

10.0g

Chitosan

10.0g

carnauba wax

10.0

Calcium hydrogen phosphate

164.0g

Povidone K30

5.0g

water

Appropriate amount

Magnesium stearate

1.0g

Co-made

1000 pieces

[0030] Preparation:

[0031] 1. The main drug darfenacin is micronized, with a particle size of 10 μm;

[0032] 2. Mix the main ingredients in the prescription, chitosan, carnauba wax, calcium hydrogen phosphate, and povidone K30, then add water as a wetting agent, granulate, dry at 50°C, granulate with a 20-mesh sieve, and then add stearic acid Magnesium, compressed.

Embodiment 3

[0033] Embodiment 3: Darfinacine Sustained-release Tablets

[0034] Darfenacin

100.0g

Alginic acid

50.0g

microcrystalline cellulose

44.0g

Povidone K30

5.0g

water

Appropriate amount

Magnesium stearate

1.0g

Co-made

1000 pieces

[0035] Preparation:

[0036] 1. The main drug darfenacin is micronized, with a particle size of 10 μm;

[0037] 2. Mix the main ingredients in the prescription, alginic acid, microcrystalline cellulose, and povidone K30, add water as a wetting agent, granulate, dry at 50°C, granulate with a 20-mesh sieve, add magnesium stearate, and press into tablets .

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PUM

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Abstract

The present invention provides a darfinesine sustained-release preparation with good patient compliance, small side effects, long-lasting and stable drug effect and a preparation method thereof. The darfinesine sustained-release preparation includes a main drug and a pH-sensitive high molecular polymer. Further, when darfenacin and auxiliary materials are prepared into tablet cores or pellets, the high molecular polymer can be used as a coating layer material, as a sustained-release coating layer. The darfinacine sustained-release preparation also includes a hydrophobic matrix. The hydrophobic substance can be selected according to the requirements of the preparation, that is, it can be a filler, a lubricant, etc., or it can be a slow-release matrix material, and further, it can also control the release of darfinacine together with the high molecular polymer.

Description

technical field [0001] The invention relates to a darfinacine sustained-release preparation and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Overactive bladder (OAB) is a common disease, which is a syndrome with frequent urination, urgency and urge incontinence as the main symptoms. The Urinary Continence Group of the Urology Branch of the Chinese Medical Association defines Overactive Bladder Clinical Guidelines as: OAB is a symptom composed of frequent urination, urgency, and urge urinary incontinence. These symptoms can appear alone or in any combination. form appears. The etiology is still not very clear, it may be due to central inhibitory efferent pathways, peripheral sensory afferent pathways or damage to the bladder muscle itself, these reasons can exist alone or in combination. Causes of exercise urge incontinence include: 1. Urinary tract obstruction below the bladder; 2. Nervous syst...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/22A61K9/52A61K31/4025A61K47/32A61K47/34A61K47/36A61P13/10
Inventor 蒋海松王锦刚
Owner COSCI MED TECH CO LTD
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