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A kind of sustained-release preparation containing darfinacin hydrobromide and preparation method thereof

A technology of darfinacine hydrobromide and sustained-release preparations, which is applied in the directions of medical preparations containing active ingredients, medical preparations without active ingredients, and pill delivery, etc. Especially stable and other problems, to achieve the effect of good slow release effect, reduce the difficulty of preparation, and complete the effect

Active Publication Date: 2019-11-22
JIANGXI SHIMEI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the above method has achieved better bioavailability, the final in vitro release rate is slightly lower, and the blood drug concentration in the body is not particularly stable.

Method used

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  • A kind of sustained-release preparation containing darfinacin hydrobromide and preparation method thereof
  • A kind of sustained-release preparation containing darfinacin hydrobromide and preparation method thereof
  • A kind of sustained-release preparation containing darfinacin hydrobromide and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] A sustained-release composition preparation containing darfinen hydrobromide, comprising the following components:

[0031] Darfenacine hydrobromide 8.93g; Carbomer 1.0g; HPMC K4M 60.0g; Lactose 128.07g; Magnesium stearate 2g. A total of 1000 tablets were produced.

[0032] The preparation method of the preparation comprises the following steps: passing the darfenazine hydrobromide through a 100-mesh sieve, passing the sustained-release agent carbomer 974P and HPMC K4M, and the filling agent calcium phosphate through a 80-mesh sieve, and then mixing thoroughly and uniformly. Add the prescribed amount of magnesium stearate into the above mixture, continue to mix evenly, make f8mm shallow concave punched tablets, and use gastric soluble coating powder coating.

Embodiment 2

[0034] A sustained-release composition preparation containing darfinen hydrobromide, comprising the following components:

[0035] Darfenacine hydrobromide 8.93g; Carbomer 1.0g; HPMC K4M 68.93g; Microcrystalline cellulose 119.14g; Micropowder silica gel 2g. A total of 1000 tablets were produced.

[0036] The preparation method of the preparation comprises the following steps: passing the darfenazine hydrobromide through a 100-mesh sieve, passing the sustained-release agent carbomer 974P and HPMC K4M, and the filling agent calcium phosphate through a 80-mesh sieve, and then mixing thoroughly and uniformly. Add the prescribed amount of micro-powder silica gel to the above mixture, continue to mix evenly, and make f8mm shallow concave punched tablets, which are coated with gastric-soluble coating powder.

Embodiment 3

[0038] A sustained-release composition preparation containing darfinen hydrobromide, comprising the following components:

[0039] Darfenacine hydrobromide 17.86g; Carbomer 1.0g; HPMC K4M 50g; Dextrin 129.14g; Talc powder 2g. A total of 1000 tablets were produced.

[0040]The preparation method of the preparation comprises the following steps: passing the darfenazine hydrobromide through a 100-mesh sieve, passing the sustained-release agent carbomer 974P and HPMC K4M, and the filling agent calcium phosphate through a 80-mesh sieve, and then mixing thoroughly and uniformly. Add the prescribed amount of magnesium stearate into the above mixture, continue to mix evenly, make f8mm shallow concave punched tablets, and use gastric soluble coating powder coating.

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Abstract

The invention discloses a sustained-release preparation containing darifenacin hydrobromide and a preparation method of the sustained-release preparation. The sustained-release preparation consists of the following medicinal components in percentage by weight: 1-20% of the darifenacin hydrobromide, 0.1-0.9% of carbomer, 25-40% of hydroxypropyl methyl cellulose, 40-70% of a filler and 0.1-10% of a lubricant. On the basis of a synergistic effect generated from the combined use of two sustained-release agents, the sustained-release preparation provided by the invention can guarantee better release of medicines. According to the sustained-release preparation provided by the invention, a release curve of the medicines is adjusted by changing the overall level of polymers and the proportions of the two polymers, so that a prescription preparation process is larger in design space and the shortcoming of a narrow fluctuation window in the prescription due to the application of a single sustained-release agent is overcome. Moreover, it is accidentally discovered that the sustained-release preparation provided by the invention, after reaching a peak, is more stable than a darifenacin hydrobromide sustained-release preparation in the prior art in blood concentration.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a slow-release preparation containing darfenazine hydrobromide and a preparation method thereof. Background technique [0002] Darfenacine Hydrobromide Sustained-release Tablets are used for the treatment of overactive bladder (OAB) such as urinary incontinence, urgency and frequency. The US FDA approved Novartis Pharmaceuticals’ darfenacine hydrobromide on December 22, 2004. Sustained Release Tablets listed. Darfenacin plays a role by blocking the M3 receptor that mainly responds to bladder muscle contraction. It is a potent muscarinic receptor blocker, which helps to reduce the incidence of urinary incontinence, increase bladder urine storage, and reduce the frequency of urination And reduce pressure and urgency to urinate. The M3 effect of darfenacine hydrobromide is unique among all OAB treatment drugs. It is made into sustained-release tablets to st...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/22A61K31/4025A61K47/32A61K47/38A61P13/00A61P13/10
CPCA61K9/0002A61K9/2027A61K9/2054A61K9/2806A61K31/4025
Inventor 江鸿吕传涛李冉厉建超王宪磊闵清
Owner JIANGXI SHIMEI PHARM CO LTD
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