Alfuzosin hydrochloride sustained release preparation and preparation method thereof

A technology of alfuzosin hydrochloride and alfuzosin hydrochloride, which is applied in the field of alfuzosin hydrochloride sustained-release preparations and its preparation, can solve the problems of difficult medication for patients, poor release effect, low uniformity of stability and content, etc. Achieve the effect of improving the uniformity of drug content, improving drug stability, and wide application

Active Publication Date: 2022-03-22
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In order to overcome the deficiencies of the prior art, the first object of the present invention is to provide a sustained-release preparation of alfuzosin hydrochloride with high stability, excellent release effect and high content uniformity, which adopts the synergistic control of skeleton type and membrane control type , is conducive to the release of drugs, avoids the peak-valley phenomenon of blood drug concentration, makes alfuzosin hydrochloride achieve the effect of sustained release, and solves the problems of poor release effect, low stability and content uniformity, and difficult medication for some patients. Improve the safety and effectiveness of the drug, increase the scope of application of the drug, and have good reproducibility of the release curve, suitable for large-scale industrial production

Method used

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  • Alfuzosin hydrochloride sustained release preparation and preparation method thereof
  • Alfuzosin hydrochloride sustained release preparation and preparation method thereof
  • Alfuzosin hydrochloride sustained release preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Embodiment 1: 20000 tablets

[0030] Prescription of pellets

[0031]

[0032]

[0033] Micropellet preparation method:

[0034] (1) Soft material: Pre-dissolve alfuzosin hydrochloride in purified water, mix the filler, lubricant, and stabilizer in a granulator first, mix, then add the solution containing the raw materials, and then add the slow-release Skeleton material, plasticizer, appropriate amount of purified water, and granulation to obtain a suitable soft material;

[0035] (2) extrude: pour the soft material obtained in the step (1) into an extruder and extrude to obtain broken particles;

[0036] (3) Spheronization: Pour the granules obtained in step (2) into a spheronizer for spheronization, the rotating speed of the turntable is 100rmp, 10min;

[0037] (4) Drying: drying the wet pellets obtained in step (3) in a drying oven to obtain dry pellets;

[0038] (5) Coating: prepare coating liquid coating, coating weight gain is 4%;

[0039] (6) Pellet c...

Embodiment 2

[0043] Embodiment 2: 50000 pieces

[0044]

[0045]

[0046] Pellet prescription and preparation process are the same as embodiment 1

[0047] Pellet compression:

[0048] components Content (g) Pellets 152 Microcrystalline Cellulose 102 82 Sodium carboxymethyl starch 28 colloidal silica 4 Calcium stearate 9 sucrose 25

[0049] Preparation method: with the preparation method of embodiment 1.

Embodiment 3

[0050] Embodiment 3: 20000 pieces

[0051] Prescription of pellets

[0052]

[0053] Preparation process is with embodiment 1

[0054] Pellet compression:

[0055]

[0056]

[0057] Preparation method: with the preparation method of embodiment 1.

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Abstract

The invention belongs to the field of sustained release preparations, and particularly relates to an alfuzosin hydrochloride sustained release preparation and a preparation method thereof. The alfuzosin hydrochloride sustained-release preparation provided by the invention comprises a drug-loaded pellet, a sustained-release coating layer and a pharmaceutic adjuvant layer, and the drug-loaded pellet comprises alfuzosin hydrochloride, a filler, a plasticizer, a sustained-release framework material, a lubricant and a stabilizer; the sustained-release coating layer comprises a film-forming material, a plasticizer, a lubricant and purified water. The pharmaceutic adjuvant layer comprises a filling agent, a disintegrating agent, a flavoring agent, a lubricating agent and a flow aid. The preparation of the alfuzosin hydrochloride orally disintegrating tablet has the characteristics that the alfuzosin hydrochloride orally disintegrating tablet can be disintegrated or dissolved without water in the oral cavity, has the characteristics of convenience in taking, quick absorption and high bioavailability, and can improve the medication compliance of patients and increase the clinical medication choices of doctors for different patients.

Description

technical field [0001] The invention belongs to the field of sustained-release preparations, in particular to an alfuzosin hydrochloride sustained-release preparation and a preparation method thereof. Background technique [0002] Prostatic hyperplasia (BPH), also known as benign prostatic hypertrophy, is one of the common diseases of middle-aged and elderly men. Its cause is related to the imbalance of androgen and estrogen in the human body. The lesion originates from the glandular tissue, connective tissue, and smooth muscle tissue of the middle lobe or lateral lobe under the posterior urethral mucosa, forming a mixed spherical nodule. The hyperplasia of both lobes and middle lobes is obvious, protruding into the bladder or urethra, compressing the bladder neck or urethra, causing lower urinary tract obstruction [0003] Alfuzosin hydrochloride (AlfuzosineHCl) is a powerful blocker of alpha adrenergic receptors and is a widely used preparation for the treatment of benign...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/517A61K47/38A61K47/26A61K47/36A61K47/14A61P13/08
CPCA61K9/2095A61K9/2054A61K9/205A61K9/2018A61K9/2013A61K31/517A61P13/08
Inventor 张贵民王宜尚刘阿利亓凤刘月静
Owner SHANDONG NEWTIME PHARMA
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