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Doxazosin mesylate sustained release tablet and preparation method thereof

A technology of doxazosin mesylate and sustained-release tablets, which is applied in the fields of pharmaceutical formulation, drug delivery, metabolic diseases, etc., can solve the problems of restricting large-scale production, complex production process, and high equipment requirements, so as to reduce side effects and overcome The production process is complicated and the effect of eliminating the peak and valley phenomenon

Inactive Publication Date: 2016-01-06
LIAONING YAOLIAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] However, the "Keduohua" controlled-release preparation adopts a double-layer tablet core structure with a booster layer. Due to the difficulty of this technology, the production process is complicated and the equipment requirements are high, which restricts large-scale production.

Method used

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  • Doxazosin mesylate sustained release tablet and preparation method thereof
  • Doxazosin mesylate sustained release tablet and preparation method thereof
  • Doxazosin mesylate sustained release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] prescription composition

[0033]

[0034] Preparation:

[0035] The crude drug is crushed through a 100-mesh sieve, and the tablet core excipients are passed through an 80-mesh sieve. Weigh the excipients of the tablet core according to the prescription ratio, mix them uniformly, and then compress the tablet to obtain the doxazosin mesylate tablet, ie the tablet core.

[0036] Add PEG6000 and talcum powder into purified water, homogenize for 10 minutes with a high-shear homogenizer, slowly add the talc powder suspension into the polyacrylic acid resin aqueous dispersion, and at the same time stir with a mixer at a medium speed, and mix The suspension is filtered with a 40-mesh sieve to obtain a sustained-release coating solution. Coat the plain tablet with a coating pan, dry it, and increase the weight of the coating by 3.5% to 4.5%.

Embodiment 2

[0038] prescription composition

[0039]

[0040] Preparation:

[0041] The preparation method of doxazosin mesylate sustained-release tablets is the same as in Example 1.

Embodiment 3

[0043] prescription composition

[0044]

[0045] Preparation:

[0046] The tablet core preparation method is the same as in Example 1.

[0047] Take 45% of the water in the formula and heat it to 70-80°C; add Tween 80, triethyl citrate and glyceryl monostearate to the hot water, and use a high-shear homogenizer to homogenize for 10 minutes. Add the remaining water to the emulsion and keep stirring to cool to room temperature; slowly pour the suspension into the polyacrylic resin water dispersion, and stir at a medium speed with an ordinary mixer at the same time; filter the suspension with a 40-mesh sieve, Sustained-release coating solution was prepared. Coat the plain tablets with a coating pan, dry, and increase the weight of the coating by 1.5% to 2.5%.

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Abstract

The invention discloses a doxazosin mesylate sustained release tablet and a preparation method thereof. The doxazosin mesylate sustained release tablet contains doxazosin mesylate and pharmaceutically acceptable auxiliary materials, and comprises a tablet core and a sustained release coating, wherein the tablet core comprises a hydrophilic gel framework material and an acidifying agent, the hydrophilic gel framework material accounts for 5-25 percent, and the acidifying agent accounts for 10-30 percent; and the weight of the sustained coating layer is 1-5 percent of that of the tablet core. The prepared doxazosin mesylate sustained release tablet can well control release of doxazosin mesylate, has similar release curves to 'cardura XL' in different dissolution media, is not interfered and influenced by the pH of stomach and intestine, enables the plasma concentration to be stable, eliminates a peak-valley phenomenon, effectively reduces side effects and the dosage frequency, improves the compliance of patients and meets the clinical medication requirements.

Description

technical field [0001] The invention relates to pharmaceutical preparation technology, in particular to an oral doxazosin mesylate sustained-release tablet and a preparation method thereof. Background technique [0002] Doxazosin Mesylate is a selective alpha 1 Adrenergic receptor blockers are mainly used in the treatment of benign prostatic hyperplasia and high blood pressure. Its structural formula is shown below. [0003] [0004] Doxazosin mesylate causes peripheral vasodilation by blocking the post-synaptic α1 adrenergic receptors, decreases peripheral resistance and lowers blood pressure; the other α 1 Adrenergic receptor blockade can relax bladder neck, prostate, and prostate capsule smooth muscle, thereby reducing urethral resistance, pressure, and bladder resistance, and is used to treat benign prostatic hyperplasia; in addition, this drug can slightly reduce total cholesterol, lower Density lipoprotein cholesterol and triacylglycerols stimulate lipoproteinase...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K9/32A61K31/517A61P9/12A61P13/08A61P3/06
Inventor 陶闰红毕洪书梁胜男
Owner LIAONING YAOLIAN PHARMA
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