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Nebivolol hydrochloric acid orally disintegrating tablet and preparation method thereof

A technology of nebivolol hydrochloride oral cavity and nebivolol hydrochloride, which is applied in the direction of pharmaceutical formulations, medical preparations containing active ingredients, pill delivery, etc., and can solve the problem of nebivolol hydrochloride having peculiar smell and long dissolution time Absorption, inconvenient use and other problems, to achieve good taste, improve bioavailability, improve compliance

Inactive Publication Date: 2009-02-11
刘全胜
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] But present nebivolol hydrochloride tablet, except that dissolving time is long and difficult to absorb, because nebivolol hydrochloride has peculiar smell, so mouthfeel is also bad
It needs to be taken with water when taking it, so it is inconvenient for middle-aged and elderly patients, patients with drinking water and swallowing difficulties, and those who are inconvenient to get water when traveling

Method used

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  • Nebivolol hydrochloric acid orally disintegrating tablet and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Preparation of Nebivolol Hydrochloride Orally Disintegrating Tablets

[0032] Raw material name dosage

[0033] Nebivolol Hydrochloride 5.0g

[0034] Mannitol 84.5g

[0035] Aspartame 1.5g

[0036] Menthol 1.0g

[0037] Chocolate Powder Flavor 1.0g

[0038] Low-substituted hydroxypropyl cellulose 6.0g

[0039] Magnesium Stearate 1.0g

[0040] Preparation method: Weigh nebivolol hydrochloride, mannitol, aspartame, menthol, and chocolate powder essence passed through a 100-mesh sieve, mix well, add appropriate amount of water to make 20-mesh granules, and place in an oven at 60°C Dry for 3 to 4 hours, take the dry granules, add the prescribed amount of low-substituted hydroxypropyl cellulose and magnesium stearate, mix evenly, and press 1000 tablets to get the product.

Embodiment 2

[0042] Preparation of Nebivolol Hydrochloride Orally Disintegrating Tablets

[0043] Raw material name dosage

[0044] Nebivolol Hydrochloride 7.5g

[0045] Lactose 80.0g

[0046] Aspartame 0.8g

[0047] Menthol 1.3g

[0048] Apple Powder Flavor 1.0g

[0049] Low-substituted hydroxypropyl cellulose 6.0g

[0050] Sodium carboxymethyl starch 2.6g

[0051] Magnesium stearate 0.8g

[0052] Preparation method: Weigh nebivolol hydrochloride, lactose, aspartame, menthol, and apple powder essence passed through a 100-mesh sieve, mix well, add appropriate amount of water to make 20-mesh granules, and dry in an oven at 60°C After 3 to 4 hours, take the dry granules, add the prescribed amount of low-substituted hydroxypropyl cellulose, sodium carboxymethyl starch, and magnesium stearate, mix evenly, and press 1000 tablets to obtain.

Embodiment 3

[0054] Preparation of Nebivolol Hydrochloride Orally Disintegrating Tablets

[0055] Name Dosage

[0056] Nebivolol Hydrochloride 7.5g

[0057] Erythrose 160.0g

[0058] Aspartame 2.0g

[0059] Menthol 1.0g

[0060] Sweet Orange Flavor 1.5g

[0061] Sodium carboxymethyl starch 8.5g

[0062] Microcrystalline Cellulose 18.0g

[0063] Magnesium Stearate 1.5g

[0064] Preparation method: Weigh nebivolol hydrochloride, erythrose, aspartame, menthol, and sweet orange flavor through a 100-mesh sieve, mix well, add 5% polyvinylpyrrolidone ethanol solution to make 20-mesh granules , placed in an oven at 60°C to dry for 3 to 4 hours, take the dry granules, add the prescribed amount of sodium carboxymethyl starch, microcrystalline cellulose and magnesium stearate, mix evenly, and press 1000 tablets to get the product.

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Abstract

The invention discloses a Nebivolol HCL orally disintegrating tablet, which comprises the following components by weight: 3.7-7.5 percent of Nebivolol HCL, 75.0-85.0 percent of water-solubility bulking agent, 6.0-15.5 percent of disintegrant, 2.0-3.5 percent of disguising odor and 0.7-1.5 percent of lubricant.

Description

technical field [0001] The invention relates to a medicine, which belongs to the field of medicine, in particular to a nebivolol hydrochloride tablet. Background technique [0002] Nebivolol hydrochloride (Hydrochloride Nebivolol) is a new type of antihypertensive drug, is a selective β1 receptor blocker with vasodilator effect, and is currently on the market abroad. Its chemical name is: bis[2-(6-fluorochroman-2-yl)-2-hydroxyethyl]amine hydrochloride. [0003] The structure and molecular weight of nebivolol hydrochloride are as follows: [0004] [0005] Molecular formula: C 22 h 25 f 2 NO 4 • HCl. [0006] Nebivolol hydrochloride is a fat-soluble selective beta 1 Receptor blockers are clinically used in the treatment of essential hypertension, and can also be used in the treatment of chronic heart failure. Nebivolol is a new, potent and selective third-generation receptor blocker. It can increase the level of nitric oxide and has a vasodilation effect. selecti...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/353A61P9/12
Inventor 曹俊伍曾利刘全胜马明
Owner 刘全胜
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