Diphenhydramine citrate orally disintegrating tablet and preparation method thereof

A technology of diphenhydramine citrate and orally disintegrating tablets is applied in pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc., and can solve the problems of small first-pass effect, etc. High bioavailability, easy operation and low cost effect

Inactive Publication Date: 2012-05-09
SOUTHWEST UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, most of diphenhydramine is metabolized and converted by the liver after oral administration, and the first-pass effect is obvious, and about 50% of it is metabolized before the systemic circulation. Therefore, it is necessary to develop a diphenhydramine with small first-pass effect and high bioavailability Preparations, easy to store, carry, and take at the same time, and patients have good medication compliance

Method used

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  • Diphenhydramine citrate orally disintegrating tablet and preparation method thereof
  • Diphenhydramine citrate orally disintegrating tablet and preparation method thereof
  • Diphenhydramine citrate orally disintegrating tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] prescription:

[0026]

[0027] Preparation:

[0028] Crush each component in the prescription into a fine powder passing through a 100-mesh sieve, take the prescribed amount of diphenhydramine citrate and all the excipients except magnesium stearate, mix them evenly, and then add the prescribed amount of magnesium stearate , mix evenly, control the tablet hardness to be 7±2N and compress the tablet to obtain diphenhydramine citrate orally disintegrating tablets, each containing 19 mg of diphenhydramine citrate.

Embodiment 2

[0030] prescription:

[0031]

[0032] Preparation:

[0033] Grind each component in the prescription into fine powder passing through a 100-mesh sieve, take the prescribed amount of diphenhydramine citrate and stevioside, mix them evenly, and then add the prescribed amount of mannitol, lactose, microcrystalline cellulose and cross-linked Lipovidone, mix evenly, use ethanol solution with a volume fraction of 50% as a wetting agent to make a soft material, granulate with a 30-mesh sieve, ventilate and dry at 50-55°C, and granulate with a 30-mesh sieve. Add acid, sodium bicarbonate, orange essence and micropowder silica gel to the dry granules, mix evenly, then add the prescribed amount of magnesium stearate, mix evenly, control the tablet hardness to 7±2N, and press the tablet to obtain benzene citrate Diphenhydramine orally disintegrating tablets, each containing 19mg of diphenhydramine citrate.

Embodiment 3

[0035] prescription:

[0036]

[0037] Preparation:

[0038] Grind each component in the prescription into fine powder passing through a 100-mesh sieve, take the prescribed amount of diphenhydramine citrate and aspartame, mix them evenly, then add the prescribed amount of mannitol and erythritol, and two Mix microcrystalline cellulose and cross-linked povidone one-half of the prescription amount evenly, use ethanol solution with a volume fraction of 50% as a wetting agent to make a soft material, granulate with a 30-mesh sieve, and ventilate and dry at 50-55°C. Sieve the 30-mesh granule, add the remaining prescription amount of microcrystalline cellulose and crospovidone, and the prescription amount of citric acid, sodium bicarbonate, lemon essence and talcum powder into the dry granules, mix well, and then add the prescription amount of magnesium stearate, mixed uniformly, and controlled tablet hardness is 7 ± 2N tabletting, promptly obtains diphenhydramine citrate orally...

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Abstract

The invention discloses a diphenhydramine citrate orally disintegrating tablet, the prescription is composed by the following components in mass percent: 19% of diphenhydramine citrate, 45 swung dash 58% of filler, 15 swung dash 25% of disintegrating agent, 4 swung dash 8% of effervescent disintegrant, 0.5 swung dash 1% of lubricant, 1 swung dash 3% glidant, 1 swung dash 2% of sweetner, 0.2swung dash 0.6% aromatic and 0 swung dash 0.5% of surfactant, wherein the filler uses mannitol, or mannitol and lactose or erythritol, the disintegrating agent uses any one of polyplasdone, crosslinking sodium carboxy methyl cellulose and low substitution hydroxyl propyl cellulose together with microcrystalline cellulose, the effervescent disintegrant comprises citric acid and sodium bicarbonate which have the mass ratio of 1 swung dash 2 / 1, the lubricant is magnesium stearate, the glidant is aerosil or talcum powder, the sweetner is aspartame or stevia rebaudianum, the aromatic is the pharmaceutically acceptable essence, and the surfactant is lauryl sodium sulfate; and the invention further discloses a preparation method of the orally disintegrating tablet, which is simple to operate, the cost is low, the obtained product is in accordance with the quality requirement of the orally disintegrating tablet, and has attractive appearance, good taste and stable quality.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, relates to an orally disintegrating tablet, and also relates to a preparation method of the orally disintegrating tablet. Background technique [0002] Diphenhydramine is an H1 receptor antagonist, which can antagonize the effect of histamine on blood vessels, gastrointestinal tract and bronchial smooth muscle, and eliminate various allergic symptoms, but it cannot antagonize the secretion of gastric juice by histamine; it has strong central nervous system inhibition It has the effect of sedation and hypnosis; it has anticholinergic effect, which can relieve bronchospasm; it also has local anesthetic effect and antiemetic effect. It is commonly used clinically for skin and mucous membrane allergy diseases such as hay fever, urticaria, allergic dermatitis, hay fever, angioedema and skin itching, etc. It can also inhibit vomiting caused by radiotherapy, surgery, drugs and motion sickness,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/135A61K47/38A61P1/08A61P17/00A61P17/04A61P21/00A61P25/14A61P25/18A61P25/20A61P37/08
Inventor 李逐波陈立何小燕左华胡默刘天亮刘晓华
Owner SOUTHWEST UNIV
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