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Preparation method of diclofenac sodium orally disintegrating tablet

A technology of diclofenac sodium and orally disintegrating tablets, which is applied in the directions of non-active ingredients medical preparations, medical preparations containing active ingredients, and pharmaceutical formulas, can solve problems such as gastric irritation and injury, and achieve fast disintegration speed and no Foreign body sensation, effect of small amount of related substances

Inactive Publication Date: 2015-05-06
孟红琳
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, since long-term use of diclofenac sodium can cause certain irritation and damage to the stomach, it is particularly important to provide a preparation that can avoid disintegration and release in the stomach

Method used

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  • Preparation method of diclofenac sodium orally disintegrating tablet

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] The preparation method of diclofenac sodium orally disintegrating tablet comprises the steps:

[0022] Step 1, coating for the first time: by weight, get 2 parts of diclofenac sodium, 10 parts of dipalmitoylphosphatidylcholine, 1 part of hydroxypropyl methylcellulose, 2 parts of isosorbide mononitrate, respectively Pass through an 80 mesh sieve, then dissolve in 30 parts of ethanol aqueous solution with a volume content of 50%, spray the mixed solution on the blank pellet core in an inverted conical stainless steel fluidized bed, coat and dry, and the bed layer of the fluidized bed The temperature is 35°C, the fluidization gas velocity is 1.5m / s, the flow velocity of the feed liquid is: 1.0ml / min, and the atomization pressure is 0.25MPa; continue to keep warm for 10min after the coating is completed;

[0023] Step 2, the second coating: Dissolve 10 parts of hydroxyethyl methylcellulose in 30 parts of ethanol aqueous solution, spray the first coating product in an invert...

Embodiment 2

[0027] The preparation method of diclofenac sodium orally disintegrating tablet comprises the steps:

[0028] The first step, coating for the first time: by weight, get 8 parts of diclofenac sodium, 15 parts of dipalmitoylphosphatidylcholine, 3 parts of hydroxypropyl methylcellulose, 4 parts of isosorbide mononitrate, respectively Pass through an 80 mesh sieve, then dissolve in 50 parts of ethanol aqueous solution with a volume content of 70%, spray the mixed solution on the blank pellet core in an inverted conical stainless steel fluidized bed, coat and dry, and the bed layer of the fluidized bed The temperature is 35°C, the fluidization gas velocity is 1.5m / s, the flow velocity of the feed liquid is: 1.0ml / min, and the atomization pressure is 0.25MPa; continue to keep warm for 10min after the coating is completed;

[0029] Step 2, the second coating: Dissolve 15 parts of hydroxyethyl methylcellulose in 50 parts of ethanol aqueous solution, spray the first coating product in ...

Embodiment 3

[0033] The preparation method of diclofenac sodium orally disintegrating tablet comprises the steps:

[0034] The first step, coating for the first time: by weight, get 4 parts of diclofenac sodium, 13 parts of dipalmitoylphosphatidylcholine, 2 parts of hydroxypropyl methylcellulose, 3 parts of isosorbide mononitrate, respectively Pass through an 80 mesh sieve, then dissolve in 40 parts of ethanol aqueous solution with a volume content of 60%, spray the mixed solution on the blank pellet core in an inverted conical stainless steel fluidized bed, coat and dry, and the bed layer of the fluidized bed The temperature is 35°C, the fluidization gas velocity is 1.5m / s, the flow velocity of the feed liquid is: 1.0ml / min, and the atomization pressure is 0.25MPa; continue to keep warm for 10min after the coating is completed;

[0035] Step 2, the second coating: dissolve 12 parts of hydroxyethyl methylcellulose in 40 parts of ethanol aqueous solution, spray the first coating product in ...

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Abstract

The invention relates to a preparation method of a diclofenac sodium orally disintegrating tablet and belongs to the technical field of pharmaceutical preparations. The preparation method comprises the following steps: respectively sieving diclofenac sodium, phospholipid, hydroxypropyl methyl cellulose and isosorbide mononitrate and then dissolving in an ethanol aqueous solution, atomizing a hollow pill core by the mixed solution and drying the coating; dissolving hydroxyethyl methylcellulose in the ethanol aqueous solution, atomizing the first coating product and drying the coating; dissolving acrylic resin in ethanol, atomizing the second coating product and drying; uniformly mixing the third coating product with a filler and a disintegrating agent, mixing with a lubricant, and sieving and tabletting to obtain the tablet. The diclofenac sodium orally disintegrating tablet is prepared by way of coating for three times. By adding phospholipid, the tablet is quick in disintegrating speed in oral cavity, free of foreign body sensation, good in troche stability, and small in amount of related substances after long-term storage.

Description

technical field [0001] The invention relates to a preparation method of diclofenac sodium orally disintegrating tablets, belonging to the technical field of pharmaceutical preparations. Background technique [0002] The China Non-Prescription Association recently announced that "pain" is one of the important diseases that affect the lives and work of ordinary people in our country. Among them, the incidence rate of muscle pain and joint pain over the age of 45 exceeds 58%. In order to arouse the attention of the whole society to the harm of pain, the International Pain Society designates October 11th as "Pain Day". At present, non-steroidal anti-inflammatory drugs, which have antipyretic, analgesic and anti-inflammatory properties in one analgesic class, occupy an important and preferred position in the treatment of pain. Such as: ibuprofen, naproxen, fenbid, diclofenac sodium, etc. Diclofenac sodium is a cyclooxygenase inhibitor, which can relieve pain by inhibiting the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/196A61K47/24A61P29/00
Inventor 孟红琳
Owner 孟红琳