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Preparation method of paracetamol pseudoephedrine hydrochloride and cholrphenamine maleate oral disintegration tablet

The technology of oral disintegrating tablets and paracetamol is applied in the field of preparation of oral disintegrating tablets of paracetamol and pseudomanramine, which can solve the problems of large difference in specific gravity, poor fluidity, unqualified content uniformity of tablets and the like, and achieves good uniformity. , the effect of high bioavailability

Inactive Publication Date: 2006-07-19
HONGGUAN BIO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the published Shuangpu pseudoma oral disintegrating tablet and its preparation method patent (CN200310121987.4), the method of powder direct compression is used for preparation. According to the test, it is found that the process has the following disadvantages: (1) the acetyl Aminophenol occupies a relatively large proportion in the prescription, and the fluidity of this material is poor, and the proportion of the other raw and auxiliary materials in the prescription is quite different. If direct powder compression is used without preparing granules, tablet compression may occur during large-scale production. (2) The three main ingredients of acetaminophen, pseudoephedrine hydrochloride and chlorpheniramine all have different degrees of bad bitterness, and account for more than half of the prescription amount, and only rely on adding taste Better fillers and flavors are not enough to mask the bitter taste in the mouth, so that the benefits of the formulation are not fully realized

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Mix 80g of acetaminophen and 125g of powdered mannitol evenly, use 5% hydroxypropyl methylcellulose aqueous solution as a binder in an appropriate amount to make granules and place them in a fluidized bed; mix 7.5g of pseudoephedrine hydrochloride, maleic acid Dissolve 0.5g of chlorpheniramine in anhydrous ethanol-2% hydroxypropyl methylcellulose aqueous solution (volume ratio 1:1), mix well and spray on the acetaminophen granules, stir well and spray the package On the paracetamol granules, and then coated with acrylic resin Eudragit E100 dispersion to obtain 275g of taste-masking granules below 450μm, then add 65g of mannitol (500DC), 57g of sorbitol, 20g of sodium carboxymethyl starch, Mix 3g of aspartame and 1.2g of flavor evenly, then add 1.5g of magnesium stearate, mix well and press into tablets to make 1000 tablets, each weighing 422.7mg, which contains 275mg of coated taste-masking granules of active ingredients of the drug, Excipients 147.7mg.

Embodiment 2

[0022] Mix 160g of acetaminophen and 250g of powdered mannitol evenly, use an appropriate amount of 5% hydroxypropyl methylcellulose aqueous solution as a binder to make granules and place them in a fluidized bed; Dissolve 1 g of pheniramine in anhydrous ethanol-2% hydroxypropyl methylcellulose aqueous solution (volume ratio 1:1), stir evenly, and then spray it on the paracetamol granules, then use 5% ethyl cellulose Coating with plain ethanol solution to obtain 490g of taste-masking granules below 450μm, then add 735g of mannitol (500DC), 112g of cross-linked polyvinylpyrrolidone, 14g of AK sugar and mix well, then add 14g of magnesium stearate and 7g of micropowder silica gel and mix well After compression, 1000 tablets were made, each weighing 1372 mg, which contained 490 mg of the active ingredient coating and taste-masking granules, and 882 mg of auxiliary materials.

Embodiment 3

[0024] Acetaminophen 160g, pseudoephedrine hydrochloride 15g, chlorpheniramine maleate 1g, obtain 490g of taste-masking particles below 450 μm with the method of Example 2, then add MicroceLac  60g, 136g of mannitol (500DC), 20g of sodium carboxymethyl starch, 10g of cross-linked polyvinylpyrrolidone, 5g of aspartame, 2.5g of essence, mix well, then add 2.5g of sodium stearyl fumarate, mix well and press into tablets , made into 1000 tablets, each weighing 726mg, which contains 490mg of coated taste-masking granules of active pharmaceutical ingredients and 236mg of auxiliary materials.

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Abstract

The invention provides a process for preparing paracetamol pseudoephedrine hydrochloride and chlorphenamine malease orally disintegrating tablets, mixing paracetamol with bulking agent for granulating, making solution from pseudoephedrine hydrochloride, chlorphenamine maleate and spray packaging material, coating onto obtained paracetamol particles, then dressing to obtain flavor masked particles, finally mixing the particles with other adjuvant and tabletting.

Description

(1) Technical field [0001] The invention relates to a preparation method of an orally disintegrating tablet of acetaminophen pseudoanamin for treating common cold or influenza. (2) Background technology [0002] Most of the currently commercially available preparations for the treatment of common cold or influenza symptoms need to be taken with water, which is often very inconvenient; orally disintegrating tablets are a new type of dosage form. However, it disintegrates quickly when it encounters saliva in the mouth, and enters the stomach with the swallowing action, which can greatly improve the efficacy (bioavailability), especially for the elderly, children and the environment where water is inconvenient. Convenience, which can improve the compliance of patients taking medicine. Therefore, the preparation has a certain market advantage over similar products and has broad application prospects. [0003] The new dosage form of orally disintegrating tablets mainly involves...

Claims

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Application Information

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IPC IPC(8): A61K31/4402A61K9/20A61P31/00
Inventor 阮剑山郭殿武吴春霞
Owner HONGGUAN BIO PHARMA CO LTD
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