CN1698607A - Paracetamol pseudoephedrine hydrochloride and cholrphenamine maleate oral cavity disintegration tablet for treating cold and preparation method thereof - Google Patents

Paracetamol pseudoephedrine hydrochloride and cholrphenamine maleate oral cavity disintegration tablet for treating cold and preparation method thereof Download PDF

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Publication number
CN1698607A
CN1698607A CN 200410038987 CN200410038987A CN1698607A CN 1698607 A CN1698607 A CN 1698607A CN 200410038987 CN200410038987 CN 200410038987 CN 200410038987 A CN200410038987 A CN 200410038987A CN 1698607 A CN1698607 A CN 1698607A
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CN
China
Prior art keywords
oral cavity
disintegration tablet
cavity disintegration
tablet according
medicine
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Application number
CN 200410038987
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Chinese (zh)
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CN100427088C (en
Inventor
张莉
阮剑山
郭殿武
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Guangzhou Ren Heng Pharmaceutical Technology Co., Ltd
Original Assignee
Hangzhou Minsheng Pharmaceutical Co Ltd
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Priority to CNB2004100389872A priority Critical patent/CN100427088C/en
Publication of CN1698607A publication Critical patent/CN1698607A/en
Application granted granted Critical
Publication of CN100427088C publication Critical patent/CN100427088C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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  • Medicinal Preparation (AREA)

Abstract

The invention is related to a compound preparation for treating common cold, i.e. paracetamol pseudoephedrine hydrochloride and chlorphenamine maleate orally disintegrating tablet, and its preparing process, wherein the orally disintegrating tablet is prepared from principal ingredients and several subsidiary materials through the conventional compressing technique, its advantages include no requirement of administration with water, easy administration, quick disintegration in oral cavity when contacting saliva, thus facilitating patients with dysphagia, difficulty of fetching water and busy work, especially suitable for children and the elderly.

Description

Paracetamol pseudoephedrine hydrochloride and cholrphenamine maleate oral disintegration tablet of treatment flu and preparation method thereof
Technical field
The present invention relates to a kind of compound medicine novel form of pharmaceutical, particularly treatment common cold or grippal paracetamol pseudoephedrine hydrochloride and cholrphenamine maleate oral disintegration tablet and preparation method thereof.
Background technology
The commercially available preparation that is used for the treatment of common cold or influenza symptom need be used water delivery service mostly when taking at present, and is usually very inconvenient; The present invention is a kind of novel dosage form, though adopt common sheeting equipment and preparation technology, has certain rigidity, but after putting into the oral cavity and running into saliva is rapid disintegrate, go into the stomach onset with swallowing act, it is very convenient that this can improve under the environment of drug effect (bioavailability), especially old man, child and water intaking inconvenience medication greatly, from and can improve the compliance that the patient takes medicine.Therefore, said preparation has certain market advantage than like product, is with a wide range of applications.
Summary of the invention
The object of the present invention is to provide a kind of oral cavity disintegration tablet that contains multiple active constituents of medicine and preparation method thereof, this sheet adopts common sheeting equipment and easy manufacture technology, have certain rigidity, can satisfy the requirement of production, packing, accumulating, have good mouthfeel simultaneously again.
Technical solution of the present invention is:
A kind of that quick oral cavity disintegration tablet of the pseudo-fiber crops of compound paracetamol for the treatment of and alleviating common cold or influenza symptom is made up of principal agent and adjuvant, wherein:
Acetaminophen: 15%~40%
Pseudoephedrine hydrochloride: 0.1%~10%
Chlorphenamine maleate: 0.01%~5%
Filler: 5%~70%
Disintegrating agent: 1%~15%
Correctives: 1%
Lubricant: 0.5%
The method for preparing that quick oral cavity disintegration tablet of the pseudo-fiber crops of compound compound paracetamol is:
Take by weighing the active constituents of medicine of ormal weight, mix homogeneously is after the adding suitable quantity of water is granulated, with Eudragit E 100 dispersions granule is carried out the taste masking Cotton seeds, obtain the following taste masked particle of 450 μ m, then with above-mentioned all the other adjuvant mix homogeneously, tabletting, packing behind the adding lubricant.
Oral cavity disintegration tablet provided by the invention, each active component content uniformity is better, need not to use water delivery service, disintegrate in 5~50 seconds in the oral cavity, no sand type in the oral cavity, bioavailability is higher, is particularly useful for the patient of infant and child, old people and water intaking inconvenience.
The specific embodiment
Enumerate three embodiment below, the present invention is further specified.
Embodiment 1
With acetaminophen 80g, pseudoephedrine hydrochloride 7.5g, chlorphenamine maleate 0.5g mix homogeneously, after adding the suitable quantity of water granulation, with the strange E100 dispersion of acrylic resin You Te coating, obtain the following taste masked particle 145g of 450 μ m, add mannitol 65g, sorbitol 57g, carboxymethyl starch sodium 20g, aspartame 3g, essence 1g mix homogeneously then, add sodium stearyl fumarate 1.5g again, tabletting behind the mixing, make 1000, every heavy 292.5mg, wherein contain medicine active component coating taste masked particle 145mg, adjuvant 147.5mg.
Embodiment 2
Acetaminophen 160g, pseudoephedrine hydrochloride 15g, chlorphenamine maleate 1g mix homogeneously obtain taste masked particle 264g below the 450 μ m with embodiment 1 method, add StarLac then 90g, mannitol 204g, crospolyvinylpyrrolidone 30g, aspartame 6g, essence 3g mix homogeneously, add tabletting behind the sodium stearyl fumarate 3g mixing again, make 1000, every heavy 600mg, wherein contain medicine active component coating taste masked particle 264mg, adjuvant 336mg.
Embodiment 3
Acetaminophen 160g, pseudoephedrine hydrochloride 15g, chlorphenamine maleate 1g mix homogeneously obtain taste masked particle 264g below the 450 μ m with embodiment 1 method, add MicroceLac then 60g, mannitol 136g, carboxymethyl starch sodium 20g, crospolyvinylpyrrolidone 10g, aspartame 5g, essence 2.5g mix homogeneously, add tabletting behind the sodium stearyl fumarate 2.5g mixing again, make 1000, every heavy 500mg, wherein contain medicine active component coating taste masked particle 264mg, adjuvant 236mg.
More than the disintegration time of three made slice, thin pieces of embodiment be respectively 28 seconds, 40 seconds, 36 seconds; The dissolution in vitro of slightly solubility component acetaminophen (changeing the basket method) data are respectively: 45min stripping 90.6%, 88.5%, 89.9% respectively.
Product of the present invention is mainly used in treatment and alleviates the symptoms such as heating, headache, extremities aching pain, sneeze, rhinorrhea, nasal obstruction, cough and pharyngalgia that common cold or influenza cause.

Claims (10)

1, a kind of that quick oral cavity disintegration tablet of the pseudo-fiber crops of compound paracetamol for the treatment of flu, it is characterized in that it is made up of principal agent and adjuvant, principal agent comprises acetaminophen, pseudoephedrine hydrochloride and three kinds of active constituents of medicine of chlorphenamine maleate, and the percentage by weight proportioning of each component is as follows:
Acetaminophen: 15%~40%
Pseudoephedrine hydrochloride: 0.1%~10%
Chlorphenamine maleate: 0.01%~5%
Filler: 5%~70%
Disintegrating agent: 1%~15%
Correctives: 1%
Lubricant: 0.5%
2, oral cavity disintegration tablet according to claim 1 is characterized in that active constituents of medicine need carry out Cotton seeds to cover bitterness.
3, oral cavity disintegration tablet according to claim 2 carries out the taste masking coating with coating material to granule, increases weight to be particulate 15%~70%.
4, oral cavity disintegration tablet according to claim 2, the granule after the taste masking Cotton seeds is below 450 μ m.
5, oral cavity disintegration tablet according to claim 1, used filler comprises mannitol, sorbitol, lactose, StarLac , MicroceLac , also can be the compositions of above-mentioned each component.
6, oral cavity disintegration tablet according to claim 1, used disintegrating agent comprises the compositions of carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, microcrystalline Cellulose and above-mentioned disintegrating agent.
7, oral cavity disintegration tablet according to claim 1, used correctives comprises aspartame, acesulfame potassium, stevioside.
8, oral cavity disintegration tablet according to claim 1, institute with lubricator comprises PEG6000, boric acid, sodium stearyl fumarate, fumaric acid, magnesium stearate and micropowder silica gel.
9, oral cavity disintegration tablet according to claim 1 is characterized in that slice, thin piece can disintegrate in 5~50 seconds.
10, the preparation method of oral cavity disintegration tablet according to claim 1 is characterized in that may further comprise the steps:
The preparation of active constituents of medicine taste masked particle: take by weighing the active constituents of medicine (can add an amount of correctives) of ormal weight,, after the adding suitable quantity of water is granulated, granule is carried out the taste masking Cotton seeds with Eudragit E 100 dispersions with its mixing.
After active constituents of medicine taste masked particle and all the other auxiliary materials and mixing, add the moderate lubrication agent, tabletting, packing.
CNB2004100389872A 2004-05-17 2004-05-17 Paracetamol pseudoephedrine hydrochloride and cholrphenamine maleate oral cavity disintegration tablet for treating cold and preparation method thereof Expired - Fee Related CN100427088C (en)

Priority Applications (1)

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CNB2004100389872A CN100427088C (en) 2004-05-17 2004-05-17 Paracetamol pseudoephedrine hydrochloride and cholrphenamine maleate oral cavity disintegration tablet for treating cold and preparation method thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CNB2004100389872A CN100427088C (en) 2004-05-17 2004-05-17 Paracetamol pseudoephedrine hydrochloride and cholrphenamine maleate oral cavity disintegration tablet for treating cold and preparation method thereof

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CN1698607A true CN1698607A (en) 2005-11-23
CN100427088C CN100427088C (en) 2008-10-22

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100358523C (en) * 2006-01-24 2008-01-02 杭州民生药业集团有限公司 Preparation method of paracetamol pseudoephedrine hydrochloride and cholrphenamine maleate oral disintegration tablet
CN105982859A (en) * 2015-01-29 2016-10-05 北京科信必成医药科技发展有限公司 Acetaminophen granule with odor masked and preparation method of same

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1476898A (en) * 2002-08-23 2004-02-25 涛 吴 Compound skeleton tablet capable of prolonging release after oral administrationi for curing common cold

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100358523C (en) * 2006-01-24 2008-01-02 杭州民生药业集团有限公司 Preparation method of paracetamol pseudoephedrine hydrochloride and cholrphenamine maleate oral disintegration tablet
CN105982859A (en) * 2015-01-29 2016-10-05 北京科信必成医药科技发展有限公司 Acetaminophen granule with odor masked and preparation method of same

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Publication number Publication date
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Owner name: HANGZHOU MINSHENG MEDCINE CO., LTD.

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Address after: No. 108 Tong Road, Hangzhou, Zhejiang, Yuhang

Patentee after: Hangzhou Minsheng Pharmaceutical Co., Ltd.

Address before: No. 108 Tong Road, Hangzhou, Zhejiang, Yuhang

Patentee before: Hangzhou Minsheng Pharmaceutical Group Co., Ltd.

ASS Succession or assignment of patent right

Owner name: GUANGZHOU RENHENG PHARMACEUTICAL TECHNOLOGY CO., L

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Effective date: 20150528

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Effective date of registration: 20150528

Address after: 510305 west side of the third floor of A4 building, 171 Haizhuqu District Road, Guangdong, Guangzhou

Patentee after: Guangzhou Ren Heng Pharmaceutical Technology Co., Ltd

Address before: 310011 No. 108 Tong Road, Hangzhou, Zhejiang, Yuhang

Patentee before: Hangzhou Minsheng Pharmaceutical Co., Ltd.

CF01 Termination of patent right due to non-payment of annual fee

Granted publication date: 20081022

Termination date: 20160517

CF01 Termination of patent right due to non-payment of annual fee