CN102657616B - Paracetamol dry suspension for treating common cold in children - Google Patents

Paracetamol dry suspension for treating common cold in children Download PDF

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CN102657616B
CN102657616B CN 201210138734 CN201210138734A CN102657616B CN 102657616 B CN102657616 B CN 102657616B CN 201210138734 CN201210138734 CN 201210138734 CN 201210138734 A CN201210138734 A CN 201210138734A CN 102657616 B CN102657616 B CN 102657616B
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acetaminophen
dry suspension
paracetamol
milk flavour
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CN102657616A (en
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孙雪燕
朱燕玲
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QINGDAO GUOHAI BIOLOGICAL PHARMACEUTICAL Co Ltd
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QINGDAO GUOHAI BIOLOGICAL PHARMACEUTICAL Co Ltd
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Abstract

The invention discloses a paracetamol dry suspension for treating common cold in children. The paracetamol dry suspension comprises paracetamol, a diluting agent, a disintegrating agent, a suspending agent, a sweeting agent, a bitterness retarder, a milk flavor enhancer and an adhesive in a weight ratio of (25-35):(50-70):(3-5):(1-2):(1-2):(1-2):1:(1-2). The paracetamol dry suspension has the advantages of pure milk flavor, no discomfort smell, uniformity in suspension, high absorption, quick response and extreme suitability for being taken by child patients (2-12 ages).

Description

A kind of acetaminophen dry suspension for the treatment of infantile common cold
Technical field
The invention belongs to field of pharmaceutical preparations, be specifically related to a kind of acetaminophen dry suspension of the fragrance treatment infantile common cold of suckling.
Background technology
Acetaminophen is the most frequently used non-steroidal anti-inflammatory antipyretic analgesic, is used for the heating that common cold or influenza cause, also is used for alleviating mild to moderate pain such as headache, arthralgia, migraine, toothache, myalgia, neuralgia, dysmenorrhea.Moreover, acetaminophen is the most effective, safest child's febrifuge of world health organisation recommendations, and being used for the heating that child's common cold or influenza cause has good effect.
But because the acetaminophen bitter in the mouth, the child can not accept, and therefore must adopt the measure of taste masking.Covering of bitter taste of drug can obviously improve the especially therapeutic quality of child patient of patient.Taste masking mode to pharmaceutical preparation mainly contains correctives (comprising sweeting agent and aromatic), bitter tasting retarding agent, the worn-out technology of bag (comprising enclose, microencapsulation and packaging technique etc.) and other taste masking technology at present.
Children's cold medication in the market is mostly with the mode of adding correctives, and is often not satisfactory for the taste masking effect of the stronger medicine of the such bitterness of acetaminophen.The present invention is directed to this situation and adopted the taste masking mode more than 2 kinds simultaneously, be respectively correctives (sweeting agent and aromatic), bitter tasting retarding agent and granulation technique, acetaminophen is made dry suspension, good mouthfeel.
Summary of the invention
The object of the present invention is to provide a kind of acetaminophen dry suspension of the fragrance of suckling, its milk flavor is pure, fragrant and sweet good to eat, and suspendible is even, good absorbing effect, is very suitable for children taking.
For achieving the above object, the invention provides following technical scheme:
A kind of acetaminophen dry suspension comprises the component of following weight proportion: acetaminophen: diluent: disintegrating agent: suspending agent: sweeting agent: bitter tasting retarding agent: milk flavour enhancer: binding agent=(25~35): (50~70): (3~5): (1~2): (1~2): (1~2): 1: (1~2).Wherein, diluent of the present invention, disintegrating agent, sweeting agent and binding agent etc. can be the conventional materials that uses pharmaceutically.
Described diluent is selected from starch, dextrin, microcrystalline Cellulose, sucrose, lactose, mannitol, pregelatinized Starch etc., in preferred use pregelatinized Starch, lactose, mannitol and the sucrose one or more, it mainly acts on is the bitterness of dilution medicine, and because of its good water-solubility, more can promote the release of medicine.
Described disintegrating agent is selected from carboxymethyl starch sodium, polyvinylpolypyrrolidone, uprightly collapses with sodium carboxymethyl cellulose etc., preferably uses one or both of polyvinylpolypyrrolidone and upright metrorrhagia.Polyvinylpolypyrrolidone has powerful disintegration, can improve the stripping of insoluble drug.Upright collapsing is high intumescent carboxymethylstach sodium, compares with common carboxymethylstach sodium, and the faster expansive force of water absorbing properties is stronger, and has good flowability, is conducive to be uniformly dispersed.
Described suspending agent is selected from sodium carboxymethyl cellulose, hypromellose, sodium alginate, xanthan gum etc.; In preferred use hypromellose and the xanthan gum one or both.
Described sweeting agent selects white saccharin sodium, aspartame, glycyrrhizin, stevioside, cyclamate and xylitol etc., preferably uses in aspartame and the stevioside one or both.
Described bitter tasting retarding agent is Mai Litian, not only keeps the characteristic of sweeting agent, can also effectively cover hardship, bad pleasant impression such as puckery, plays to strengthen and improve the effect of putting forward sugariness, brings even natural sweet taste.
Described milk flavour enhancer is milk flavour.
Described binding agent is selected from water, ethanol, starch slurry, syrup, polyvinylpyrrolidone, sodium carboxymethyl cellulose and hydroxypropyl cellulose etc., preferably uses hydroxypropyl cellulose.
Acetaminophen dry suspension of the present invention can comprise each component is formed by the mixing of prescription proportioning, granulation by conventional method preparation known in the art.In one embodiment, acetaminophen is carried out micronization, make particle diameter more than 90% less than 100 μ m, add diluent, disintegrating agent, suspending agent, sweeting agent, bitter tasting retarding agent and milk flavour enhancer mixing then, add binder aqueous solution again and be mixed and made into soft material, granulation, drying.
The specific embodiment
Further describe the present invention with preferred embodiment below, be conducive to the present invention and effect thereof, advantage are better understood, but described embodiment only is used for explanation the present invention rather than restriction the present invention.Used material is common commercially available prod in following examples.
Embodiment 1: the preparation of acetaminophen dry suspension
Prescription 1:
Figure BSA00000712970900031
Preparation method: acetaminophen is pulverized with pulverizing mill, and wherein about 90% grain diameter is less than 100 μ m.Add diluent, disintegrating agent, suspending agent, sweeting agent, bitter tasting retarding agent, milk flavour enhancer mixing then, mix with 10% binder aqueous solution again and make soft material, granulate with 18~24 mesh sieves, put into 60 ℃ of dryings of drying baker then or with boiling-bed drying drying (inlet temperature is 120 ℃~140 ℃).
Embodiment 2: the preparation of acetaminophen dry suspension
Prescription 2:
Figure BSA00000712970900032
Figure BSA00000712970900041
Preparation method: with embodiment 1.
Embodiment 3: the preparation of acetaminophen dry suspension
Prescription 3:
Figure BSA00000712970900042
Preparation method: with embodiment 1.
Embodiment 4: the preparation of acetaminophen dry suspension
Prescription 4:
Figure BSA00000712970900043
Figure BSA00000712970900051
Preparation method: with embodiment 1.
Embodiment 5: the preparation of acetaminophen dry suspension
Prescription 5:
Figure BSA00000712970900052
Preparation method: with embodiment 1.
Embodiment 6: the preparation of acetaminophen dry suspension
Prescription 6:
Figure BSA00000712970900053
Figure BSA00000712970900061
Preparation method: with embodiment 1.
Mouthfeel test and conclusion
Attempt testing through many moral standings, the milk fragrance acetaminophen dry suspension good mouthfeel that the present invention makes do not have uncomfortable taste, and milk is pure, and suspendible is even, is fit to very much child patient (2~12 years old) and takes.

Claims (1)

1. an acetaminophen dry suspension for the treatment of infantile common cold is characterized in that component and weight proportion thereof are: acetaminophen: diluent: disintegrating agent: suspending agent: sweeting agent: bitter tasting retarding agent: the milk flavour enhancer: binding agent=(25~35): (50~70): (3~5): (1~2): (1~2): (1~2): 1: (1~2); Wherein said diluent is selected from one or more in pregelatinized Starch, lactose, mannitol and the sucrose; Described disintegrating agent is selected from one or both of polyvinylpolypyrrolidone and upright metrorrhagia; Described suspending agent is selected from one or both in hypromellose and the xanthan gum; Described sweeting agent is selected from one or both in aspartame and the stevioside; Described bitter tasting retarding agent is Mai Litian; Described milk flavour enhancer is milk flavour; Described binding agent is hydroxypropyl cellulose; Acetaminophen is pulverized with pulverizing mill, make 90% grain diameter less than 100 μ m, add diluent, disintegrating agent, suspending agent, sweeting agent, bitter tasting retarding agent, milk flavour enhancer mixing then, mix with 10% binder aqueous solution again and make soft material, granulate with 18~24 mesh sieves, put into 60 ℃ of dryings of drying baker then or use the boiling-bed drying drying, inlet temperature is 120 ℃~140 ℃.
CN 201210138734 2012-04-30 2012-04-30 Paracetamol dry suspension for treating common cold in children Active CN102657616B (en)

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CN103083248B (en) * 2013-02-18 2014-07-23 青岛正大海尔制药有限公司 Polysaccharide sulfate dry suspension
CN103127125B (en) * 2013-02-19 2014-08-20 青岛正大海尔制药有限公司 Paracetamol and caffeine dry suspension and preparation method thereof
CN103230367B (en) * 2013-05-07 2014-11-12 山东罗欣药业集团股份有限公司 Cefpodoxime proxetil composition dry suspension and preparation method thereof
CN105012243A (en) * 2015-08-05 2015-11-04 安丘市鲁安药业有限责任公司 Paracetamol granules and preparation method thereof
CN105106130B (en) * 2015-08-05 2017-03-22 安丘市鲁安药业有限责任公司 Acetaminophen diphenhydramine granules and preparation method thereof
CN112587483A (en) * 2020-12-16 2021-04-02 上海应用技术大学 Compound infant cold dry suspension with taste masking effect and preparation method and application thereof

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CN1360892A (en) * 2000-12-28 2002-07-31 营口奥达制药有限公司 Dry mixed suspension of Meptin and pseudoephe and its prepn
CN1616102A (en) * 2004-10-12 2005-05-18 李�杰 Compound dry suspensoid agent for curing cold and its prescription and preparing method
CN100571683C (en) * 2007-02-05 2009-12-23 深圳致君制药有限公司 dry suspension and preparation method thereof
CN101940598B (en) * 2010-06-21 2011-11-02 湖南中和制药有限公司 Preparation method of Huang children paracetamol-particles
CN102228474A (en) * 2010-08-25 2011-11-02 邹巧根 Compound dry suspension used for treating children's cold and its preparation method

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