CN102349883A - Acetaminophen oral instant membrane and preparation method thereof - Google Patents
Acetaminophen oral instant membrane and preparation method thereof Download PDFInfo
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- CN102349883A CN102349883A CN2011103188042A CN201110318804A CN102349883A CN 102349883 A CN102349883 A CN 102349883A CN 2011103188042 A CN2011103188042 A CN 2011103188042A CN 201110318804 A CN201110318804 A CN 201110318804A CN 102349883 A CN102349883 A CN 102349883A
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- acetaminophen
- oral instant
- instant membrane
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Abstract
The invention discloses an acetaminophen oral instant membrane and a preparation method thereof, and particularly relates to an oral instant membrane which contains acetaminophen and at least one type of biologically acceptable and water-soluble polymer and a preparation method thereof. The oral instant membrane has the effect of relieving fever and pain and can be used to relieve the symptoms of cold and fever, arthralgia, neurodynia, migraine and cancer pain and can relieve the pain after surgeries. Moreover, the oral instant membrane contains the acetaminophen and the at least one type of biologically acceptable and water-soluble polymer, wherein the acetaminophen accounts for 5-90% of the weight of the membrane and the biologically acceptable and water-soluble polymer accounts for 10-95% of the weight of the membrane. The biologically acceptable and water-soluble polymer is one or the mixture of more than two of the polymers of methylcellulose, hydroxypropyl methyl cellulose, hydroxy propyl cellulose, maltodextrin, pullulan, xanthan gum, locust bean gum, agar and gelatin and the like.
Description
Technical field
Acetaminophen oral instant membrane of the present invention and preparation method thereof relates to a kind of oral instant film preparation that contains acetaminophen and the acceptable water-soluble polymer of at least a biology and preparation method thereof; Have antipyretic effect, be used for relevant symptoms such as cat fever, arthralgia, neuralgia, migraine, cancer pain and operation back pain relieving.
Background technology
Acetaminophen (acetaminophen), International Nonproprietary Name are Paracetamol.It is the most frequently used non-steroidal anti-inflammatory antipyretic analgesic, and refrigeration function is similar with aspirin, analgesic activity a little less than, no antiinflammatory anti rheumatism action is a best kind in the acetophenone amine medicine.Be particularly suitable for to use the patient of carboxylic acids medicine.Be used for diseases such as flu, toothache.Oral absorption is rapid, fully, in body fluid, is evenly distributed, and most of mesostate is poisonous to liver at liver metabolism, and with the glucuronide conjugate form or from renal excretion, the half-life was generally 1-4 hour.Only to light, moderate pain is effective.The no obvious anti-inflammatory and anti effect of these article.
Oral easy absorption, blood drug level 0.5~1h peaking, 95% combines and inactivation with glucuronic acid or sulphuric acid in vivo, and 5% is converted into the virose metabolite of liver through hydroxylation, all from urine, discharges.Plasma protein binding rate is 25%.90~95% at liver metabolism, mainly combines with glucuronic acid, sulphuric acid and cysteine.Mesostate is to the toxic effect of liver.Acetaminophen mainly with the bonded form of glucuronic acid from renal excretion, have in 24 hours 3% to discharge with urine approximately with original shape.
Prior dosage form has tablet, injection, suppository, instant effervescent particles, and syrup.But for the child, old man and the patient of dysphagia is arranged mainly is to use syrup preparation.But syrup preparation is taken also inconvenient, needs soupspoon or glass when taking, and drug dose is difficult to control, takes inconvenience especially under the situation such as driving, carries also inconvenience simultaneously, has influenced the application to these types patient of Aceta Elixir greatly.
Existing patent does not all have to take the way of acetaminophen oral instant membrane to solve to above problem, and other known technologies do not take the acetaminophen oral instant membrane to improve the suggestion of above defective yet.
Summary of the invention
The objective of the invention is provides instant film of acetaminophen and preparation method thereof to above weak point; The acetaminophen oral instant membrane is a kind of acetaminophen oral formulations; This oral instant membrane is easy to carry, can under anhydrous situation, take, and mouthfeel is joyful; Good stability; And onset is rapid, and supplementary product consumption is little, and technical process is simple; Thereby resulting cost is lower, has considerable economic and social benefit.
A kind of acetaminophen oral instant membrane; Contain acetaminophen; And the acceptable water-soluble polymer of at least a biology, wherein the content of acetaminophen is 5~90% of said film weight, the content of biological acceptable water-soluble polymer is 10~95% of said film weight.The chemical name that it is characterized in that acetaminophen is N-(4-hydroxy phenyl) acetamide, English name: 4-Acetamino phenol; N-(4-hydroxyphenyl)-Acetamide; 4 '-hydroxyacetanilide, structural formula is:
Molecular formula is C8H9N02, and molecular weight is 151.17.
The acceptable water-soluble polymer of described biology is selected from methylcellulose, hydroxypropyl emthylcellulose; Hydroxypropyl cellulose; Maltodextrin; Amylopectin; Hydroxyethyl-cellulose; Polyvinyl alcohol; Pectin; Chondrus ocellatus Holmes polysaccharide; Na-alginate; Potassium alginate; Carboxymethyl cellulose; Polyvidone; Elsinan; Pullulan; Xanthan gum; Herba Albiziae natural gum; Tragacanth; Tracasol; Agar; Gelatin; Chitosan; Chitin; Polyvinylpyrrolidone; Polyethylene Glycol; Guar gum; Radix Acaciae senegalis; Polyacrylic acid; Methyl methacrylate resin copolymer; Amylose; Chitin; Chitosan; Levan; Zein; Gluten; Soybean protein isolate; Whey isolate protein; A kind of or mixture in the network albumen etc.
Acetaminophen oral instant membrane, its component can also comprise the acceptable component of other biological:
Account for 0.1~50% at least a flavoring agent or sweeting agent of said film weight;
Account for 0.1~50% at least a bitter tasting retarding agent of said film weight;
Account for 0.01~10% at least a coloring agent of said film weight;
Account for 0.1~25% at least a plasticizer of said film weight;
Account for 0.1~20% at least a antiseptic of said film weight;
Account for 0.1~30% at least a saliva stimulant of said film weight;
Account for 0.1~50% at least a disintegrating agent of said film weight;
Account for 0.1~30% water of said film weight.
Described flavoring agent is selected from a kind of or mixture in aspartame, the multitudinous sugar of trichlorine, stevioside, glycyrrhizin, saccharin sodium, glucide, mannitol, xylitol, sorbitol, fructose, sucrose, maltose, essence, spice, the sodium glutamate;
Described bitter tasting retarding agent is selected from a kind of or mixture in adenylic acid, sorbitol, mannitol, starch, glycine, saccharin sodium, spice, the corn syrup;
Described coloring agent is selected from a kind of or mixture in FD&C dyestuff, color lake, the pigment;
Described plasticizer is selected from a kind of or mixture in Polyethylene Glycol, glycerol, mono glycerinate, diglyceride, the polyethylene glycol oxide sorbitol ester;
Described antiseptic is selected from a kind of or mixture in methyl hydroxybenzoate, ethyl hydroxybenzoate, sodium benzoate, the potassium sorbate; Described saliva stimulant is selected from a kind of or mixture in citric acid, tartaric acid, lactic acid, the fumaric acid;
Described disintegrating agent is selected from a kind of or mixture in polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose, Sodium Hydroxymethyl Stalcs, cross-linking sodium carboxymethyl cellulose, the pregelatinized Starch.
The water that contains acetaminophen film weight 0.1~30% can guarantee that oral instant membrane has the intensity and the toughness of suitable cutting packing.
The method for preparing of acetaminophen oral instant membrane is to take following scheme to realize:
Water soluble ingredient that will be except that water-soluble polymer is soluble in water, obtains aqueous solution;
The acceptable water-soluble polymer of at least a biology is joined in the aqueous solution under stirring, and fully dispersed with stirring obtains polymer gel:
In above-mentioned polymer gel, add plasticizer and stir;
Add acetaminophen and other components and stir and obtain the acetaminophen polymer gel;
The degassing is evenly coated the acetaminophen polymer gel on the flat board uniformly;
Air blast heat drying, heating-up temperature are 70~80 ℃, and cutting obtains the acetaminophen oral instant membrane.
A kind of acetaminophen oral instant membrane; Contain acetaminophen and the acceptable water-soluble polymer of at least a biology; Wherein the content of acetaminophen is 5~90% of said film weight, and the content of biological acceptable water-soluble polymer is 10~95% of said film weight.Described water-soluble polymer is selected from a kind of or mixture in methylcellulose, hydroxypropyl emthylcellulose, hydroxypropyl cellulose, maltodextrin, amylopectin, hydroxyethyl-cellulose, polyvinyl alcohol, pectin, chondrus ocellatus Holmes polysaccharide, Na-alginate, potassium alginate, carboxymethyl cellulose, polyvidone, elsinan, Pullulan, xanthan gum, agar, gelatin, chitosan, the chitin.
This oral instant membrane has solved the acetaminophen conventional tablet and the capsule onset is slow, takes inconvenience, and oral liquid carries inconvenience, taking dose inaccuracy, the shortcoming of existence.This oral instant membrane is easy to carry; Can under anhydrous situation, take; Mouthfeel is joyful, and the compliance of taking medicine is good, and suitable especially child old man and the patient who swallows because of difficulty take medicine; Steady quality; Onset is rapid, and supplementary product consumption is little in the production, and technical process is simple; Resulting cost is lower, has considerable economic and social benefit.
The beneficial effect that the present invention brought is: have antipyretic effect, be used for relevant symptoms such as cat fever, arthralgia, neuralgia, migraine, cancer pain and operation back pain relieving.
The specific embodiment
Further specify the present invention through embodiment below.Should correct understanding be: embodiments of the invention are only used for the present invention is described and provide, rather than limitation of the present invention, so, under method prerequisite of the present invention to simple modifications of the present invention or revise and all belong to the present invention and require the scope protected.
Embodiment 1:
Take above-mentioned method for preparing to obtain the acetaminophen oral instant membrane.This film has pleasant outward appearance and taste, meets water and dissolves rapidly.
Embodiment 2:
Take above-mentioned method for preparing to obtain the acetaminophen oral instant membrane.This film has pleasant outward appearance and taste, meets water and dissolves rapidly.
Embodiment 3:
Take above-mentioned method for preparing to obtain the acetaminophen oral instant membrane.This film has pleasant outward appearance and taste, meets water and dissolves rapidly.
Embodiment 4:
Take above-mentioned method for preparing to obtain the acetaminophen oral instant membrane.This film has pleasant outward appearance and taste, meets water and dissolves rapidly.
Embodiment 5:
Take above-mentioned method for preparing to obtain the acetaminophen oral instant membrane.This film has pleasant outward appearance and taste, meets water and dissolves rapidly.
Embodiment 6:
Take above-mentioned method for preparing to obtain the acetaminophen oral instant membrane.This film has pleasant outward appearance and taste, meets water and dissolves rapidly.
Embodiment 7:
Take above-mentioned method for preparing to obtain the acetaminophen oral instant membrane.This film has pleasant outward appearance and taste, meets water and dissolves rapidly.
Embodiment 8:
Take above-mentioned method for preparing to obtain the acetaminophen oral instant membrane.This film has pleasant outward appearance and taste, meets water and dissolves rapidly.
Embodiment 9:
Take above-mentioned method for preparing to obtain the acetaminophen oral instant membrane.This film has pleasant outward appearance and taste, meets water and dissolves rapidly.
Embodiment 10:
Take above-mentioned method for preparing to obtain the acetaminophen oral instant membrane.This film has pleasant outward appearance and taste, meets water and dissolves rapidly.
Embodiment 11:
Take above-mentioned method for preparing to obtain the acetaminophen oral instant membrane.This film has pleasant outward appearance and taste, meets water and dissolves rapidly.
Embodiment 12:
Take above-mentioned method for preparing to obtain the acetaminophen oral instant membrane.This film has pleasant outward appearance and taste, meets water and dissolves rapidly.
Embodiment 13:
Take above-mentioned method for preparing to obtain the acetaminophen oral instant membrane.This film has pleasant outward appearance and taste, meets water and dissolves rapidly.
Embodiment 14:
Take above-mentioned method for preparing to obtain the acetaminophen oral instant membrane.This film has pleasant outward appearance and taste, meets water and dissolves rapidly.
Embodiment 15:
Take above-mentioned method for preparing to obtain the acetaminophen oral instant membrane.This film has pleasant outward appearance and taste, meets water and dissolves rapidly.
Embodiment 16:
Take above-mentioned method for preparing to obtain the acetaminophen oral instant membrane.This film has pleasant outward appearance and taste, meets water and dissolves rapidly.
Embodiment 17:
Take above-mentioned method for preparing to obtain the acetaminophen oral instant membrane.This film has pleasant outward appearance and taste, meets water and dissolves rapidly.
Embodiment 18:
Take above-mentioned method for preparing to obtain the acetaminophen oral instant membrane.This film has pleasant outward appearance and taste, meets water and dissolves rapidly.
Embodiment 19:
Take above-mentioned method for preparing to obtain the acetaminophen oral instant membrane.This film has pleasant outward appearance and taste, meets water and dissolves rapidly.
Embodiment 20:
Take above-mentioned method for preparing to obtain the acetaminophen oral instant membrane.This film has pleasant outward appearance and taste, meets water and dissolves rapidly.
Embodiment 21:
Take above-mentioned method for preparing to obtain the acetaminophen oral instant membrane.This film has pleasant outward appearance and taste, meets water and dissolves rapidly.
Embodiment 22:
Take above-mentioned method for preparing to obtain the acetaminophen oral instant membrane.This film has pleasant outward appearance and taste, meets water and dissolves rapidly.
Claims (5)
1. the acetaminophen oral instant membrane is characterized in that containing acetaminophen, and its chemical name is N-(4-hydroxy phenyl) acetamide, English name: 4-Acetamino phenol; N-(4-hydroxyphenyl)-Acetamide; 4 '-hydroxyacetanilide, structural formula is:
Molecular formula is C8H9N02; Molecular weight is 151.17; And contain the acceptable water-soluble polymer of at least a biology, and wherein the content of acetaminophen is 5~90% of said film weight, the content of biological acceptable water-soluble polymer is 10~95% of said film weight.
2. acetaminophen oral instant membrane according to claim 1 is characterized in that the acceptable water-soluble polymer of described biology is selected from methylcellulose; Hydroxypropyl emthylcellulose; Hydroxypropyl cellulose; Maltodextrin; Amylopectin; Hydroxyethyl-cellulose; Polyvinyl alcohol; Pectin; Chondrus ocellatus Holmes polysaccharide; Na-alginate; Potassium alginate; Carboxymethyl cellulose; Polyvidone; Elsinan; Pullulan; Xanthan gum; Herba Albiziae natural gum; Tragacanth; Tracasol; Agar; Gelatin; Chitosan; Chitin; Polyvinylpyrrolidone; Polyethylene Glycol; Guar gum; Radix Acaciae senegalis; Polyacrylic acid; Methyl methacrylate resin copolymer; Amylose; Chitin; Chitosan; Levan; Zein; Gluten; Soybean protein isolate; Whey isolate protein; A kind of or mixture in the network albumen.
3. acetaminophen oral instant membrane according to claim 1 is characterized in that comprising the acceptable component of other biological:
Account for 0.1~50% at least a flavoring agent or sweeting agent of said film weight;
Account for 0.1~50% at least a bitter tasting retarding agent of said film weight;
Account for 0.01~10% at least a coloring agent of said film weight;
Account for 0.1~25% at least a plasticizer of said film weight;
Account for 0.1~20% at least a antiseptic of said film weight;
Account for 0.1~30% at least a saliva stimulant of said film weight;
Account for 0.1~50% at least a disintegrating agent of said film weight;
Account for 0.1~30% water of said film weight.
4. acetaminophen oral instant membrane according to claim 1 is characterized in that described flavoring agent is selected from a kind of or mixture in aspartame, the multitudinous sugar of trichlorine, stevioside, glycyrrhizin, saccharin sodium, glucide, mannitol, xylitol, sorbitol, fructose, sucrose, maltose, essence, spice, the sodium glutamate; Bitter tasting retarding agent is selected from a kind of or mixture in adenylic acid, sorbitol, mannitol, starch, glycine, saccharin sodium, spice, the corn syrup; Coloring agent is selected from a kind of or mixture in FD&C dyestuff, color lake, the pigment; Plasticizer is selected from a kind of or mixture in Polyethylene Glycol, glycerol, mono glycerinate, diglyceride, the polyethylene glycol oxide sorbitol ester; Antiseptic is selected from a kind of or mixture in methyl hydroxybenzoate, ethyl hydroxybenzoate, sodium benzoate, the potassium sorbate; Saliva stimulant is selected from a kind of or mixture in citric acid, tartaric acid, lactic acid, the fumaric acid; Disintegrating agent is selected from a kind of or mixture in polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose, Sodium Hydroxymethyl Stalcs, cross-linking sodium carboxymethyl cellulose, the pregelatinized Starch.
5. the method for preparing of the described acetaminophen oral instant membrane of claim 1 is characterized in that method for preparing is: water soluble ingredient that will be except that water-soluble polymer is soluble in water, obtains aqueous solution:
The acceptable water-soluble polymer of at least a biology is joined in the aqueous solution under stirring, and fully dispersed with stirring obtains polymer gel;
In above-mentioned polymer gel, add plasticizer and stir;
Add acetaminophen and other components and stir and obtain the acetaminophen polymer gel:
The degassing is evenly coated the acetaminophen polymer gel on the flat board;
Air blast heat drying, heat drying temperature are 70~80 ℃, and cutting obtains said acetaminophen oral instant membrane.
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CN2011103188042A CN102349883A (en) | 2011-10-13 | 2011-10-13 | Acetaminophen oral instant membrane and preparation method thereof |
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CN2011103188042A CN102349883A (en) | 2011-10-13 | 2011-10-13 | Acetaminophen oral instant membrane and preparation method thereof |
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
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CN103784967A (en) * | 2014-02-11 | 2014-05-14 | 天津商业大学 | Soy isolate protein drug sustained release thin film and preparation method thereof |
CN104940174A (en) * | 2015-07-23 | 2015-09-30 | 合肥华方医药科技有限公司 | Preparation method of donepezil oral fast dissolving film |
CN111065384A (en) * | 2018-04-18 | 2020-04-24 | 希尔帕医疗保健有限公司 | Composition of orally disintegrating film of paracetamol |
Citations (3)
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CN1750809A (en) * | 2003-04-25 | 2006-03-22 | 沃尼尔·朗伯有限责任公司 | Fast dissolving orally consumable films containing pharmaceutically active agents |
CN100998551A (en) * | 2006-12-22 | 2007-07-18 | 江苏奥赛康药业有限公司 | Oral cavity quick dissolved film containing civeran, and method for preparing the same |
CN101081218A (en) * | 2006-06-02 | 2007-12-05 | 范敏华 | Rapid-disintegrated oral film and method for making same |
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2011
- 2011-10-13 CN CN2011103188042A patent/CN102349883A/en active Pending
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
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CN1750809A (en) * | 2003-04-25 | 2006-03-22 | 沃尼尔·朗伯有限责任公司 | Fast dissolving orally consumable films containing pharmaceutically active agents |
CN101081218A (en) * | 2006-06-02 | 2007-12-05 | 范敏华 | Rapid-disintegrated oral film and method for making same |
CN100998551A (en) * | 2006-12-22 | 2007-07-18 | 江苏奥赛康药业有限公司 | Oral cavity quick dissolved film containing civeran, and method for preparing the same |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN103784967A (en) * | 2014-02-11 | 2014-05-14 | 天津商业大学 | Soy isolate protein drug sustained release thin film and preparation method thereof |
CN103784967B (en) * | 2014-02-11 | 2015-06-10 | 天津商业大学 | Soy isolate protein drug sustained release thin film and preparation method thereof |
CN104940174A (en) * | 2015-07-23 | 2015-09-30 | 合肥华方医药科技有限公司 | Preparation method of donepezil oral fast dissolving film |
CN111065384A (en) * | 2018-04-18 | 2020-04-24 | 希尔帕医疗保健有限公司 | Composition of orally disintegrating film of paracetamol |
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Application publication date: 20120215 |