CN102961365A - Terbutaline sulfate oral instant film and preparation method thereof - Google Patents
Terbutaline sulfate oral instant film and preparation method thereof Download PDFInfo
- Publication number
- CN102961365A CN102961365A CN2012105482340A CN201210548234A CN102961365A CN 102961365 A CN102961365 A CN 102961365A CN 2012105482340 A CN2012105482340 A CN 2012105482340A CN 201210548234 A CN201210548234 A CN 201210548234A CN 102961365 A CN102961365 A CN 102961365A
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- China
- Prior art keywords
- terbutaline sulphate
- oral instant
- instant membrane
- terbutaline
- membrane according
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- 238000002360 preparation method Methods 0.000 title claims abstract description 15
- 229960005105 terbutaline sulfate Drugs 0.000 title abstract description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 15
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 14
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- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 claims description 18
- 239000000203 mixture Substances 0.000 claims description 13
- UQSXHKLRYXJYBZ-UHFFFAOYSA-N Iron oxide Chemical compound [Fe]=O UQSXHKLRYXJYBZ-UHFFFAOYSA-N 0.000 claims description 12
- 238000003756 stirring Methods 0.000 claims description 12
- 239000006185 dispersion Substances 0.000 claims description 11
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- ZZVUWRFHKOJYTH-UHFFFAOYSA-N diphenhydramine Chemical compound C=1C=CC=CC=1C(OCCN(C)C)C1=CC=CC=C1 ZZVUWRFHKOJYTH-UHFFFAOYSA-N 0.000 description 1
- 229960000520 diphenhydramine Drugs 0.000 description 1
- 239000003651 drinking water Substances 0.000 description 1
- 235000020188 drinking water Nutrition 0.000 description 1
- 239000003937 drug carrier Substances 0.000 description 1
- 239000002360 explosive Substances 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 210000003630 histaminocyte Anatomy 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 230000009545 invasion Effects 0.000 description 1
- 230000000366 juvenile effect Effects 0.000 description 1
- 230000002045 lasting effect Effects 0.000 description 1
- MKXZASYAUGDDCJ-CGTJXYLNSA-N levomethorphan Chemical compound C([C@H]12)CCC[C@@]11CCN(C)[C@@H]2CC2=CC=C(OC)C=C21 MKXZASYAUGDDCJ-CGTJXYLNSA-N 0.000 description 1
- 229960002160 maltose Drugs 0.000 description 1
- 230000000936 membranestabilizing effect Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 229960005343 ondansetron Drugs 0.000 description 1
- 230000002688 persistence Effects 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 239000006187 pill Substances 0.000 description 1
- 239000011148 porous material Substances 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 230000005180 public health Effects 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 239000000018 receptor agonist Substances 0.000 description 1
- 229940044601 receptor agonist Drugs 0.000 description 1
- 238000012827 research and development Methods 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 230000008719 thickening Effects 0.000 description 1
- 239000010409 thin film Substances 0.000 description 1
- 210000003437 trachea Anatomy 0.000 description 1
- 229960005486 vaccine Drugs 0.000 description 1
- 238000012795 verification Methods 0.000 description 1
- 229940052751 zuplenz Drugs 0.000 description 1
Abstract
The invention discloses a terbutaline sulfate oral instant film and a preparation method thereof, and belongs to the technical field of medicines. The terbutaline sulfate oral instant film comprises active ingredients, such as terbutaline sulfate, film-forming materials, disintegrating agents and opacifying agent with effective dosages, and necessary pharmaceutically acceptable filling agents, sweetening agents and wetting agents; and coloring agents are added according to requirements. The terbutaline sulfate oral instant film is good in palatability, fast in response, small in size, and suitable for children, elders, completely-bedridden persons and patients with severe disability; the film can be rapidly dissolved in a disintegrating mode in the oral cavity; water is not needed to orally take; and people can take the medicines any time under a condition that water is inconvenient to drink.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, be specifically related to a kind of oral instant membrane that contains terbutaline sulphate and preparation method thereof.It is in case contact with saliva of buccal cavity, very fast dissolving or disintegrate, rapid-action and have take, easy to carry, do not need with characteristics such as water delivery services.The bronchial smooth muscle that can relax suppresses endogenous and causes the release of spasm material and the edema that the endogenous medium causes; Strengthen bronchial mucosa epithelial cell fiber movement, accelerate mucus and eliminate, bronchorelaxing activity is arranged; Be effective to bronchial asthma, chronic asthma bronchitis, obstructive emphysema and other treatments with the bronchospasm pulmonary disease.
Background technology
Along with improving constantly of people's living standard, people's health care consciousness also strengthens gradually, and the generation of some diseases is paid close attention in beginning more; But, along with the improvement of people's living standard, in the world under the impact of air pollution and ecological deterioration, so that a lot of people still keeps away the invasion and attack of unavoidable asthma.In recent years, the M ﹠ M of asthma presents ever-increasing trend, has become a kind of main chronic disease that threatens public health.Asthma not only the serious harm people physically and mentally healthy, weaken work capacity, reduce quality of life, and be difficult to radical cure.It is repeatedly outbreak easily, but threat to life when serious.Because asthma is a kind of anaphylactic disease, infector is arranged unlike infectious disease, can prevent with vaccine, guarantee the patient for a long time, correctly medication, effectively prevention of asthma shows effect.
Terbutaline sulphate (terbutaline sulphate, 1) claims again terbutaline, it is first generation beta 2 receptor agonist, has stronger mastocyte membrane stabilizing action, alternative excited beta 2-adrenergic receptor, lax bronchial smooth muscle is difficult for being transformed by monoamine oxidase, MAO, and effect is lasting; Suppress endogenous and cause the release of spasm material and the edema that the endogenous medium causes; Strengthen bronchial mucosa epithelial cell fiber movement, accelerate mucus and eliminate, improve the bronchial mucosa ciliated epithelial cell and clean up ability, bronchorelaxing activity is arranged; Be applicable to clinically treat bronchial asthma, chronic asthma bronchitis, obstructive emphysema and other is with pulmonary disease such as bronchospasms.
Terbutaline was got permission registration by China's clinical verification in 1985 early than beginning clinical trial in 1967, and this medicine is used more than 100 country's listings so far.In China, the history in existing more than 20 years of the clinical practice of broxaterol (being beta 2-adrenergic receptor agonist) is that present clinical practice is wide, the more bronchial spasmolytic agent of kind.Many experts think that broxaterol is the main medicine of relieving asthma acute attack, both can be used for intermittent acute attack, also can be used for helping controlling the bronchospasm of the persistence of trachea.At present, the multiple terbutaline sulphate oral formulations (tablet, granule, capsule, oral liquid, aerosol, atomized liquid, inhalation powder spray) that gone on the market both at home and abroad.
Because conventional tablet, granule, capsule are through the gastrointestinal Degradation, bioavailability is lower, and is difficult for swallowing, and juvenile crowd and gerontal patient are not too applicable; Do not take having to be not easy to the patient in the situation of water yet.Oral liquid carries inconvenience, is easy to breakage, also is unfavorable for quantitatively taking.The aerosol complicated process of preparation has troublesome poeration, the shortcomings such as explosive.The powder spray poor stability, cost is higher, and effect duration is short.Atomized liquid is Portable belt not, and treatment time is longer.
Oral instant membrane of the present invention means that the effective ingredient of doses is dispersed in the thin film formulations that processes in the filmogen.The medicine film is rich in pliability, during use, directly the medicine film is placed on the tongue, and the medicine film is in case contact with saliva of buccal cavity, will very fast dissolving or disintegrate, swallow afterwards Fast Stripping in gastrointestinal tract.This kind new formulation can avoid solid preparation to stop up the repulsion psychology of danger and patient's medication of throat, and need not drink water and can take; Be particularly useful for child, old age, be unable to leave the bed and serious disable patient, and people's at any time medication in the situation of inconvenience drinking-water.The oral instant film preparation as far back as 2003 in North America listing, preparation has that volume is little, dissolubility is high, rapid-action and can make and be grown up especially that the child grasps the characteristics such as accurate medication dose easily, by the extensive use of International Pharmaceutical market.Such as the instant membrane of ondansetron (Zuplenz) of Strative drugmaker exploitation, diphenhydramine film (the Triaminic Strips Cough﹠amp of Novartis Co.,Ltd's listing; Runny Nose), dextromethorphan membrane (TherafluThin Strip).
Patent CN102416167A provides atomized inhalation and the preparation technology thereof of a kind of interferon-ALPHA and terbutaline sulphate.Patent CN1813695A provides a kind of terbutaline sulfate dropping pill and preparation technology thereof.Above-mentioned terbutaline sulphate dosage form, cost is higher, and complicated process of preparation is difficult for storage, also is unfavorable for quantitatively taking.At present, there is not for the time being the research and development record of terbutaline sulphate oral instant membrane in the international market.
Summary of the invention
Purpose of the present invention is not only provides a kind of agreeable to the taste degree good, meets saliva and collapse rapidly molten, rapid-action terbutaline sulphate oral instant membrane in the oral cavity, for child, old age, be unable to leave the bed and serious disable patient provides new medication to select; Also provide a kind of volume little, need not use water delivery service, take, terbutaline sulphate oral instant membrane easy to carry, overcome common listing dosage form and be difficult for swallowing, be difficult to quantitatively carry inconvenience, the puzzlement of the problems such as complicated operation.
Characteristics of the present invention be macromolecular material by selecting good water solubility as filmogen, guaranteed that the medicine film can dissolve fast in the oral cavity; The simple filmogen of good water solubility that uses can not satisfy oral instant membrane rapidly requirement of dissolving in the oral cavity, adds an amount of disintegrating agent among the present invention, utilizes the capillarity of disintegrating agent and expansion can solve this technical barrier.
The prescription of terbutaline sulphate oral instant membrane provided by the invention is composed as follows:
Terbutaline sulphate, filmogen, disintegrating agent, filler, sweeting agent, wetting agent, opacifier, coloring agent.
Described filmogen is not only pharmaceutical carrier, also need pass through film forming, performance thickening, figuration effect.Its stable in properties, not with drug interaction, also should have good aqueous solubility, be convenient to human body dissolving, absorb.Filmogen of the present invention is selected from hypromellose, xanthan gum, sodium alginate, sodium carboxymethyl cellulose, polyvidone, methylcellulose, hydroxypropyl cellulose, high a kind of or its mixture that replaces in the hypromellose.
Disintegrating agent has capillarity and expansion, has pore structure after making the film drying, forms the capillary channel that is easy to moistening, can be by water-wet, contact afterwards with water that water can enter film inside with capillary channel rapidly, and impel the rapid disintegrate of film.Disintegrating agent of the present invention is selected from a kind of or its mixture in microcrystalline Cellulose, pregelatinized Starch, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula sodium and the starch.
Opacifier of the present invention can stop that light sees through, and makes active component stable.Gradient color behind the terbutaline sulphate raw material chance light, the present invention adds in right amount opacifier and improves membrane to the stability of light.Opacifier of the present invention is selected from a kind of or its mixture in titanium dioxide, iron oxide red, iron oxide yellow, the iron oxide brown; Preferred titanium dioxide;
Filler of the present invention is selected from a kind of or its mixture in mannitol, sucrose, glucose, maltose, lactose, sorbitol, xylitol, maltose alcohol, galactitol, erythritol, dextrin, the trehalose.
Another purpose of the present invention provides a kind of preparation method of terbutaline sulphate oral instant film preparation, comprises the steps:
A mixes, films: take by weighing terbutaline sulphate, aspartame, microcrystalline Cellulose, mannitol, titanium dioxide by prescription, water or glycerine water solution disperse, and adding pigment aqueous solution, hydroxypropyl methylcellulose aqueous solution stir;
B films, drying: above-mentioned terbutaline sulphate suspendible glue is applied on the flat board drying uniformly;
The C demoulding cuts into a certain size, packing.
In the said process, described terbutaline sulphate oral instant membrane can be every 1cm
2The terbutaline sulphate oral instant membrane that contains 1～30mg terbutaline sulphate in the preparation.
Described terbutaline sulphate oral instant membrane has certain pliability, is convenient to take, there is not sense of discomfort when taking, but simply dissolving or disintegrate in mouth, and medicine enters digestive tract with swallowing act and absorbs, dissolubility is high, in 37 ℃ of water disintegration time in 30 seconds, rapid-action.
Advantage of the present invention: 1. mouthfeel is joyful, and agreeable to the taste degree is good; 2. meeting saliva in the oral cavity collapses rapidly molten, rapid-action; 3. need not use water delivery service, be applicable to child, old age, be unable to leave the bed and serious disable patient, easy to use; 4. steady quality is convenient to preserve, carry.
The specific embodiment
Come terbutaline sulphate oral instant membrane of the present invention done further specifying by following examples, but scope of the present invention is not limited in these embodiment.So, under method prerequisite of the present invention, simple modifications of the present invention is all belonged to the scope of protection of present invention.
Embodiment 1
Every terbutaline sulphate oral instant membrane sulfur acid terbutaline 2.5mg, the consisting of of per 1000 membrane:
Specific operation process: take by weighing terbutaline sulphate, aspartame, microcrystalline Cellulose, mannitol, titanium dioxide, after the dispersion of 30% glycerite, add 0.3% pigment solution, 2% hydroxypropyl methylcellulose solution, the limit edged stirs, and is after stirring, degassed, be coated in uniformly above-mentioned terbutaline sulphate suspendible glue on the flat board, drying, cutting (2cm * 2cm), namely get the terbutaline sulphate oral instant membrane.
This membrane becomes pink, and pliability is good, and entrance dissolves rapidly dispersion, good mouthfeel, and it is sweet to distinguish the flavor of, solution time 25s.
Embodiment 2
Every terbutaline sulphate oral instant membrane sulfur acid terbutaline 2.5mg, the consisting of of per 1000 membrane:
Specific operation process: take by weighing terbutaline sulphate, aspartame, pregelatinized Starch, trehalose, titanium dioxide, after the dispersion of 30% glycerite, add 0.3% pigment solution, 1% sodium alginate soln, the limit edged stirs, and is after stirring, degassed, be coated in uniformly above-mentioned terbutaline sulphate suspendible glue on the flat board, drying, cutting (2cm * 2cm), namely get the terbutaline sulphate oral instant membrane.
This membrane pliability is better, and entrance dissolves rapidly dispersion, good mouthfeel, and it is sweet to distinguish the flavor of, solution time 15～20s.
Embodiment 3
Every terbutaline sulphate oral instant membrane sulfur acid terbutaline 2.5mg, the consisting of of per 1000 membrane:
Specific operation process: take by weighing terbutaline sulphate, aspartame, low-substituted hydroxypropyl cellulose, maltose alcohol, titanium dioxide, after the dispersion of 30% glycerite, add 0.3% pigment solution, 0.3% xanthan gum solution, the limit edged stirs, and is after stirring, degassed, be coated in uniformly above-mentioned terbutaline sulphate suspendible glue on the flat board, drying, cutting (2cm * 2cm), namely get the terbutaline sulphate oral instant membrane.
This membrane toughness is better, and entrance dissolves rapidly dispersion, good mouthfeel, and it is sweet to distinguish the flavor of, solution time 15～20s.
Embodiment 4
Every terbutaline sulphate oral instant membrane sulfur acid terbutaline 2.5mg, the consisting of of per 1000 membrane:
Specific operation process: take by weighing terbutaline sulphate, aspartame, microcrystalline Cellulose, pregelatinized Starch, maltose alcohol, titanium dioxide, after the dispersion of 30% glycerite, add 0.3% pigment solution, 1% carboxymethylcellulose sodium solution, the limit edged stirs, and is after stirring, degassed, be coated in uniformly above-mentioned terbutaline sulphate suspendible glue on the flat board, drying, cutting (2cm * 2cm), namely get the terbutaline sulphate oral instant membrane.
This membrane pliability is good, and entrance dissolves rapidly dispersion, good mouthfeel, and it is sweet to distinguish the flavor of, solution time 15～20s.
Embodiment 5
Every terbutaline sulphate oral instant membrane sulfur acid terbutaline 2.5mg, the consisting of of per 1000 membrane:
Specific operation process: take by weighing terbutaline sulphate, aspartame, crosslinked carboxymethyl fecula sodium, mannitol, titanium dioxide, after the dispersion of 30% glycerite, add 0.3% pigment solution, 2% carboxymethylcellulose sodium solution, the limit edged stirs, and is after stirring, degassed, be coated in uniformly above-mentioned terbutaline sulphate suspendible glue on the flat board, drying, cutting (2cm * 2cm), namely get the terbutaline sulphate oral instant membrane.
This membrane toughness is better, and entrance dissolves rapidly dispersion, good mouthfeel, and it is sweet to distinguish the flavor of, solution time 15～20s.
Claims (8)
1. terbutaline sulphate oral instant membrane, it is characterized in that containing active component terbutaline sulphate, filmogen, disintegrating agent and the opacifier of effective dose, and the necessary acceptable filler of pharmacy, sweeting agent, wetting agent,, also can add as required coloring agent.
2. terbutaline sulphate oral instant membrane according to claim 1 is characterized by described filmogen and is selected from hypromellose, xanthan gum, sodium alginate, sodium carboxymethyl cellulose, polyvidone, methylcellulose, hydroxypropyl cellulose, high a kind of or its mixture that replaces in the hypromellose.
3. terbutaline sulphate oral instant membrane according to claim 1 is characterized in that described disintegrating agent is selected from a kind of or its mixture in microcrystalline Cellulose, pregelatinized Starch, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula sodium and the starch.
4. terbutaline sulphate oral instant membrane according to claim 1 is characterized in that described filler is selected from a kind of or its mixture in mannitol, sucrose, glucose, maltose, lactose, sorbitol, xylitol, maltose alcohol, galactitol, erythritol, dextrin, the trehalose.
5. terbutaline sulphate oral instant membrane according to claim 1 is characterized in that described sweeting agent is selected from a kind of or its mixture in aspartame, sucralose, fructose, sucrose, stevioside, glycyrrhizin, essence, spice, glucide and the saccharin sodium.
6. terbutaline sulphate oral instant membrane according to claim 1 is characterized in that described wetting agent is selected from a kind of or its mixture in glycerol, butanediol, propylene glycol and the Polyethylene Glycol.
7. terbutaline sulphate oral instant membrane according to claim 1 is characterized in that described opacifier is selected from a kind of or its mixture in titanium dioxide, iron oxide red, iron oxide yellow, the iron oxide brown.
8. terbutaline sulphate oral instant membrane according to claim 1 is characterized in that its preparation method comprises the steps:
A. dissolving with mixes: take by weighing terbutaline sulphate, disintegrating agent, sweeting agent, filler, opacifier, the dispersion of the aqueous solution of water or wetting agent, adding coloring agent, filmogen aqueous solution stir;
B. film, drying: above-mentioned terbutaline sulphate suspendible glue is applied on the flat board drying uniformly;
C. demoulding cuts into a certain size, packing.
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Cited By (6)
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| CN103263402A (en) * | 2013-05-31 | 2013-08-28 | 天津市聚星康华医药科技有限公司 | Water-drinking-free oral drug composition and preparation method thereof |
| CN104127370A (en) * | 2014-07-31 | 2014-11-05 | 天津市聚星康华医药科技有限公司 | Oral folic acid instantly-dissolved membrane and preparation method thereof |
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| CN111467365A (en) * | 2019-01-24 | 2020-07-31 | 开封九福来生物技术有限公司 | Oral instant film agent containing dendrobium polysaccharide and preparation method thereof |
| US11007144B2 (en) | 2016-11-15 | 2021-05-18 | Klaria Pharma Holding Ab | Pharmaceutical formulation |
| US11219600B2 (en) | 2017-06-08 | 2022-01-11 | Klaria Pharma Holding Ab | Pharmaceutical formulation |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| GB201808462D0 (en) * | 2018-05-23 | 2018-07-11 | Klaria Pharma Holding Ab | Pharmaceutical formulation |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103263402A (en) * | 2013-05-31 | 2013-08-28 | 天津市聚星康华医药科技有限公司 | Water-drinking-free oral drug composition and preparation method thereof |
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| CN104224756A (en) * | 2014-09-26 | 2014-12-24 | 天津市聚星康华医药科技有限公司 | Doxazosin mesylate oral instant film and preparation method thereof |
| US11007144B2 (en) | 2016-11-15 | 2021-05-18 | Klaria Pharma Holding Ab | Pharmaceutical formulation |
| US11219600B2 (en) | 2017-06-08 | 2022-01-11 | Klaria Pharma Holding Ab | Pharmaceutical formulation |
| US11904049B2 (en) | 2017-06-08 | 2024-02-20 | Klaria Pharma Holding Ab | Pharmaceutical formulation |
| CN111467365A (en) * | 2019-01-24 | 2020-07-31 | 开封九福来生物技术有限公司 | Oral instant film agent containing dendrobium polysaccharide and preparation method thereof |
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