CN102871984B - A kind of Phenylephrine hydrochloride oral instant membrane and preparation method thereof - Google Patents
A kind of Phenylephrine hydrochloride oral instant membrane and preparation method thereof Download PDFInfo
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- CN102871984B CN102871984B CN201210434832.5A CN201210434832A CN102871984B CN 102871984 B CN102871984 B CN 102871984B CN 201210434832 A CN201210434832 A CN 201210434832A CN 102871984 B CN102871984 B CN 102871984B
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- phenylephrine
- phenylephrine hydrochloride
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- 229960003733 phenylephrine hydrochloride Drugs 0.000 title claims abstract description 58
- 239000012528 membrane Substances 0.000 title claims abstract description 36
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- 229960001802 phenylephrine Drugs 0.000 claims description 26
- SONNWYBIRXJNDC-VIFPVBQESA-N phenylephrine Chemical compound CNC[C@H](O)C1=CC=CC(O)=C1 SONNWYBIRXJNDC-VIFPVBQESA-N 0.000 claims description 26
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Abstract
The invention belongs to medical art, relate to a kind of Phenylephrine hydrochloride oral instant membrane and preparation method thereof.Its taste is good, and energy rapid solution or disintegrate in oral cavity, release is rapid, absorbs onset fast after swallowing in gastrointestinal tract.Phenylephrine hydrochloride oral instant membrane of the present invention, for eliminating nasopharynx part mucous hyperemia, is alleviated nasal decongestion, swelling, is alleviated flu, influenza, allergy or non-allergic rhinitis etc. and cause nasal obstruction symptom.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, relate to a kind of Phenylephrine hydrochloride oral instant membrane and preparation method thereof, for eliminating nasopharynx part mucous hyperemia, alleviating nasal decongestion, swelling, alleviating the nasal obstruction symptom that flu, influenza, allergy or non-allergic rhinitis etc. cause.
Background technology
Flu is the common cold disease caused by virus, mixed infection or allergy; Most to be caused by Respirovirus, wherein with coronavirus and rhinovirus for principal causative virus.Virus entry mucosa especially nasal mucosa, can distend the blood vessels, congested, swollen tissue, and secretions increase, affect the ventilation of nasal cavity, the one-sided or bilateral of nasal cavity is blocked, causes nasal obstruction.Can alleviate after blowing out nasal mucus, often with dizzy, headache, indolent and listless, absent-minded, hypomnesis, nasal mucus refluence, enter the pharyngeal performances such as sputum that spued by mouth.
Nasal obstruction is the common sympton of flu, but has a strong impact on work and the life of people.Nasal obstruction causes hypopnea, and mouth breathing causes maxillary dry, is far more than and allows people lie awake all night.Blow one's nose for a long time and be easy to hurt in mucosa, and hand Long contact time nasal mucus affects health, the course of disease may be extended and increase the chance being transmitted to other people, a lot of inconvenience is caused to the life of people.
Decongestant can make the mucosa vasoconstriction of nasal cavity improve BITONG gas/breath state to reach and shorten the flu course of disease.Active component many employings adrenomimetic drug class of clinical oral administration nasal decongestant is as nasal decongestant.It is collapsible upper respiratory tract blood capillary, reduce nasal cavity blood flow, eliminate nasopharynx part mucous hyperemia, alleviate nasal decongestion, swelling, alleviate the nasal obstruction symptom that flu, influenza, allergy or other respiratory disorders (as sinusitis, bronchitis etc.) cause.In China, pseudoephedrine or the methylephedrine of adopting as subtracting nasal congestion active component, and has gone on the market application for many years.Because of derivant amphetamines (Methamphetamine) similar of ephedrine and its synthetic, can methamphetamine hydrochloride be manufactured after extraction, cause serious social danger and public health problem.The U.S. implemented the federal bill of CombatMethamphetamineEpidemicActof2005 in 2006, the application of constraint ephedrines medicine.National Drug Administration of China has formulated a series of policies and regulations about ephedrines preparation in succession, enhances the Production&Operations Management containing yellow bases preparation, limits the sale of this type of medicine.
Phenylephrine hydrochloride be directly act on receptor sympathomimetic by medicine, direct selective excitement α receptor, upper respiratory tract blood capillary is caused to shrink, expansion bronchus, reduce nasal cavity blood flow, eliminate nasopharynx part mucous hyperemia, alleviate nasal decongestion, swelling, alleviate the nasal obstruction symptom that flu, influenza, allergy or other respiratory disorders (as sinusitis, bronchitis etc.) cause.Because it does not cause the release of endogenous phenylephrine hydrochloride, not easily produce as insomnia, anxiety, agitation and being on tenterhooks etc. stimulates the relevant side effect of central nervous system phenylephrine hydrochloride and the acceptable salt of pharmaceutics thereof to be widely used as the oral nasal congestion agent that subtracts abroad, alternative pseudoephedrine is applied.The folk prescription of the many phenylephrine hydrochloride of the U.S. and the multiple dosage formulation of compound recipe are as OTC (over-the-counter) class drug product.Phenylephrine hydrochloride series products, current China only has phenylephrine hydrochloride inj to go on the market, as shock vasoactive drug with improve heart and brain circulation medicine, maintain blood pressure and Supraventricular Tachycardia when treatment shock and anesthesia.
Summary of the invention
An object of the present invention be to provide a kind of taste good, dissolve rapidly in oral cavity, release Phenylephrine hydrochloride oral instant membrane rapidly, the hydrochloric phenylephrine 10mg of every sheet film.
Another object of the present invention is to provide the preparation technology of Phenylephrine hydrochloride oral instant membrane, by selecting the odor mask, filmogen, filler and the sweeting agent that are applicable to, preparation Phenylephrine hydrochloride oral instant membrane, preparation technology is simple and easy to do, with low cost.
Phenylephrine hydrochloride oral instant membrane provided by the invention comprises following component: phenylephrine hydrochloride, odor mask, filmogen, filler, sweeting agent, plasticizer, coloring agent and essence.
Described filmogen is selected from xanthan gum, sodium carboxymethyl cellulose, hypromellose, sodium alginate, gelatin, dextrin, Lac, arabic gum, methylcellulose, high replaces one in hypromellose, polyvidone, agar, alginic acid or its mixture; The preferred filmogen of the present invention is the combination of xanthan gum and hypromellose or the combination of xanthan gum and sodium carboxymethyl cellulose.
Described filler is selected from one in microcrystalline Cellulose, mannitol, lactose, sorbitol, xylitol, maltose alcohol, low-substituted hydroxypropyl cellulose, starch, pregelatinized Starch or its mixture; Preferably microcrystalline cellulose.
Described sweeting agent is selected from one in sucralose, aspartame, stevioside, glycyrrhizin, glucide, saccharin sodium or its mixture.
Described plasticizer is selected from one in glycerol, Polyethylene Glycol, propylene glycol, silicone oil, polypropylene glycol, hexanediol or its mixture.
By weight, it consists of described Phenylephrine hydrochloride oral instant membrane:
The preparation method of Phenylephrine hydrochloride oral instant membrane provided by the invention comprises the steps:
A. the medicated resin suspension of hydrochloric phenylephrine is prepared: take phenylephrine hydrochloride, with 500 times of (V/W) water dissolutioies, stirred at ambient temperature adds polacrilin potassium resin after dissolving, continuous stirring carries out ion exchange 1 hour, obtains phenylephrine hydrochloride medicated resin suspension;
B. mixing, film: add filler and sweeting agent in the suspension of A gained, stirring makes it be uniformly dispersed, add a kind of filmogen again, leave standstill swelling 1 hour, add the aqueous solution of another kind of filmogen under then stirring, after stirring, add plasticizer, coloring agent and essence, degassed after mix homogeneously, obtain the suspendible glue of hydrochloric phenylephrine, it is coated on flat board uniformly, dry;
C. demoulding, cuts into a certain size, and packaging, to obtain final product.
Phenylephrine hydrochloride oral instant membrane of the present invention has following advantage: taste is good, and without the need to drinking-water when taking medicine, at rapid oral dissolution, patient medication compliance is high; Preparation technology is simple, with low cost.
Detailed description of the invention
The present invention is further elaborated by following examples, but scope of the present invention is not limited to these embodiments.So, under method prerequisite of the present invention, all the scope of protection of present invention is belonged to simple modifications of the present invention.
Embodiment 1
The hydrochloric phenylephrine 10.0mg of every sheet, consisting of of every 1000 phenylephrine hydrochloride membrane:
The preparation method of Phenylephrine hydrochloride oral instant membrane provided by the invention comprises the steps:
A. the medicated resin suspension of hydrochloric phenylephrine is prepared: take phenylephrine hydrochloride, with 500 times of (V/W) water dissolutioies, stirred at ambient temperature adds polacrilin potassium resin after dissolving, continuous stirring carries out ion exchange 1 hour, obtains phenylephrine hydrochloride medicated resin suspension;
B. mixing, film: add microcrystalline Cellulose and sucralose in the suspension of A gained, stirring makes it be uniformly dispersed, add sodium carboxymethyl cellulose again, leave standstill swelling 1 hour, add 0.3% xanthan gum solution under then stirring, after stirring, add 30% glycerine water solution, 0.3% kermes cellulose solution and fruity liquid essence, degassed after mix homogeneously, obtain the suspendible glue of hydrochloric phenylephrine, it is coated on flat board uniformly, dry;
C. demoulding, cuts, and packaging, to obtain final product.
Evaluate: this membrane pinkiness, toughness is better, and fast at dissolved in oral cavity, taste is fragrant and sweet, and solution time is 20s.
Embodiment 2
The hydrochloric phenylephrine 10.0mg of every sheet, consisting of of every 1000 phenylephrine hydrochloride membrane:
The preparation method of Phenylephrine hydrochloride oral instant membrane provided by the invention comprises the steps:
A. the medicated resin suspension of hydrochloric phenylephrine is prepared: take phenylephrine hydrochloride, with 500 times of (V/W) water dissolutioies, stirred at ambient temperature adds polacrilin potassium resin after dissolving, continuous stirring carries out ion exchange 1 hour, obtains phenylephrine hydrochloride medicated resin suspension;
B. mixing, film: add microcrystalline Cellulose and aspartame in the suspension of A gained, stirring makes it be uniformly dispersed, add hypromellose again, leave standstill swelling 1 hour, add 0.3% xanthan gum solution under then stirring, after stirring, add 30% glycerine water solution, 0.3% kermes cellulose solution and fruity liquid essence, degassed after mix homogeneously, obtain the suspendible glue of hydrochloric phenylephrine, it is coated on flat board uniformly, dry;
C. demoulding, cuts, and packaging, to obtain final product.
Evaluate: this membrane pinkiness, toughness is better, and fast at dissolved in oral cavity, taste is fragrant and sweet, and solution time is 22s.
Embodiment 3
The hydrochloric phenylephrine 10.0mg of every sheet, consisting of of every 1000 phenylephrine hydrochloride membrane:
The preparation method of Phenylephrine hydrochloride oral instant membrane provided by the invention comprises the steps:
A. the medicated resin suspension of hydrochloric phenylephrine is prepared: take phenylephrine hydrochloride, with 500 times of (V/W) water dissolutioies, stirred at ambient temperature adds polacrilin clock resin after dissolving, continuous stirring carries out ion exchange 1 hour, obtains phenylephrine hydrochloride medicated resin suspension;
B. mixing, film: add microcrystalline Cellulose and sucralose in the suspension of A gained, stirring makes it be uniformly dispersed, add sodium carboxymethyl cellulose again, leave standstill swelling 1 hour, add 0.3% xanthan gum solution under then stirring, after stirring, add 30% glycerine water solution, 0.3% kermes cellulose solution and fruity liquid essence, degassed after mix homogeneously, obtain the suspendible glue of hydrochloric phenylephrine, it is coated on flat board uniformly, dry;
C. demoulding, cuts, and packaging, to obtain final product.
Evaluate: this membrane pinkiness, toughness is better, fast at dissolved in oral cavity, and taste is slightly bitter, and solution time is 20s.
Embodiment 4
The hydrochloric phenylephrine 10.0mg of every sheet, consisting of of every 1000 phenylephrine hydrochloride membrane:
The preparation method of Phenylephrine hydrochloride oral instant membrane provided by the invention comprises the steps:
A. the medicated resin suspension of hydrochloric phenylephrine is prepared: take phenylephrine hydrochloride, with 500 times of (V/W) water dissolutioies, stirred at ambient temperature adds polacrilin potassium resin after dissolving, continuous stirring carries out ion exchange 1 hour, obtains phenylephrine hydrochloride medicated resin suspension;
B. mixing, film: add microcrystalline Cellulose, sorbitol and aspartame in the suspension of A gained, stirring makes it be uniformly dispersed, add sodium carboxymethyl cellulose again, leave standstill swelling 1 hour, add 0.3% xanthan gum solution under then stirring, after stirring, add 30% glycerine water solution, 0.3% kermes cellulose solution and fruity liquid essence, degassed after mix homogeneously, obtain the suspendible glue of hydrochloric phenylephrine, it is coated on flat board uniformly, dry;
C. demoulding, cuts, and packaging, to obtain final product.
Evaluate: this membrane pinkiness, toughness is better, and fast at dissolved in oral cavity, taste is fragrant and sweet, and solution time is 25s.
Embodiment 5
The hydrochloric phenylephrine 10.0mg of every sheet, consisting of of every 1000 phenylephrine hydrochloride membrane:
The preparation method of Phenylephrine hydrochloride oral instant membrane provided by the invention comprises the steps:
A. the medicated resin suspension of hydrochloric phenylephrine is prepared: take phenylephrine hydrochloride, with 500 times of (V/W) water dissolutioies, stirred at ambient temperature adds polacrilin potassium resin after dissolving, continuous stirring carries out ion exchange 1 hour, obtains phenylephrine hydrochloride medicated resin suspension;
B. mixing, film: add microcrystalline Cellulose and saccharin sodium in the suspension of A gained, stirring makes it be uniformly dispersed, add sodium carboxymethyl cellulose again, leave standstill swelling 1 hour, add 0.3% sodium alginate aqueous solution under then stirring, after stirring, add 30% glycerine water solution, 0.3% kermes cellulose solution and fruity liquid essence, degassed after mix homogeneously, obtain the suspendible glue of hydrochloric phenylephrine, it is coated on flat board uniformly, dry;
C. demoulding, cuts, and packaging, to obtain final product.
Evaluate: this membrane pinkiness, toughness is general, fast at dissolved in oral cavity, and taste is slightly bitter, and solution time is 25s.
Claims (3)
1. a Phenylephrine hydrochloride oral instant membrane, it is characterized in that the hydrochloric phenylephrine 10.0mg of every sheet Phenylephrine hydrochloride oral instant membrane, every 1000 Phenylephrine hydrochloride oral instant membrane are made up of phenylephrine hydrochloride 10.0g, polacrilin potassium 10.0g, microcrystalline Cellulose 12.0g, sucralose 6.0g, sodium carboxymethyl cellulose 4.0g, xanthan gum 0.72g, glycerol 2.4g, carmine pigment 0.012g, fruity liquid essence 4.0g, water 5245g, and its preparation method comprises the steps:
A. the medicated resin suspension of hydrochloric phenylephrine is prepared: take phenylephrine hydrochloride, with 500 times of (V/W) water dissolutioies, stirred at ambient temperature adds polacrilin potassium resin after dissolving, continuous stirring carries out ion exchange 1 hour, obtains phenylephrine hydrochloride medicated resin suspension;
B. mixing, film: add microcrystalline Cellulose and sucralose in the suspension of A gained, stirring makes it be uniformly dispersed, add sodium carboxymethyl cellulose again, leave standstill swelling 1 hour, add 0.3% xanthan gum solution under then stirring, after stirring, add 30% glycerine water solution, 0.3% kermes cellulose solution and fruity liquid essence, degassed after mix homogeneously, obtain the suspendible glue of hydrochloric phenylephrine, it is coated on flat board equably, dry;
C. demoulding, cuts, and packaging, to obtain final product.
2. a Phenylephrine hydrochloride oral instant membrane, it is characterized in that the hydrochloric phenylephrine 10.0mg of every sheet Phenylephrine hydrochloride oral instant membrane, every 1000 Phenylephrine hydrochloride oral instant membrane are made up of phenylephrine hydrochloride 10.0g, polacrilin potassium 20.0g, microcrystalline Cellulose 12.0g, aspartame 6.0g, hypromellose 6.0g, xanthan gum 0.72g, glycerol 2.4g, carmine pigment 0.012g, fruity liquid essence 4.0g, water 5245g, and its preparation method comprises the steps:
A. the medicated resin suspension of hydrochloric phenylephrine is prepared: take phenylephrine hydrochloride, with 500 times of (V/W) water dissolutioies, stirred at ambient temperature adds polacrilin potassium resin after dissolving, continuous stirring carries out ion exchange 1 hour, obtains phenylephrine hydrochloride medicated resin suspension;
B. mixing, film: add microcrystalline Cellulose and aspartame in the suspension of A gained, stirring makes it be uniformly dispersed, add hypromellose again, leave standstill swelling 1 hour, add 0.3% xanthan gum solution under then stirring, after stirring, add 30% glycerine water solution, 0.3% kermes cellulose solution and fruity liquid essence, degassed after mix homogeneously, obtain the suspendible glue of hydrochloric phenylephrine, it is coated on flat board equably, dry;
C. demoulding, cuts, and packaging, to obtain final product.
3. a Phenylephrine hydrochloride oral instant membrane, it is characterized in that the hydrochloric phenylephrine 10.0mg of every sheet Phenylephrine hydrochloride oral instant membrane, every 1000 Phenylephrine hydrochloride oral instant membrane are made up of phenylephrine hydrochloride 10.0g, polacrilin potassium 10.0g, microcrystalline Cellulose 10.0g, sorbitol 4.0g, aspartame 5.0g, sodium carboxymethyl cellulose 4.0g, xanthan gum 0.72g, glycerol 2.4g, carmine pigment 0.012g, fruity liquid essence 4.0g, water 5245g, and its preparation method comprises the steps:
A. the medicated resin suspension of hydrochloric phenylephrine is prepared: take phenylephrine hydrochloride, with 500 times of (V/W) water dissolutioies, stirred at ambient temperature adds polacrilin potassium resin after dissolving, continuous stirring carries out ion exchange 1 hour, obtains phenylephrine hydrochloride medicated resin suspension;
B. mixing, film: add microcrystalline Cellulose, sorbitol and aspartame in the suspension of A gained, stirring makes it be uniformly dispersed, add sodium carboxymethyl cellulose again, leave standstill swelling 1 hour, add 0.3% xanthan gum solution under then stirring, after stirring, add 30% glycerine water solution, 0.3% kermes cellulose solution and fruity liquid essence, degassed after mix homogeneously, obtain the suspendible glue of hydrochloric phenylephrine, it is coated on flat board equably, dry;
C. demoulding, cuts, and packaging, to obtain final product.
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| CN104971066A (en) * | 2015-06-17 | 2015-10-14 | 天津市聚星康华医药科技有限公司 | Medicinal composition containing vardenafil, and preparation method thereof |
| AU2017359973B2 (en) | 2016-11-15 | 2023-02-16 | Klaria Pharma Holding Ab | Pharmaceutical formulation |
| GB201709141D0 (en) | 2017-06-08 | 2017-07-26 | Klaria Pharma Holding Ab | Pharmaceutical formulation |
| CN108078962A (en) * | 2018-01-29 | 2018-05-29 | 中国药科大学 | A kind of instant film of donepezil hydrochloride orally and preparation method thereof |
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| CN1321080A (en) * | 1998-09-25 | 2001-11-07 | 沃尼尔·朗伯公司 | Fast dissolving orally consumable films |
| CN1419441A (en) * | 2000-03-23 | 2003-05-21 | 沃尼尔·朗伯公司 | Fast dissolving orally consumable films containing an ion exchange resin as a taste masking agent |
| CN101422447A (en) * | 2007-09-28 | 2009-05-06 | 兴和株式会社 | Instant film preparation containing phenylephrine hydrochloride |
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| EP1830851A2 (en) * | 2004-12-06 | 2007-09-12 | Themis Laboratories Private Limited | Rapid disintegrating taste masked compositions and a process for its preparations |
| US8343546B2 (en) * | 2005-09-13 | 2013-01-01 | Coating Place, Inc. | Ion exchange resin treated to control swelling |
| WO2008039358A2 (en) * | 2006-09-30 | 2008-04-03 | Capricorn Pharma Inc. | Resin-complex granulation for water-soluble drugs and associated methods |
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| CN1321080A (en) * | 1998-09-25 | 2001-11-07 | 沃尼尔·朗伯公司 | Fast dissolving orally consumable films |
| CN1419441A (en) * | 2000-03-23 | 2003-05-21 | 沃尼尔·朗伯公司 | Fast dissolving orally consumable films containing an ion exchange resin as a taste masking agent |
| CN101422447A (en) * | 2007-09-28 | 2009-05-06 | 兴和株式会社 | Instant film preparation containing phenylephrine hydrochloride |
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