CN103860523A - Chlorphenamine maleate oral fast dissolving film and preparation method thereof - Google Patents
Chlorphenamine maleate oral fast dissolving film and preparation method thereof Download PDFInfo
- Publication number
- CN103860523A CN103860523A CN201210548160.0A CN201210548160A CN103860523A CN 103860523 A CN103860523 A CN 103860523A CN 201210548160 A CN201210548160 A CN 201210548160A CN 103860523 A CN103860523 A CN 103860523A
- Authority
- CN
- China
- Prior art keywords
- chlorphenamine maleate
- oral instant
- instant membrane
- chlorphenamine
- stirring
- 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.)
- Granted
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- DBAKFASWICGISY-BTJKTKAUSA-N Chlorpheniramine maleate Chemical compound OC(=O)\C=C/C(O)=O.C=1C=CC=NC=1C(CCN(C)C)C1=CC=C(Cl)C=C1 DBAKFASWICGISY-BTJKTKAUSA-N 0.000 title claims abstract description 76
- 238000002360 preparation method Methods 0.000 title claims abstract description 18
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- 239000003795 chemical substances by application Substances 0.000 claims abstract description 13
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- 238000003756 stirring Methods 0.000 claims description 32
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- WVWZXTJUCNEUAE-UHFFFAOYSA-M potassium;1,2-bis(ethenyl)benzene;2-methylprop-2-enoate Chemical compound [K+].CC(=C)C([O-])=O.C=CC1=CC=CC=C1C=C WVWZXTJUCNEUAE-UHFFFAOYSA-M 0.000 claims description 13
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- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims description 2
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims description 2
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- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims description 2
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Landscapes
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
The invention belongs to the technical field of medicines, and relates to a chlorphenamine maleate oral fast dissolving film and a preparation method thereof. The chlorphenamine maleate oral fast dissolving film comprises an effective amount of the active component chlorphenamine maleate, an odor mask, a film forming material and a disintegrating agent, and necessary pharmaceutically acceptable filler, sweetener and plasticizer, and a coloring agent and essence both added according to need. The oral fast dissolving film is capable of rapidly disintegrating and dissolving in oral cavity, is good in mouthfeel, fast in drug release speed and rapid in effect onset, and is beneficial for improving medicine compliance of patients especially child patients and elderly patients. Also the oral fast dissolving film is convenient to take, and the problem that medicine taking is not timely in the absence of water is solved.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, be specifically related to chlorphenamine maleate oral instant membrane and preparation method thereof, it can collapse fast molten and discharge medicine in oral cavity, absorbs fast onset after swallowing in gastrointestinal tract.Chlorphenamine maleate oral instant membrane of the present invention, be applicable to skin allergy: urticaria, eczema, dermatitis, drug eruption, skin pruritus, neurodermatitis, insect bite disease, solar dermatitis, also can be used for allergic rhinitis, vasomotor rhinitis, medicine and food anaphylaxis.
Background technology
Histamine is the autacoid being extensively present in tissue, with the basophilic granulocyte content in mastocyte and blood in connective tissue for the highest.After 20th century, found histamine receptor the sixties, start to apply H1 receptor antagonist treatment allergic disease.Start application so far from first antihistaminic, existing more than 50 plant H1 receptor antagonist can supply clinical practice.Generally the antihistaminic going on the market in the past the eighties in 20th century is called to first generation antihistaminic, the antihistaminic going on the market after the eighties is called second filial generation antihistaminic, chlorphenamine maleate belongs to first generation antihistaminic, is applicable to skin allergy: urticaria, eczema, dermatitis, drug eruption, skin pruritus, neurodermatitis, insect bite disease, solar dermatitis.Also can be used for allergic rhinitis, vasomotor rhinitis, medicine and food anaphylaxis.
Antihistamine drug be clinical in widely used kind, be mainly used in the desensitization treatment of human immune system's allergic disease.In the treatment of urticaria and allergic dermatitis, allergic rhinitis and allergic asthma, play an important role.In addition, be also mixed with compound preparation with Antipyretics thing or pseudoephedrine class medicine, for catching a cold, the clinical treatment of heating and respiratory tract disease, on prescription drugs and OTC market, all have demand widely.In recent years, due to the quickening of environmental pollution and rhythm of life, anaphylactic disease sickness rate constantly rises, and the consumption of antihistamine drug also shows a rising trend.
Due to conventional tablet and capsule under one's belt disintegrate could start to discharge medicine, onset is compared with slow and because volume is swallowed compared with being difficult to greatly, infant, critical patient and gerontal patient are not too applicable; In the situation that there is no water, be also difficult to take.Although liquid preparation can quick acting, takes and needs soupspoon or Measuring glass, in the situations such as driving, take inconvenience especially, be also unfavorable for quantitatively taking accurately, carry inconvenience simultaneously.And although oral cavity disintegration tablet and chewable tablet have solved the problems referred to above to a certain extent, due to its formulation characteristic, the frangible easy moisture absorption of product, to producing, pack, have high requirement, preparation process is used a large amount of adjuvants, and energy consumption is larger, and cost is higher.
Oral instant membrane of the present invention is a kind of emerging drug delivery system, and its size, shape, thickness are similar to stamp.Oral instant membrane is met saliva moistening immediately, and quick dissolving or disintegrate, release medicine in oral cavity absorb fast onset in gastrointestinal tract after swallowing.The feature such as do not need drinking-water because this dosage form has, the several seconds is dissolved on tongue, release is rapid, taste is pleasant, to the research of this dosage form gradually deeply, applies extensive gradually both at home and abroad.Comprise Dextromethorphan oral cavity dissolving films, risperidone orally dissolving films, Ondansetron Hydrochloride oral instant membrane etc. at the product of European & American Market listing.
All there is no at present the listing of chlorphenamine maleate oral instant membrane both at home and abroad.The raw material bitter in the mouth of chlorphenamine maleate, dissolves or disintegrate in oral cavity and be prepared into the requirement of oral instant membrane, fast so need to use odor mask to carry out taste masking processing to raw material.Because oral instant membrane size thickness is limited, its adjuvant amount is restricted, and accounts for after certain proportion at odor mask, and the corresponding decline of filmogen proportion, has higher requirement for the film property of filmogen.
Summary of the invention
One of object of the present invention is to provide that a kind of taste is good, drug release rate is fast, the chlorphenamine maleate oral instant membrane of onset rapidly, and raising patient is the compliance of child patient and gerontal patient's medication especially.
Another object of the present invention is to provide one and is easy to carry, the chlorphenamine maleate oral instant membrane of taking convenience, solve the common dosage form of current chlorphenamine maleate and carried inconvenience as tablet, drop pill, and the problem that can not take medicine in time in the situation that there is no water.
Feature of the present invention is, by ion exchange resin, medicine is carried out to taste masking, has solved bitterness when chlorphenamine maleate is taken; Select the macromolecular material of good water solubility as filmogen, ensured that medicine film can dissolve fast in oral cavity; The simple filmogen that uses good water solubility can not meet the requirement that oral instant membrane dissolves rapidly in oral cavity, adds appropriate disintegrating agent in the present invention, utilizes the capillarity of disintegrating agent and expansion can solve this difficult problem.
The prescription of chlorphenamine maleate oral instant membrane provided by the invention is composed as follows:
Chlorphenamine maleate, ion exchange resin, filmogen, disintegrating agent, filler, sweeting agent, plasticizer, coloring agent, essence.
Described ion exchange resin, for by preparing the medicated resin of chlorphenamine maleate, carries out taste masking to chlorphenamine maleate.Ion exchange resin is the inertia macromolecular material of a class with functional group, can be directly used in oral formulations to cover the poor taste of medicine, improves medicine mouthfeel.Due to this material have molecular weight greatly, the feature such as water-soluble and not easily digested hardly, thereby by the official approval of pharmaceutical control and administration department of western countries can be directly as pharmaceutic adjuvant for oral formulations.The preferred polacrilin potassium of the present invention.
The polacrilin potassium resin that the present invention uses can directly use polacrilin potassium resin, also can be prepared from by polacrilin resin.
Polacrilin potassium process for preparing resins: take polacrilin resin 200g, add the 1mol/L potassium hydroxide solution 1000ml preparing, low rate mixing 2 hours, leaves standstill 4-10 hour, removes alkali liquor, sucking filtration, wash with water until filtrate, for neutral, is dried 1 hour under 60 DEG C of freeze-day with constant temperature conditions, pulverized 200 orders, obtain polacrilin potassium resin, for subsequent use.
Filmogen should be nontoxic, nonirritant, stable in properties, free from extraneous odour, do not have an effect with medicine, also must have good film property and demoulding, can dissolve rapidly in oral cavity.Filmogen of the present invention is selected from Kollicoat IR, xanthan gum, sodium alginate, sodium carboxymethyl cellulose, polyvidone, arabic gum, methylcellulose, hydroxypropyl methylcellulose, high a kind of or its mixture replacing in hypromellose and alginic acid.
Disintegrating agent has capillarity and expansion, has pore structure after making film dry, forms the capillary channel that is easy to moistening, can be by water-wet, and contact water afterwards with water and can enter film inside with capillary channel rapidly, impel the rapid disintegrate of film.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 starch.
Filler can increase membrane weight and volume, reduces molding shrinkage, regulates resin viscosity, reduces surface roughness.The present invention adopts appropriate filler to improve membrane performance and outward appearance, and preparation process is carried out smoothly.Filler of the present invention a kind of or its mixture in microcrystalline Cellulose, pregelatinized Starch, mannitol, lactose, sorbitol, xylitol, dextrin, trehalose, maltose alcohol, low-substituted hydroxypropyl cellulose and starch.
The present invention also provides the preparation method of chlorphenamine maleate oral instant film preparation, comprises the steps:
Take chlorphenamine maleate, with water dissolution, under room temperature, after stirring and dissolving, add polacrilin potassium resin, continuous stirring is carried out ion exchange 1-2 hour, obtain chlorphenamine maleate medicated resin solution, add again sweeting agent, filler, stirring is uniformly dispersed it, add the colloidal solution of filmogen, color element, essence and plasticizer etc., limit edged stirs, after stirring, degassed, above-mentioned chlorphenamine maleate suspendible glue is coated on flat board uniformly, heat blowing is dry, cutting (2cm × 2cm), obtain chlorphenamine maleate oral instant membrane.
Described chlorphenamine maleate oral instant membrane, it is characterized in that, the rapid disintegrate in oral cavity, then disperse or dissolve, the disintegration rate of diaphragm has direct relation for the curative effect of medicine, and the investigation index of evaluating its disintegrate is disintegration, the oral instant membrane of preparing by the present invention disintegration time in the water of 37 DEG C is less than 30 seconds, has reached the object of rapid onset.
Advantage of the present invention: 1, medicine collapses rapidly moltenly in oral cavity, and onset is rapid; 2, do not need with water delivery service, the danger of not stopping up trachea, the severe case who is applicable to infant, old people and dysphagia takes, and the patient who produces nausea and vomiting symptom for water companion clothes provides new selection; 3, medicine mouthfeel is joyful, has improved the compliance that patient takes medicine; 4, good stability, is convenient to preserve, easy to carry.
Detailed description of the invention
By following examples, chlorphenamine maleate oral instant membrane of the present invention is done further and illustrated, 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 chlorphenamine maleate oral instant membrane is containing chlorphenamine maleate 4mg, the consisting of of every 1000 membrane:
Concrete preparation process:
Beta-schardinger dextrin-is made into saturated solution, adds chlorphenamine maleate to mix ultrasonic 30 minutes, add sucralose, microcrystalline Cellulose, mannitol, stirring is uniformly dispersed it, add pigment, essence, 30% glycerol, 2% hydroxypropyl methylcellulose solution, limit edged stirs, after being uniformly mixed, degassed, obtain chlorphenamine maleate suspendible glue, be coated in uniformly flat board upper, heat blowing is dry, cutting (2cm*2cm), obtains chlorphenamine maleate oral instant membrane.
This membrane pinkiness, toughness is better, and entrance dissolves fast, and mouthfeel is more bitter, solution time 20s.
Embodiment 2
Every chlorphenamine maleate oral instant membrane is containing chlorphenamine maleate 4mg, the consisting of of every 1000 membrane:
Concrete preparation process:
Take chlorphenamine maleate 4g, water 120mL dissolves, under room temperature, after stirring and dissolving, add polacrilin potassium resin 4g, continuous stirring is carried out ion exchange 1 hour, obtain chlorphenamine maleate medicated resin solution, add again sucralose, pregelatinized Starch, mannitol, stirring is uniformly dispersed it, add pigment, essence, 30% glycerol, 2% hydroxypropyl methylcellulose solution, limit edged stirs, after being uniformly mixed, degassed, above-mentioned chlorphenamine maleate suspendible glue is coated on flat board uniformly, heat blowing is dry, cutting (2cm × 2cm), obtain chlorphenamine maleate oral instant membrane.
This membrane pinkiness, toughness is better, and entrance dissolves soon, good mouthfeel, solution time 10-15s.
Embodiment 3
Every chlorphenamine maleate oral instant membrane is containing chlorphenamine maleate 4mg, the consisting of of every 1000 membrane:
Concrete preparation process:
Take chlorphenamine maleate 4g, water 120mL dissolves, under room temperature, after stirring and dissolving, add polacrilin potassium resin 4g, continuous stirring is carried out ion exchange 1.5 hours, obtain chlorphenamine maleate medicated resin solution, add again aspartame, microcrystalline Cellulose, sorbitol, stirring is uniformly dispersed it, add pigment, essence, 30% glycerol, 1% carboxymethylcellulose sodium solution, limit edged stirs, after being uniformly mixed, degassed, above-mentioned chlorphenamine maleate suspendible glue is coated on flat board uniformly, heat blowing is dry, cutting (2cm × 2cm), obtain chlorphenamine maleate oral instant membrane.
This membrane pinkiness, toughness is better, and entrance dissolves fast, and mouthfeel is better, solution time 15-20s.
Embodiment 4
Every chlorphenamine maleate oral instant membrane is containing chlorphenamine maleate 4mg, the consisting of of every 1000 membrane:
Concrete preparation process:
Take chlorphenamine maleate 4g, water 120mL dissolves, under room temperature, after stirring and dissolving, add polacrilin potassium resin 2g, continuous stirring is carried out ion exchange 1 hour, obtain chlorphenamine maleate medicated resin solution, add again sucralose, starch, trehalose, stirring is uniformly dispersed it, add pigment, essence, 30% glycerol, 3% methocel solution, limit edged stirs, after being uniformly mixed, degassed, above-mentioned chlorphenamine maleate suspendible glue is coated on flat board uniformly, heat blowing is dry, cutting (2cm × 2cm), obtain chlorphenamine maleate oral instant membrane.
This membrane pinkiness, toughness is better, and entrance dissolves fast, good mouthfeel, solution time 20s.
Through the ratio of upper comparative optimization embodiment 2.
Embodiment 5
Every chlorphenamine maleate oral instant membrane is containing chlorphenamine maleate 4mg, the consisting of of every 1000 membrane:
Concrete preparation process:
Take chlorphenamine maleate 4g, water 120mL dissolves, under room temperature, after stirring and dissolving, add polacrilin potassium resin 4g, continuous stirring is carried out ion exchange 2 hours, obtain chlorphenamine maleate medicated resin solution, add again aspartame, low-substituted hydroxypropyl cellulose, maltose alcohol, stirring is uniformly dispersed it, add pigment, essence, 30% glycerol, 1% Hydroxypropylcelliloxe solution, limit edged stirs, after being uniformly mixed, degassed, above-mentioned chlorphenamine maleate suspendible glue is coated on flat board uniformly, heat blowing is dry, cutting (2cm × 2cm), obtain chlorphenamine maleate oral instant membrane.
This membrane pinkiness, toughness is better, and entrance dissolves fast, and mouthfeel is good, solution time 15-20s.
Embodiment 6
Every chlorphenamine maleate oral instant membrane is containing chlorphenamine maleate 4mg, the consisting of of every 1000 membrane:
Concrete preparation process:
Take chlorphenamine maleate 4g, water 120mL dissolves, under room temperature, after stirring and dissolving, add polacrilin potassium resin 4g, continuous stirring is carried out ion exchange 1 hour, obtain chlorphenamine maleate medicated resin solution, add again sucralose, microcrystalline Cellulose, xylitol, stirring is uniformly dispersed it, add pigment, essence, 30% glycerol, 0.3% xanthan gum solution, limit edged stirs, after being uniformly mixed, degassed, above-mentioned chlorphenamine maleate suspendible glue is coated on flat board uniformly, heat blowing is dry, cutting (2cm × 2cm), obtain chlorphenamine maleate oral instant membrane.
This membrane pinkiness, toughness is better, and entrance dissolves fast, and mouthfeel is good, solution time 15-20s.
Claims (9)
1. chlorphenamine maleate oral instant membrane, is characterized in that the active component chlorphenamine maleate, odor mask, filmogen and the disintegrating agent that contain effective dose; And the necessary acceptable filler of pharmacy, sweeting agent, plasticizer; Also can add as required coloring agent and essence.
2. odor mask according to claim 1, it is characterized by ion exchange resin, it act as the medicated resin that contains chlorphenamine maleate by preparation chlorphenamine maleate is carried out to taste masking processing, by weight, its consumption is chlorphenamine maleate 0.5 times～2.5 times.
3. odor mask according to claim 1, is characterized by polacrilin potassium, by weight, its consumption is chlorphenamine maleate 1 times～2 times.
4. chlorphenamine maleate oral instant membrane according to claim 1, is characterized in that described filmogen is selected from Kollicoat IR, xanthan gum, sodium alginate, sodium carboxymethyl cellulose, polyvidone, arabic gum, methylcellulose, hydroxypropyl methylcellulose, high a kind of or its mixture replacing in hypromellose and alginic acid.
5. chlorphenamine maleate 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 starch.
6. chlorphenamine maleate oral instant membrane according to claim 1, is characterized in that described filler is selected from a kind of or its mixture in mannitol, lactose, sorbitol, xylitol, dextrin, trehalose and maltose alcohol.
7. chlorphenamine maleate oral instant membrane according to claim 1, is characterized in that described sweeting agent is selected from a kind of or its mixture in sucralose, aspartame, stevioside, glycyrrhizin, glucide, saccharin sodium, fructose and sucrose.
8. chlorphenamine maleate oral instant membrane according to claim 1, is characterized in that described plasticizer is selected from a kind of or its mixture in Polyethylene Glycol, glycerol, propylene glycol, polypropylene glycol and hexanediol.
9. chlorphenamine maleate oral instant membrane according to claim 1, is characterized in that its preparation method comprises the steps:
Take chlorphenamine maleate, with water dissolution, under room temperature, after stirring and dissolving, add polacrilin potassium resin, continuous stirring is carried out ion exchange 1-2 hour, obtain chlorphenamine maleate medicated resin solution, add again sweeting agent, filler, stirring is uniformly dispersed it, add the colloidal solution of filmogen, color element, essence and plasticizer etc., limit edged stirs, after stirring, degassed, above-mentioned chlorphenamine maleate suspendible glue is coated on flat board uniformly, heat blowing is dry, cut into certain little, obtain chlorphenamine maleate oral instant membrane.
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