CN101732320B - Novel medicinal composition for relieving cough - Google Patents
Novel medicinal composition for relieving cough Download PDFInfo
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- CN101732320B CN101732320B CN2010100028441A CN201010002844A CN101732320B CN 101732320 B CN101732320 B CN 101732320B CN 2010100028441 A CN2010100028441 A CN 2010100028441A CN 201010002844 A CN201010002844 A CN 201010002844A CN 101732320 B CN101732320 B CN 101732320B
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Abstract
The invention discloses a medicinal composition capable of relieving cough and reducing sputum and a production method thereof. The composition is especially used for treating cough symptoms in the diseases of the respiratory system, such as influenza, whooping cough, bronchitis, laryngitis and the like. A medicine prepared from the composition comprises the following effective components in unit dose: 0.01-20mg of pholcodine, 0.1-300mg of guaiphenesin and 0.01-20mg of maleic acid/or hydrochloride chlorpheniramine. The medicinal composition is an oral preparation. Compared with the similar medicine, the medicinal composition has the characteristics of small dosage, favorable curative effect, high safety and convenient taking.
Description
Technical field
The present invention relates to Pharmaceutical composition, more particularly, relate to a kind ofly with pholcodine, guaifenesin and chlorphenamine or its pharmaceutically acceptable salt are the Pharmaceutical composition and the production method of active component.
Background technology
Cough, coughing up phlegm is two common big symptoms of respiratory system disease, closely related on pathology, and general cough is every presss from both sides expectorant more, and abundant expectoration also often causes cough, more possibly not cause emphysema, bronchiectasis, pulmonary heart disease etc. for a long time.
At present, cough suppressing medicine commonly used has codeine phosphate, dextromethorphan hydrobromide, pholcodine etc. in the pharmacy medicine.
Codeine phosphate is the nervus centralis class chemical drugs that is widely used in cough-relieving or flu, but in recent years because its serious adverse reaction is improved its supervisory level by the state food pharmaceuticals administration again and again.Common untoward reaction has: psychopathology or illusion; Shallow breathing, slow or irregular; Heart rate is fast or slow, unusual.Rare untoward reaction: convulsions, tinnitus, tremble or muscular movement that can not automatic control etc.; Urticaria; Anaphylaxiss such as rash is itched, erythra or face are swollen; Spirit depressing and muscle rigidity etc.Prolonged application can cause dependency.A little less than usual amounts causes that dependent tendency than other morphine class medicines is.Typical symptoms is: goose pimples, loss of appetite, diarrhoea, toothache, nausea and vomiting, watery nasal discharge, shiver, sneeze, yawn, sleep disorder, stomach spasm, hyperhidrosis, languishment, heart rate speedup, excited or agnogenic heating.
Publication number is that the Chinese patent (" a kind of capsule composition of compound cough-relieving and phlegm-eliminating medicine ") of CN 1771955A discloses a kind of soft capsule by dextromethorphan hydrobromide, guaifenesin, disperse medium, glycerol, surfactant preparation.Dextromethorphan hydrobromide also is the nervus centralis class chemistry antitussive of using always, and consumer can buy in pharmacy.But along with the increase of its consumption, serious adverse reaction, particularly abuse condition have also occurred, reported that repeatedly the patient causes death because of the capsule that excessive use powdery dextromethorphan is packaged into abroad.U.S. food Drug Administration pays close attention to the abuse condition of dextromethorphan constantly, and sends the warning of not abusing dextromethorphan.U.S. food Drug Administration representes that low dose of correct use of dextromethorphan can be suppressed cold symptoms safely and effectively, can cause death and other serious adverse effects but abuse, like brain injury, epilepsy, loss of consciousness and irregular heartbeats.
Pholcodine is the maincenter cough medicine also, has the maincenter antitussive effect similar with codeine phosphate, and calmness and analgesic activity are arranged, but addiction property than codeine phosphate a little less than, neonate and child tolerate this medicine.And it is slower that this medicine absorbs fast elimination, and to reducing medicining times, safe medication has positive role.
Summary of the invention
The purpose of this invention is to provide a kind of is the compound preparation of maincenter cough medicine with the pholcodine, and said preparation can be treated influenza, pertussis, bronchitis, the cough symptom in the respiratory system diseases such as laryngitis.This medicine is processed certain dosage form, not only is fit to the adult and takes, and also is fit to child and old man and takes.
The purpose of this invention is to provide a kind ofly with pholcodine, guaifenesin and chlorphenamine maleate are the Pharmaceutical composition of active component.
Another object of the present invention provides the method for preparing of above-mentioned Pharmaceutical composition.
The 3rd purpose of the present invention provides the purposes of above-mentioned Pharmaceutical composition.
Specifically, the invention provides a kind of Pharmaceutical composition, it contains pholcodine, and guaifenesin and chlorphenamine or its pharmaceutically acceptable salt are as active component, and acceptable accessories.
In embodiments of the invention, said chlorphenamine pharmaceutically acceptable salt is selected from chlorphenamine maleate and hydrochloric acid chlorphenamine, preferred chlorphenamine maleate.
In one embodiment of the present invention, the invention provides a kind of with pholcodine, guaifenesin and maleic acid/or the hydrochloric acid chlorphenamine be the Pharmaceutical composition of active component, wherein the dosage of pholcodine is 0.01-20mg, is preferably 0.1-5.0mg.
In one embodiment of the present invention; The invention provides a kind of with pholcodine; Guaifenesin and maleic acid/or the hydrochloric acid chlorphenamine be the Pharmaceutical composition of active component, wherein the dosage of guaifenesin is 0.1-300mg, is preferably 1-180mg.
In one embodiment of the present invention; The invention provides a kind of with pholcodine; Guaifenesin and maleic acid/or the hydrochloric acid chlorphenamine be the Pharmaceutical composition of active component, wherein maleic acid/or the dosage of hydrochloric acid chlorphenamine be 0.01-20mg, be preferably 0.1-5.0mg.
In one embodiment of the present invention; The invention provides a kind of with pholcodine, guaifenesin and maleic acid/or the hydrochloric acid chlorphenamine be the Pharmaceutical composition of active component, wherein; The dosage of pholcodine is 0.01-20mg, is preferably 0.1-5.0mg; The dosage of guaifenesin is 0.1-300mg, is preferably 1-180mg; Maleic acid/or the dosage of hydrochloric acid chlorphenamine be 0.01-20mg, be preferably 0.1-5.0mg.
Provided by the present invention with pholcodine, guaifenesin and maleic acid/or the hydrochloric acid chlorphenamine be the Pharmaceutical composition of active component, this Pharmaceutical composition is an oral formulations.
Provided by the present invention with pholcodine; Guaifenesin and maleic acid/or the hydrochloric acid chlorphenamine be the Pharmaceutical composition of active component, this Pharmaceutical composition can be made into liquid oral medicine or solid orally ingestible, described liquid oral medicine comprises: oral liquid; Syrup; Drop, suspensoid, gel preparation etc.; Described solid orally ingestible comprises: granule, tablet, capsule, chewable tablet, dispersible tablet, slow releasing tablet, slow releasing capsule, micropill etc.
In Pharmaceutical composition provided by the present invention, for example above-mentioned oral liquid is such as oral liquid; Syrup, suspensoid, liquid oral class preparations such as gel preparation; Wherein do not specify said active component, pholcodine if having; Guaifenesin and maleic acid/or the hydrochloric acid chlorphenamine, its content is UD, is the content in every 1ml Pharmaceutical composition.
In Pharmaceutical composition provided by the present invention, for example above-mentioned oral solid formulation such as granule, tablet, capsule; Chewable tablet, dispersible tablet, slow releasing tablet, slow releasing capsule; Oral solid formulations such as micropill, wherein, said active component, pholcodine; Guaifenesin and maleic acid/or hydrochloric acid chlorphenamine, its content is UD, is the content in every,, bag Pharmaceutical composition.
In Pharmaceutical composition provided by the present invention; Wherein, Said acceptable accessories is one or more pharmaceutic adjuvants, and described pharmaceutic adjuvant includes but not limited to diluent or excipient, surfactant, binding agent, lubricant, plasticizer, disintegrating agent, solvent, buffer agent, coloring agent, correctives, antiseptic, hydrophilic gel material and other pharmaceutic adjuvant as known in the art.
For oral solid formulation; The combination of one or more of the optional self-lubricating agent of described pharmaceutically acceptable adjuvant, surfactant, coloring agent, binding agent, fluidizer, correctives (sweeting agent, aromatic etc.), antibacterial/stabilizing agent, disintegrating agent, diluent, solvent, hydrophilic polymer (being used for slow releasing agent).
For oral liquid; Described pharmaceutically acceptable adjuvant can be selected from one or more the combination in excipient, surfactant, gel, thickening agent, wetting agent, coloring agent, plasticizer, correctives (sweeting agent, aromatic etc.), antibacterial/stabilizing agent, the solvent.
In Pharmaceutical composition provided by the present invention, wherein, said diluent can be so that the material that dosage form is easier to handle for increasing the volume of dosage form.In embodiments of the invention, the said typical diluent that is used for solid dosage forms (for example tablet and capsule) includes but not limited to lactose, glucose, sucrose, cellulose, starch and calcium phosphate; The olive oil and the ethyl oleate that are used for soft capsule; Other suitable dilution agent includes but not limited to sucrose, glucosan, dextrin, maltodextrin, microcrystalline Cellulose, micropowder cellulose, cellulose powder, pregelatinized Starch, calcium phosphate dihydrate, soybean polysaccharide, gelatin, silicon dioxide, calcium sulfate, calcium carbonate, magnesium carbonate, magnesium oxide, sorbitol, mannitol, Kaolin, polymethacrylates, potassium chloride, sodium chloride and Pulvis Talci.
In Pharmaceutical composition provided by the present invention, wherein, said binding agent includes but not limited to saccharide, for example sucrose, lactose, glucose, compound syrup, soybean polysaccharide; Gelatin; Polyvidone; Cellulose derivative, for example microcrystalline Cellulose, hydroxypropyl emthylcellulose, hydroxypropyl cellulose, ethyl cellulose, ethyl cellulose, sodium carboxymethyl cellulose and methylcellulose; Acrylic acid and EUDRAGIT S100; Carbomer; Polyethylene polypyrrole alkane; Polyethylene Glycol; Medicinal syrup; Alginate, for example alginic acid and sodium alginate; Glue class, for example Radix Acaciae senegalis, guar gum and arabic gum; Astragalus glue; Dextrin and maltodextrin; The derivant of milk, for example milk surum; Starch based, for example pregelatinized Starch and starch slurry; Hydrogenated vegetable oil; Magnesiumaluminumsilicate, and other conventional binding agent well known by persons skilled in the art.
In Pharmaceutical composition provided by the present invention, wherein, said fluidizer includes but not limited to silicon dioxide, silica gel, Pulvis Talci, magnesium trisilicate, magnesium stearate or calcium, micropowder cellulose, starch and calcium phosphate.
In Pharmaceutical composition provided by the present invention, wherein, said thickening agent includes but not limited to sodium alginate, and effervescent mixture (the for example mixture of sodium bicarbonate and organic acid composition).
In Pharmaceutical composition provided by the present invention, wherein, said wetting agent comprises lecithin, polysorbate or lauryl sulfate class.
In Pharmaceutical composition provided by the present invention; Wherein, said lubricant includes but not limited to stearic acid, stearate, glyceryl monostearate, glyceryl palmitostearate, silica gel, magnesium silicate, silicon dioxide, sodium stearyl fumarate, nitrogenize vegetable oil, Pulvis Talci, Polyethylene Glycol and mineral wet goods.
In Pharmaceutical composition provided by the present invention; Wherein, Said plasticizer includes but not limited to hydrophobicity and/or hydrophilic plasticizer, for example diethyl phthalate, BPBG, ethyl sebacate, dibutyl sebacate, triethyl citrate, citric acid acetyl triethyl, lemon acid acetyl tributyl .beta.-methylacrylic acid, propylene glycol, Oleum Ricini, acetin, Polyethylene Glycol, propylene glycol, glycerol and sorbitol.Plasticizer is specially adapted to contain the Pharmaceutical composition of polymer and Pharmaceutical composition in soft capsule and thin film one coated tablet.
In Pharmaceutical composition provided by the present invention, wherein, said disintegrating agent can improve the material of the dissolution rate of Pharmaceutical composition.Said disintegrating agent includes but not limited to alginate (for example alginic acid and sodium alginate), carboxymethylcellulose calcium, sodium carboxymethyl cellulose, cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone, polyethylene polypyrrole alkane, low-substituted hydroxypropyl cellulose, methylcellulose, microcrystalline Cellulose, polacrilin potassium, cellulose powder, starch, pregelatinized Starch, sodium starch glycolate.
In Pharmaceutical composition provided by the present invention, wherein, described solvent is the mixture of a kind of solvent or multiple solvent.Described solvent includes but not limited to water, alcohols (for example ethanol and isopropyl alcohol), vegetable oil, polyhydric alcohol (for example Polyethylene Glycol, propylene glycol and glycerol etc.) or its mixture.
In Pharmaceutical composition provided by the present invention, wherein, said buffer agent is by the buffer system of various bufferings to constituting, and is intended to guarantee certain pH environment.Cushion right composition and include but not limited to lactic acid/sodium lactate, citric acid/sodium citrate, acetic acid/sodium acetate and phosphate etc.
In Pharmaceutical composition provided by the present invention, wherein, said coloring agent is to be used to improve outward appearance, perhaps is used to discern Pharmaceutical composition.Said coloring agent includes but not limited to food coloring.
In Pharmaceutical composition provided by the present invention, wherein, said correctives is divided into sweeting agent, aromatic etc., is used to improve palatability, is specially adapted to chewable tablet or liquid dosage form.Said correctives includes but not limited to sucrose, citric acid, artificial essence, maltose alcohol, vanillin, ethyl vanillin, menthol, citric acid, fumaric acid, ethyl maltitol and tartaric acid.Said sweeting agent comprises but is not limited to sorbitol, glucide, saccharin sodium, aspartame, fructose, mannitol and Nulomoline.
In Pharmaceutical composition provided by the present invention, wherein, said antibacterial/stabilizing agent is meant the material that can improve storage characteristics, includes but not limited to that ethanol, sodium benzoate, Yoshinox BHT, butylation are to fragrant ether of hydroxyl tube and ethylenediaminetetraacetic acid.
In Pharmaceutical composition provided by the present invention, wherein, the said hydrophilic gel material that is used for slow releasing preparation comprises: one or more natural or part or all of synthetic hydrophilic gel class, for example arabic gum, astragalus glue; The cellulosic material of improvement, for example methylcellulose, hydroxy methocel, hydroxypropyl emthylcellulose, hydroxypropyl cellulose, hydroxyethyl-cellulose, carboxymethyl cellulose; Other hydrophilic polymer is agar, pectin, alginic acid salt, carbomer, gelatin, casein, zein, Magnesiumaluminumsilicate, polysaccharide, modified starch derivant and other hydrophilic polymer well known by persons skilled in the art or this type of for example.
In addition, Pharmaceutical composition of the present invention can be blister package or other this type of drug packages.And compositions of the present invention can also comprise or with labelling, it makes people can discern as being used for prescribed treatment product combination thing.Said labelling can also comprise the above-mentioned indication that gives the special time cycle of compositions in addition.For example, said labelling can give the special time or the conventional time of compositions for indication every day, and perhaps said labelling can be to indicate the date stamp that specifically when gives compositions weekly.
On the other hand, the present invention also provides the production method of above-mentioned Pharmaceutical composition, and it comprises pholcodine, and guaifenesin is with chlorphenamine or pharmaceutically acceptable salt, mix with acceptable accessories mutually.
The third aspect, the present invention also provides the purposes of above-mentioned Pharmaceutical composition, is used to treat influenza, pertussis, bronchitis, the cough symptom in the respiratory system diseases such as laryngitis.
Pharmacological experiment has proved that Pharmaceutical composition of the present invention has the synergy of eliminating phlegm and relieving cough, and guaifenesin can obviously strengthen the antitussive effect of pholcodine.
The medical practitioner can be according to confirming dosage.Dosage range depends on multiple factor, comprises the approach of patient's age, body weight and health and administration. the syrup that provides with discrete units and other said dosage form can contain daily dose or its suitable aliquot of Pharmaceutical composition easily.
The specific embodiment
Come pholcodine of the present invention through following instance, guaifenesin and Chlorahist (being designated hereinafter simply as compound recipe pholcodine preparation) are done further and are specified, but are not limited in following instance.
Embodiment 1: pholcodine, guaifenesin and chlorphenamine maleate syrup
Method for preparing:
In 100,000 grades of clean areas
A540g sucrose is dissolved in the water that 200mL boils processes syrup, filters;
B takes by weighing pholcodine 0.1g and is dissolved in the adequate amount of ethanol;
C takes by weighing chlorphenamine maleate 0.1g, and guaifenesin 4.0g is in the 50mL purified water;
D mixes A step .B step and C step gained solution, and purified water adds to 1000mL, filters, and gets syrup, inspection, and packing gets final product.
Embodiment 2: pholcodine, guaifenesin and chlorphenamine maleate oral liquid
Method for preparing:
In 100,000 grades of clean areas
A takes by weighing pholcodine 0.1g, is dissolved in the adequate amount of ethanol;
B takes by weighing chlorphenamine maleate 0.1g, and guaifenesin 4.0g is in the 50mL purified water;
C mixes A step .B step gained solution, adds citric acid, sodium citrate, and correctives, potassium sorbate, EDTA-2Na dissolving purified water adds to 1000mL, filters, inspection, packing, sterilization gets final product.
Embodiment 3: pholcodine, guaifenesin and chlorphenamine maleate granule
Method for preparing:
In 100,000 grades of clean areas
A pholcodine, guaifenesin, chlorphenamine maleate, citric acid, starch, cane sugar powder are crossed the 100# sieve;
B takes by weighing the pholcodine of recipe quantity, guaifenesin, chlorphenamine maleate, citric acid, starch, cane sugar powder and an amount of correctives, mix homogeneously;
C takes by weighing certain amount of H PMC, is configured to 2% concentration with 50% alcoholic solution, and essence is dissolved in the HPMC solution;
D makes soft material, crosses the 18# sieve, 50 ℃ of dryings, and control moisture 1.8%, 16# sieves granulate.
The E splitting, packing.
Embodiment 4 pholcodines, guaifenesin and Chlorate
Method for preparing
In 100,000 grades of clean areas
A pholcodine, guaifenesin, chlorphenamine maleate are crossed the 100# sieve;
B takes by weighing the principal agent and the microcrystalline Cellulose of prescription consumption, pre-paying starch, PVPP, mix homogeneously;
The soft ability of C3%PVP solution system, 18# granulates, drying, control moisture 3%;
The D18# granulate adds magnesium stearate and mixes, and tabletting promptly gets.
Effect embodiment
Method for preparing by embodiment 1 prepares sample, and test as follows.
Test Example 1 (antitussive effect)
Mice ammonia draws the method for coughing
Get 50 of the healthy mices of body weight 18～22g, be divided into 5 groups at random by body weight, 10 every group, male and female half and half.Each group is respectively compound recipe pholcodine syrup low dosage (10ml/kg), middle dosage (20ml/kg), high dose (40ml/kg) administration group; Normal saline blank group (20ml/kg); Pholcodine sheet (pholcodine sheet specification 10mg/ sheet is mixed with the solution of concentration 0.1mg/ml) positive controls (20ml/kg).Every mouse is gastric infusion according to dosage, for three days on end, and every day 1 time; Behind the last administration 1h mice is placed in the airtight glass device; Sprayed into 25% strong aqua ammonia 20 seconds with ultrasound atomizer, spraying is taken out mice after stopping immediately; Shrinking and magnify mouth with the mice abdominal muscle is cough action indication, writes down cough number of times and the incubation period of mice in 3 minutes.See table 1.
Table 1 compound recipe pholcodine syrup to mice ammonia draw the effect of coughing influence (x ± s, n=10)
By all obviously resisting the caused cough effect of ammonia after the visible high, medium and low dose groups administration of compound recipe pholcodine syrup of experimental result, and can prolong the incubation period that generation is coughed, and compound recipe pholcodine syrup antitussive effect is better than the administration of pholcodine sheet folk prescription.Heal wooden phenol glycerin ether, chlorphenamine maleate, pholcodine synergy of prompting wound can strengthen the antitussive effect of pholcodine.
Test Example 2 (phlegm-dispelling functions)
The phenol red expectorant test of mice
50 of the healthy mices of body weight 20～25g are divided into 5 groups at random, 10 every group, male and female half and half.Each group is respectively compound recipe pholcodine syrup low dose group (10ml/kg), middle dose groups (20ml/kg), high dose group (40ml/kg), normal saline blank group (20ml/kg), guaifenesin sheet (guaifenesin sheet specification 0.2g/ sheet is mixed with the solution of concentration 4mg/ml) positive controls (20ml/kg).Continuous three days gastric infusions are tested fasting in preceding 24 hours and can't help water.30 minutes pneumoretroperitoneums of last administration are injected 5% phenol red solution 500g/kg; Put to death mice after 30 minutes, peel off the trachea surrounding tissue, cut one section trachea down to the trachea bifurcation from thyroid cartilage; Put in the test tube that the people fills the 1ml normal saline, add 1molL in every part of specimen fluids
-1Sodium hydroxide solution 0.1ml gets supernatant behind the immersion 24h, surveys the A value at wavelength 546nm.According to phenol red standard curve, absorbance is converted into phenol red content.See table 2.
Table 2 compound recipe pholcodine syrup to phenol red excretory influence in the mice trachea (x ± s, n=10)
Compare with blank and guaifenesin folk prescription, compound recipe pholcodine group can increase excretion phenol red in the mice trachea, and this means that also heal wooden phenol glycerin ether, chlorphenamine maleate, pholcodine synergy of wound can strengthen mice expectoration ability.
Claims (9)
1. Pharmaceutical composition, it contains pholcodine, and the salt that guaifenesin and chlorphenamine or its are pharmaceutically accepted is as active component, and acceptable accessories; Wherein, the dosage of pholcodine is 0.01-20mg; The dosage of guaifenesin is 0.1-300mg; The dosage of chlorphenamine or its pharmaceutically acceptable salt is 0.01-20mg.
2. Pharmaceutical composition according to claim 1, wherein, the dosage of pholcodine is 0.1-5.0mg; The dosage of guaifenesin is 1-180mg; The dosage of chlorphenamine or its pharmaceutically acceptable salt is 0.1-5.0mg.
3. Pharmaceutical composition according to claim 1, wherein, said chlorphenamine or its pharmaceutically acceptable salt are chlorphenamine maleate or hydrochloric acid chlorphenamine.
4. Pharmaceutical composition according to claim 3, wherein, said chlorphenamine or its pharmaceutically acceptable salt are chlorphenamine maleate.
5. according to the described Pharmaceutical composition of arbitrary claim in the claim 1 to 4, wherein, described Pharmaceutical composition is an oral formulations.
6. Pharmaceutical composition according to claim 5, wherein, described Pharmaceutical composition is solid orally ingestible or liquid oral medicine.
7. Pharmaceutical composition according to claim 6, wherein, described solid orally ingestible comprises: granule, tablet, capsule, micropill; Described liquid oral medicine comprises: oral liquid, syrup, drop, suspensoid, gel preparation.
8. Pharmaceutical composition according to claim 7; Wherein, the pharmaceutically acceptable adjuvant of said liquid oral medicine is selected from one or more the combination in lubricant, surfactant, coloring agent, binding agent, fluidizer, correctives, antibacterial/stabilizing agent, disintegrating agent, diluent, solvent, the hydrophilic polymer; The pharmaceutically acceptable adjuvant of said solid orally ingestible is selected from one or more the combination in excipient, surfactant, gel, thickening agent, wetting agent, coloring agent, plasticizer, correctives, antibacterial/stabilizing agent, the solvent.
9. the application in the medicine of the excessive phlegm cough symptom of the said Pharmaceutical composition of arbitrary claim in preparation treatment respiratory system disease in the claim 1 to 8.
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| CN2010100028441A CN101732320B (en) | 2010-01-20 | 2010-01-20 | Novel medicinal composition for relieving cough |
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| CN2010100028441A CN101732320B (en) | 2010-01-20 | 2010-01-20 | Novel medicinal composition for relieving cough |
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