CN109010341A - A kind of compound oral solution and preparation method thereof containing dextromethorphan hydrobromide - Google Patents
A kind of compound oral solution and preparation method thereof containing dextromethorphan hydrobromide Download PDFInfo
- Publication number
- CN109010341A CN109010341A CN201811264791.3A CN201811264791A CN109010341A CN 109010341 A CN109010341 A CN 109010341A CN 201811264791 A CN201811264791 A CN 201811264791A CN 109010341 A CN109010341 A CN 109010341A
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- compound oral
- acid
- oral pharmaceutical
- pharmaceutical solutions
- dextromethorphan hydrobromide
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
- A61K31/485—Morphinan derivatives, e.g. morphine, codeine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/02—Nasal agents, e.g. decongestants
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/14—Antitussive agents
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Abstract
The invention belongs to field of pharmaceutical preparations, and in particular to a kind of dextromethorphan hydrobromide and the compound oral solution of PHENYLEPHRINE HYDROCHLORIDE and preparation method thereof.Dextromethorphan hydrobromide is clinically widely used in the various types of coughs for the treatment of, neo-synephrine is vasoconstrictor, respiratory mucosa oedema can be reduced, increase the drainage of sinus cavities, this compound oral pharmaceutical solutions can be used for catching a cold caused cough, nose or throat is itched, shed tears, having a stuffy nose, reducing nasal meatus swelling.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, and in particular to deoxygenate adrenal gland containing dextromethorphan hydrobromide and hydrochloric acid to a kind of
The compound oral solution and preparation method thereof of element.
Technical background
Dextromethorphan hydrobromide is a kind of central antitussive, mainly inhibits the coughing centre of medulla oblongata and plays a role, leads to
The sensibility for reducing intrapulmonary sensory nerve is crossed, under therapeutic dose, the effect of unrestraint breathing and respiratory mucosa secretion, not exclusively
Inhibit cough reflex, without additive, clinic is mainly used for dry cough caused by flu and a variety of causes or has phlegm and excessively frequent
Cough caused by acute cough is a kind of safely and effectively antitussive medicine, and the affinity of dextromethorphan hydrobromide and its receptor is lower, controls
Adverse reaction is less under treatment dosage, and safe range is wide, and neural and Psychotoxicity and cardiovascular response are seldom, is used for a long time without habituation
Property and tolerance, children and old man can be used, also have and do not increase fetus terateger rate using this product during document report gestation；
PHENYLEPHRINE HYDROCHLORIDE be ɑ 1-ADR excitomotor, it is very faint to the effect of β-ADR, act on it is similar to NA but
It is weaker, but since chemical property stablizes event persistent, predominantly vasoconstriction, increase blood pressure；It is mucocutaneous, internal organ such as kidney
It is reduced with the blood flow of lung and four limbs.It is a kind of powerful vasoconstrictor, is used as nasal decongestant and electrocardio agent, goes
Oxygen adrenaline also results in Pulmonary Vascular contraction and subsequent pulmonary artery pressure increases, the vessel retraction under respiratory mucosa
Oedema can be reduced, the drainage of sinus cavities is increased.
The current product of dextromethorphan hydrobromide has tablet, capsule etc., and it is husky containing the right U.S. of hydrobromic acid that the present invention relates to one kind
Sweet smell is free of pigment in the compound oral solution, while antioxidant is added with the compound oral solution of PHENYLEPHRINE HYDROCHLORIDE, shows
Work reduces chemical explanation.Compared with other solid dosage forms, two kinds of drugs are significant in efficacy under therapeutic effect, and this product water solubility is good
Well, the advantages that Small side effects have convenient to take, compliance height, are conveniently adjusted dosage is especially suitable for children and the elderly's clothes
With；It joined corrigent appropriate in this oral administration solution simultaneously, can suitably cover the poor taste of drug, substantially increase children
And the compliance of the elderly's medication.
Summary of the invention
It is an object of the invention to: a kind of dextromethorphan hydrobromide without pigment is provided and PHENYLEPHRINE HYDROCHLORIDE is multiple
Square oral solution formulation and preparation method thereof.
Wherein, every 1ml contains dextromethorphan hydrobromide 0.5-2mg and PHENYLEPHRINE HYDROCHLORIDE 0.5-2mg, and antioxidant contains
Amount is 5-20mg.
Oral administration solution pH of the invention is 2.5-6.5, and preferably pH is 3.0-5, and more preferable pH is 3.5.The inventors discovered that
The compound oral liquid is more stable at low ph conditions, especially in the case where using low content buffer as pH adjusting agent, sample
Product are more stable.
The pH adjusting agent can be organic or inorganic edible acid and its salt.The organic or inorganic edible acid is selected from
One of citric acid and its salt, potassium hydroxide, sodium hydroxide, phosphoric acid and its salt form are several.Preferably citric acid and its
The form of salt forms buffer solution.
The bacteriostatic agent is benzoic acid, sodium benzoate, one of sorbic acid, potassium sorbate or several.
The corrigent is in sucrose, Sucralose, Steviosin, saccharin sodium, sorbierite, maltitol and mannitol
It is one or several kinds of；Refiner essence is added in solution simultaneously, increases aromatic odor, selectable essence fruit essence, strawberry
One or more of essence, orange essence, lemon extract, flavoring pineapple essence, sweetener, fragrant refiner be able to solve patient according to
From property, children, infant are easier to receive.
The solvent is by one or several kinds of in water, ethyl alcohol, propylene glycol, glycerol.It is preferred that water, propylene glycol, glycerol form
Double solvents.
Another aspect of the present invention provides a kind of compound oral containing dextromethorphan hydrobromide and PHENYLEPHRINE HYDROCHLORIDE
The preparation method of solution includes the following steps: to take suitable purified water, pH adjusting agent is added, stirs and be added to after being completely dissolved
Dextromethorphan hydrobromide and PHENYLEPHRINE HYDROCHLORIDE；After adding corrigent, bacteriostatic agent dissolution completely, refiner, molten is added
Agent is uniformly mixed；Finally it is settled to full dose with purified water, after filtering to obtain the final product.
The utility model has the advantages that
The present invention contains dextromethorphan hydrobromide and corrigent, mouth is added in the compound oral solution of PHENYLEPHRINE HYDROCHLORIDE
Sense preferably, is particularly suitable for children.
The present invention uses pH adjusting agent buffer system, makes the pH stable of product, increases bacteriostatic agent, can prevent microorganism
Growth, significantly reduces chemical degradation.
The compound oral stability of solution of the present invention from the dextromethorphan hydrobromide and PHENYLEPHRINE HYDROCHLORIDE is high,
Antioxidant is added, significantly reduces chemical degradation.
It is provided by the invention to prepare work containing the compound oral solution of dextromethorphan hydrobromide and PHENYLEPHRINE HYDROCHLORIDE
Skill is simple, quality controllable, low production cost, is suitble to large-scale production.
Specific embodiment
Embodiment 1
Preparation process:
It takes the purified water of oral administration solution total volume 25% in liquid dispensing tank, adds after recipe quantity sodium citrate stirring and dissolving is added
Enter recipe quantity dextromethorphan hydrobromide, PHENYLEPHRINE HYDROCHLORIDE stirring and dissolving；Sequentially add sodium hydrogensulfite, edetic acid(EDTA) two
After sodium, acesulfame potassium, sodium benzoate dissolution completely, propylene glycol stirring and dissolving is added, it is molten to sequentially add essence, 80% maltose
Liquid, stirring to solution are clarified, and weigh vitamin and purified water is added to be configured to 20% vitamin c solution, be added into above-mentioned solution,
Stirring.Different pH value are adjusted to 20% citric acid solution of pH adjusting agent, 2.5,3.0,3.98,4.96,5.98,6.5.Finally use
Purified water is settled to enough.
Embodiment 2
Preparation process:
It takes the purified water of oral administration solution total volume 25% in liquid dispensing tank, adds after recipe quantity sodium citrate stirring and dissolving is added
Enter recipe quantity dextromethorphan hydrobromide, PHENYLEPHRINE HYDROCHLORIDE stirring and dissolving；Sequentially add sodium metabisulfite, edetic acid(EDTA) two
After sodium, acesulfame potassium, sodium benzoate dissolution completely, propylene glycol stirring and dissolving is added, it is molten to sequentially add essence, 80% maltose
Liquid, stirring to solution are clarified, stirring.Then pH to 3.5 is adjusted with 20% citric acid solution of pH adjusting agent.Finally use purified water
It is settled to enough.
Embodiment 3
Preparation process:
It takes the purified water of oral administration solution total volume 25% in liquid dispensing tank, sequentially add sodium citrate, dextromethorphan, deoxidation
Adrenaline, citric acid (1/3 recipe quantity).Survey pH about 3.4 or so, sequentially add natrium adetate, acesulfame potassium, sodium benzoate,
Propylene glycol, 2/3 recipe quantity citric acid, essence, pigment, 80% maltitol solution, measurement pH.Finally foot is settled to purified water
Amount.
The above various embodiments sample and commercially available product are respectively placed in 30 DEG C, 40 DEG C of illumination (4500 ± 500lx), high temperature
Under the conditions of carry out primary stability test, the results showed that be not added containing pigment and antioxidant in the embodiment of the present invention 3,
Impurity growth trend is significantly greater than other embodiments sample.Illustrate containing dextromethorphan hydrobromide and PHENYLEPHRINE HYDROCHLORIDE
Antioxidant is added in compound oral solution can improve its stability, and the degradation of its principal component is effectively reduced.
Illumination (4500 ± 500lx) carries out primary stability test result under the conditions of 40 DEG C, 30 DEG C of high temperature and is shown in Table 1, table
2, table 3:
Table 1
Table 2
Table 3.
Claims (9)
1. a kind of compound oral pharmaceutical solutions characterized by comprising dextromethorphan hydrobromide, PHENYLEPHRINE HYDROCHLORIDE and
Antioxidant, the compound oral pharmaceutical solutions are free of pigment.
2. compound oral pharmaceutical solutions according to claim 1, it is characterised in that: the dextromethorphan hydrobromide content is
0.5-2mg/ml, PHENYLEPHRINE HYDROCHLORIDE content be 0.5-2mg/ml, antioxidant content 5-20g/ml.
3. compound oral pharmaceutical solutions according to claim 1, it is characterised in that: the antioxidant is selected from vitamin C,
Gallic acid third lipoprotein, sodium pyrosulfite, one or more of sodium hydrogensulfite.
4. compound oral pharmaceutical solutions according to claim 1, it is characterised in that: the compound oral pharmaceutical solutions are into one
Step includes 0.1% pH adjusting agent, 0.4% bacteriostatic agent, 0.01% complexing agent and 75% corrigent.
5. compound oral pharmaceutical solutions according to claim 4, it is characterised in that: the pH adjusting agent be selected from tartaric acid,
One or more of citric acid, fumaric acid, malic acid, maleic acid, hydrochloric acid, phosphoric acid and its salt.
6. compound oral pharmaceutical solutions according to claim 4, it is characterised in that: the bacteriostatic agent is selected from sorbic acid, mountain
The one or more of potassium sorbate, benzoic acid and its salt.
7. compound oral pharmaceutical solutions according to claim 4, it is characterised in that: the complexing agent is selected from tartaric acid, gathers
The one or more of acrylic acid, sodium alginate, triethanolamine, natrium adetate.
8. compound oral pharmaceutical solutions according to claim 4, it is characterised in that: the corrigent be selected from fruit essence,
Strawberry essence, orange essence, lemon extract, flavoring pineapple essence, sucrose, Steviosin, saccharin sodium, sorbierite, maltitol and sweet dew
One or more of alcohol.
9. a kind of preparation method of the compound oral solution containing dextromethorphan hydrobromide and PHENYLEPHRINE HYDROCHLORIDE, feature
It is, comprising the following steps:
(1) appropriate purified water is taken, pH adjusting agent is first added, dextromethorphan hydrobromide is added to after dissolving for stirring and hydrochloric acid deoxygenates kidney
Upper parathyrine；
(2) antioxidant and other auxiliary materials are added, is stirred evenly；
(3) pH adjusting agent is added, is adjusted to pH2.5-6.5.；
(4) it is settled to full dose with purified water, it is filling.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811264791.3A CN109010341A (en) | 2018-10-29 | 2018-10-29 | A kind of compound oral solution and preparation method thereof containing dextromethorphan hydrobromide |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811264791.3A CN109010341A (en) | 2018-10-29 | 2018-10-29 | A kind of compound oral solution and preparation method thereof containing dextromethorphan hydrobromide |
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| Publication Number | Publication Date |
|---|---|
| CN109010341A true CN109010341A (en) | 2018-12-18 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201811264791.3A Pending CN109010341A (en) | 2018-10-29 | 2018-10-29 | A kind of compound oral solution and preparation method thereof containing dextromethorphan hydrobromide |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110279695A (en) * | 2019-08-07 | 2019-09-27 | 北京博达绿洲医药科技研究有限公司 | It is a kind of to treat pharmaceutical compositions of cold symptoms such as runny nose, nasal obstruction and its preparation method and application |
| CN110302149A (en) * | 2019-08-07 | 2019-10-08 | 北京博达绿洲医药科技研究有限公司 | A kind of suitable 4-11 years old children taking anti-cold medicine and preparation method thereof |
| CN114159387A (en) * | 2021-12-10 | 2022-03-11 | 江苏汉晨药业有限公司 | Dextromethorphan hydrobromide oral solution |
| CN117017993A (en) * | 2023-10-07 | 2023-11-10 | 山东则正医药技术有限公司 | Compound paracetamol and renin pharmaceutical composition for children, preparation and preparation process thereof |
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| US20070249566A1 (en) * | 2006-04-21 | 2007-10-25 | The Procter & Gamble Company | Compositions and methods useful for treatment of respiratory illness |
| WO2012018742A2 (en) * | 2010-08-01 | 2012-02-09 | Trinity Laboratories, Inc. | Dextromethorphan antitussive compositions |
| CN103565735A (en) * | 2013-09-30 | 2014-02-12 | 北京万全德众医药生物技术有限公司 | Oral liquor containing dextromethorphan hydrobromide as well as preparation method thereof |
| CN104546671A (en) * | 2006-07-14 | 2015-04-29 | 惠氏公司 | Enhanced stability phenylephrine liquid compositions |
| CN105982897A (en) * | 2015-02-13 | 2016-10-05 | 北京韩美药品有限公司 | Liquid preparation, and preparation method and application thereof |
-
2018
- 2018-10-29 CN CN201811264791.3A patent/CN109010341A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20070249566A1 (en) * | 2006-04-21 | 2007-10-25 | The Procter & Gamble Company | Compositions and methods useful for treatment of respiratory illness |
| CN104546671A (en) * | 2006-07-14 | 2015-04-29 | 惠氏公司 | Enhanced stability phenylephrine liquid compositions |
| WO2012018742A2 (en) * | 2010-08-01 | 2012-02-09 | Trinity Laboratories, Inc. | Dextromethorphan antitussive compositions |
| CN103565735A (en) * | 2013-09-30 | 2014-02-12 | 北京万全德众医药生物技术有限公司 | Oral liquor containing dextromethorphan hydrobromide as well as preparation method thereof |
| CN105982897A (en) * | 2015-02-13 | 2016-10-05 | 北京韩美药品有限公司 | Liquid preparation, and preparation method and application thereof |
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110279695A (en) * | 2019-08-07 | 2019-09-27 | 北京博达绿洲医药科技研究有限公司 | It is a kind of to treat pharmaceutical compositions of cold symptoms such as runny nose, nasal obstruction and its preparation method and application |
| CN110302149A (en) * | 2019-08-07 | 2019-10-08 | 北京博达绿洲医药科技研究有限公司 | A kind of suitable 4-11 years old children taking anti-cold medicine and preparation method thereof |
| CN110279695B (en) * | 2019-08-07 | 2022-04-08 | 北京博智绿洲医药科技有限公司 | A pharmaceutical composition for treating common cold with symptoms of watery nasal discharge and nasal obstruction, and its preparation method and application |
| CN114159387A (en) * | 2021-12-10 | 2022-03-11 | 江苏汉晨药业有限公司 | Dextromethorphan hydrobromide oral solution |
| CN114159387B (en) * | 2021-12-10 | 2022-08-19 | 江苏汉晨药业有限公司 | Dextromethorphan hydrobromide oral solution |
| CN117017993A (en) * | 2023-10-07 | 2023-11-10 | 山东则正医药技术有限公司 | Compound paracetamol and renin pharmaceutical composition for children, preparation and preparation process thereof |
| CN117017993B (en) * | 2023-10-07 | 2024-01-26 | 山东则正医药技术有限公司 | Compound paracetamol and renin pharmaceutical composition for children, preparation and preparation process thereof |
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Application publication date: 20181218 |