CN110302149A - A kind of suitable 4-11 years old children taking anti-cold medicine and preparation method thereof - Google Patents
A kind of suitable 4-11 years old children taking anti-cold medicine and preparation method thereof Download PDFInfo
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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
- 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
- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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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
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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
-
- 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
Abstract
A kind of suitable 4-11 years old children taking anti-cold medicine of the present invention and preparation method thereof, using dextromethorphan hydrobromide and PHENYLEPHRINE HYDROCHLORIDE as active ingredient, additional PH regulator reconciles the auxiliary elements such as pH value 3.8 ± 2 and cosolvent, stabilizer, thickener, bacteriostatic agent, the effective solution deficiency of the prior art, increases the stability of drug.It joined a certain amount of corrigent, aromatic simultaneously, improve the compliance of children taking.Present invention is mainly used for alleviate 4-11 years old children because having a stuffy nose, coughing caused by flu.
Description
Technical field
The invention belongs to medicament research and development formulation arts, and in particular to a kind of suitable 4-11 years old children taking anti-cold medicine and
Preparation method.
Technical background
Children catch a cold, and majority is as caused by virus infection, and in medication, children are seldom with cold drug, in China
Because inappropriate medication either taking dose it is excessive, cause hepatic and renal function, nervous system equivalent damage it is countless.
Dextromethorphan hydrobromide is the dextroisomer of m orphine levo-dromoran methyl ether, by inhibiting oblongata coughing centre
Play central antitussive effect.Its antitussive effect is strong, and prolonged application has no tolerance and additive.But overdose has been taken
The symptoms such as dizziness, mild drowsiness, dry, constipation.
PHENYLEPHRINE HYDROCHLORIDE is α 1-ADR excitomotor, has expansion vascular smooth muscle and spasmolysis, is a kind of strong
Big vasoconstrictor, is used as nasal decongestant and electrocardio agent, and neo-synephrine also results in Pulmonary Vascular contraction, Yi Jisui
Pulmonary artery pressure afterwards increases, the vessel retraction under respiratory mucosa.
Application No. is 201811264791.3 application for a patent for invention, disclose " a kind of containing dextromethorphan hydrobromide
The patent of invention of compound oral solution and preparation method thereof ", this application are by dextromethorphan hydrobromide and hydrochloric acid deoxidation adrenal gland
Plain and a certain amount of pH adjusting agent, bacteriostatic agent, the auxiliaries such as corrigent, complexing agent are at a kind of oral liquid, purpose
It is to prepare one kind without pigment, convenient to take, compliance is high, the good Coritab of stability.
Through, application No. is 201811264791.3 application for a patent for invention analysis, 0.1% pH adjusting agent being added to above-mentioned
(adjustment pH value 2.5-6.5) and 5-20% antioxidant (0.5% sodium hydrogensulfite and 10% vitamin C are added in embodiment 1,
Joined 0.5% sodium pyrosulfite in embodiment 2), although reducing the degradation of drug to a certain extent, use bisulfite
As antioxidant, the two all has the smell of strong sulfur dioxide for sodium and sodium pyrosulfite, has unhappy smell, is less suitable for
It is virgin.And sodium pyrosulfite cannot be deposited long.Easily decomposite SO2, thus it is not suitable as the antioxidant of the invention patent.The hair
It is bright it is middle with vitamin C be antioxidant (in embodiment 1), but vitamin C has specific pharmacological activity, if will affect hydrobromic acid
The chemical activity and pharmacological action of dextromethorphan and PHENYLEPHRINE HYDROCHLORIDE, the patent do not provide corresponding expression or solution
It releases.
Summary of the invention
A kind of suitable 4-11 year old children taking anti-cold medicine of the present invention and preparation method thereof, with dextromethorphan hydrobromide with
PHENYLEPHRINE HYDROCHLORIDE is active ingredient, and additional PH regulator reconciles pH value 3.8 ± 2 and cosolvent, stabilizer, thickening
The auxiliary elements such as agent, bacteriostatic agent, the effective solution deficiency of the prior art, increase the stability of drug.It joined simultaneously
A certain amount of corrigent, aromatic improve the compliance of children.Present invention is mainly used for alleviate 4-11 years old children because of sense
Emit caused nasal obstruction, cough.
Realize that technical scheme is as follows:
Prescription: contain in 1000ml of the present invention:
1, active constituent: dextromethorphan hydrobromide 1g PHENYLEPHRINE HYDROCHLORIDE 0.5g,
2, other auxiliary elements: sweetener 0.1-900.0g, antioxidant 0.05-0.1g, cosolvent 50.0-100.0g,
Preservative 0.1-2.0g, thickener 100.00-400.0g, colorant 0.1-1.0g, aromatic 0.1-1.0g, PH regulator are suitable
Amount, solubilizer to 1000ml.
The antioxidant includes but is not limited to propylgallate, sodium thiosulfate, disodium ethylene diamine tetraacetate, sulphur
Urea, thioacetic acid, propylgallate, hydroquinone, tea polyphenols, tocopherol, flavonoids, butylated hydroxy anisole, dibutyl
Hydroxy-methylbenzene, tert-butyl hydroquinone and their mixture.It is further preferred that the stabilizer is ethylenediamine tetrem
Acid disodium.
The cosolvent includes but is not limited to propylene glycol, glycerol, ethyl alcohol, it is further preferred that the cosolvent is glycerol
And propylene glycol mixture.
The corrigent includes but is not limited to sucrose, acesulfame potassium, Steviosin, Sucralose, maltitol, glycyrrhizic acid, into
Preferably, the corrigent is acesulfame potassium to one step.
The thickener include but is not limited to xanthan gum, carbomer, crosslinking sodium polyacrylate, poloxamer, maltitol,
Polyvinyl alcohol, sodium alginate, further preferably maltitol.
The PH mediator agent include but is not limited to potassium hydrogen phosphate, dibastic sodium phosphate, citric acid, sodium citrate, anhydrous citric acid,
Potassium dihydrogen phosphate or sodium dihydrogen phosphate, it is further preferred that the PH mediator agent is the mixture of citric acid and sodium citrate,
The preservative includes but is not limited to benzoic acid, sodium benzoate, sorbic acid, sodium sorbate, it is further preferred that institute
Stating preservative is sodium benzoate.
The complexing agent includes but is not limited to disodium ethylene diamine tetraacetate, natrium adetate, citric acid, phosphoric acid, further
Preferably, the complexing agent is disodium ethylene diamine tetraacetate.
The aromatic includes but is not limited to red grape essence, cherry essence, flavoring apple essence, orange essence, further excellent
Selection of land, the aromatic cherry essence.
The pigment includes but is not limited to allured red pigment, brilliant blue pigment, brilliant green pigment, Yellow pigment, further preferably
Ground, the pigment are allured red pigment.
The solvent includes but is not limited to purified water, deionized water or distilled water, it is preferable that the solvent is purified water.
Preparation method of the invention is, for preparing 1000ml:
1, it takes solvent about 200-300ml to set in 1000ml beaker, the cosolvent of above-mentioned recipe quantity is added, be placed in 60 DEG C of water-baths
Under the conditions of heat after, sequentially add dextromethorphan hydrobromide, the PHENYLEPHRINE HYDROCHLORIDE of recipe quantity, shake, make it dissolve, obtain
Material a；
2, recipe quantity corrigent, complexing agent, preservative are weighed to set in 500mL beaker, solvent 300-400ml, heating is added
To 50-70 DEG C or so, stirs to solution clear, obtain material b；
3, material b is transferred in material a, continues to stir, obtain material c；
4, under stirring, the stabilizer of recipe quantity, pigment are added in material c, aromatic supplements remaining recipe quantity solvent
To 1000ml, it is appropriate to be added PH regulator, shakes up, makes the pH value 3.8 ± 2 of solution, and filtering is cooled to room temperature, filling, i.e.
?.
Preparation method of the invention is preferably (for preparation 1000ml):
1, active constituent: dextromethorphan hydrobromide 1g PHENYLEPHRINE HYDROCHLORIDE 0.5g,
2, other auxiliary elements: acesulfame potassium 1.0g, citric acid and sodium citrate about 2-40g, disodium ethylene diamine tetraacetate
0.1g, propylene glycol 92.0g, sodium benzoate 1.0g, maltitol 380g lure red 0.5g, cherry essence 0.5g, and solubilizer is extremely
1000ml。
1, it takes solvent about 200-300ml to set in 1000ml beaker, the disodium ethylene diamine tetraacetate of above-mentioned recipe quantity is added, sets
After heating under 60 DEG C of water bath conditions, dextromethorphan hydrobromide, the PHENYLEPHRINE HYDROCHLORIDE of recipe quantity are sequentially added, is shaken,
It makes it dissolve, obtains material a；
2, recipe quantity maltitol, acesulfame potassium, sodium benzoate are weighed to set in 500mL beaker, solvent 300-400ml is added,
It is heated to 50-70 DEG C or so, stirs to solution clear, obtains material b；
3, material b is transferred in material a, continues to stir, obtain material c；
4, under stirring, the stabilizer of recipe quantity, pigment are added in material c, aromatic supplements remaining recipe quantity solvent
To 1000ml, citric acid about 5g, sodium citrate about 6g is added, reconciles the pH value of solution, makes the pH value 3.8 ± 2 of solution, shake
Even, filtering, is cooled to room temperature, filling, to obtain the final product.
Present invention be primarily characterized in that for alleviating 4-11 years old children because having a stuffy nose, coughing caused by flu.
Usage and dosage of the invention is to take orally, 4-6 years old children 5ml/4 hours；6-11 years old: 10ml/4 hour.
Beneficial effect
A kind of suitable 4-11 years old children taking anti-cold medicine of the present invention and preparation method thereof, is by dextromethorphan hydrobromide
And PHENYLEPHRINE HYDROCHLORIDE, a certain amount of PH regulator, antioxidant, thickener, bacteriostatic agent, cosolvent and aromatic etc. is added
A kind of oral liquid that auxiliary element is prepared, the effective solution of the present invention deficiency of the prior art, increases medicine
The stability of object improves the compliance of children taking.Present invention is mainly used for alleviate 4-11 years old children because of nose caused by catching a cold
Plug, cough.Usage and dosage of the invention is to take orally, 4-6 years old children 5ml/4 hours；6-11 years old: 10ml/4 hour.
Specific embodiment
Embodiment 1 (for preparation 1000ml)
1, active constituent: dextromethorphan hydrobromide 1g PHENYLEPHRINE HYDROCHLORIDE 0.5g,
2, other auxiliary elements: sucrose 600.00g, appropriate dibastic sodium phosphate, tert-butyl hydroquinone 0.05, propylene glycol 85g,
Sodium sorbate 0.5g, xanthan gum 300.0g lure red 0.5g, flavoring apple essence 0.5g, add purified water to 1000ml.
3 preparation methods:
3.1, it takes purified water about 200ml to set in 1000ml beaker, the propylene glycol of above-mentioned recipe quantity is added, be placed in 60 DEG C of water-baths
Under the conditions of heat after, sequentially add dextromethorphan hydrobromide, the PHENYLEPHRINE HYDROCHLORIDE of recipe quantity, shake, make it dissolve, obtain
Material a；
3.2, recipe quantity xanthan gum, sucrose, tert-butyl hydroquinone, sodium sorbate are weighed to set in 500mL beaker, is added molten
Agent 300ml is heated to 50-70 DEG C or so, stirs to solution clear, obtains material b；
3.3, material b is transferred in material a, continues to stir, obtain material c；
3.4, recipe quantity is added under stirring, in material c and lures red, flavoring apple essence, adds recipe quantity purified water extremely
1000ml shakes up, dibastic sodium phosphate is added, and adjusts the pH value of solution, makes the pH value 3.8 ± 2 of solution, and filtering is cooled to room temperature,
It is filling, to obtain the final product.
Embodiment 2 (for preparation 1000ml):
1, active constituent: dextromethorphan hydrobromide 1g PHENYLEPHRINE HYDROCHLORIDE 0.5g,
2, other auxiliary elements: Steviosin 0.1g, appropriate anhydrous citric acid, propylgallate 0.1g, glycerol 92.0g,
Sodium benzoate 1.0g, sucrose 0.1-1.0g, carbomer 380.0g, brilliant green pigment 0.1g, orange essence 0.1-1.0g, solubilizer is extremely
1000ml。
3, preparation method:
3.1, it takes solvent about 200-300ml to set in 1000ml beaker, the glycerol of above-mentioned recipe quantity is added, be placed in 60 DEG C of water-baths
Under the conditions of heat after, sequentially add dextromethorphan hydrobromide, the PHENYLEPHRINE HYDROCHLORIDE of recipe quantity, shake, make it dissolve, obtain
Material a；
3.2, recipe quantity sucrose, Steviosin, propylgallate, sodium benzoate are weighed to set in 500mL beaker, solvent is added
300-400ml is heated to 50-70 DEG C or so, stirs to solution clear, obtains material b；
3.3, material b is transferred in material a, continues to stir, obtain material c；
3.4, under stirring, brilliant green pigment, the orange essence of recipe quantity are added in material c, it is molten to supplement remaining recipe quantity
Agent is added potassium hydrogen phosphate and dibastic sodium phosphate, reconciles the pH value of solution, make the pH value 3.8 ± 2 of solution, shake up, mistake to 1000ml
Filter, is cooled to room temperature, filling, to obtain the final product.
Embodiment 3 (for preparation 1000ml): (preferably)
1, active constituent: dextromethorphan hydrobromide 1g PHENYLEPHRINE HYDROCHLORIDE 0.5g,
2, other auxiliary elements: acesulfame potassium 1.0g, citric acid, sodium citrate about 2-40g, disodium ethylene diamine tetraacetate
0.1g, propylene glycol 92.0g, sodium benzoate 1.0g, maltitol 380g lure red 0.5g, cherry essence 0.5g, and solubilizer is extremely
1000ml。
1, it takes solvent about 200-300ml to set in 1000ml beaker, the disodium ethylene diamine tetraacetate of above-mentioned recipe quantity is added, sets
After heating under 60 DEG C of water bath conditions, dextromethorphan hydrobromide, the PHENYLEPHRINE HYDROCHLORIDE of recipe quantity are sequentially added, is shaken,
It makes it dissolve, obtains material a；
2, recipe quantity maltitol, acesulfame potassium, sodium benzoate are weighed to set in 500mL beaker, solvent 300-400ml is added,
It is heated to 50-70 DEG C or so, stirs to solution clear, obtains material b；
3, material b is transferred in material a, continues to stir, obtain material c；
4, under stirring, the stabilizer of recipe quantity, pigment are added in material c, aromatic supplements remaining recipe quantity solvent
To 1000ml, citric acid, sodium citrate is added, reconciles the pH value of solution, makes the pH value 3.8 ± 2 of solution, shake up, filter, it is cold
But filling, to room temperature to obtain the final product.
Embodiment 4
Stability test is carried out to above-described embodiment 1 to embodiment 3, investigates the clarity of medical fluid:
Test method: the medical fluid for taking above-described embodiment 1 to prepare to embodiment 3 each 10, every 100ml places 37 DEG C of perseverances
It in incubator, monthly checks primary, checks 12 months altogether, as soon as if it find that there is crystallization be precipitated or muddy in each embodiment,
Judgement can be carried out in accordance with regulations.(inspection result see the table below).
Table one: medical fluid clarity test
Clarification indicates that a small amount of crystallization precipitation is indicated with "+" with "-"；Mass crystallization is precipitated or muddy " ++ " expression.
Inspection method:
Clarification: sample inversion is observed in the sun, no little particle or turbid phenomenon；
Crystallization is precipitated on a small quantity: sample inversion being observed in the sun, has little particle or crystallizes with a small amount of；
Mass crystallization is precipitated or muddiness: sample inversion being observed in the sun, granule number increases, and bottom of bottle has a large amount of knot
It is brilliant.
Conclusion: investigating through stability test, embodiment 3 from January to December be medical fluid clear state, find no knot
Partial crystallization goes out, and thus, embodiment 3 is preferred preparation method.
Embodiment 5
Further to investigate stability of the invention, high temperature, high humidity and illumination are carried out to drug prepared by embodiment 3 and tried
It tests, further investigates:
Investigation method, sample 1200ml prepared by Example 3, in the glass container for setting 12 white clears, every
100ml is divided into 3 groups, is individually positioned under the conditions of temperature is 60 DEG C, humidity is 95 ± 2% and illumination 4500Lx ± 500Lx
Place 30 days, using dextromethorphan hydrobromide (being indicated with a) and PHENYLEPHRINE HYDROCHLORIDE (indicated with b) content as Testing index,
In the 10th day, 20 days and the 30th day sample detection.It the results are shown in Table two.
Table two: medical fluid high temperature, high humidity and illumination condition test
Experiments have shown that: under high temperature, Qiang Guang, super-humid conditions, effective component can change a lot the said goods, wherein becoming
Changing maximum condition is high temperature.And other two condition variations are less, in the reasonable range of statistics.
Claims (16)
1. a kind of suitable 4-11 years old children taking anti-cold medicine and preparation method thereof, it is characterised in that preparation 1000ml of the present invention
Prescription are as follows: active constituent: dextromethorphan hydrobromide 1g PHENYLEPHRINE HYDROCHLORIDE 0.5g, other auxiliary elements: sweetener 0.1-
900.0g, antioxidant 0.05-0.1g, cosolvent 50.0-100.0g, preservative 0.1-2.0g, thickener 100.00-
400.0g, colorant 0.1-1.0g, aromatic 0.1-1.0g, PH regulator are appropriate, solubilizer to 1000ml.
2. anti-cold medicine according to claim 1, it is characterised in that the antioxidant includes but is not limited to gallic acid
Propyl ester, sodium thiosulfate, disodium ethylene diamine tetraacetate, thiocarbamide, thioacetic acid, propylgallate, hydroquinone, tea polyphenols,
Tocopherol, flavonoids, butylated hydroxy anisole, dibutyl hydroxy toluene, tert-butyl hydroquinone and their mixture,
It is further preferred that the stabilizer is disodium ethylene diamine tetraacetate.
3. anti-cold medicine according to claim 1, it is characterised in that the cosolvent includes but is not limited to propylene glycol, sweet
Oil, ethyl alcohol, it is further preferred that the cosolvent is glycerol and propylene glycol mixture.
4. anti-cold medicine according to claim 1, it is characterised in that the corrigent includes but is not limited to sucrose, An Sai
Honey, Steviosin, Sucralose, maltitol, glycyrrhizic acid, it is further preferred that the corrigent is acesulfame potassium.
5. anti-cold medicine according to claim 1, it is characterised in that the thickener includes but is not limited to xanthan gum, card wave
Nurse, crosslinking sodium polyacrylate, poloxamer, maltitol, polyvinyl alcohol, sodium alginate, further preferably maltitol.
6. anti-cold medicine according to claim 1, it is characterised in that the PH mediator agent include but is not limited to potassium hydrogen phosphate,
Dibastic sodium phosphate, citric acid, sodium citrate, anhydrous citric acid, potassium dihydrogen phosphate or sodium dihydrogen phosphate, it is further preferred that described
PH mediator agent is the mixture of citric acid and sodium citrate.
7. anti-cold medicine according to claim 1, it is characterised in that the preservative includes but is not limited to benzoic acid, benzene first
Sour sodium, sorbic acid, sodium sorbate, it is further preferred that the preservative is sodium benzoate.
8. anti-cold medicine according to claim 1, it is characterised in that the complexing agent includes but is not limited to ethylenediamine tetrem
Acid disodium, natrium adetate, citric acid, phosphoric acid, it is further preferred that the complexing agent is disodium ethylene diamine tetraacetate.
9. anti-cold medicine according to claim 1, it is characterised in that the aromatic include but is not limited to red grape essence,
Cherry essence, flavoring apple essence, orange essence, it is further preferred that the aromatic cherry essence.
10. anti-cold medicine according to claim 1, it is characterised in that the pigment include but is not limited to allured red pigment,
Brilliant blue pigment, brilliant green pigment, Yellow pigment, it is further preferred that the pigment is allured red pigment.
11. anti-cold medicine according to claim 1, it is characterised in that the solvent include but is not limited to purified water, go from
Sub- water or distilled water, it is preferable that the solvent is purified water.
12. preparation method according to claim 1, it is characterised in that preparation method is, for preparing 1000ml:
12.1, it takes solvent about 200-300ml to set in 1000ml beaker, cosolvent in above-mentioned prescription is added, be placed in 60 DEG C of water-bath items
After heating under part, the dextromethorphan hydrobromide, PHENYLEPHRINE HYDROCHLORIDE described in above-mentioned prescription are being sequentially added, is shaking, makes
It is dissolved, and obtains material a；
12.2, corrigent described in above-mentioned prescription, complexing agent, preservative are weighed to set in 500mL beaker, solvent 300-400ml is added,
It is heated to 50-70 DEG C or so, stirs to solution clear, obtains material b；
12.3, material b is transferred in material a, continues to stir, obtain material c；
12.4, under stirring, stabilizer described in prescription, pigment are added in material c, aromatic supplements remaining recipe quantity solvent
It to 1000ml, is added that PH regulator described in above-mentioned prescription is appropriate, shakes up, makes the pH value 3.8 ± 2 of solution, filter, be cooled to room
Temperature, it is filling, to obtain the final product.
13. a kind of suitable 4-11 years old children taking anti-cold medicine and preparation method thereof according to claim 1, feature exists
In its prescription preferably with:
13.1, active constituent: dextromethorphan hydrobromide 1g PHENYLEPHRINE HYDROCHLORIDE 0.5g,
13.2, other auxiliary elements: acesulfame potassium 1.0g, citric acid and sodium citrate about 2-40g, disodium ethylene diamine tetraacetate
0.1g, propylene glycol 92.0g, sodium benzoate 1.0g, maltitol 380g lure red 0.5g, cherry essence 0.5g, and solubilizer is extremely
1000ml。
14. according to claim 1 with preparation method described in claim 12, it is characterised in that preparation method preferably and, with preparation
For 1000ml:
14.1, it takes solvent about 200-300ml to set in 1000ml beaker, disodium ethylene diamine tetraacetate described in claim 13 is added,
It is placed in 60 ° and (after heating under C water bath condition, sequentially adds dextromethorphan hydrobromide described in claim 13, hydrochloric acid deoxidation kidney
Upper parathyrine, shaking, makes it dissolve, obtains material a；
14.2, maltitol, acesulfame potassium described in claim 13 are weighed, sodium benzoate is set in 500mL beaker, addition solvent 300-
400ml is heated to 50-70 DEG C or so, stirs to solution clear, obtains material b；
14.3, material b is transferred in material a, continues to stir, obtain material c；
14.4, under stirring, propylene glycol described in claim 13 is added in material c, lures red, cherry essence, supplement is remaining
Recipe quantity solvent is added citric acid about 5g, sodium citrate about 6g, reconciles the pH value of solution, make the pH value of solution to 1000ml
3.8 ± 2, it shakes up, filter, be cooled to room temperature, it is filling, to obtain the final product.
15. a kind of suitable 4-11 years old children taking anti-cold medicine and preparation method thereof according to claim 1, feature exists
Nasal obstruction, cough caused by for alleviating 4-11 years old children because of flu.
16. a kind of suitable 4-11 years old children taking anti-cold medicine and preparation method thereof according to claim 1, feature exists
It is to take orally, 4-6 years old children 5ml/4 hours in usage and dosage；6-11 years old: 10ml/4 hour.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
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