CN109771372A - A kind of dextromethorphan hydrobromide sustained-release suspension and preparation method thereof - Google Patents
A kind of dextromethorphan hydrobromide sustained-release suspension and preparation method thereof Download PDFInfo
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- CN109771372A CN109771372A CN201910230640.4A CN201910230640A CN109771372A CN 109771372 A CN109771372 A CN 109771372A CN 201910230640 A CN201910230640 A CN 201910230640A CN 109771372 A CN109771372 A CN 109771372A
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Abstract
The invention discloses a kind of dextromethorphan hydrobromide sustained-release suspensions, the suspension is made of the raw material of following mass percent: suspension base 85%~95%, carries medicated resin 0.1%~0.5%, EDTA 0.01%~0.08%, surfactant 0.1%~0.3% at coating resin 0.5%~1.5%, and surplus is water；The load medicated resin is made of dextromethorphan hydrobromide bulk pharmaceutical chemicals, kayexalate type cation exchange resin, pure water, the raw material for preparing of the coating resin includes impregnating resin, methylene chloride, vegetable oil, ethyl cellulose and acetone, and the raw material for preparing of the impregnating resin includes polyethylene glycol, pure water and the load of preparation medicated resin.The invention also discloses a kind of preparation methods of dextromethorphan hydrobromide sustained-release suspension.Slow release effect of the present invention is preferable, and drug therapy persistent, therapeutic effect is good, can obviously reduce times for spraying, and the problems such as overcome the sense of taste discomfort of solid sustained-release preparation, dysphagia, inaccurate divided dose, can be convenient the medication of child patient.
Description
Technical field
The invention belongs to pharmaceutical technology field, in particular to a kind of dextromethorphan hydrobromide sustained-release suspension and its preparation side
Method.
Background technique
At present in more than 3500 kinds of China chemical preparation, 90% drug does not have children's dosage form, not for children special-purpose
100 kinds of foot.And the liquid preparation of children special-purpose is less.In only children less than 10%, it is most of be also into
What mouth or joint venture produced.Domestic many pharmaceutical producing enterprises' references be all the external Clinical Report done or only to
General dosage conversions method out.In this manner it is achieved that tablet or capsule solid pharmaceutical preparation are just difficult to adapt to a point metering.And it is conventional
Suspension perhaps oral solution often need three times per day in this way to upper kindergarten or the children to go to school medication it is totally unfavorable.Cause
And the problems such as sense of taste discomfort, dysphagia, inaccurate divided dose in order to overcome solid pharmaceutical preparation and convenient for children patient
Medication and enhancing therapeutic effect, develop a kind of slow release effect and the preferable liquid oral sustained-release preparation of therapeutic effect to Guan Chong
It wants.
Summary of the invention
In order to solve the above technical problems, the purpose of the present invention is to provide a kind of dextromethorphan hydrobromide sustained-release suspension and
Liquid sustained-release preparation is made in dextromethorphan hydrobromide by preparation method, divided dose can be needed to take according to various dose,
Medicine-releasing system is administered with more unit grain dosage forms, big in gastrointestinal tract distribution area, is absorbed fastly, and blood concentration is steady, biology benefit
Expenditure is high, and therapeutic effect is good, can reduce the stimulation to gastrointestinal tract, and internal behavior is seldom influenced by gastric emptying rate, hence it is evident that is subtracted
Few times for spraying, can be convenient the medication of child patient.
To realize above-mentioned technical purpose and the technique effect, the invention is realized by the following technical scheme: Yi Zhongqing
Bromic acid dextromethorphan slow-release suspension, the suspension are made of the raw material of following mass percent: suspension base 85%~
95%, it is coated resin 0.5%~1.5%, carries medicated resin 0.1%~0.5%, EDTA 0.01%~0.08%, surfactant
0.1%~0.3%, surplus is water；The load medicated resin is made of the raw material of following mass percent: dextromethorphan hydrobromide is former
Material medicine 1%~5%, kayexalate type cation exchange resin 3%~5%, pure water 90%~96% are made, the coating
The raw material for preparing of resin includes impregnating resin 8%~15%, methylene chloride 70%~85%, vegetable oil 0.2%~1%, ethyl
Cellulose 3%~6.8% and acetone 3%~8%, the impregnating resin prepare raw material include polyethylene glycol 10%~30%, it is pure
The load medicated resin 5%~15% of water 65%~75% and preparation.
Preferably, which is made of the raw material of following mass percent: suspension base 92%, coating resin
1.25%, medicated resin 0.32%, EDTA 0.05%, surfactant 0.19% are carried, surplus is water；The load medicated resin be by with
The raw material of lower mass percent is made: dextromethorphan hydrobromide bulk pharmaceutical chemicals 2%, kayexalate type cation exchange resin
3.8%, pure water 94.2% is made, and the raw material for preparing of the coating resin includes impregnating resin 11.58%, methylene chloride 77%, plants
Object oil 0.38%, ethyl cellulose 5.4% and acetone 5.64%, the impregnating resin prepare raw material include polyethylene glycol 18%,
The load medicated resin 9% of pure water 73% and preparation.
Further, suspension base is made of the raw material of following mass percent: citric acid 0.1%~0.4%,
FD&C eats yellow pigment No. 6 0.001%~0.002%, mandarin orange flavor 0.045%~0.11%, high-fructose corn syrup
25%~46.5%, methyl p-hydroxybenzoate 0.1%~0.25%, propylparaben 0.02%~0.054%, third
Glycol 1%~7%, sucrose 10%~18%, tragacanth 0.2%~0.85%, xanthan gum 0..05%~0.3% and purifying
Water 35%~55%.
Preferably, the surfactant is polyoxyethylene sorbitan monoleate.
The present invention also provides a kind of preparation methods of dextromethorphan hydrobromide sustained-release suspension, comprising the following steps:
(1) preparation carries medicated resin: measuring pure water, weighs dextromethorphan hydrobromide bulk pharmaceutical chemicals, by dextromethorphan hydrobromide original
Expect that medicine is added in pure water, and heat, make it dissolve, then add kayexalate type cation exchange resin, stirs
And heat, it after being completely dissolved, cools, removes supernatant, filter, the mixture after drying is sieved for subsequent use in drying；
(2) prepare impregnating resin: weighing polyethylene glycol, be added in pure water, and heat and make it dissolve in pure water, then plus
Enter step (1) load medicated resin obtained, stirs evenly, filtered after cooling, dry, sieve for subsequent use；
(3) preparation coating resin: methylene chloride and vegetable oil are weighed, vegetable oil is made to be dissolved in the dichloromethane under stirring
In alkane, then ethyl cellulose is slowly added thereto, after ethyl cellulose is completely dissolved, acetone is added, after stirring, packet is made
Then clothing liquid takes impregnating resin prepared by step (2), which is placed on fluidized bed, air inlet makes impregnating resin object
Material is in fluidized state, and prepared coating solution is atomized and is sprayed into, coating solution is made to be wrapped in impregnating resin surface, and coating tree is made
Coating resin obtained is dried, is sieved for subsequent use by rouge；
(4) prepare suspension: then production suspension base first weighs suspension base according to dosage, pure water is added,
Stirring, and EDTA is added, after EDTA dissolution, desired amount of coating resin is added and carries medicated resin, poly- mountain is added after stirring
Pear ester 80 is packed into brown bottle after mixing evenly, dextromethorphan hydrobromide sustained-release suspension is made.
Further, the manufacturing process of the suspension base in step (4) are as follows: a container A is first taken, purified water is measured, it will
Citric acid is dissolved in purified water, and sucrose then is added and high-fructose corn syrup stirs to form solution, FD&C is eaten yellow
Pigment 6 are dissolved in the solution to be formed, and then separately take a container B that propylene glycol is added, and be heated to 45-50 DEG C, are then added
Methyl p-hydroxybenzoate and propylparaben, it is after two kinds of p-hydroxybenzoates dissolve, solution is cooling, then
Xanthan gum and tragacanth are slowly added in solution, after dissolution completely, then the solution in container B is added to the molten of container A
In liquid, mandarin orange flavor mixing is eventually adding until uniform, to form suspension base.
Preferably, in step (3), the intake of fluidized bed is 40m3/ h, inlet air temperature are 40 DEG C, coating solution atomization spray
Fashionable atomizing pressure is 0.2MPa.
The beneficial effects of the present invention are: first load medicated resin is made in dextromethorphan hydrobromide bulk pharmaceutical chemicals by the present invention, it is then right
Carry after medicated resin impregnated, then coating resin is made in impregnating resin, will finally carry medicated resin and coating resin jointly with mix
Suspension matrix, EDTA, surfactant are mixed and made into dextromethorphan hydrobromide sustained-release suspension.The dextromethorphan hydrobromide sustained-release
The slow release effect of suspension is preferable, divided dose can be needed to take according to various dose, and medicine-releasing system is with more unit grain dosage forms
Administration, it is big in gastrointestinal tract distribution area, it absorbs fastly, blood concentration is steady, and bioavilability is high, drug therapy persistent,
Therapeutic effect is good, and at being grouped as rationally, toxic side effect is low, drug safety, can reduce the stimulation to gastrointestinal tract, and internal behavior is seldom
It is influenced by gastric emptying rate, hence it is evident that reduce times for spraying, and the sense of taste for overcoming solid sustained-release preparation is uncomfortable, it is tired to swallow
Difficult, the problems such as divided dose is inaccurate, it can be convenient the medication of child patient.
Specific embodiment
The preferred embodiments of the present invention will be described in detail below so that advantages and features of the invention can be easier to by
It will be appreciated by those skilled in the art that so as to make a clearer definition of the protection scope of the present invention.
Embodiment 1
A kind of dextromethorphan hydrobromide sustained-release suspension, the suspension are made of the raw material of following mass percent: being suspended
Agent matrix 85%, carries medicated resin 0.5%, EDTA 0.08%, surfactant 0.3% at coating resin 1.5%, and surplus is water；
The load medicated resin is made of the raw material of following mass percent: dextromethorphan hydrobromide bulk pharmaceutical chemicals 1%, kayexalate
Type cation exchange resin 3%, pure water 96% is made, and the raw material for preparing of the coating resin includes impregnating resin 8%, methylene chloride
85%, vegetable oil 1%, ethyl cellulose 3% and acetone 3%, the impregnating resin prepare raw material include polyethylene glycol 10%, it is pure
The load medicated resin 15% of water 75% and preparation.
Wherein, suspension base is made of the raw material of following mass percent: citric acid 0.1%, FD&C eat yellow
Pigment No. 6 0.002%, mandarin orange flavor 0.11%, high-fructose corn syrup 25%, methyl p-hydroxybenzoate 0.25%, to hydroxyl
Yl benzoic acid propyl ester 0.038%, propylene glycol 1%, sucrose 18%, tragacanth 0.2%, xanthan gum 0.3% and purified water 55%.
The preparation method of above-mentioned dextromethorphan hydrobromide sustained-release suspension, comprising the following steps:
(1) preparation carries medicated resin: measuring pure water, weighs the dextromethorphan hydrobromide bulk pharmaceutical chemicals of recipe quantity, by the hydrobromic acid right side
Dextromethorphan bulk pharmaceutical chemicals are added in pure water, and are heated to 40 DEG C, make it dissolve, then add the kayexalate of recipe quantity
Type cation exchange resin is stirred and is heated 2 hours, after being completely dissolved, cools, remove supernatant, is filtered, drying, after drying
Mixture cross 80 meshes, it is spare；
(2) it prepares impregnating resin: weighing the polyethylene glycol of recipe quantity, be added in pure water, and be heated to 60 DEG C, make it dissolve
In pure water, step (1) load medicated resin obtained is then added, stirs evenly, is filtered after cooling, dried, crosses 80 meshes, it is standby
With；
(3) preparation coating resin: a beaker is taken, the methylene chloride of recipe quantity is added, weighs vegetable oil, keeps vegetable oil molten
Solution is slowly added thereto in the methylene chloride under stirring, then by ethyl cellulose, after ethyl cellulose is completely dissolved,
Acetone is added, after stirring, coating solution is made, then takes impregnating resin prepared by step (2), which is placed in fluidisation
On bed, air inlet, intake 40m3/ h, inlet air temperature are 40 DEG C, make impregnating resin material in fluidized state, by prepared packet
Clothing liquid mistization sprays into, and atomizing pressure 0.2Mpa makes coating solution be wrapped in impregnating resin surface, and coating resin is made, will be made
Coating resin drying, sieve for subsequent use；
(4) suspension is prepared: production suspension base first, the manufacturing process are as follows: a container A is first taken, purified water is measured,
Citric acid is dissolved in purified water, sucrose then is added and high-fructose corn syrup stirs to form solution, by the edible Huang of FD&C
Color pigment 6 are dissolved in the solution to be formed, and then separately take a container B that propylene glycol is added, and are heated to 45-50 DEG C, then plus
Enter methyl p-hydroxybenzoate and propylparaben, it is after two kinds of p-hydroxybenzoates dissolve, solution is cooling,
Xanthan gum and tragacanth are slowly added in solution again, after dissolution completely, then the solution in container B is added to container A
In solution, mandarin orange flavor mixing is eventually adding until uniform, to form suspension base；Then suspension base is weighed according to dosage
Matter is added pure water, stirring, and EDTA is added, and after EDTA dissolution, desired amount of coating resin is added and carries medicated resin, stirring
After polyoxyethylene sorbitan monoleate is added, after mixing evenly be packed into brown bottle in, dextromethorphan hydrobromide sustained-release suspension is made.
Embodiment 2
A kind of dextromethorphan hydrobromide sustained-release suspension, the suspension are made of the raw material of following mass percent: being suspended
Agent matrix 92%, carries medicated resin 0.32%, EDTA 0.05%, polyoxyethylene sorbitan monoleate 0.19% at coating resin 1.25%, and surplus is
Water；The load medicated resin is made of the raw material of following mass percent: dextromethorphan hydrobromide bulk pharmaceutical chemicals 2%, polystyrene sulphur
Sour sodium form cation exchange resin 3.8%, pure water 94.2% are made, and the raw material for preparing of the coating resin includes impregnating resin
11.58%, methylene chloride 77%, vegetable oil 0.38%, ethyl cellulose 5.4% and acetone 5.64%, the system of the impregnating resin
Standby raw material includes the load medicated resin 9% of polyethylene glycol 18%, pure water 73% and preparation.
Wherein, suspension base is made of the raw material of following mass percent: citric acid 0.3%, FD&C eat yellow
Pigment No. 6 0.0015%, mandarin orange flavor 0.0985%, high-fructose corn syrup 29.7%, methyl p-hydroxybenzoate 0.2%,
Propylparaben 0.02%, propylene glycol 4.5%, sucrose 14.5%, tragacanth 0.5%, xanthan gum 0.18% and pure
Change water 50%.
The preparation method is the same as that of Example 1 for above-mentioned dextromethorphan hydrobromide sustained-release suspension.
Embodiment 3
A kind of dextromethorphan hydrobromide sustained-release suspension, the suspension are made of the raw material of following mass percent: being suspended
Agent matrix 95%, carries medicated resin 0.1%, EDTA 0.01%, surfactant 0.1% at coating resin 0.5%, and surplus is water；
The load medicated resin is made of the raw material of following mass percent: dextromethorphan hydrobromide bulk pharmaceutical chemicals 5%, kayexalate
Type cation exchange resin 5%, pure water 90% is made, and the raw material for preparing of the coating resin includes impregnating resin 15%, dichloromethane
The raw material for preparing of alkane 70%, vegetable oil 0.2%, ethyl cellulose 6.8% and acetone 8%, the impregnating resin includes polyethylene glycol
30%, the load medicated resin 5% of pure water 65% and preparation.
Wherein, suspension base is made of the raw material of following mass percent: citric acid 0.4%, FD&C eat yellow
It is pigment No. 6 0.001%, mandarin orange flavor 0.045%, high-fructose corn syrup 46.5%, methyl p-hydroxybenzoate 0.1%, right
Nipasol 0.054%, propylene glycol 7%, sucrose 10%, tragacanth 0.85%, xanthan gum 0.05% and purified water
35%.
The preparation method is the same as that of Example 1 for above-mentioned dextromethorphan hydrobromide sustained-release suspension.
The above description is only an embodiment of the present invention, is not intended to limit the scope of the invention, all to utilize this hair
Equivalent structure or equivalent flow shift made by bright description is applied directly or indirectly in other relevant technology necks
Domain is included within the scope of the present invention.
Claims (7)
1. a kind of dextromethorphan hydrobromide sustained-release suspension, which is characterized in that the suspension by following mass percent raw material
Be made: suspension base 85%~95%, carries medicated resin 0.1%~0.5%, EDTA at coating resin 0.5%~1.5%
0.01%~0.08%, surfactant 0.1%~0.3%, surplus are water；The load medicated resin is by following mass percent
Raw material is made: dextromethorphan hydrobromide bulk pharmaceutical chemicals 1%~5%, kayexalate type cation exchange resin 3%~5%,
Pure water 90%~96% is made, the coating resin prepare raw material include impregnating resin 8%~15%, methylene chloride 70%~
85%, vegetable oil 0.2%~1%, ethyl cellulose 3%~6.8% and acetone 3%~8%, the impregnating resin prepare raw material
Load medicated resin 5%~15% including polyethylene glycol 10%~30%, pure water 65%~75% and preparation.
2. a kind of dextromethorphan hydrobromide sustained-release suspension according to claim 1, which is characterized in that the suspension by with
The raw material of lower mass percent is made: suspension base 92%, carries medicated resin 0.32%, EDTA at coating resin 1.25%
0.05%, surfactant 0.19%, surplus are water；The load medicated resin is made of the raw material of following mass percent: hydrogen bromine
Sour dextromethorphan bulk medicine 2%, kayexalate type cation exchange resin 3.8%, pure water 94.2% are made, the coating
The raw material for preparing of resin includes impregnating resin 11.58%, methylene chloride 77%, vegetable oil 0.38%, 5.4% and of ethyl cellulose
Acetone 5.64%, the impregnating resin prepare the load medicated resin 9% that raw material includes polyethylene glycol 18%, pure water 73% and preparation.
3. a kind of dextromethorphan hydrobromide sustained-release suspension according to claim 1, which is characterized in that suspension base is
It is made of the raw material of following mass percent: the edible yellow pigment No. 6 0.001% of citric acid 0.1%~0.4%, FD&C~
0.002%, mandarin orange flavor 0.045%~0.11%, high-fructose corn syrup 25%~46.5%, methyl p-hydroxybenzoate
0.1%~0.25%, propylparaben 0.02%~0.054%, propylene glycol 1%~7%, sucrose 10%~18%,
Tragacanth 0.2%~0.85%, xanthan gum 0..05%~0.3% and purified water 35%~55%.
4. a kind of dextromethorphan hydrobromide sustained-release suspension according to claim 1, which is characterized in that the surface-active
Agent is polyoxyethylene sorbitan monoleate.
5. such as a kind of described in any item preparation methods of dextromethorphan hydrobromide sustained-release suspension of Claims 1-4, feature
It is, comprising the following steps:
(1) preparation carries medicated resin: measuring pure water, dextromethorphan hydrobromide bulk pharmaceutical chemicals is weighed, by dextromethorphan hydrobromide bulk pharmaceutical chemicals
It is added in pure water, and heats, make it dissolve, then add kayexalate type cation exchange resin, stir and add
Heat after being completely dissolved, cools, and removes supernatant, filters, and the mixture after drying is sieved for subsequent use in drying；
(2) it prepares impregnating resin: weighing polyethylene glycol, be added in pure water, and heat and make it dissolve in pure water, step is then added
Suddenly (1) is obtained carries medicated resin, stirs evenly, filters after cooling, dries, sieve for subsequent use；
(3) preparation coating resin: methylene chloride and vegetable oil are weighed, vegetable oil is made to be dissolved in the methylene chloride under stirring
In, then ethyl cellulose is slowly added thereto, after ethyl cellulose is completely dissolved, acetone is added, after stirring, coating is made
Then liquid takes impregnating resin prepared by step (2), which is placed on fluidized bed, air inlet makes impregnating resin material
In fluidized state, prepared coating solution is atomized and is sprayed into, coating solution is made to be wrapped in impregnating resin surface, coating resin is made,
Coating resin obtained is dried, is sieved for subsequent use；
(4) prepare suspension: then production suspension base first weighs suspension base according to dosage, pure water is added, stirs
It mixes, and EDTA is added, after EDTA dissolution, desired amount of coating resin is added and carries medicated resin, poly- sorb is added after stirring
Ester 80 is packed into brown bottle after mixing evenly, dextromethorphan hydrobromide sustained-release suspension is made.
6. a kind of preparation method of dextromethorphan hydrobromide sustained-release suspension according to claim 5, which is characterized in that step
Suddenly the manufacturing process of the suspension base in (4) are as follows: first take a container A, measure purified water, citric acid is dissolved in purified water
In, it sucrose and high-fructose corn syrup is then added stirs to form solution, FD&C is eaten yellow pigment 6 and is dissolved in be formed
It in solution, then separately takes a container B that propylene glycol is added, and is heated to 45-50 DEG C, methyl p-hydroxybenzoate and right is then added
Nipasol, it is after two kinds of p-hydroxybenzoates dissolve, solution is cooling, then xanthan gum and tragacanth are delayed
It is slow to be added in solution, after dissolution completely, then the solution in container B is added in the solution of container A, is eventually adding mandarin orange flavor
Mixing is until uniform, to form suspension base.
7. a kind of preparation method of dextromethorphan hydrobromide sustained-release suspension according to claim 5, which is characterized in that
In step (3), the intake of fluidized bed is 40m3/ h, inlet air temperature are 40 DEG C, and atomizing pressure when coating solution atomization sprays into is
0.2MPa。
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Application publication date: 20190521 |
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