CN108186579A - Xiao ' er Anfen Huangnamin composition grain and preparation method thereof - Google Patents
Xiao ' er Anfen Huangnamin composition grain and preparation method thereof Download PDFInfo
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- CN108186579A CN108186579A CN201810103111.3A CN201810103111A CN108186579A CN 108186579 A CN108186579 A CN 108186579A CN 201810103111 A CN201810103111 A CN 201810103111A CN 108186579 A CN108186579 A CN 108186579A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/37—Digestive system
- A61K35/413—Gall bladder; Bile
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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
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
- A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
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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
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4402—Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 2, e.g. pheniramine, bisacodyl
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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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
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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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
Abstract
The present invention relates to a kind of Xiao ' er Anfen Huangnamin composition grains and preparation method thereof, are related to field of medicaments.It is made by following methods：Raw material to the utmost, raw material include the paracetamol of 25~27 parts by weight, the calculus bovis factitius of 0.85~1 parts by weight, the chlorphenamine maleate of 0.09~0.18 parts by weight, the essence of the sucrose of 750~800 parts by weight and 1~1.5 parts by weight；Sucrose is divided into first part's sucrose and second part sucrose；Paracetamol, calculus bovis factitius, chlorphenamine maleate and first part's sucrose are mixed, obtained mixture is mixed with the aqueous solution of second part sucrose under the state of seething, is pelletized, dry for the first time, after the solution for spraying essence, second dry.By reasonably matching and the cooperation of preparation method, effectively improve the stability of product and improve mouthfeel when taking.
Description
Technical field
The present invention relates to field of medicaments, and more particularly to a kind of Xiao ' er Anfen Huangnamin composition grain and its preparation side
Method.
Background technology
Pediatric paracetamol granule for flu medication class non-prescribed medicine drug, former name：It is children's quick-acting cold particle, small
Youngster's used quick-resulted anti-cold pills or the quick-acting cold electuaries of children.
Pediatric paracetamol granule is one of common Coritab of current children.This product is a kind of compound preparation, main
It to be made of paracetamol (paracetamol), chlorphenamine maleate (chlorpheniramine) and calculus bovis factitius.Paracetamol
It is a kind of analgesic-antipyretic, it mainly by inhibiting the synthesis of prostaglandin, increases blood flow, perspiration and the heat leakage of skin and rise
Refrigeration function.Chlorphenamine maleate is histamine H 1 receptor antagonist, can be to the capillary caused by antianaphylaxis (histamine)
Expansion reduces the permeability of capillary, with paracetamol compatibility, can enhance its analgesia and alleviate the caused nose of flu
The effect of the symptoms such as plug, runny nose, sneezing.Calculus bovis factitius has antipyretic, relieving convulsion effect.It can be clinically used for treatment cold in children
Or the symptoms such as headache, fever, sore-throat, nasal obstruction, runny nose caused by influenza.
Preparation method traditional at present, there are main ingredient and the non-uniform problem of auxiliary material mixing, causes finished product in pelletization
Middle chlorphenamine maleate differentiates that item is unqualified, and content is uneven, and content fluctuation is big, and unstable product quality, particle is not instant,
It is not easy to take, Simultaneous Stabilization is poor.
Invention content
The purpose of the present invention is to provide a kind of Xiao ' er Anfen Huangnamin composition grain, product quality is stablized, treatment
Effect is good.
Another object of the present invention is to provide a kind of preparation method of Xiao ' er Anfen Huangnamin composition grain, preparation side
Method is simple, quality controllable, suitable for industrialized production, effectively improves the stability of product and improves mouthfeel when taking.
The present invention is solved its technical problem and is realized using following technical scheme.
The present invention proposes a kind of Xiao ' er Anfen Huangnamin composition grain, is made by following methods：
Raw material to the utmost, raw material include the paracetamol of 25~27 parts by weight, the calculus bovis factitius of 0.85~1 parts by weight,
The essence of the chlorphenamine maleate of 0.09~0.18 parts by weight, the sucrose of 750~800 parts by weight and 1~1.5 parts by weight；
Sucrose is divided into first part's sucrose and second part sucrose；By Paracetamol, calculus bovis factitius, chlorphenamine maleate with
And first part's sucrose mixing, obtained mixture with the aqueous solution of second part sucrose under the state of seething is mixed, is pelletized,
Dry for the first time, after the solution for spraying essence, second dry.
The present invention proposes a kind of preparation method of above-mentioned Xiao ' er Anfen Huangnamin composition grain, and sucrose is divided into first
Divide sucrose and second part sucrose；
Paracetamol, calculus bovis factitius, chlorphenamine maleate and first part's sucrose are mixed, the mixing that will be obtained
Object is mixed with the aqueous solution of second part sucrose under the state of seething, granulation, dry for the first time, after the solution for spraying essence, the
Redrying.
The advantageous effect of the Xiao ' er Anfen Huangnamin composition grain of the embodiment of the present invention and preparation method thereof is：
The formulation ratio is reasonable, by and Xiao ' er Anfen Huangnamin composition grain preparation method combination, effectively carry
High stability.
Wherein, obtained mixture is mixed with the aqueous solution of second part sucrose under the state of seething so that addition
The aqueous solution of second part sucrose is sufficiently mixed with mixture, while chlorphenamine maleate is soluble easily in water, is dissolved in water by it
In, it is mixed under the state of seething with remaining active ingredient, fully so that each drug component is uniformly mixed, while the sugarcane of second part
Sugar is also adequately uniformly mixed with remaining drug so that more preferably, children are easier to take mouthfeel.Meanwhile under this condition for second
The molecular structure of acylamino- phenol, calculus bovis factitius, chlorphenamine maleate and sucrose and pharmacological property etc. are turned over without ill-effect
It rises and is mixed under state, pelletized so that granulation obtains more micropore spherical particles, effectively improves particle melting, and with preferable
Stability.
Specific embodiment
Purpose, technical scheme and advantage to make the embodiment of the present invention are clearer, below will be in the embodiment of the present invention
Technical solution be clearly and completely described.The person that is not specified actual conditions in embodiment, builds according to normal condition or manufacturer
The condition of view carries out.Reagents or instruments used without specified manufacturer is the conventional production that can be obtained by commercially available purchase
Product.
Xiao ' er Anfen Huangnamin composition grain of the embodiment of the present invention and preparation method thereof is specifically described below.
The present invention provides a kind of Xiao ' er Anfen Huangnamin composition grain, is made by following methods：
S1. raw material to the utmost.
Raw material includes：The paracetamol of 25~27 parts by weight, the calculus bovis factitius of 0.85~1 parts by weight, 0.09~
The essence of the chlorphenamine maleate of 0.18 parts by weight, the sucrose of 750~800 parts by weight and 1~1.5 parts by weight.
Preferably, raw material includes：The paracetamol of 25~27 parts by weight, the calculus bovis factitius of 0.85~1 parts by weight,
The essence of the chlorphenamine maleate of 0.09~0.18 parts by weight, the sucrose of 750~800 parts by weight and 1~1.5 parts by weight.
Wherein, essence is included in lemon flavor essence, sweet orange flavor essence, strawberry flavor essence and honey peach flavor essence
It is at least one.
S2. sucrose is divided into first part's sucrose and second part sucrose；By Paracetamol, calculus bovis factitius, Malaysia
Sour chlorphenamine and first part's sucrose mixing, by the aqueous solution of obtained mixture and second part sucrose in the state of seething
Lower mixing, granulation is dry for the first time, and after the solution for spraying essence, second dry.
Wherein, sucrose is divided into first part's sucrose and second part sucrose according to actual conditions, it is preferable that in by sugarcane
Before sugar is first part's sucrose and second part sucrose, whole sucrose are added in pulverizer, are ground into fine powder, released,
80 mesh sieve is crossed, optionally, qualified sucrose is packed into and is cased in the plastic crate of clean polybag after sieving, spare, convenient for subsequently mixing
It closes uniformly and accelerates to be dissolved in water.
Wherein Paracetamol, calculus bovis factitius, chlorphenamine maleate and first part's sucrose are mixed, it is preferable that
In order to make being more uniformly distributed for mixing, it is mixed into after first mixing Paracetamol, calculus bovis factitius, chlorphenamine maleate, in 30
Point 2~5 addition first part sucrose, obtain mixture under conditions of~65r/min.By repeatedly a small amount of addition, while
Under the subsidiary conditions of suitable stir speed (S.S.), effectively so that Paracetamol, calculus bovis factitius, chlorphenamine maleate and first
Sucrose mixing in part is more uniformly distributed, and effectively avoids in pelletization that there are each drug components to mix non-uniform problem.
Obtained mixture is mixed with the aqueous solution of second part sucrose under the state of seething, including it is following any one
Scheme：
The first, it is preferable that mixture is added in into second part sucrose under conditions of 1000~3000Pa, 25~35 DEG C
Aqueous solution make softwood, wherein, 1000~3000Pa, under conditions of 25~35 DEG C so that the second part sucrose of addition
Aqueous solution is in boiling-like, and aqueous solution and the mixture of boiling are sufficiently mixed, while chlorphenamine maleate is soluble easily in water, pass through it
It is soluble in water, it is mixed in the state of boiling with remaining active ingredient, fully so that each drug component is uniformly mixed, while second
Partial sucrose is also adequately uniformly mixed with remaining drug so that more preferably, children are easier to take mouthfeel.Preferably, it adds in
Second part sucrose aqueous solution temperature for 30~35 DEG C, hold further such that paracetamol is soluble in second
The aqueous solution of point sucrose, at the same the condition and at a temperature of, increase the solubility of calculus bovis factitius, and then Paracetamol, manually
Cow-bezoar, chlorphenamine maleate and sucrose mix more abundant, simultaneously because the aqueous solution of second part sucrose is in boiling
Shape so that water is uniformly mixed with active ingredient in softwood, and through granulation, after dry for the first time, moisture evaporation is formed preferably,
Even more micropore spherical particles, good stability, while convenient for dissolving, convenient for taking.Also, for acetyl ammonia under above-mentioned condition
The molecular structure of base phenol, calculus bovis factitius, chlorphenamine maleate and sucrose and pharmacological property etc. are without ill-effect.
It in order to make the neither too hard, nor too soft of the softwood of making, can be molded, it is preferable that the addition of the aqueous solution of second part sucrose
Amount and the volume ratio of the additive amount of mixture are 1：0.5~0.6.Wherein, the present invention adopts water as purified water, prevents impurity from doing
It disturbs.
Under these conditions, in order to which the boiling degree of the aqueous solution of second part sucrose is made to keep preferable condition, while just
In mixing, optionally, a concentration of 20~30wt% of the aqueous solution of second part sucrose further improves mixture homogeneity.
The dry temperature of material obtained in granulation carries out 28~35min under conditions of being 60~65 DEG C for the first time.Effectively
It is dry, after the completion of dry for the first time, temperature of charge is preferably made to be down to 35 DEG C hereinafter, discharging can be shut down.
Second, it is preferable that by the aqueous solution of obtained mixture and second part sucrose in Fluidbedgranulatingdrier
It is mixed under the state of seething, granulation and for the first time drying.It is flowed in a ring by the way that mixture is placed in Fluidbedgranulatingdrier
Change state by by purified heating air preheat and mixing, is sprayed into being atomized in the aqueous solution of second part sucrose, is made
Several particle buildups due to continuous drying of the hot-air to material, make moisture evaporation in granule, glue into the granule containing adhesive
Mixture solidifies, this process constantly repeats, and forms ideal, uniform more micropore spherical particles.It will mix, pelletize, the
Primary drying, which synchronizes, to carry out, meanwhile, the aqueous solution of second part sucrose at this time effectively adjusts sugariness, on the other hand as viscous
Tie agent, charmed particle aggregation.
Above two mode, which has reached, is uniformly mixed each drug component, obtains more micropore spherical particles, effectively improves
Its particle melting, and there is preferable stability.
Optionally, in order to increase the forming degree of Xiao ' er Anfen Huangnamin composition grain and stability so that after granulation
The epigranular of particle etc., it is preferable that raw material further includes chitosan, the additive amount and paracetamol of water soluble chitosan
Additive amount mass ratio be 0.01~0.05：25~27.
Under these conditions, during preparation, optionally, water solubility is additionally added in the aqueous solution of second part sucrose
The weight ratio of chitosan, water soluble chitosan and paracetamol is 0.01~0.05：25~27, under the conditions of the ratio, have
The problem of imitating and improve forming degree, while preventing additive amount from viscosity excessively being caused to lead to follow-up bad digestion greatly.Wherein, water soluble shells
Glycan is, for example, deacetylation to be carried out under the conditions of homogeneous reaction, and control the deacetylated chitosan for being 50% or so.
Meanwhile children's immunocompetence is relatively grown up low, and chitosan is in human body, has and inhibits bacteria, improves the works such as human immunological competence
With further improving the health degree of children, collaboration improves the therapeutic effect of Xiao ' er Anfen Huangnamin composition grain.
Optionally, it pelletizes and is pelletized in oscillating granulator with 15~16 mesh stainless steel cloths.
Preferably, sieving is further included between dry for the first time and spraying essence solution, for screening qualified particle.
Specifically, it is first sieved with 60 mesh stainless steel mesh, on-the-sieve material is recycled, by obtained undersize material after 10 purposes
Stainless steel mesh is sieved, and recycles undersize material, the granule materials sieved.
Optionally, essence can may not be for water solubility, not limit herein, according to the property of essence, according to existing
There are technology and equipment, and after the solution of essence for being configured to suitable concentration according to practical situation, by obtained sieve
Grain material is all pumped into two-dimensional motion mixer, and the solution for spraying into essence mixes 15 minutes, discharging.Particle is contained with clean container
Dress.It should be noted that ratio this field staff of the granule materials in the amount and sieve of the solution of essence can be according to reality
Please road conditions set.
After the solution of spraying essence, warm air drying to water content is less than 5% under conditions of 60~65 DEG C, stands, profit
With residual heat drying.
Finally, optionally, automatic granular packaging machine is opened, corresponding measuring cup is selected to be dispensed by technological parameter, such as
Per packed amount 4g.Loading amount and heat sealing quality are checked according to the prior art and equipment simultaneously.Per packed amount compared with indicating loading amount
Compared with content uniformity limit should must not be more than 2 bags, and must not have 1 bag beyond limit within ± 7% beyond content uniformity limit
1 times of degree.
The feature and performance of the present invention are described in further detail with reference to embodiments.
Embodiment 1
A kind of Xiao ' er Anfen Huangnamin composition grain, is made by following methods：
The raw material of active ingredient is configured, including：The paracetamol of 25 parts by weight, the calculus bovis factitius of 1 parts by weight,
The essence of the chlorphenamine maleate of 0.095 parts by weight, the sucrose of 779 parts by weight and 1.2 parts by weight.
Sucrose is added in pulverizer, is ground into fine powder, after crossing 80 mesh sieve, is divided into first part's sucrose and second part
Sucrose.Paracetamol, calculus bovis factitius, chlorphenamine maleate and first part's sucrose are mixed, obtain mixture.It will mixing
The aqueous solution that object adds in second part sucrose under conditions of 3000Pa, 35 DEG C makes softwood, after granulation, first with 60 mesh stainless steels
Sieve is sieved, and recycles on-the-sieve material, and stainless steel mesh of the obtained undersize material after 10 mesh is sieved, recycles undersize material,
After sieving by the granule materials on being sieved granule materials temperature to carry out 30min under conditions of 65 DEG C, spray essence
After solution, warm air drying to water content is less than 5% under conditions of 65 DEG C, stands.
Wherein, the volume ratio of the additive amount of the additive amount and mixture of the aqueous solution of second part sucrose is 1：0.5.Second
A concentration of 25wt% of the aqueous solution of part sucrose.
Embodiment 2
A kind of Xiao ' er Anfen Huangnamin composition grain, is made by following methods：
The raw material of active ingredient is configured, including：The paracetamol of 25 parts by weight, the calculus bovis factitius of 1 parts by weight,
The essence of the chlorphenamine maleate of 0.095 parts by weight, the sucrose of 779 parts by weight and 1.2 parts by weight.
Sucrose is added in pulverizer, is ground into fine powder, after crossing 80 mesh sieve, is divided into first part's sucrose and second part
Sucrose.After first Paracetamol, calculus bovis factitius, chlorphenamine maleate are mixed, point 5 additions under conditions of 45r/min
First part's sucrose, obtains mixture.Mixture is added in the aqueous solution system of second part sucrose under conditions of 3000Pa, 35 DEG C
Make softwood, after granulation, be first sieved with 60 mesh stainless steel mesh, on-the-sieve material recycled, by obtained undersize material after 10 purposes
Stainless steel mesh be sieved, recycle undersize material, after sieving by the granule materials on sieve granule materials temperature be 65 DEG C
Under conditions of carry out 30min, after the solution for spraying essence, under conditions of 65 DEG C warm air drying to water content be less than 5%, it is quiet
It puts.
Wherein, the volume ratio of the additive amount of the additive amount and mixture of the aqueous solution of second part sucrose is 1：0.5.Second
A concentration of 25wt% of the aqueous solution of part sucrose.
Embodiment 3
A kind of Xiao ' er Anfen Huangnamin composition grain, is made by following methods：
The raw material of active ingredient is configured, including：The paracetamol of 25 parts by weight, the calculus bovis factitius of 1 parts by weight,
The chlorphenamine maleate of 0.095 parts by weight, the sucrose of 779 parts by weight, the water soluble chitosan of 0.03 parts by weight and 1.2
The essence of parts by weight.Sucrose is added in pulverizer, is ground into fine powder, after crossing 80 mesh sieve, is divided into first part's sucrose and the
Two part sucrose.Paracetamol, calculus bovis factitius, chlorphenamine maleate and first part's sucrose are mixed, obtain mixture.
The aqueous solution that mixture is added in second part sucrose under conditions of 3000Pa, 35 DEG C makes softwood, after granulation, first with 60 mesh
Stainless steel mesh is sieved, and recycles on-the-sieve material, stainless steel mesh of the obtained undersize material after 10 mesh is sieved, under recycling sieve
Material, after sieving by the granule materials on being sieved granule materials temperature to carry out 30min under conditions of 65 DEG C, spraying is fragrant
After the solution of essence, warm air drying to water content is less than 5% under conditions of 65 DEG C, stands.
Wherein, the volume ratio of the additive amount of the additive amount and mixture of the aqueous solution of second part sucrose is 1：0.5.Second
A concentration of 25wt% of the aqueous solution of part sucrose.Also gather in the aqueous solution of second part sucrose added with above-mentioned water soluble shells
Sugar.
Embodiment 4
A kind of Xiao ' er Anfen Huangnamin composition grain, is made by following methods：
The raw material of active ingredient is configured, including：The paracetamol of 25 parts by weight, the calculus bovis factitius of 1 parts by weight,
The chlorphenamine maleate of 0.095 parts by weight, the sucrose of 779 parts by weight, the water soluble chitosan of 0.03 parts by weight and 1.2
The essence of parts by weight.
Sucrose is added in pulverizer, is ground into fine powder, after crossing 80 mesh sieve, is divided into first part's sucrose and second part
Sucrose.After first Paracetamol, calculus bovis factitius, chlorphenamine maleate are mixed, point 5 additions under conditions of 45r/min
First part's sucrose, obtains mixture.Mixture is added in the aqueous solution system of second part sucrose under conditions of 3000Pa, 35 DEG C
Make softwood, after granulation, be first sieved with 60 mesh stainless steel mesh, on-the-sieve material recycled, by obtained undersize material after 10 purposes
Stainless steel mesh be sieved, recycle undersize material, after sieving by the granule materials on sieve granule materials temperature be 65 DEG C
Under conditions of carry out 30min, after the solution for spraying essence, under conditions of 65 DEG C warm air drying to water content be less than 5%, it is quiet
It puts.
Wherein, the volume ratio of the additive amount of the additive amount and mixture of the aqueous solution of second part sucrose is 1：0.5.Second
A concentration of 25wt% of the aqueous solution of part sucrose.Also gather in the aqueous solution of second part sucrose added with above-mentioned water soluble shells
Sugar.
Embodiment 5
A kind of Xiao ' er Anfen Huangnamin composition grain, is made by following methods：
The raw material of active ingredient is configured, including：The paracetamol of 26 parts by weight, the calculus bovis factitius of 0.9 parts by weight,
The chlorphenamine maleate of 0.1 parts by weight, the sucrose of 780 parts by weight, the water soluble chitosan of 0.02 parts by weight and 1.5 weights
Measure the essence of part.Sucrose is added in pulverizer, is ground into fine powder, after crossing 80 mesh sieve, is divided into first part's sucrose and second
Part sucrose.After first mixing Paracetamol, calculus bovis factitius, chlorphenamine maleate, divide 3 times under conditions of 30r/min
First part's sucrose is added in, obtains mixture.Mixture is mixed in by mixture in Fluidbedgranulatingdrier under the state of seething
It closes, granulation and for the first time drying are first sieved with 60 mesh stainless steel mesh after dry for the first time, recycle on-the-sieve material, will obtain
Undersize material after 10 mesh stainless steel mesh be sieved, recycle undersize material, the granule materials on being sieved are existed after sieving
After the solution for spraying essence, warm air drying to water content is less than 5% under conditions of 63 DEG C, stands.
Wherein, the volume ratio of the additive amount of the additive amount and mixture of the aqueous solution of second part sucrose is 1：0.6.Second
A concentration of 28wt% of the aqueous solution of part sucrose.Also gather in the aqueous solution of second part sucrose added with above-mentioned water soluble shells
Sugar.
Embodiment 6
A kind of Xiao ' er Anfen Huangnamin composition grain, is made by following methods：
The raw material of active ingredient is configured, including：The paracetamol of 25 parts by weight, the calculus bovis factitius of 1 parts by weight,
The essence of the chlorphenamine maleate of 0.095 parts by weight, the sucrose of 779 parts by weight and 1.2 parts by weight.
Sucrose is added in pulverizer, is ground into fine powder, after crossing 80 mesh sieve, is divided into first part's sucrose and second part
Sucrose.Paracetamol, calculus bovis factitius, chlorphenamine maleate and first part's sucrose are mixed, obtain mixture.It will mixing
Object mixes in Fluidbedgranulatingdrier under the state of seething, granulation and for the first time drying, for the first time first with 60 mesh after drying
Stainless steel mesh is sieved, and recycles on-the-sieve material, stainless steel mesh of the obtained undersize material after 10 mesh is sieved, under recycling sieve
Material, after the solution of granule materials spraying essence that will be sieved after sieving, warm air drying is to aqueous under conditions of 65 DEG C
Amount is less than 5%, stands.
Wherein, the volume ratio of the additive amount of the additive amount and mixture of the aqueous solution of second part sucrose is 1：0.5.Second
A concentration of 25wt% of the aqueous solution of part sucrose.
Test example
1) Examples 1 to 6 is repeated, enough Xiao ' er Anfen Huangnamin composition grains are made according to batch, as examination
Test group.It does experiment a group stability test, wherein, the analysis method of stability test investigates such as table 1-3 institutes such as time and project
Show.
1 standard stability of table investigates condition and content
2 stability test project of table, method and limit
| Project | Test method | Shelf life standard |
| Character | Ocular estimate | This product is white, off-white color, faint yellow to yellow or greenish orange yellow particle. |
| Loss on drying | Oven drying method | It should must not cross 2.0%. |
| Granularity | Sieve method | It should must not cross 15%. |
| Melting | Dissolution method | It should all dissolve or slight turbid, must not there is foreign matter. |
| Microbial limit | Conventional method | Meet regulation |
| Content | UV methods | This product (C containing paracetamol8H9NO2) it should be the 95.0%~105.0% of labelled amount. |
The inspection item at 3 each time point of table
| Detection project | Long term test (moon) |
| Character | June~24 month |
| Loss on drying | June~24 month |
| Granularity | June~24 month |
| Melting | June~24 month |
| Microbial limit | June~24 month |
| Content | June~24 month |
1. accelerated test
Examples 1 to 4 is repeated, makes the Xiao ' er Anfen Huangnamin composition grain of three batches as test group 1-3,
Investigation condition：40 DEG C ± 2 DEG C of temperature, carries out 6 months under conditions of humidity RH75% ± 5%.As a result as shown in Table 4-6.
4 test group of table, 1 accelerated test result
5 test group of table, 2 accelerated test result
6 test group of table, 3 accelerated test result
Embodiment 5-6 is repeated, enough Xiao ' er Anfen Huangnamin composition grains are made as test group 4, investigate item
Part：40 DEG C ± 2 DEG C of temperature, carries out 6 months under conditions of humidity RH75% ± 5%.The results are shown in Table 7.
7 test group of table, 4 accelerated test result
It by table 4-7 it is found that under the conditions of accelerated test, is investigated by study on the stability project, indices and 0 month ratio
Relatively illustrate this quality quite stable without substantially changeing.
2. long term test
Examples 1 to 4 is repeated, makes the Xiao ' er Anfen Huangnamin composition grain of three batches as test group 5-7,
The Xiao ' er Anfen Huangnamin composition grain for being made enough carries out long term test, investigates condition：25 DEG C ± 2 DEG C of temperature, humidity
Long term test is carried out under conditions of RH60% ± 10%.As a result as shown in table 8-10.
8 test group of table, 5 long-term test results
9 test group of table, 6 long-term test results
10 test group of table, 7 long-term test results
Embodiment 5-6 is repeated, obtained enough Xiao ' er Anfen Huangnamin composition grains are done long-term as test group 8
Condition is investigated in experiment：25 DEG C ± 2 DEG C of temperature, carries out long-term investigation under conditions of humidity RH60% ± 10%.As a result such as 11 institute of table
Show.
11 long-term test results of table
It by table 8-11 it is found that under the conditions of long term test, is investigated by study on the stability project, indices and 0 month
Compare without substantially changeing, illustrate this quality quite stable.Meanwhile above-mentioned table 4- tables 11, it can be seen that provided by the invention two
Xiao ' er Anfen Huangnamin composition grain quality made from kind mode is stablized.
2) scheme that embodiment 4 provides is repeated, enough Xiao ' er Anfen Huangnamin composition grains are made, as experiment
Group, sets control group 1, and the scheme that control group 1 is provided with test group differs only in：It will be added under mixture normal temperature and pressure conditions
After the aqueous solution of second part sucrose makes softwood, it is granulated in common screw Squeezinggranulator.
Xiao ' er Anfen Huangnamin prepared by Xiao ' er Anfen Huangnamin composition grain and control group 1 prepared by test group
Composition grain carries out chlorphenamine maleate item and differentiates detection respectively, takes three parts respectively by every group, every part 3 packet does parallel examination
It tests, method is as follows：
Xiao ' er Anfen Huangnamin composition grain 3 is taken to wrap, it is finely ground, add chloroform 20ml, make dissolving, filter, take continuous filter
Liquid is as test solution；Paracetamol reference substance and chlorphenamine maleate reference substance separately are taken, chloroform is added to be made
The solution (filtering when necessary) of 1ml 10mg containing paracetamol, chlorphenamine maleate 0.15mg are as reference substance solution.According to
Thin-layered chromatography is tested, and the above-mentioned solution point of draws equal amounts is on same silica gel g thin-layer plate respectively, with methanol~liquor ammoniae fortis
(the two volume ratio is 20: 0.15) is solvent, after expansion, is dried, and is smoked with iodine steam.
As a result it is as follows：Test group prepare Xiao ' er Anfen Huangnamin composition grain chlorphenamine maleate discriminating be
The spot of same color is shown on position corresponding with reference substance chromatography, while the gradation of color of each spot is without apparent poor
It is different；Show：Xiao ' er Anfen Huangnamin composition grain chlorphenamine maleate prepared by test example of the present invention differentiates that item conforms to
It asks, and is uniformly mixed.
Xiao ' er Anfen Huangnamin composition grain chlorphenamine maleate discriminating prepared by control group 1 is with compareing
The spot of same color is shown on the corresponding position of product chromatography, but compared to test example 4, the spot colors of regional area are thin,
Local speckle without and some areas spot colors it is denseer；Show：Xiao ' er Anfen Huangnamin composition prepared by control group 1
Particle chlorphenamine maleate differentiates although item meets the requirements, but in chlorphenamine maleate content under the same conditions, mixes
It closes uneven, illustrates Xiao ' er Anfen Huangnamin composition grain prepared by the present invention, content is uniform in finished product, uniformity of dosage units fluctuation
Small, product quality is stably and controllable.Preparation method provided by the invention is better than traditional preparation methods simultaneously.
It carries out embodiment 1-3 and 5-6 and carries out above-mentioned experiment with corresponding control group, the results showed that this hair
The preparation method of bright offer is better than traditional preparation methods.
To sum up, the Xiao ' er Anfen Huangnamin composition grain of the offer of the embodiment of the present invention, product quality are stablized, treatment
Effect is good.Preparation method is simple, quality controllable, suitable for industrialized production, effectively improves the stability of product and improves clothes
The mouthfeel of used time.
Embodiments described above is part of the embodiment of the present invention, instead of all the embodiments.The reality of the present invention
The detailed description for applying example is not intended to limit the range of claimed invention, but is merely representative of the selected implementation of the present invention
Example.Based on the embodiments of the present invention, those of ordinary skill in the art are obtained without creative efforts
Every other embodiment, shall fall within the protection scope of the present invention.
Claims (10)
1. a kind of Xiao ' er Anfen Huangnamin composition grain, which is characterized in that it is made by following methods：
Raw material to the utmost, the raw material include the paracetamol of 25~27 parts by weight, the calculus bovis factitius of 0.85~1 parts by weight,
The essence of the chlorphenamine maleate of 0.09~0.18 parts by weight, the sucrose of 750~800 parts by weight and 1~1.5 parts by weight；
The sucrose is divided into first part's sucrose and second part sucrose；By the Paracetamol, calculus bovis factitius, maleic acid chlorine
That quick and described first part of benzene sucrose mixing, by the aqueous solution of obtained mixture and the second part sucrose in seething
It mixes, pelletizes under state, dry for the first time, after the solution for spraying the essence, second dry.
2. Xiao ' er Anfen Huangnamin composition grain according to claim 1, which is characterized in that the raw material includes：
The paracetamol of 25~26 parts by weight, the calculus bovis factitius of 0.9~1 parts by weight, the Malaysia of 0.09~0.17 parts by weight
The essence of sour chlorphenamine, the sucrose of 750~780 parts by weight and 1~1.3 parts by weight.
3. the Xiao ' er Anfen Huangnamin composition grain according to claim 1~2 any one, which is characterized in that described
Raw material further includes water soluble chitosan, the matter of the additive amount of the water soluble chitosan and the additive amount of the paracetamol
Amount is than being 0.01~0.05：25~27.
4. Xiao ' er Anfen Huangnamin composition grain according to claim 1, which is characterized in that the essence includes lemon
At least one of flavor essence, sweet orange flavor essence, strawberry flavor essence and honey peach flavor essence.
5. the preparation method of Xiao ' er Anfen Huangnamin composition grain as described in claim 1, which is characterized in that
The sucrose is divided into first part's sucrose and second part sucrose；
The Paracetamol, calculus bovis factitius, chlorphenamine maleate and first part's sucrose are mixed, by what is obtained
Mixture is mixed with the aqueous solution of the second part sucrose under the state of seething, granulation, dry for the first time, sprays the essence
Solution after, second dry.
6. preparation method as claimed in claim 5, which is characterized in that the condition for seething state is in 1000~3000Pa 25
It is carried out under conditions of~35 DEG C；
Preferably, the volume ratio of the additive amount of the additive amount and mixture of the aqueous solution of the second part sucrose is 1：
0.5~0.6；
It is highly preferred that a concentration of 20~30wt% of the aqueous solution of the second part sucrose.
7. preparation method according to claim 6, which is characterized in that the dry temperature of material obtained in granulation for the first time
28~35min is carried out under conditions of being 60~65 DEG C.
8. preparation method as claimed in claim 5, which is characterized in that by obtained mixture and the second part sucrose
Aqueous solution mixes in Fluidbedgranulatingdrier under the state of seething, granulation and for the first time drying.
9. preparation method according to claim 5, which is characterized in that be additionally added in the aqueous solution of the second part sucrose
The weight ratio of water soluble chitosan, the water soluble chitosan and the paracetamol is 0.01~0.05：25~27.
10. preparation method according to claim 5, which is characterized in that be mixed into the Paracetamol, the people first
After work cow-bezoar, chlorphenamine maleate mixing, divide 2~5 times under conditions of 30~65r/min and add in the first part
Sucrose.
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| CN108904452A (en) * | 2018-08-15 | 2018-11-30 | 康美保宁（四川）制药有限公司 | A kind of preparation method of pediatric paracetamol granule |
| CN109602709A (en) * | 2018-10-08 | 2019-04-12 | 江西济民可信药业有限公司 | A kind of preparation method improving pediatric paracetamol granule yield and homogeneity |
| WO2023241662A1 (en) * | 2022-06-15 | 2023-12-21 | 河北长天药业有限公司 | Compound paracetamol and chlorphenamine maleate granule and process for preparing same |
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| CN109602709A (en) * | 2018-10-08 | 2019-04-12 | 江西济民可信药业有限公司 | A kind of preparation method improving pediatric paracetamol granule yield and homogeneity |
| WO2023241662A1 (en) * | 2022-06-15 | 2023-12-21 | 河北长天药业有限公司 | Compound paracetamol and chlorphenamine maleate granule and process for preparing same |
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Application publication date: 20180622 |