CN109602709A - A kind of preparation method improving pediatric paracetamol granule yield and homogeneity - Google Patents
A kind of preparation method improving pediatric paracetamol granule yield and homogeneity Download PDFInfo
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- CN109602709A CN109602709A CN201910061688.7A CN201910061688A CN109602709A CN 109602709 A CN109602709 A CN 109602709A CN 201910061688 A CN201910061688 A CN 201910061688A CN 109602709 A CN109602709 A CN 109602709A
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- chlorphenamine maleate
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- sucrose
- paracetamol
- syrup solution
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- 238000002360 preparation method Methods 0.000 title claims abstract description 60
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 title claims abstract description 55
- 229960005489 paracetamol Drugs 0.000 title claims abstract description 55
- 239000008187 granular material Substances 0.000 title claims abstract description 21
- DBAKFASWICGISY-BTJKTKAUSA-N Chlorpheniramine maleate Chemical compound OC(=O)\C=C/C(O)=O.C=1C=CC=NC=1C(CCN(C)C)C1=CC=C(Cl)C=C1 DBAKFASWICGISY-BTJKTKAUSA-N 0.000 claims abstract description 82
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims abstract description 69
- 229930006000 Sucrose Natural products 0.000 claims abstract description 69
- 229960004793 sucrose Drugs 0.000 claims abstract description 69
- 239000006188 syrup Substances 0.000 claims abstract description 67
- 235000020357 syrup Nutrition 0.000 claims abstract description 67
- 239000005720 sucrose Substances 0.000 claims abstract description 57
- 238000002156 mixing Methods 0.000 claims abstract description 29
- 239000000843 powder Substances 0.000 claims abstract description 19
- 238000005469 granulation Methods 0.000 claims abstract description 16
- 230000003179 granulation Effects 0.000 claims abstract description 16
- 239000011122 softwood Substances 0.000 claims abstract description 15
- 238000003756 stirring Methods 0.000 claims abstract description 15
- 239000000203 mixture Substances 0.000 claims abstract description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 11
- 238000010438 heat treatment Methods 0.000 claims description 10
- 238000007873 sieving Methods 0.000 claims description 2
- 239000002002 slurry Substances 0.000 claims 3
- 206010004542 Bezoar Diseases 0.000 claims 1
- 229960003291 chlorphenamine Drugs 0.000 claims 1
- 238000000034 method Methods 0.000 description 17
- 239000003814 drug Substances 0.000 description 6
- 229940079593 drug Drugs 0.000 description 5
- 238000002474 experimental method Methods 0.000 description 4
- 239000002245 particle Substances 0.000 description 4
- 238000012360 testing method Methods 0.000 description 4
- 238000001914 filtration Methods 0.000 description 3
- 238000012216 screening Methods 0.000 description 3
- 239000007779 soft material Substances 0.000 description 3
- 230000009286 beneficial effect Effects 0.000 description 2
- 230000000052 comparative effect Effects 0.000 description 2
- 239000006185 dispersion Substances 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 206010037660 Pyrexia Diseases 0.000 description 1
- 240000000111 Saccharum officinarum Species 0.000 description 1
- 235000007201 Saccharum officinarum Nutrition 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 229940000406 drug candidate Drugs 0.000 description 1
- 235000013399 edible fruits Nutrition 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000003777 experimental drug Substances 0.000 description 1
- 206010022000 influenza Diseases 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 230000001788 irregular Effects 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 201000009240 nasopharyngitis Diseases 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
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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
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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
-
- 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
- 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
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/14—Antivirals for RNA viruses
- A61P31/16—Antivirals for RNA viruses for influenza or rhinoviruses
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Abstract
The invention belongs to pharmaceutical fields, it is related to a kind of preparation method for improving pediatric paracetamol granule yield and homogeneity, steps are as follows: (1) preparation of chlorphenamine maleate syrup solution: taking part sucrose that syrup is made, adding chlorphenamine maleate stirring makes sufficiently to dissolve, and chlorphenamine maleate syrup solution is made.(2) remaining sucrose sieves with 100 mesh sieve crushing with Universalpulverizer.(3) pelletize: calculus bovis factitius crush after with paracetamol equal increments mix after again with it is 5-10 minutes dry-mixed in cane sugar powder to high speed wet granulator; it is added the wet mixing of chlorphenamine maleate syrup solution 5-10 minutes, softwood, granulation is made; it is dry to get.
Description
Technical field
The invention belongs to pharmaceutical fields, are related to a kind of preparation method for improving chemical drug granule yield, and in particular to a kind of
Dispersion adhesive Technology application is in the preparation method of pediatric paracetamol granule.
Background technique
Pediatric paracetamol granule is compound preparation, and every bag contains 125 milligrams of paracetamol, chlorphenamine maleate
0.5 milligram, 5 milligrams of calculus bovis factitius.Auxiliary material are as follows: sucrose, essence.
Pediatric paracetamol granule is mainly used for fever, head caused by alleviation children's common cold and influenza
Bitterly, it has aches in the limbs, sneeze, having a running nose, having a stuffy nose, the symptoms such as pharyngalgia.
Existing pediatric paracetamol granule is the preparation method comprises the following steps: Paracetamol, calculus bovis factitius, chlorphenamine maleate
Quick, sucrose mixes, and adds water softwood, is made particle, it is dry to get.
The particle of prior art preparation, shaped granule yield is low, and the changes of contents of chlorphenamine maleate is different,
The problem of evenness difference, often results in unqualified batch, to find out its cause, being to cause medicine because preparation method is caused using thick mixing method
Material wastes and there are hidden danger of quality.
In order to improve the stability of drug, improve the quality of drug, applicant improves preparation method.
Summary of the invention
The purpose of the present invention is to provide a kind of preparation methods of pediatric paracetamol granule.
The present invention can be uniformly mixed pediatric paracetamol granule and viscosity improves, and solves that particle yield is low and content
Uniform problem, to improve the quality of pediatric paracetamol granule.Preparation process of the present invention is convenient and practical, and easily controllable production
Quality, the present invention are achieved in the following ways.
The formula composition of pediatric paracetamol granule of the present invention:
Paracetamol 1250g calculus bovis factitius 50g
Chlorphenamine maleate 5g sucrose 15000-20000g.
Preparation method of the present invention, comprising the following steps:
(1) it the preparation of chlorphenamine maleate syrup solution: takes part sucrose that syrup is made, adds chlorphenamine maleate
Quick stirring makes sufficiently to dissolve, and chlorphenamine maleate syrup solution is made；
(2) remaining sucrose is taken to be crushed with Universalpulverizer；
(3) it pelletizes: being mixed after first crushing calculus bovis factitius with paracetamol equal increments, later by itself and cane sugar powder
It is 3-20 minutes dry-mixed in high speed wet granulator, it is added the wet mixing of chlorphenamine maleate syrup solution 5-20 minutes, is made soft
Material, granulation, it is dry to get.
Wherein, step (1) the part sucrose is 7.5-15%, the preferably 8-12% that sucrose total amount is added in formula,
More preferably 9-11%.Manufactured syrup concentration be 60-90%, preferably 60-80%, most preferably 70% syrup, i.e.,
In 100ml syrup, containing 70g sucrose, gained syrup is anhydrous or white viscous liquid.
Wherein, step (2) takes remaining sucrose to sieve with 100 mesh sieve crushing with Universalpulverizer；
Wherein, step (3) is pelletized: being mixed after first crushing calculus bovis factitius with paracetamol equal increments, later will
Its with it is 3-10 minutes dry-mixed in cane sugar powder to high speed wet granulator, chlorphenamine maleate syrup solution wet mixing 5-10 point is added
Clock, is made softwood, granulation, it is dry to get.
Wherein, step (3) equal increments, the method is as follows:
A, calculus bovis factitius is crushed with 80-120 mesh
B, after mixing 10-30 minutes in calculus bovis factitius powder and equivalent paracetamol to three-dimensional mixer, 2 are added
Times calculus bovis factitius powder amount paracetamol mixing 10-30 minutes；
C, 2 are added2、23、24It is respectively mixed in calculus bovis factitius amount Paracetamol to three-dimensional mixer 10-30 minutes,
Until calculus bovis factitius is all uniformly mixed with Paracetamol.
Preferably, preparation method of the invention, comprising the following steps:
(1) preparation of chlorphenamine maleate syrup solution: taking the sucrose of the 8-12% of sucrose total amount that concentration is made is 60-
80% syrup, adding chlorphenamine maleate stirring makes sufficiently to dissolve, and chlorphenamine maleate syrup solution is made；
(2) remaining sucrose sieves with 100 mesh sieve crushing with Universalpulverizer；
(3) it pelletizes: being mixed after first crushing calculus bovis factitius with paracetamol equal increments, later by itself and cane sugar powder
It is 3-10 minutes dry-mixed in high speed wet granulator, it is added the wet mixing of chlorphenamine maleate syrup solution 5-10 minutes, is made soft
Material, granulation, it is dry to get.
It is further preferred that preparation method of the invention, comprising the following steps:
(1) preparation of chlorphenamine maleate syrup solution: taking 1800g sucrose to add water heating for dissolving that concentration is made is 60%
Syrup, adding chlorphenamine maleate stirring makes sufficiently to dissolve, and 60% syrup solution of chlorphenamine maleate is made；
(2) remaining sucrose sieves with 100 mesh sieve crushing with Universalpulverizer；
(3) it pelletizes: being mixed after first sieving with 100 mesh sieve calculus bovis factitius with pulverizer with paracetamol equal increments, it
Afterwards again with it is 5-10 minutes dry-mixed in cane sugar powder to high speed wet granulator, be added chlorphenamine maleate syrup solution wet mixing 5-10
Minute, be made softwood, granulation, it is dry to get.
It is further preferred that preparation method of the invention, comprising the following steps:
Prescription:
Paracetamol 1250g calculus bovis factitius 50g
Chlorphenamine maleate 5g sucrose 18695g
Preparation method:
(1) preparation of chlorphenamine maleate syrup solution: taking 2000g sucrose to add water heating for dissolving that concentration is made is 70%
Syrup, adding chlorphenamine maleate stirring makes sufficiently to dissolve, and 70% syrup solution of chlorphenamine maleate is made；
(2) remaining sucrose sieves with 100 mesh sieve crushing with Universalpulverizer；
(3) pelletize: calculus bovis factitius crushing sieve with 100 mesh sieve after and paracetamol equal increments mixing after again with sucrose
It is 5-10 minutes dry-mixed in powder to high speed wet granulator, it is added the wet mixing of chlorphenamine maleate syrup solution 5-10 minutes, is made
Softwood, granulation, it is dry to get.
It is further preferred that preparation method of the invention, comprising the following steps:
Prescription:
Paracetamol 1250g calculus bovis factitius 50g
Chlorphenamine maleate 5g sucrose 18695g
Preparation method:
(1) preparation of chlorphenamine maleate syrup solution: taking 2200g sucrose to add water heating for dissolving that concentration is made is 80%
Syrup, adding chlorphenamine maleate stirring makes sufficiently to dissolve, and 80% syrup solution of chlorphenamine maleate is made；
(2) remaining sucrose sieves with 100 mesh sieve crushing with Universalpulverizer；
(3) pelletize: calculus bovis factitius crushing sieve with 100 mesh sieve after and paracetamol equal increments mixing after again with sucrose
It is 5-10 minutes dry-mixed in powder to high speed wet granulator, it is added the wet mixing of chlorphenamine maleate syrup solution 5-10 minutes, is made
Softwood, granulation, it is dry to get.
Beneficial effects of the present invention are further illustrated by the following contents.
The preparation method is that screened by many experiments, screening process is as follows:
Test one, preparation method screening experiment
The preparation method conditional filtering of step 1 chlorphenamine maleate syrup solution:
Step 3 calculus bovis factitius crush after with paracetamol equal increments method conditional filtering
Step 3 method of granulating conditional filtering
By above-mentioned a series of screening, obtain it is of the invention best the preparation method is as follows:
Prescription: paracetamol 1250g calculus bovis factitius 50g
Chlorphenamine maleate 5g sucrose 18695g
Preparation method:
(1) preparation of chlorphenamine maleate syrup solution: taking 2000g sucrose to add water heating for dissolving that 70% syrup is made,
Adding chlorphenamine maleate stirring makes sufficiently to dissolve, and 70% syrup solution of chlorphenamine maleate is made.
(2) remaining sucrose sieves with 100 mesh sieve crushing with Universalpulverizer.
(3) pelletize: calculus bovis factitius crushing sieve with 100 mesh sieve after with paracetamol equal increments mixing after again with cane sugar powder
It is 5-10 minutes dry-mixed in high speed wet granulator, it is added the wet mixing of chlorphenamine maleate syrup solution 5-10 minutes, is made soft
Material, granulation, it is dry to get.
Test 2, control experiment
Product and existing product of the invention are compared, experimental result is as follows
Comparative test 1:
It can be obtained from upper table, the pediatric paracetamol granule chlorphenamine maleate content of present invention process preparation is equal
One, the pediatric paracetamol granule chlorphenamine maleate content of original process preparation is inhomogenous, very different；Present invention process
The pediatric paracetamol granule yield of preparation improves 10% or more compared with original process.
Comparative test 2:
From upper table accelerated stability test result, it can be concluded that, present invention process accelerates 6 months stable contents, and every inspection
Survey qualified, the sample of original process production accelerates the variation of 6 months chlorphenamine maleate contents irregular, main cause be containing
Measure inhomogenous cause.
Using embodiment 2 as experimental drug, original process group is prepared the present invention with the technique mentioned in background technique
Drug.
Preparation method of the invention, it is viscous using dispersion relative to the preparation method of existing pediatric paracetamol granule
Conjunction technology, which disperses chlorphenamine maleate in syrup made of sucrose, pelletizes, this point improves, and produces unexpected effect
Fruit: the pediatric paracetamol granule made of improved method, uniform content, and particle yield is obviously improved.
Specific embodiment
The present invention is further detailed by following specific embodiments, but not as a limitation of the invention.
Embodiment 1:
Prescription: paracetamol 1250g calculus bovis factitius 50g
Chlorphenamine maleate 5g sucrose 18695g
Preparation method:
(1) preparation of chlorphenamine maleate syrup solution: taking 1800g sucrose to add water heating for dissolving that 60% syrup is made,
Adding chlorphenamine maleate stirring makes sufficiently to dissolve, and 60% syrup solution of chlorphenamine maleate is made.
(2) remaining sucrose sieves with 100 mesh sieve crushing with Universalpulverizer.
(3) pelletize: calculus bovis factitius with pulverizer sieve with 100 mesh sieve after with paracetamol equal increments mixing after again with sugarcane
It is 5-10 minutes dry-mixed in Icing Sugar to high speed wet granulator, it is added the wet mixing of chlorphenamine maleate syrup solution 5-10 minutes, system
Softwood, granulation, it is dry to get.
Embodiment 2:
Prescription: paracetamol 1250g calculus bovis factitius 50g
Chlorphenamine maleate 5g sucrose 18695g
Preparation method:
(1) preparation of chlorphenamine maleate syrup solution: taking 2000g sucrose to add water heating for dissolving that 70% syrup is made,
Adding chlorphenamine maleate stirring makes sufficiently to dissolve, and 70% syrup solution of chlorphenamine maleate is made.
(2) remaining sucrose sieves with 100 mesh sieve crushing with Universalpulverizer.
(3) pelletize: calculus bovis factitius crushing sieve with 100 mesh sieve after and paracetamol equal increments mixing after again with sucrose
It is 5-10 minutes dry-mixed in powder to high speed wet granulator, it is added the wet mixing of chlorphenamine maleate syrup solution 5-10 minutes, is made
Softwood, granulation, it is dry to get.
Embodiment 3:
Prescription: paracetamol 1250g calculus bovis factitius 50g
Chlorphenamine maleate 5g sucrose 18695g
Preparation method:
(1) preparation of chlorphenamine maleate syrup solution: taking 2200g sucrose to add water heating for dissolving that 80% syrup is made,
Adding chlorphenamine maleate stirring makes sufficiently to dissolve, and 80% syrup solution of chlorphenamine maleate is made.
(2) remaining sucrose sieves with 100 mesh sieve crushing with Universalpulverizer.
(3) pelletize: calculus bovis factitius crushing sieve with 100 mesh sieve after and paracetamol equal increments mixing after again with sucrose
It is 5-10 minutes dry-mixed in powder to high speed wet granulator, it is added the wet mixing of chlorphenamine maleate syrup solution 5-10 minutes, is made
Softwood, granulation, it is dry to get.
In above-mentioned experiment, the present invention select embodiment 2 be used as experimental subjects, other methods of the invention also with embodiment 2
Equally, same or similar beneficial effect can be also generated, the quality of drug is improved.
Claims (10)
1. a kind of preparation method of pediatric paracetamol granule, which is characterized in that steps are as follows:
(1) preparation of chlorphenamine maleate syrup solution: taking part sucrose that syrup is made, and adds chlorphenamine maleate and stirs
Mixing makes sufficiently to dissolve, and chlorphenamine maleate syrup solution is made；
(2) remaining sucrose is taken to sieve with 100 mesh sieve crushing with Universalpulverizer；
(3) it pelletizes: being mixed after first crushing calculus bovis factitius with paracetamol equal increments, it is later that it is supreme with cane sugar powder
It is 3-20 minutes dry-mixed in fast wet granulator, it is added the wet mixing of chlorphenamine maleate syrup solution 5-20 minutes, softwood, system is made
Grain, it is dry to get.
2. preparation method according to claim 1, which is characterized in that steps are as follows:
(1) preparation of chlorphenamine maleate syrup solution: taking part sucrose that concentration is made is 60-80% syrup, adds horse
Carrying out sour chlorphenamine stirring makes sufficiently to dissolve, and chlorphenamine maleate syrup solution is made；
(2) remaining sucrose sieves with 100 mesh sieve crushing with Universalpulverizer；
(3) it pelletizes: being mixed after first crushing calculus bovis factitius with paracetamol equal increments, it is later that it is supreme with cane sugar powder
It is 3-10 minutes dry-mixed in fast wet granulator, it is added the wet mixing of chlorphenamine maleate syrup solution 5-10 minutes, softwood, system is made
Grain, it is dry to get.
3. preparation method according to claim 1, which is characterized in that the formula composition of pediatric paracetamol granule is such as
Under:
Paracetamol 1250g calculus bovis factitius 50g
Chlorphenamine maleate 5g sucrose 15000-20000g.
4. preparation method according to claim 1, which is characterized in that the formula composition of pediatric paracetamol granule is such as
Under:
Paracetamol 1250g calculus bovis factitius 50g
Chlorphenamine maleate 5g sucrose 18695g.
5. preparation method according to claim 1, which is characterized in that wherein, step (1) the part sucrose is in formula
The 7.5-15%, preferably 8-12%, more preferably 9-11% of sucrose total amount is added.Manufactured syrup concentration is 60-90%,
Preferably 60-80%, most preferably 70% syrup.
6. preparation method according to claim 1, which is characterized in that wherein, step (2) takes remaining sucrose with omnipotent crushing
Machine sieves with 100 mesh sieve crushing.
7. preparation method according to claim 1, which is characterized in that wherein, step (3) granulation: first by artificial bezoar powder
It is mixed after broken with paracetamol equal increments, later by itself and dry-mixed 5-10 in cane sugar powder to high speed wet granulator points
Clock, be added the wet mixing of chlorphenamine maleate syrup solution 5-10 minute, be made softwood, granulation, dry to get.
8. preparation method according to claim 1, which comprises the following steps:
Prescription:
Paracetamol 1250g calculus bovis factitius 50g
Chlorphenamine maleate 5g sucrose 18695g
Preparation method:
(1) preparation of chlorphenamine maleate syrup solution: taking 1800g sucrose to add water heating for dissolving that concentration is made is 60% sugar
Slurry, adding chlorphenamine maleate stirring makes sufficiently to dissolve, and 60% syrup solution of chlorphenamine maleate is made；
(2) remaining sucrose sieves with 100 mesh sieve crushing with Universalpulverizer；
(3) it pelletizes: being mixed after first sieving with 100 mesh sieve calculus bovis factitius with pulverizer with paracetamol equal increments, Zhi Houzai
With 5-10 minutes dry-mixed in cane sugar powder to high speed wet granulator, chlorphenamine maleate syrup solution wet mixing 5-10 points of addition
Clock, is made softwood, granulation, it is dry to get.
9. preparation method according to claim 1, which comprises the following steps:
Prescription:
Paracetamol 1250g calculus bovis factitius 50g
Chlorphenamine maleate 5g sucrose 18695g
Preparation method:
(1) preparation of chlorphenamine maleate syrup solution: taking 2000g sucrose to add water heating for dissolving that concentration is made is 70% sugar
Slurry, adding chlorphenamine maleate stirring makes sufficiently to dissolve, and 70% syrup solution of chlorphenamine maleate is made；
(2) remaining sucrose sieves with 100 mesh sieve crushing with Universalpulverizer；
(3) pelletize: calculus bovis factitius crushing sieve with 100 mesh sieve after and paracetamol equal increments mixing after again with cane sugar powder extremely
It is 5-10 minutes dry-mixed in high speed wet granulator, it is added the wet mixing of chlorphenamine maleate syrup solution 5-10 minutes, softwood is made,
Granulation, it is dry to get.
10. preparation method according to claim 1, which comprises the following steps:
Prescription:
Paracetamol 1250g calculus bovis factitius 50g
Chlorphenamine maleate 5g sucrose 18695g
Preparation method:
(1) preparation of chlorphenamine maleate syrup solution: taking 2200g sucrose to add water heating for dissolving that concentration is made is 80% sugar
Slurry, adding chlorphenamine maleate stirring makes sufficiently to dissolve, and 80% syrup solution of chlorphenamine maleate is made；
(2) remaining sucrose sieves with 100 mesh sieve crushing with Universalpulverizer；
(3) pelletize: calculus bovis factitius crushing sieve with 100 mesh sieve after and paracetamol equal increments mixing after again with cane sugar powder extremely
It is 5-10 minutes dry-mixed in high speed wet granulator, it is added the wet mixing of chlorphenamine maleate syrup solution 5-10 minutes, softwood is made,
Granulation, it is dry to get.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2018111660696 | 2018-10-08 | ||
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| US20010044472A1 (en) * | 1999-09-16 | 2001-11-22 | Upadhyay Ajay Hasmukhlal | Directly compressible acetaminophen compositions |
| CN101982179A (en) * | 2010-11-04 | 2011-03-02 | 海南新中正制药有限公司 | Xiao er Anfen Huang Namin granule and preparation method thereof |
| CN102091096A (en) * | 2009-12-14 | 2011-06-15 | 汤明昌 | Artificial cow-bezoar and chlorphenamine maleate granules containing bezoar cultured in vitro and preparation method thereof |
| JP2013231091A (en) * | 2013-08-23 | 2013-11-14 | Toyama Chem Co Ltd | Granular solid preparation containing tosufloxacin |
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| CN108186579A (en) * | 2018-02-01 | 2018-06-22 | 重庆希尔安药业有限公司 | Xiao ' er Anfen Huangnamin composition grain and preparation method thereof |
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| CN102091096A (en) * | 2009-12-14 | 2011-06-15 | 汤明昌 | Artificial cow-bezoar and chlorphenamine maleate granules containing bezoar cultured in vitro and preparation method thereof |
| CN101982179A (en) * | 2010-11-04 | 2011-03-02 | 海南新中正制药有限公司 | Xiao er Anfen Huang Namin granule and preparation method thereof |
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Denomination of invention: A kind of preparation method for improving the yield and homogeneity of Pediatric acetaminophen granules Effective date of registration: 20220905 Granted publication date: 20210504 Pledgee: Bank of China Limited Nanchang Qingyunpu sub branch Pledgor: JIANGXI JEMINCARE GROUP Co.,Ltd. Registration number: Y2022980014583 |
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Denomination of invention: A Preparation Method for Improving the Yield and Uniformity of Children's Aminophenol Huang Namin Granules Effective date of registration: 20230831 Granted publication date: 20210504 Pledgee: Bank of China Limited Nanchang Qingyunpu sub branch Pledgor: JIANGXI JEMINCARE GROUP Co.,Ltd. Registration number: Y2023980054957 |