CN109602709B - Preparation method for improving yield and uniformity of pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granules - Google Patents
Preparation method for improving yield and uniformity of pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granules Download PDFInfo
- Publication number
- CN109602709B CN109602709B CN201910061688.7A CN201910061688A CN109602709B CN 109602709 B CN109602709 B CN 109602709B CN 201910061688 A CN201910061688 A CN 201910061688A CN 109602709 B CN109602709 B CN 109602709B
- Authority
- CN
- China
- Prior art keywords
- preparation
- sucrose
- chlorphenamine maleate
- maleate
- mixing
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
- 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 title claims abstract description 78
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 title claims abstract description 68
- 229960005489 paracetamol Drugs 0.000 title claims abstract description 43
- 238000002360 preparation method Methods 0.000 title claims abstract description 42
- 206010004542 Bezoar Diseases 0.000 title claims abstract description 23
- 239000008187 granular material Substances 0.000 title claims abstract description 20
- 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 50
- 229930006000 Sucrose Natural products 0.000 claims abstract description 50
- 239000006188 syrup Substances 0.000 claims abstract description 50
- 235000020357 syrup Nutrition 0.000 claims abstract description 50
- 239000005720 sucrose Substances 0.000 claims abstract description 47
- 238000002156 mixing Methods 0.000 claims abstract description 29
- 229940046978 chlorpheniramine maleate Drugs 0.000 claims abstract description 26
- 238000007873 sieving Methods 0.000 claims abstract description 18
- 238000010298 pulverizing process Methods 0.000 claims abstract description 16
- 239000000843 powder Substances 0.000 claims abstract description 14
- 238000001035 drying Methods 0.000 claims abstract description 13
- 238000007580 dry-mixing Methods 0.000 claims abstract description 12
- 239000007779 soft material Substances 0.000 claims abstract description 12
- 238000003756 stirring Methods 0.000 claims abstract description 9
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 9
- 238000010438 heat treatment Methods 0.000 claims description 6
- 229960004793 sucrose Drugs 0.000 description 43
- 238000000034 method Methods 0.000 description 16
- 238000002474 experimental method Methods 0.000 description 8
- 238000012216 screening Methods 0.000 description 7
- 239000003814 drug Substances 0.000 description 6
- 238000005516 engineering process Methods 0.000 description 3
- 238000005469 granulation Methods 0.000 description 3
- 230000003179 granulation Effects 0.000 description 3
- 230000000052 comparative effect Effects 0.000 description 2
- 239000006185 dispersion Substances 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 206010019233 Headaches Diseases 0.000 description 1
- 206010028748 Nasal obstruction Diseases 0.000 description 1
- 206010037660 Pyrexia Diseases 0.000 description 1
- 208000036071 Rhinorrhea Diseases 0.000 description 1
- 206010039101 Rhinorrhoea Diseases 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 231100000869 headache Toxicity 0.000 description 1
- 206010022000 influenza Diseases 0.000 description 1
- 230000001788 irregular Effects 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 239000000203 mixture 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
Classifications
-
- 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
-
- 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
-
- 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
-
- 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
-
- 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
-
- A—HUMAN NECESSITIES
- 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]
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Virology (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Pulmonology (AREA)
- Molecular Biology (AREA)
- Pain & Pain Management (AREA)
- Oncology (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Biomedical Technology (AREA)
- Biotechnology (AREA)
- Cell Biology (AREA)
- Developmental Biology & Embryology (AREA)
- Immunology (AREA)
- Zoology (AREA)
- Biophysics (AREA)
- Communicable Diseases (AREA)
- Rheumatology (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention belongs to the field of pharmacy, and relates to a preparation method for improving the yield and the uniformity of pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granules, which comprises the following steps: (1) preparation of chlorpheniramine maleate syrup solution: preparing part of sucrose into syrup, adding chlorphenamine maleate, stirring to dissolve completely, and making into chlorphenamine maleate syrup solution. (2) And sieving the residual sucrose with a 100-mesh sieve by using a universal pulverizer to pulverize. (3) And (3) granulating: pulverizing calculus bovis, mixing with acetaminophen in equal amount, dry mixing with sucrose powder in a high-speed wet granulator for 5-10 min, adding chlorphenamine maleate syrup solution, wet mixing for 5-10 min to obtain soft material, granulating, and drying.
Description
Technical Field
The invention belongs to the field of pharmacy, relates to a preparation method for improving the yield of chemical drug granules, and particularly relates to a preparation method for applying a dispersion adhesion technology to pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granules.
Background
The pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granules are compound preparations, and each bag contains 125 mg of paracetamol, 0.5 mg of chlorphenamine maleate and 5 mg of artificial bezoar. The auxiliary materials are as follows: sucrose and essence.
The pediatric paracetamol and chlorphenamine maleate granules are mainly used for relieving symptoms of fever, headache, soreness of limbs, sneeze, rhinorrhea, nasal obstruction, pharyngalgia and the like caused by common cold and influenza of children.
The existing preparation method of pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granules comprises the following steps: mixing acetaminophen, artificial bezoar, chlorphenamine maleate and sucrose, adding water to make soft mass, granulating, and drying.
The granules prepared by the prior art have low yield of formed granules, and the problems of inconsistent content change and poor uniformity of chlorpheniramine maleate often result in unqualified batches, which are caused by the coarse mixing method adopted by the preparation method, so that medicinal materials are wasted and potential quality hazards exist.
In order to improve the stability of the medicine and the quality of the medicine, the applicant improves the preparation method.
Disclosure of Invention
The invention aims to provide a preparation method of pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granules.
The invention can uniformly mix the pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granules and improve the viscosity, and solves the problems of low granule yield and uniform content, thereby improving the quality of the pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granules. The preparation process is convenient and practical, the product quality is easy to control, and the preparation method is realized in the following mode.
The invention relates to a pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granule, which comprises the following components in percentage by weight:
1250g of acetaminophen and 50g of calculus bovis factitius
Chlorpheniramine maleate 5g sucrose 15000-.
The preparation method comprises the following steps:
(1) preparation of chlorpheniramine maleate syrup solution: preparing part of sucrose into syrup, adding chlorphenamine maleate, and stirring to dissolve completely to obtain chlorphenamine maleate syrup solution;
(2) crushing the residual cane sugar by a universal crusher;
(3) and (3) granulating: pulverizing calculus bovis, mixing with acetaminophen in equal amount, dry mixing with sucrose powder in a high-speed wet granulating machine for 3-20 min, adding chlorphenamine maleate syrup solution, wet mixing for 5-20 min to obtain soft material, granulating, and drying.
Wherein, the part of the sucrose in the step (1) is 7.5 to 15 percent of the total amount of the sucrose added into the formula, preferably 8 to 12 percent, and more preferably 9 to 11 percent. The syrup is prepared in a concentration of 60-90%, preferably 60-80%, most preferably 70%, i.e. 100ml syrup containing 70g sucrose, and the syrup is an anhydrous or white viscous liquid.
Wherein, the residual cane sugar in the step (2) is taken and sieved by a 100-mesh sieve by a universal pulverizer to be pulverized;
wherein, the step (3) is granulation: pulverizing calculus bovis, mixing with acetaminophen in equal amount, dry mixing with sucrose powder in a high-speed wet granulator for 3-10 min, adding chlorphenamine maleate syrup solution, wet mixing for 5-10 min to obtain soft material, granulating, and drying.
Wherein, the equivalent increment in the step (3) is carried out by the following method:
a. pulverizing artificial calculus bovis with 80-120 mesh sieve
b. Mixing artificial bezoar powder and equivalent amount of acetaminophen in a three-dimensional mixer for 10-30 minutes, and then adding 2 times of artificial bezoar powder and mixing for 10-30 minutes;
c. adding 22、23、24Mixing acetaminophen in the amount of the artificial bezoar in the three-dimensional mixer for 10-30 minutes until the artificial bezoar and the acetaminophen are completely mixed uniformly.
Preferably, the preparation method comprises the following steps:
(1) preparation of chlorpheniramine maleate syrup solution: preparing syrup with concentration of 60-80% from sucrose 8-12% of sucrose total amount, adding chlorphenamine maleate, stirring to dissolve completely, and making into chlorphenamine maleate syrup solution;
(2) sieving the residual sucrose with a 100 mesh sieve by using a universal pulverizer, and pulverizing;
(3) and (3) granulating: pulverizing calculus bovis, mixing with acetaminophen in equal amount, dry mixing with sucrose powder in a high-speed wet granulator for 3-10 min, adding chlorphenamine maleate syrup solution, wet mixing for 5-10 min to obtain soft material, granulating, and drying.
Further preferably, the preparation method of the invention comprises the following steps:
(1) preparation of chlorpheniramine maleate syrup solution: heating and dissolving 1800g of sucrose in water to prepare syrup with the concentration of 60%, adding chlorphenamine maleate, and stirring to fully dissolve the chlorphenamine maleate to prepare 60% syrup solution of chlorphenamine maleate;
(2) sieving the residual sucrose with a 100 mesh sieve by using a universal pulverizer, and pulverizing;
(3) and (3) granulating: sieving calculus bovis factitius with a 100-mesh sieve, gradually increasing the amount of the calculus bovis factitius and acetaminophen, uniformly mixing, dry-mixing with sucrose powder in a high-speed wet granulator for 5-10 minutes, adding chlorphenamine maleate syrup solution, wet-mixing for 5-10 minutes to obtain a soft material, granulating, and drying to obtain the calculus bovis factitius.
Further preferably, the preparation method of the invention comprises the following steps:
prescription:
1250g of acetaminophen and 50g of calculus bovis factitius
Chlorpheniramine maleate 5g sucrose 18695g
The preparation method comprises the following steps:
(1) preparation of chlorpheniramine maleate syrup solution: adding water into 2000g of sucrose, heating and dissolving to prepare syrup with the concentration of 70%, adding chlorphenamine maleate, and stirring to fully dissolve to prepare chlorphenamine maleate syrup solution with the concentration of 70%;
(2) sieving the residual sucrose with a 100 mesh sieve by using a universal pulverizer, and pulverizing;
(3) and (3) granulating: pulverizing calculus bovis, sieving with 100 mesh sieve, mixing with acetaminophen in equal amount, dry mixing with sucrose powder in high-speed wet granulating machine for 5-10 min, adding chlorphenamine maleate syrup solution, wet mixing for 5-10 min to obtain soft material, granulating, and drying.
Further preferably, the preparation method of the invention comprises the following steps:
prescription:
1250g of acetaminophen and 50g of calculus bovis factitius
Chlorpheniramine maleate 5g sucrose 18695g
The preparation method comprises the following steps:
(1) preparation of chlorpheniramine maleate syrup solution: heating 2200g sucrose in water to dissolve to obtain 80% syrup, adding chlorphenamine maleate, and stirring to dissolve completely to obtain 80% chlorphenamine maleate syrup solution;
(2) sieving the residual sucrose with a 100 mesh sieve by using a universal pulverizer, and pulverizing;
(3) and (3) granulating: pulverizing calculus bovis, sieving with 100 mesh sieve, mixing with acetaminophen in equal amount, dry mixing with sucrose powder in high-speed wet granulating machine for 5-10 min, adding chlorphenamine maleate syrup solution, wet mixing for 5-10 min to obtain soft material, granulating, and drying.
The advantageous effects of the present invention are further explained by the following.
The preparation method is obtained by screening a large number of experiments, and the screening process is as follows:
experiment I, screening experiment of preparation method
Step 1, screening the preparation method conditions of the chlorpheniramine maleate syrup solution:
step 3, screening the method condition of equivalent incremental increase of the crushed artificial bezoar and the acetaminophen
Step 3 granulation method condition screening
Through the series of screening, the optimal preparation method of the invention is obtained as follows:
prescription: 1250g of acetaminophen and 50g of calculus bovis factitius
Chlorpheniramine maleate 5g sucrose 18695g
The preparation method comprises the following steps:
(1) preparation of chlorpheniramine maleate syrup solution: 2000g of sucrose is taken and added with water to be heated and dissolved to prepare 70 percent syrup, and then chlorpheniramine maleate is added and stirred to be fully dissolved to prepare 70 percent syrup solution of chlorpheniramine maleate.
(2) And sieving the residual sucrose with a 100-mesh sieve by using a universal pulverizer to pulverize.
(3) And (3) granulating: pulverizing calculus bovis, sieving with 100 mesh sieve, mixing with acetaminophen in equal amount, dry mixing with sucrose powder in a high-speed wet granulating machine for 5-10 min, adding chlorphenamine maleate syrup solution, wet mixing for 5-10 min to obtain soft material, granulating, and drying.
Experiment 2, control experiment
The product of the invention was compared with existing products and the experimental results were as follows
Comparative experiment 1:
the method can be obtained from the above table that the pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate prepared by the process of the invention has uniform content, and the pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate prepared by the original process has nonuniform content and great difference; the yield of the pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granules prepared by the process is improved by more than 10 percent compared with the original process.
Comparative experiment 2:
the accelerated stability test results in the table show that the process of the invention has stable content after being accelerated for 6 months, all detection indexes are qualified, and the samples produced by the original process have irregular content change of chlorpheniramine maleate after being accelerated for 6 months, and the main reason is caused by uneven content.
The invention takes the example 2 as an experimental medicine, and the original process group prepares the obtained medicine by the process mentioned in the background technology.
Compared with the existing preparation method of pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granules, the preparation method of the invention adopts a dispersion and adhesion technology to disperse chlorphenamine maleate in syrup prepared from cane sugar for granulation, and the improvement produces unexpected effects: the pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granules prepared by the improved method have uniform content and obviously improved granule yield.
Detailed Description
The present invention will be further illustrated by the following specific examples, which are not intended to limit the scope of the present invention.
Example 1:
prescription: 1250g of acetaminophen and 50g of calculus bovis factitius
Chlorpheniramine maleate 5g sucrose 18695g
The preparation method comprises the following steps:
(1) preparation of chlorpheniramine maleate syrup solution: heating and dissolving 1800g of sucrose in water to prepare 60% syrup, adding chlorphenamine maleate, and stirring to fully dissolve the chlorphenamine maleate to prepare 60% syrup solution of chlorphenamine maleate.
(2) And sieving the residual sucrose with a 100-mesh sieve by using a universal pulverizer to pulverize.
(3) And (3) granulating: sieving calculus bovis artifactus with a 100-mesh sieve, gradually increasing the amount of the calculus bovis artifactus and acetaminophen, uniformly mixing, dry-mixing with sucrose powder in a high-speed wet granulating machine for 5-10 minutes, adding chlorphenamine maleate syrup solution, wet-mixing for 5-10 minutes to obtain a soft material, granulating, and drying to obtain the calculus bovis artifactus.
Example 2:
prescription: 1250g of acetaminophen and 50g of calculus bovis factitius
Chlorpheniramine maleate 5g sucrose 18695g
The preparation method comprises the following steps:
(1) preparation of chlorpheniramine maleate syrup solution: 2000g of sucrose is taken and added with water to be heated and dissolved to prepare 70 percent syrup, and then chlorpheniramine maleate is added and stirred to be fully dissolved to prepare 70 percent syrup solution of chlorpheniramine maleate.
(2) And sieving the residual sucrose with a 100-mesh sieve by using a universal pulverizer to pulverize.
(3) And (3) granulating: pulverizing calculus bovis, sieving with 100 mesh sieve, mixing with acetaminophen in equal amount, dry mixing with sucrose powder in high-speed wet granulating machine for 5-10 min, adding chlorphenamine maleate syrup solution, wet mixing for 5-10 min to obtain soft material, granulating, and drying.
Example 3:
prescription: 1250g of acetaminophen and 50g of calculus bovis factitius
Chlorpheniramine maleate 5g sucrose 18695g
The preparation method comprises the following steps:
(1) preparation of chlorpheniramine maleate syrup solution: heating and dissolving 2200g of sucrose in water to prepare 80% syrup, adding chlorphenamine maleate, and stirring to fully dissolve, thereby preparing 80% chlorphenamine maleate syrup solution.
(2) And sieving the residual sucrose with a 100-mesh sieve by using a universal pulverizer to pulverize.
(3) And (3) granulating: pulverizing calculus bovis, sieving with 100 mesh sieve, mixing with acetaminophen in equal amount, dry mixing with sucrose powder in high-speed wet granulating machine for 5-10 min, adding chlorphenamine maleate syrup solution, wet mixing for 5-10 min to obtain soft material, granulating, and drying.
In the above experiment, the invention selects the embodiment 2 as the experimental object, and other methods of the invention are the same as the embodiment 2, and can also produce the same or similar beneficial effects, and improve the quality of the medicine.
Claims (1)
1. A preparation method of pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granules is characterized by comprising the following steps:
prescription:
1250g of acetaminophen and 50g of calculus bovis factitius
Chlorpheniramine maleate 5g sucrose 18695g
The preparation method comprises the following steps:
(1) preparation of chlorpheniramine maleate syrup solution: adding water into 2000g of sucrose, heating and dissolving to prepare syrup with the concentration of 70%, adding chlorphenamine maleate, and stirring to fully dissolve to prepare chlorphenamine maleate syrup solution with the concentration of 70%;
(2) sieving the residual sucrose with a 100 mesh sieve by using a universal pulverizer, and pulverizing;
(3) and (3) granulating: pulverizing calculus bovis, sieving with 100 mesh sieve, mixing with acetaminophen in equal amount, dry mixing with sucrose powder in high-speed wet granulating machine for 5-10 min, adding chlorphenamine maleate syrup solution, wet mixing for 5-10 min to obtain soft material, granulating, and drying.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2018111660696 | 2018-10-08 | ||
| CN201811166069 | 2018-10-08 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN109602709A CN109602709A (en) | 2019-04-12 |
| CN109602709B true CN109602709B (en) | 2021-05-04 |
Family
ID=66020416
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201910061688.7A Active CN109602709B (en) | 2018-10-08 | 2019-01-23 | Preparation method for improving yield and uniformity of pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granules |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN109602709B (en) |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20010044472A1 (en) * | 1999-09-16 | 2001-11-22 | Upadhyay Ajay Hasmukhlal | Directly compressible acetaminophen compositions |
| JP2013231091A (en) * | 2013-08-23 | 2013-11-14 | Toyama Chem Co Ltd | Granular solid preparation containing tosufloxacin |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN101982179B (en) * | 2010-11-04 | 2012-07-25 | 海南新中正制药有限公司 | Xiao er Anfen Huang Namin granule |
| CN107126442B (en) * | 2017-05-09 | 2018-06-05 | 葵花药业集团(衡水)得菲尔有限公司 | A kind of pediatric paracetamol granule preparation process |
| 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 |
-
2019
- 2019-01-23 CN CN201910061688.7A patent/CN109602709B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20010044472A1 (en) * | 1999-09-16 | 2001-11-22 | Upadhyay Ajay Hasmukhlal | Directly compressible acetaminophen compositions |
| JP2013231091A (en) * | 2013-08-23 | 2013-11-14 | Toyama Chem Co Ltd | Granular solid preparation containing tosufloxacin |
Also Published As
| Publication number | Publication date |
|---|---|
| CN109602709A (en) | 2019-04-12 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN101332188B (en) | Method for preparing powder injection using attritioning technique and prepared products | |
| CN109602709B (en) | Preparation method for improving yield and uniformity of pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granules | |
| CN104151019B (en) | A kind of vegetable organic fertilizer material and preparation method thereof | |
| CN103142531B (en) | Aspirin slow release tablet and preparation method thereof | |
| CN104510758A (en) | Cornu bubali concentrated powder and preparation method for concentrated cornu bubali particles | |
| CN104958338B (en) | A kind of method for improving the medicament contg uniformity | |
| CN104171998A (en) | Method for preparing ultrafine original dry powder of mulberry | |
| CN115192652B (en) | Universal granule and preparation method thereof | |
| CN103431116A (en) | Method for processing granulated folium mori green tea | |
| CN105494935A (en) | Biological cultivation feed for freshwater crayfish growing period | |
| CN109481468A (en) | A kind of preparation method of paracetamol caffein atificial cow-bezoar pellet | |
| CN102091096A (en) | Artificial cow-bezoar and chlorphenamine maleate granules containing bezoar cultured in vitro and preparation method thereof | |
| CN103494952A (en) | Wuzi Yanzong pill and preparation process thereof | |
| CN107319510A (en) | Instant product and preparation method thereof | |
| CN102845460B (en) | Phosethyl-aluminum water dispersible granules and preparation method thereof | |
| CN112587413A (en) | Method for secondary granulation of medicine | |
| CN108148144A (en) | A kind of improvement of the preparation method of medicinal pregelatinized starch | |
| CN102643214B (en) | The preparation method of the big crystal grain of Vorinostat I crystal form and preparation | |
| CN114681404A (en) | Repaglinide granule pharmaceutical composition and preparation method thereof | |
| CN105623639A (en) | Preparation method of composite gel breaking agent | |
| CN103432125A (en) | Preparation method of compound zinc gluconate and ibuprofen granules | |
| CN112868934B (en) | Nano montmorillonite meat rabbit feed additive compound for detoxification and diarrhea prevention | |
| CN111317765A (en) | Preparation method of tortoise-plastron glue yin-nourishing granules | |
| CN101028264B (en) | Huisanliu tablets as medicine and their preparation | |
| CN109068709A (en) | instant product and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant | ||
| PE01 | Entry into force of the registration of the contract for pledge of patent right | ||
| PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: A preparation method for improving the yield and uniformity of Pediatric Paracetamol huangnamin granules Effective date of registration: 20211223 Granted publication date: 20210504 Pledgee: Bank of China Limited Nanchang Qingyunpu sub branch Pledgor: JIANGXI JEMINCARE GROUP Co.,Ltd. Registration number: Y2021980016166 |
|
| PC01 | Cancellation of the registration of the contract for pledge of patent right | ||
| PC01 | Cancellation of the registration of the contract for pledge of patent right |
Date of cancellation: 20220902 Granted publication date: 20210504 Pledgee: Bank of China Limited Nanchang Qingyunpu sub branch Pledgor: JIANGXI JEMINCARE GROUP Co.,Ltd. Registration number: Y2021980016166 |
|
| PE01 | Entry into force of the registration of the contract for pledge of patent right | ||
| PE01 | Entry into force of the registration of the contract for pledge of patent right |
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 |
|
| PC01 | Cancellation of the registration of the contract for pledge of patent right | ||
| PC01 | Cancellation of the registration of the contract for pledge of patent right |
Date of cancellation: 20230830 Granted publication date: 20210504 Pledgee: Bank of China Limited Nanchang Qingyunpu sub branch Pledgor: JIANGXI JEMINCARE GROUP Co.,Ltd. Registration number: Y2022980014583 |
|
| PE01 | Entry into force of the registration of the contract for pledge of patent right | ||
| PE01 | Entry into force of the registration of the contract for pledge of patent right |
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 |