CN107126442A - A kind of pediatric paracetamol granule preparation technology - Google Patents
A kind of pediatric paracetamol granule preparation technology Download PDFInfo
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- CN107126442A CN107126442A CN201710319623.9A CN201710319623A CN107126442A CN 107126442 A CN107126442 A CN 107126442A CN 201710319623 A CN201710319623 A CN 201710319623A CN 107126442 A CN107126442 A CN 107126442A
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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
- 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
- A61K9/1629—Organic macromolecular compounds
- A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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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
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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
- A61K9/1629—Organic macromolecular compounds
- A61K9/1658—Proteins, e.g. albumin, gelatin
Abstract
A kind of pediatric paracetamol granule preparation technology of the present invention; it is that, by paracetamol 125g, chlorphenamine maleate 0.5g, calculus bovis factitius 5g, 1765~1870g of Icing Sugar, adhesive 0.1~5%, essence 0.01~0.03%, citric acid 0.05~0.15% is constituted.The present invention solve that prior art is present it is not enough there is provided a kind of uniformity of dosage units is good, bioavilability is high, production cost is low, the quality index such as production safety and granularity, melting meet the pediatric paracetamol granule preparation technology of standard requirement.
Description
Technical field
The invention belongs to pharmaceutical technology field, and in particular to a kind of preparation technology of pediatric paracetamol granule.
Background technology
Pediatric paracetamol granule is the kind that the national drug standards are recorded, and the kind is by paracetamol
125g, calculus bovis factitius 5g and chlorphenamine maleate 0.5g are made with appropriate auxiliary material, and it is common that the product are mainly used in alleviation children
Generate heat, have a headache, having aches in the limbs, sneezing, having a running nose, having a stuffy nose caused by flu and influenza, the symptom such as pharyngalgia.The product
In preparation process, because the chlorphenamine maleate consumption in its prescription (in three taste medicines accounts for 0.38%, if by prescription very little
1000 bags of particle is made to calculate per packed 2g, only accounts for 0.015%), and because this product is pediatric pharmaceuticalses, in drug safety and curative effect
Aspect must value must be paid much attention to, so chlorphenamine maleate content uniformity problems are that current each enterprise value is obtained in the product
The problem of great attention.
Have document report, because of chlorphenamine maleate consumption very little, its it is soluble in water be made after the aqueous solution, regarded with it
Adhesive means are added, and the good dispersion so in preparation process, the uniformity of dosage units of chlorphenamine maleate is higher.(Hao Jing
Crystalline substance, the Chinese licensed pharmacist treatise .2013.14-19. of bright pediatric paracetamol granules Study on Preparation [J] in Lee sea).
Separately there is document report, adhesive therefor, incorporation time and crushing mesh number in the preparation process of pediatric paracetamol granule are entered
Research is gone, has equally been that chlorphenamine maleate is soluble in water, is added with it as adhesive means, chlorphenamine maleate
Uniformity of dosage units it is preferable.(Li Xiao nanmus pediatric paracetamol granules Study on Preparation [J] science and technology forum.73)
The B of Publication No. CN 101940598 Chinese patent：The preparation method of pediatric paracetamol granule, it is in system
Chlorphenamine maleate is equally employed in Preparation Method with being added after purified water dissolving as adhesive means.
The B of Publication No. CN 101982179 Chinese patent：In a kind of pediatric paracetamol granule, its preparation method
Chlorphenamine maleate is dissolved in after a certain amount of ethanol, a certain amount of binder aqueous solution is added into the ethanol solution and again will
It, which is added in other and well mixed medicinal powder, carries out granulation procedure.
The patent of above-mentioned two Research Literatures and Patent No. 201010204323.4 all illustrates, because of chlorphenamine maleate
Particle is prepared after being dissolved with water in the way of adhesive, because of its good dispersion, is determined using high performance liquid chromatography (HPLC), horse
The uniformity of dosage units for carrying out sour chlorphenamine is higher.But it has the disadvantage 1, because the viscosity of softwood when it is pelletized is inadequate, makes particle drying
The fine powder produced afterwards is more, and granularity does not reach standard requirement, then causes packing difficult, makes content uniformity be difficult to meet quality standard
It is required that；2 and substantial amounts of fine powder is not enough produced during whole grain because sticky, make thin powder recovery (by fine powder from works such as brand-new softwood, granulations
Sequence) frequency is high, causes the substantial amounts of waste such as man-hour, the energy, granularity is also easily destroyed in transit, so that it is more to produce fine powder,
Its same granularity is not inconsistent standardization requirement.
The patent of Patent No. 201010531685.4：By horse in a kind of pediatric paracetamol granule, its preparation method
Carry out sour chlorphenamine to be dissolved in after a certain amount of ethanol, a certain amount of binder aqueous solution is added into the ethanol solution and is added again
Enter into prescription in other well mixed medicinal powder and carry out granulation procedure.Its advantage is that this method is equally because of the Malaysia after dissolving
Sour chlorphenamine good dispersion, can then produce the higher situation of its uniformity, while because its viscosity is asked when also solving granulation
Inscribe and grain graininess is met standard requirement, but because it is using ethanol dissolving chlorphenamine maleate, (1) can be caused to drop to enterprise
The security of low production；(2) cost of product is added.
The content of the invention
A kind of pediatric paracetamol granule preparation technology of the present invention, there is provided a kind of content for the deficiency of solution prior art
The quality index such as uniformity is good, bioavilability is high, production cost is low, production safety and granularity, melting meet standard will
The pediatric paracetamol granule asked.
Prepared using following technical scheme, you can obtain the present invention：The preparation technology of pediatric paracetamol granule：
The present invention is to be prepared from by following raw material by wet granulation：
1st, prescription：
Paracetamol 125g, chlorphenamine maleate 0.5g, calculus bovis factitius 5g, 1765~1870g of Icing Sugar, adhesive
0.1~5%, essence 0.01~0.03%, citric acid 0.05~0.15%.
2nd, preparation technology comprises the following steps：
2.1 are sufficiently mixed the calculus bovis factitius of recipe quantity uniformly in the way of equal increments with paracetamol and Icing Sugar
Mixed powder is obtained, it is standby；
Adhesive described above is configured to the certain density aqueous solution by 2.2 obtains binder aqueous solution, standby；
Above-mentioned chlorphenamine maleate and citric acid are dissolved in a small amount of purified water and are made after the aqueous solution by 2.3, are added into
Stirred in the aqueous solution of above-mentioned adhesive, obtain the aqueous solution of chlorphenamine maleate adhesive, it is standby；
2.4 add the aqueous solution of above-mentioned chlorphenamine maleate adhesive in mixed powder, and stirring is made for 15~20 minutes
Softwood, through granulation, dries and whole grain, adds essence and always mixed, pediatric paracetamol granule is made.
Granulation described in preparation technology is pelletized with 24~40 eye mesh screens, is preferable over 40 mesh；
It is 65~75 DEG C, preferably 70 DEG C that its temperature is dried described in preparation technology；
Whole grain described in preparation technology is with 10~40 eye mesh screen whole grains；
Total mix is to carry out mixing 30~60 minutes with two dimension or three-dimensional mixer described in preparation technology, preferably with 45 points
Clock.
Icing Sugar is described in prescription：80 eye mesh screens are crossed after crushed.
Adhesive is described in prescription：One or more in gelatin, sodium carboxymethylcellulose, PVP K30, dextrin.
Essence is described in prescription：Steviosin, Aspartame, strawberry essence, orange essence, one kind in hawthorn essence or
It is a variety of.
Beneficial effect
The present invention dissolves chlorphenamine maleate using purified water, and by the chlorphenamine maleate aqueous solution with bonding
Pelletized, solved present in prior art because the granularity of sticky small generation is unqualified and uses after the aqueous solution mixing of agent
The production that ethanol organic solvent is brought is dangerous, and there is provided a kind of content uniformity is good, production cost for the defect such as production cost height
The quality index such as low, production safety and granularity, melting meets the pediatric paracetamol granule preparation technology of standard requirement.
Specific embodiment
Embodiment 1
The mode of calculus bovis factitius 5g equal increments and paracetamol 125g and Icing Sugar 1840g are sufficiently mixed to obtain dry powder
Mixture, it is standby；
It is water-soluble that 1.32% sodium carboxymethylcellulose is added to after chlorphenamine maleate 0.5g is dissolved with a small amount of purified water
In liquid, stirring is to being sufficiently mixed, then is added into above-mentioned powder mixture softwood is made, and is pelletized with 24 eye mesh screens, 70 DEG C are done
Dry, 10~40 eye mesh screen whole grains add Steviosin 0.2g and citric acid 3g, total mixed 40 minutes, both.
Embodiment 2
The mode of calculus bovis factitius 5g equal increments and paracetamol 125g and Icing Sugar 1800g are sufficiently mixed to obtain dry powder
Mixture, it is standby；
It is added to after chlorphenamine maleate 0.5g is dissolved with a small amount of purified water in the 3.35% PVP K30 aqueous solution,
Stirring is to being sufficiently mixed, then is added into above-mentioned powder mixture softwood is made, and is pelletized with 24 eye mesh screens, 75 DEG C of dryings, 10
~40 eye mesh screen whole grains, add strawberry essence 0.6g and citric acid 2g, total mixed 45 minutes, both.
Embodiment 3
The mode of calculus bovis factitius 5g equal increments and paracetamol 125g and Icing Sugar 1790g are sufficiently mixed to obtain dry powder
Mixture, it is standby；
It is added to after chlorphenamine maleate 0.5g is dissolved with a small amount of purified water in 3.9% dextrin in aqueous solution, stirring is extremely
It is sufficiently mixed, then is added into above-mentioned powder mixture softwood is made, is pelletized with 24 eye mesh screens, 75 DEG C of dryings, 10~40 mesh
Screen cloth whole grain, adds orange essence 0.4g and citric acid 1g, total mixed 60 minutes, both.
Embodiment 4
The mode of calculus bovis factitius 5g equal increments and paracetamol 125g and Icing Sugar 1860g are sufficiently mixed to obtain dry powder
Mixture, it is standby；
It is added to after chlorphenamine maleate 0.5g is dissolved with a small amount of purified water in the 0.32% PVP K30 aqueous solution,
Stirring is to being sufficiently mixed, then is added into above-mentioned powder mixture softwood is made, and is pelletized with 40 eye mesh screens, 70 DEG C of dryings, 10
~40 eye mesh screen whole grains, add hawthorn essence 0.5g and citric acid 2.5g, total mixed 45 minutes, both.
It is prepared by the 0.32% PVP K30 aqueous solution：Take PVP K30 6.5g add water 300-350ml soak 12-14 hours,
It is heated to thick, lets cool under stirring, both.
For above-described embodiment 1 to embodiment 4, chlorphenamine maleate content is carried out to its particle after always mixed uniform
Degree, grain graininess and melting quality index are detected that its testing result is as follows：
1st, the chlorphenamine maleate content uniformity is detected
1.1 sampling method：The sampling method as defined in NF, the particle after always being mixed to above-mentioned 4 embodiments respectively
It is sampled, each embodiment takes 5 samples.
1.2 detection method：Tested by Chinese Pharmacopoeia (2015 editions four 0512) high performance liquid chromatography,
1.3 testing results (equivalent to the percentage composition of labelled amount)：
It is above-mentioned test result indicates that, operated by the technical process of embodiment 4, through to chlorphenamine maleate in its particle
Content detected and data analyzed, and Rsd is minimum, illustrate that the precision of its numerical value is high, and chlorphenamine maleate contains
Measure distribution consistency degree best.
2nd, granularity inspection
2.1 sampling method：The sampling method as defined in NF, the particle after always being mixed to above-mentioned 4 embodiments respectively
It is sampled, each embodiment takes 5 samples.
2.2 detection method：Enter by the granularity inspection method under Chinese Pharmacopoeia (2015 editions four general rules 0104) granule
Row is checked.
2.3 testing result：
It is above-mentioned test result indicates that, operated by the technical process of embodiment 4, through checking its grain graininess, and
Its result is subjected to variance analysis, Rsd is minimum, and precision highest illustrates epigranular.
3rd, melting is detected
3.1 sampling method：The sampling method as defined in NF, the particle after always being mixed to above-mentioned 4 embodiments respectively
It is sampled, each embodiment takes 5 samples, each sample 10g carries out melting inspection.
3.2 detection method：Carried out by the melting inspection method under Chinese Pharmacopoeia (2015 editions four 0104) granule
Check
3.3 testing result：
| Embodiment | Sample 1 | Sample 2 | Sample 3 | Sample 4 | Sample 5 |
| 1 | It is qualified | It is qualified | It is qualified | It is qualified | It is qualified |
| 2 | It is qualified | It is qualified | It is qualified | It is qualified | It is qualified |
| 3 | It is qualified | It is qualified | It is qualified | It is qualified | It is qualified |
| 4 | It is qualified | It is qualified | It is qualified | It is qualified | It is qualified |
Above-mentioned experimental result explanation, melting inspection is carried out through the particle to embodiment 1 to embodiment 4, all qualified, is said
The setting of adhesive and its technological parameter is rational used in bright.
Claims (11)
1. a kind of pediatric paracetamol granule preparation technology, it is characterised in that supplementary material, which is matched, is：Paracetamol 125g,
Chlorphenamine maleate 0.5g, calculus bovis factitius 5g, 1765~1870g of Icing Sugar, adhesive 0.1~5%, essence 0.01~
0.03%, citric acid 0.05~0.15%.
2. a kind of pediatric paracetamol granule preparation technology according to claim 1, its preparation technology comprises the following steps：
The calculus bovis factitius is sufficiently mixed in the way of equal increments and uniform must mixed by 2.1 with paracetamol and Icing Sugar
Powder, it is standby；
Described adhesive is configured to the certain density aqueous solution by 2.2 obtains binder aqueous solution, standby；
The chlorphenamine maleate and citric acid are dissolved in a small amount of purified water and are made after the aqueous solution by 2.3, are added into above-mentioned
Stirred in the aqueous solution of adhesive, obtain the aqueous solution of chlorphenamine maleate adhesive, it is standby；
2.4 add the aqueous solution of above-mentioned chlorphenamine maleate adhesive in mixed powder, and softwood is made in 15~20 minutes in stirring,
Through granulation, dry and whole grain, add essence and always mixed, pediatric paracetamol granule is made.
3. preparation technology according to claim 2, it is characterised in that the granulation is pelletized with 24~40 eye mesh screens, preferably
In 40 mesh.
4. preparation technology according to claim 2, it is characterised in that its temperature of the drying is 65~75 DEG C, preferably 70
℃。
5. preparation technology according to claim 2, it is characterised in that the whole grain is with 10~40 eye mesh screen whole grains.
6. preparation technology according to claim 2, it is characterised in that total mix is carried out with two dimension or three-dimensional mixer
Mixing 30~60 minutes, preferably with 45 minutes.
7. a kind of pediatric paracetamol granule preparation technology according to claim 1, it is characterised in that the Icing Sugar is：
80 eye mesh screens are crossed after crushed.
8. a kind of pediatric paracetamol granule preparation technology according to claim 1, it is characterised in that described adhesive
It is：One or more in gelatin, sodium carboxymethylcellulose, PVP K30, dextrin.
9. a kind of pediatric paracetamol granule preparation technology according to claim 1, it is characterised in that the essence is：
One or more in Steviosin, Aspartame, strawberry essence, orange essence, hawthorn essence.
10. according to the preparation technology described in claim 2, its preferred preparation technology is：By the mode of calculus bovis factitius 5g equal increments
Powder mixture is sufficiently mixed to obtain with paracetamol 125g and Icing Sugar 1860g, it is standby；Chlorphenamine maleate 0.5g is used
It is added to after a small amount of purified water dissolving in the 0.32% PVP K30 aqueous solution, stirring is to being sufficiently mixed, then is added into above-mentioned dry
Softwood is made in powder mixture, is pelletized with 40 eye mesh screens, 70 DEG C of dryings, 10~40 eye mesh screen whole grains add hawthorn essence 0.5g
With citric acid 2.5g, always mix 45 minutes, both obtain.
11. preparation technology according to claim 10, it is characterised in that the 0.32% PVP K30 aqueous solution is by following methods
It is prepared from：Take PVP K30 6.5g add water 300-350ml soak 12-14 hours, be heated under stirring it is thick,
Let cool, both.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
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| US20040156894A1 (en) * | 2003-02-07 | 2004-08-12 | Grother Leon Paul | Use of edible acids in fast-dispersing pharmaceutical solid dosage forms |
| CN101940598A (en) * | 2010-06-21 | 2011-01-12 | 湖南中和制药有限公司 | Preparation method of Huang children paracetamol-particles |
| 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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2017
- 2017-05-09 CN CN201710319623.9A patent/CN107126442B/en active Active
Patent Citations (3)
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| US20040156894A1 (en) * | 2003-02-07 | 2004-08-12 | Grother Leon Paul | Use of edible acids in fast-dispersing pharmaceutical solid dosage forms |
| CN101940598A (en) * | 2010-06-21 | 2011-01-12 | 湖南中和制药有限公司 | Preparation method of Huang children paracetamol-particles |
| 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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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
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| CN107126442B (en) | 2018-06-05 |
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