CN109481468A - A kind of preparation method of paracetamol caffein atificial cow-bezoar pellet - Google Patents
A kind of preparation method of paracetamol caffein atificial cow-bezoar pellet Download PDFInfo
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- CN109481468A CN109481468A CN201910025597.8A CN201910025597A CN109481468A CN 109481468 A CN109481468 A CN 109481468A CN 201910025597 A CN201910025597 A CN 201910025597A CN 109481468 A CN109481468 A CN 109481468A
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- Prior art keywords
- pellet
- bezoar
- preparation
- paracetamol
- atificial cow
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- RYYVLZVUVIJVGH-UHFFFAOYSA-N caffeine Chemical compound CN1C(=O)N(C)C(=O)C2=C1N=CN2C RYYVLZVUVIJVGH-UHFFFAOYSA-N 0.000 title claims abstract description 78
- 239000008188 pellet Substances 0.000 title claims abstract description 49
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 title claims abstract description 40
- 229960005489 paracetamol Drugs 0.000 title claims abstract description 40
- 206010004542 Bezoar Diseases 0.000 title claims abstract description 31
- 238000002360 preparation method Methods 0.000 title claims abstract description 26
- 229920002261 Corn starch Polymers 0.000 claims abstract description 25
- 239000008120 corn starch Substances 0.000 claims abstract description 25
- 229940099112 cornstarch Drugs 0.000 claims abstract description 25
- 239000002245 particle Substances 0.000 claims abstract description 23
- 230000001070 adhesive effect Effects 0.000 claims abstract description 21
- 239000000853 adhesive Substances 0.000 claims abstract description 20
- 239000004594 Masterbatch (MB) Substances 0.000 claims abstract description 19
- 239000003814 drug Substances 0.000 claims abstract description 18
- 235000020985 whole grains Nutrition 0.000 claims abstract description 18
- 238000001035 drying Methods 0.000 claims abstract description 16
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 13
- 239000000463 material Substances 0.000 claims abstract description 12
- 239000002994 raw material Substances 0.000 claims abstract description 9
- 230000036961 partial effect Effects 0.000 claims abstract description 5
- 238000002156 mixing Methods 0.000 claims description 21
- 239000000126 substance Substances 0.000 claims description 21
- 239000007864 aqueous solution Substances 0.000 claims description 15
- 238000000034 method Methods 0.000 claims description 14
- 239000000203 mixture Substances 0.000 claims description 14
- 239000007788 liquid Substances 0.000 claims description 12
- 239000000243 solution Substances 0.000 claims description 10
- 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 description 9
- 150000004676 glycans Chemical class 0.000 claims description 9
- 238000005469 granulation Methods 0.000 claims description 9
- 230000003179 granulation Effects 0.000 claims description 9
- 238000010438 heat treatment Methods 0.000 claims description 9
- 239000007921 spray Substances 0.000 claims description 9
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 9
- 241000196324 Embryophyta Species 0.000 claims description 8
- 239000011230 binding agent Substances 0.000 claims description 8
- 229920001282 polysaccharide Polymers 0.000 claims description 7
- 239000005017 polysaccharide Substances 0.000 claims description 7
- 238000009395 breeding Methods 0.000 claims description 6
- 230000001488 breeding effect Effects 0.000 claims description 6
- 238000005243 fluidization Methods 0.000 claims description 6
- 238000005453 pelletization Methods 0.000 claims description 6
- 238000007873 sieving Methods 0.000 claims description 6
- 239000000725 suspension Substances 0.000 claims description 6
- 238000001816 cooling Methods 0.000 claims description 5
- 238000007599 discharging Methods 0.000 claims description 5
- 230000002045 lasting effect Effects 0.000 claims description 5
- 230000000149 penetrating effect Effects 0.000 claims description 5
- 238000005507 spraying Methods 0.000 claims description 5
- 239000002202 Polyethylene glycol Substances 0.000 claims description 4
- 229920001223 polyethylene glycol Polymers 0.000 claims description 4
- LUEWUZLMQUOBSB-FSKGGBMCSA-N (2s,3s,4s,5s,6r)-2-[(2r,3s,4r,5r,6s)-6-[(2r,3s,4r,5s,6s)-4,5-dihydroxy-2-(hydroxymethyl)-6-[(2r,4r,5s,6r)-4,5,6-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-4,5-dihydroxy-2-(hydroxymethyl)oxan-3-yl]oxy-6-(hydroxymethyl)oxane-3,4,5-triol Chemical compound O[C@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@@H](O[C@@H]2[C@H](O[C@@H](OC3[C@H](O[C@@H](O)[C@@H](O)[C@H]3O)CO)[C@@H](O)[C@H]2O)CO)[C@H](O)[C@H]1O LUEWUZLMQUOBSB-FSKGGBMCSA-N 0.000 claims description 3
- 244000247812 Amorphophallus rivieri Species 0.000 claims description 3
- 235000001206 Amorphophallus rivieri Nutrition 0.000 claims description 3
- 229920001661 Chitosan Polymers 0.000 claims description 3
- 229920002581 Glucomannan Polymers 0.000 claims description 3
- 229920002907 Guar gum Polymers 0.000 claims description 3
- 229920002752 Konjac Polymers 0.000 claims description 3
- 229920002472 Starch Polymers 0.000 claims description 3
- 235000010489 acacia gum Nutrition 0.000 claims description 3
- 239000001785 acacia senegal l. willd gum Substances 0.000 claims description 3
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 3
- 239000002775 capsule Substances 0.000 claims description 3
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 3
- 238000011049 filling Methods 0.000 claims description 3
- 238000009472 formulation Methods 0.000 claims description 3
- 229940046240 glucomannan Drugs 0.000 claims description 3
- 239000000665 guar gum Substances 0.000 claims description 3
- 235000010417 guar gum Nutrition 0.000 claims description 3
- 229960002154 guar gum Drugs 0.000 claims description 3
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 3
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 3
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 3
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims description 3
- 239000000252 konjac Substances 0.000 claims description 3
- 235000010485 konjac Nutrition 0.000 claims description 3
- 229920000609 methyl cellulose Polymers 0.000 claims description 3
- 239000001923 methylcellulose Substances 0.000 claims description 3
- 235000010981 methylcellulose Nutrition 0.000 claims description 3
- 229920001277 pectin Polymers 0.000 claims description 3
- 239000001814 pectin Substances 0.000 claims description 3
- 235000010987 pectin Nutrition 0.000 claims description 3
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims description 3
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims description 3
- 239000008107 starch Substances 0.000 claims description 3
- 235000019698 starch Nutrition 0.000 claims description 3
- 229920001285 xanthan gum Polymers 0.000 claims description 3
- 239000000230 xanthan gum Substances 0.000 claims description 3
- 235000010493 xanthan gum Nutrition 0.000 claims description 3
- 229940082509 xanthan gum Drugs 0.000 claims description 3
- TWNIBLMWSKIRAT-RWOPYEJCSA-N (1r,2s,3s,4s,5r)-6,8-dioxabicyclo[3.2.1]octane-2,3,4-triol Chemical compound O1[C@@]2([H])OC[C@]1([H])[C@@H](O)[C@H](O)[C@@H]2O TWNIBLMWSKIRAT-RWOPYEJCSA-N 0.000 claims description 2
- 239000011734 sodium Substances 0.000 claims description 2
- 229910052708 sodium Inorganic materials 0.000 claims description 2
- 229940079593 drug Drugs 0.000 abstract description 5
- 235000013339 cereals Nutrition 0.000 abstract description 4
- 239000004480 active ingredient Substances 0.000 abstract description 2
- 239000000843 powder Substances 0.000 abstract description 2
- LPHGQDQBBGAPDZ-UHFFFAOYSA-N Isocaffeine Natural products CN1C(=O)N(C)C(=O)C2=C1N(C)C=N2 LPHGQDQBBGAPDZ-UHFFFAOYSA-N 0.000 description 8
- 229960001948 caffeine Drugs 0.000 description 8
- VJEONQKOZGKCAK-UHFFFAOYSA-N caffeine Natural products CN1C(=O)N(C)C(=O)C2=C1C=CN2C VJEONQKOZGKCAK-UHFFFAOYSA-N 0.000 description 8
- 238000004090 dissolution Methods 0.000 description 6
- 230000000694 effects Effects 0.000 description 4
- NTYJJOPFIAHURM-UHFFFAOYSA-N Histamine Chemical compound NCCC1=CN=CN1 NTYJJOPFIAHURM-UHFFFAOYSA-N 0.000 description 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 description 3
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N Phenol Chemical compound OC1=CC=CC=C1 ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 description 2
- 230000036592 analgesia Effects 0.000 description 2
- 230000000903 blocking effect Effects 0.000 description 2
- 229960003291 chlorphenamine Drugs 0.000 description 2
- 235000009508 confectionery Nutrition 0.000 description 2
- 238000009826 distribution Methods 0.000 description 2
- 238000005259 measurement Methods 0.000 description 2
- 229960003742 phenol Drugs 0.000 description 2
- 238000005057 refrigeration Methods 0.000 description 2
- 229940080313 sodium starch Drugs 0.000 description 2
- 229940032147 starch Drugs 0.000 description 2
- 208000024891 symptom Diseases 0.000 description 2
- 241000894006 Bacteria Species 0.000 description 1
- 206010059109 Cerebral vasoconstriction Diseases 0.000 description 1
- 206010019233 Headaches Diseases 0.000 description 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- 206010028748 Nasal obstruction Diseases 0.000 description 1
- 208000036071 Rhinorrhea Diseases 0.000 description 1
- 206010039101 Rhinorrhoea Diseases 0.000 description 1
- GUGOEEXESWIERI-UHFFFAOYSA-N Terfenadine Chemical group C1=CC(C(C)(C)C)=CC=C1C(O)CCCN1CCC(C(O)(C=2C=CC=CC=2)C=2C=CC=CC=2)CC1 GUGOEEXESWIERI-UHFFFAOYSA-N 0.000 description 1
- 238000002835 absorbance Methods 0.000 description 1
- 230000004913 activation Effects 0.000 description 1
- 230000000172 allergic effect Effects 0.000 description 1
- 230000003266 anti-allergic effect Effects 0.000 description 1
- 230000001387 anti-histamine Effects 0.000 description 1
- 230000001754 anti-pyretic effect Effects 0.000 description 1
- 230000000840 anti-viral effect Effects 0.000 description 1
- 239000000739 antihistaminic agent Substances 0.000 description 1
- 239000002221 antipyretic Substances 0.000 description 1
- 208000010668 atopic eczema Diseases 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 239000007767 bonding agent Substances 0.000 description 1
- 210000003169 central nervous system Anatomy 0.000 description 1
- 210000003710 cerebral cortex Anatomy 0.000 description 1
- 230000002490 cerebral effect Effects 0.000 description 1
- 229960001231 choline Drugs 0.000 description 1
- 230000002860 competitive effect Effects 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 239000012738 dissolution medium Substances 0.000 description 1
- 238000011978 dissolution method Methods 0.000 description 1
- 230000005284 excitation Effects 0.000 description 1
- 239000000706 filtrate Substances 0.000 description 1
- 231100000869 headache Toxicity 0.000 description 1
- 229960001340 histamine Drugs 0.000 description 1
- 210000003016 hypothalamus Anatomy 0.000 description 1
- 206010022000 influenza Diseases 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 230000003340 mental effect Effects 0.000 description 1
- 201000009240 nasopharyngitis Diseases 0.000 description 1
- 208000004296 neuralgia Diseases 0.000 description 1
- 230000002093 peripheral effect Effects 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 150000003180 prostaglandins Chemical class 0.000 description 1
- 206010041232 sneezing Diseases 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 238000003786 synthesis reaction Methods 0.000 description 1
- 238000000870 ultraviolet spectroscopy Methods 0.000 description 1
- 230000024883 vasodilation Effects 0.000 description 1
- 229940124549 vasodilator Drugs 0.000 description 1
- 239000003071 vasodilator agent Substances 0.000 description 1
Classifications
-
- 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
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
- A61K31/52—Purines, e.g. adenine
- A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
-
- 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
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pain & Pain Management (AREA)
- Nutrition Science (AREA)
- Immunology (AREA)
- Developmental Biology & Embryology (AREA)
- Cell Biology (AREA)
- Biotechnology (AREA)
- Biomedical Technology (AREA)
- Physiology (AREA)
- Virology (AREA)
- Pulmonology (AREA)
- Zoology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a kind of preparation methods of paracetamol caffein atificial cow-bezoar pellet, part material medicine is mixed with auxiliary material and first prepares master batch, again through fluidized bed drying, the mobility for improving master batch particle, is spray-dried again through centrifugal granulating later, adhesive is sprayed into when adding powder, the paracetamol caffein atificial cow-bezoar pellet grain diameter of preparation is uniform, hardness is moderate, and raw material pharmaceutically active ingredient is evenly distributed, and solves that metho kahuangmin particle in the prior art is easy to stick to be kept away or partial size is bigger than normal or effective the technical issues of being unevenly distributed;Cornstarch, plant polyose is selected to be compounded with disintegrating agent as adhesive, improve the roundness and intensity of the pellet particle of preparation, it solves the problems, such as that pellet particle is breakable during fluidized bed drying, whole grain, improves the yield of pellet particle, drug ingedient is stablized.
Description
Technical field
The invention belongs to technical field of medicine, and in particular to a kind of preparation method of paracetamol caffein atificial cow-bezoar pellet.
Background technique
Metho kahuangmin is compound preparation, is common cold drug, prescription is mainly by paracetamol, caffeine, horse
Come sour chlorphenamine, calculus bovis factitius composition.Paracetamol has analgesia and refrigeration function, by inhibiting central nervous system
The synthesis of middle prostaglandin and the impulsion generation analgesia for blocking pain nerve tip, are generated by hypothalamus heat-regulating centers
Peripheral vasodilation perspires with radiating and plays refrigeration function.The maincenter that caffeine (low dose) acts on a cerebral cortex high position makes
Mental excitation, relieving fatigue, and cerebral vasoconstriction can be made, alleviate headache caused by cerebral vasodilators.Chlorphenamine maleate is
Antihistamine, the effect of competitive blocking histamine (H1) receptor can reduce allergic symptom, and anti-M choline receptor effect keeps nose glutinous
Film is dry, can alleviate nasal obstruction caused by flu, runny nose, sneezing symptom.Calculus bovis factitius has antipyretic calmness, kobadrin, resists
Bacterium, antiviral and anti-allergic effects, while having activation paracetamol effect, antipyretic-antalgic effect can be enhanced.
Currently, the preparation method of paracetamol caffein atificial cow-bezoar content is mainly by bulk pharmaceutical chemicals paracetamol, caffeine, horse
Come sour chlorphenamine, calculus bovis factitius mixing, auxiliary material granulation, dry, whole grain is added.The disadvantage is that: due to metho kahuangmin bulk pharmaceutical chemicals
Viscosity is larger, and material is easy agglomerating in processes of mixing and granulating, while material is easily adhered on granulation device inner wall, causes particle
Unevenly, the difficulty of granulation is increased, it is difficult to be uniformly mixed and the uniform pellet particle of particle diameter distribution;In drying, arrange
Pellet particle is brittle and frangible in the process, it is difficult to high-quality product be made, cause yield rate lower.
Summary of the invention
In view of the above shortcomings of the prior art, the purpose of the present invention is to provide a kind of preparations of paracetamol caffein atificial cow-bezoar pellet
Method improves the uniformity of drug ingedient in pellet particle.
In order to achieve the above objectives, the invention adopts the following technical scheme:
Part material medicine component is mixed master batch processed with adhesive by a kind of preparation method of paracetamol caffein atificial cow-bezoar pellet, then
It is mixed with adhesive, remaining bulk pharmaceutical chemicals component and obtains paracetamol caffein atificial cow-bezoar pellet through centrifugal granulating;
Specific step is as follows:
(1) feedstock processing:
According to raw material medicine composition used by paracetamol caffein atificial cow-bezoar prescription, appropriate bulk pharmaceutical chemicals acetparaminosalol is weighed respectively
Phenol, caffeine, chlorphenamine maleate and calculus bovis factitius carry out micronization processes;
In addition appropriate cornstarch is weighed, pure water is added, 10% corn starch liquid is made, it is spare;
(2) master batch processed:
It takes the bulk pharmaceutical chemicals of part formulation amount to put into the mixer with auxiliary material to be mixed, bulk pharmaceutical chemicals after mixing is sent
Enter in wet granulator, sprays (1) 10% corn starch liquid mixing granulation of step;
By in the wet granular investment fluidized bed of preparation, makes pellet suspension fluidization, set breeding ground temperature 45 C~65 DEG C, it is dry
Time is 40~60min, until moisture content≤5%;
(3) centrifugal granulating:
By in the master batch investment centrifugal granulating spray dryer after above-mentioned drying, continue while spraying into binder aqueous solution
It is sent into remaining bulk pharmaceutical chemicals component, lasting air inlet mixing, drying, solution continues 10~15min of heating after having sprayed, dry to complete
Afterwards, stop heating, cooling discharging obtains paracetamol caffein atificial cow-bezoar pellet;
The penetrating speed of described adhesive aqueous solution is 10~30mL/min;
(4) whole grain, total mix:
Step (3) dry pellet is placed in crushing and pelletizing machine, crosses 16 mesh screens sieving whole grain to get after whole grain
Grain can be used two-dimensional motion mixer mixing and carry out capsule filling again.
Further, the partial size of the master batch is 30 mesh~32 mesh.
Further, described adhesive aqueous solution quality volume fraction is 8-15%, selects adhesive for cornstarch, plants
Object polysaccharide and disintegrating agent are with (25-30): (3-7): 1.
Further, the disintegrating agent is selected from methylcellulose, hydroxypropyl methyl cellulose, polyethylene glycol, carboxymethyl
One or more of sodium starch, sodium carboxymethylcellulose.
Further, the plant polyose is selected from pectin, xanthan gum, Arabic gum, guar gum, konjac glucomannan, sweet dew
One or more of glycan, algal polysaccharides and chitosan.
The present invention has the beneficial effect that:
1, the present invention, which mixes part material medicine with auxiliary material, first prepares master batch, then through fluidized bed drying, improves master batch particle
Mobility, be spray-dried again through centrifugal granulating later, adhesive, the paracetamol caffein atificial cow-bezoar pellet of preparation sprayed into when adding powder
Grain diameter is uniform, and hardness is moderate, and raw material pharmaceutically active ingredient is evenly distributed, and it is easy to solve metho kahuangmin particle in the prior art
It is viscous to keep away or the technical issues of partial size is bigger than normal or is effectively unevenly distributed, improve the uniformity of effective component distribution in pellet particle.
2, cornstarch, plant polyose is selected to be compounded with disintegrating agent as adhesive, by adding in binder solution
Plant polyose and disintegrating agent with flexible molecule chain reach with starch storage crop to the activeness and quietness of starch solution adhesive
Effect improves the roundness and intensity of the pellet particle of preparation, and it is easy during fluidized bed drying, whole grain to solve pellet particle
Broken problem, improves the yield of pellet particle, while the pellet particle of preparation being made to have good disintegrating property, effective component
Dissolution is fast, and drug ingedient is stablized.
Specific embodiment
The present invention is further explained with reference to embodiments, but is not intended to limit the contents of the present invention.
A kind of specific embodiment: preparation method of paracetamol caffein atificial cow-bezoar pellet, the specific steps are as follows:
(1) feedstock processing:
According to raw material medicine composition used by paracetamol caffein atificial cow-bezoar prescription, appropriate bulk pharmaceutical chemicals acetparaminosalol is weighed respectively
Phenol, caffeine, chlorphenamine maleate and calculus bovis factitius carry out micronization processes;
In addition appropriate cornstarch is weighed, pure water is added, 10% corn starch liquid is made, it is spare;
(2) master batch processed:
It takes the bulk pharmaceutical chemicals of part formulation amount to put into the mixer with auxiliary material to be mixed, bulk pharmaceutical chemicals after mixing is sent
Enter in wet granulator, sprays (1) 10% corn starch liquid mixing granulation of step;
By in the wet granular investment fluidized bed of preparation, makes pellet suspension fluidization, set breeding ground temperature 45 C~65 DEG C, it is dry
Time is 40~60min, until moisture content≤5%;
(3) centrifugal granulating:
By in the master batch investment centrifugal granulating spray dryer after above-mentioned drying, continue while spraying into binder aqueous solution
It is sent into remaining bulk pharmaceutical chemicals component, lasting air inlet mixing, drying, solution continues 10~15min of heating after having sprayed, dry to complete
Afterwards, stop heating, cooling discharging obtains paracetamol caffein atificial cow-bezoar pellet;
The penetrating speed of described adhesive aqueous solution is 10~30mL/min;
(4) whole grain, total mix:
Step (3) dry pellet is placed in crushing and pelletizing machine, crosses 16 mesh screens sieving whole grain to get after whole grain
Grain can be used two-dimensional motion mixer mixing and carry out capsule filling again.
Further, the partial size of the master batch is 30 mesh~32 mesh.
Further, described adhesive aqueous solution quality volume fraction is 8-15%, selects adhesive for cornstarch, plants
Object polysaccharide and disintegrating agent are with (25-30): (3-7): 1.
Further, the disintegrating agent is selected from methylcellulose, hydroxypropyl methyl cellulose, polyethylene glycol, carboxymethyl
One or more of sodium starch, sodium carboxymethylcellulose.
Further, the plant polyose is selected from pectin, xanthan gum, Arabic gum, guar gum, konjac glucomannan, sweet dew
One or more of glycan, algal polysaccharides and chitosan.
Embodiment 1:
(1) feedstock processing:
According to raw material medicine composition used by paracetamol caffein atificial cow-bezoar prescription, 75kg paracetamol, 4.5kg are weighed respectively
Caffeine, 0.5kg chlorphenamine maleate and 3kg calculus bovis factitius carry out micronization processes;
In addition appropriate cornstarch is weighed, pure water is added, 10% corn starch liquid is made, it is spare;
(2) master batch processed:
It takes the bulk pharmaceutical chemicals of 1/4 formula ratio to put into the mixer with 1.6kg disintegrating agent to be mixed, by original after mixing
Expect that medicine is sent into wet granulator, spray (1) 10% corn starch liquid mixing granulation of step, crosses 30 mesh sieves;
By in the wet granular of preparation investment fluidized bed, make pellet suspension fluidization, set breeding ground temperature 50 C, drying time is
40~60min, until moisture content≤5%;
(3) centrifugal granulating:
20kg cornstarch, 3.2kg mannosan is selected to be mixed with 0.8kg disintegrating agent carboxymethyl base sodium cellulosate as bonding
Agent adds pure water to be mixed and made into the binder aqueous solution that quality volume fraction is 10%;
By in the master batch investment centrifugal granulating spray dryer after above-mentioned drying, continue while spraying into binder aqueous solution
It is sent into the bulk pharmaceutical chemicals component of remainder 3/4, lasting air inlet mixes, is dry, and solution continues 10~15min of heating, dried after having sprayed
Cheng Hou, stops heating, and cooling discharging obtains paracetamol caffein atificial cow-bezoar pellet;
The penetrating speed of described adhesive aqueous solution is 20mL/min;
(4) whole grain:
Step (3) dry pellet is placed in crushing and pelletizing machine, cross 16 mesh screens sieving whole grain to get.
Embodiment 2:
(1) feedstock processing:
According to raw material medicine composition used by paracetamol caffein atificial cow-bezoar prescription, 75kg paracetamol, 4.5kg are weighed respectively
Caffeine, 0.5kg chlorphenamine maleate and 3kg calculus bovis factitius carry out micronization processes;
In addition appropriate cornstarch is weighed, pure water is added, 10% corn starch liquid is made, it is spare;
(2) master batch processed:
It takes the bulk pharmaceutical chemicals of 1/4 formula ratio to put into the mixer with 1.6kg disintegrating agent to be mixed, by original after mixing
Expect that medicine is sent into wet granulator, spray (1) 10% corn starch liquid mixing granulation of step, crosses 30 mesh sieves;
By in the wet granular of preparation investment fluidized bed, make pellet suspension fluidization, set breeding ground temperature 50 C, drying time is
40~60min, until moisture content≤5%;
(3) centrifugal granulating:
It selects 20.0kg cornstarch, 3.0kg algal polysaccharides, the mixing of 1.0kg polyethylene glycol as adhesive, adds pure water mixed
It closes and the binder aqueous solution that quality volume fraction is 10% is made;
By in the master batch investment centrifugal granulating spray dryer after above-mentioned drying, continue while spraying into binder aqueous solution
It is sent into the bulk pharmaceutical chemicals component of remainder 3/4, lasting air inlet mixes, is dry, and solution continues 10~15min of heating, dried after having sprayed
Cheng Hou, stops heating, and cooling discharging obtains paracetamol caffein atificial cow-bezoar pellet;
The penetrating speed of described adhesive aqueous solution is 20mL/min;
(4) whole grain:
Step (3) dry pellet is placed in crushing and pelletizing machine, cross 16 mesh screens sieving whole grain to get.
Embodiment 3:
(1) feedstock processing:
According to raw material medicine composition used by paracetamol caffein atificial cow-bezoar prescription, 75kg paracetamol, 4.5kg are weighed respectively
Caffeine, 0.5kg chlorphenamine maleate and 3kg calculus bovis factitius carry out micronization processes;
In addition 35kg cornstarch is weighed, pure water is added, 10% corn starch liquid is made, it is spare;
(2) it pelletizes:
It takes the bulk pharmaceutical chemicals of formula ratio to put into the mixer with 1.6kg disintegrating agent to be mixed, by raw material after mixing
Medicine is sent into wet granulator, and (1) 10% corn starch liquid mixing granulation of step is sprayed;
By in the wet granular investment fluidized bed of preparation, makes pellet suspension fluidization, set breeding ground temperature 50 C, it is dry;
(3) whole grain:
Step (2) dry pellet is placed in crushing and pelletizing machine, cross 16 mesh screens sieving whole grain to get.
Embodiment 4: testing result
By embodiment 1-3 difference paracetamol caffein atificial cow-bezoar pellet particle obtained according to dissolution method (annex X C first
Method), 1000ml is added water to as dissolution medium using dilute hydrochloric acid 24ml, revolving speed is 100 turns per minute, it operates according to methods, when through 20 minutes,
Solution is taken to filter, precision measurement subsequent filtrate is appropriate, is diluted in every 1ml with 0.04% sodium hydroxide solution containing paracetamol
The solution of 5 μ of μ g~10 g, is respectively charged into 6 beakers, according to UV-VIS spectrophotometry (annex IV A), in the wave of 267nm
Strong point measures absorbance, by C6H 9NO2Absorptivity be 715 calculate every the amount of dissolutions, measurement result such as table 1.
1 testing result of table
As shown in table 1, compared with the dissolution rate of paracetamol caffein atificial cow-bezoar pellet particle prepared by embodiment 1,2, embodiment 3 is made
The dissolution rate of standby paracetamol caffein atificial cow-bezoar pellet particle is lower, and embodiment 1 is differed with pellet particle dissolution rate prepared by embodiment 2
Less, there is good disintegrating property using the pellet particle of the method for the present invention preparation, effective component dissolution is fast.
Claims (5)
1. a kind of preparation method of paracetamol caffein atificial cow-bezoar pellet, which is characterized in that mix part material medicine component with adhesive
Master batch processed, then mixed with adhesive, remaining bulk pharmaceutical chemicals component and obtain paracetamol caffein atificial cow-bezoar pellet through centrifugal granulating;Specific steps
It is as follows:
(1) feedstock processing:
According to raw material medicine composition used by paracetamol caffein atificial cow-bezoar prescription, appropriate bulk pharmaceutical chemicals paracetamol, coffee are weighed respectively
Coffee carries out micronization processes because of, chlorphenamine maleate and calculus bovis factitius;
In addition appropriate cornstarch is weighed, pure water is added, 10% corn starch liquid is made, it is spare;
(2) master batch processed:
It takes the bulk pharmaceutical chemicals of part formulation amount to put into the mixer with auxiliary material to be mixed, bulk pharmaceutical chemicals after mixing are sent into wet
In method granulator, (1) 10% corn starch liquid mixing granulation of step is sprayed;
By in the wet granular investment fluidized bed of preparation, makes pellet suspension fluidization, set breeding ground temperature 45 C~65 DEG C, drying time
For 40~60min, until moisture content≤5%;
(3) centrifugal granulating:
By in the master batch investment centrifugal granulating spray dryer after above-mentioned drying, it is continuously fed to while spraying into binder aqueous solution
Remaining bulk pharmaceutical chemicals component, lasting air inlet mixing, drying, solution continue 10~15min of heating and stop after the completion of dry after having sprayed
It only heats, cooling discharging, obtains paracetamol caffein atificial cow-bezoar pellet;
The penetrating speed of described adhesive aqueous solution is 10~30mL/min;
(4) whole grain, total mix:
Step (3) dry pellet is placed in crushing and pelletizing machine, crosses 16 mesh screens sieving whole grain to get the particle after whole grain can
Capsule filling is carried out using two-dimensional motion mixer mixing again.
2. a kind of preparation method of paracetamol caffein atificial cow-bezoar pellet according to claim 1, which is characterized in that the master batch
Partial size is 30 mesh~32 mesh.
3. a kind of preparation method of paracetamol caffein atificial cow-bezoar pellet according to claim 1, which is characterized in that described adhesive
Aqueous solution quality volume fraction is 8-15%, and selecting adhesive is cornstarch, plant polyose and disintegrating agent with (25-30): (3-
7): 1.
4. a kind of preparation method of paracetamol caffein atificial cow-bezoar pellet according to claim 3, which is characterized in that the disintegrating agent
Selected from one of methylcellulose, hydroxypropyl methyl cellulose, polyethylene glycol, sodium carboxymethyl starch, sodium carboxymethylcellulose
Or it is several.
5. a kind of preparation method of paracetamol caffein atificial cow-bezoar pellet according to claim 3, which is characterized in that the plant
Polysaccharide is selected from one of pectin, xanthan gum, Arabic gum, guar gum, konjac glucomannan, mannosan, algal polysaccharides and chitosan
Or it is several.
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CN111023705A (en) * | 2019-12-27 | 2020-04-17 | 上海华源安徽锦辉制药有限公司 | Drying method in acetaminophen tablet granulation procedure |
CN113713689A (en) * | 2021-08-11 | 2021-11-30 | 德州德药制药有限公司 | Preparation equipment and preparation process of Paracetamol, Caffein and chlorphenamine maleate pellet sustained-release capsule |
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