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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 PDF

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Publication number
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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pellet
bezoar
preparation
paracetamol
atificial cow
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Inventor
苏悌
刘传学
崔云梅
蒋克安
王娇
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Anhui Dongsheng International Pharmaceutical Co Ltd
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Anhui Dongsheng International Pharmaceutical Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167Amides, 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4402Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 2, e.g. pheniramine, bisacodyl
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52Purines, e.g. adenine
    • A61K31/522Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/37Digestive system
    • A61K35/413Gall bladder; Bile
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system

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  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
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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

A kind of preparation method of paracetamol caffein atificial cow-bezoar pellet
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.
CN201910025597.8A 2019-01-11 2019-01-11 A kind of preparation method of paracetamol caffein atificial cow-bezoar pellet Pending CN109481468A (en)

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Publication number Priority date Publication date Assignee Title
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
CN115844844A (en) * 2022-12-30 2023-03-28 华中药业股份有限公司 Preparation method of diazepam tablets

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Application publication date: 20190319