CN108926530A - A kind of paracetamol liquid preparation with efficient suspension effect - Google Patents

A kind of paracetamol liquid preparation with efficient suspension effect Download PDF

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CN108926530A
CN108926530A CN201810934330.6A CN201810934330A CN108926530A CN 108926530 A CN108926530 A CN 108926530A CN 201810934330 A CN201810934330 A CN 201810934330A CN 108926530 A CN108926530 A CN 108926530A
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sweetener
hydroxypropyl methylcellulose
paracetamol
preparation
liquid preparation
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徐亮亮
黄媛
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Jiangsu Keruida Pharmaceutical Co Ltd
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Jiangsu Keruida Pharmaceutical Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • 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
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/06Antimigraine agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

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Abstract

The invention discloses a kind of paracetamol liquid preparation with novel suspension system, which includes suspending agent, sweetener, acid regulator, moisturizer, defoaming agent, preservative, edible pigment, edible essence.It pelletizes first to paracetamol, particle is made by fluidized bed coating, then add in liquid suspending system and suspension is made.About liquid suspension mother liquor, first prepare 1% concentration hydroxypropyl cellulose aqueous solution, 2- methyl-silicone oil is added in process for preparation to play defoaming and increase viscosity, after 0.2% citron acid for adjusting pH is added, 5% sweetener is added as sweetener and suspending agent, 0.14% ethyl hydroxy benzoate is dissolved in a small amount of glycerol and is added, edible amaranth pigment and edible cherry essence on a small quantity are eventually adding.Novel suspension system of the present invention can effectively disperse the main ingredient in paracetamol liquid preparation, to greatly improve the suspension uniformity of preparation, guarantee that the quality of liquid preparation product is stablized.And the auxiliary material of the suspension system is easy to get, and dosage is few, low in cost.

Description

A kind of paracetamol liquid preparation with efficient suspension effect
Technical field
The present invention relates to oral liquid fields, and in particular to a kind of paracetamol with efficient suspension effect Liquid preparation.
Background technique
Acetaminophen oral solution is a kind of non-prescribed medicine, for generating heat caused by common cold or influenza, It is also used for alleviating mild to moderate pain such as headache, arthralgia, migraine, toothache, courbature, neuralgia, dysmenorrhea.
This product is acetophenone amine analgesic-antipyretic.By inhibiting Cycloxygenase, selective depression hypothalamus body heat regulation The synthesis of maincenter prostaglandin leads to peripheral blood vessel expansion, perspires and have the function that antipyretic, refrigeration function intensity and Ah department Forest form is seemingly;By inhibiting the synthesis and release of prostaglandin etc., improves the threshold of pain and play analgesic activity, belong to the analgesia of periphery property Medicine, effect is weak compared with aspirin, only to light, moderate pain is effective.This product is without obvious anti-inflammatory effect.
Liquid preparation has that dose is small, it is fast to absorb, takes and easy to carry, and is suitble to industrialized production.But suchization Closing object, main ingredient is compared with solid pharmaceutical preparation bad dispersibility in liquid preparation, in order to guarantee that the quality of liquid preparation product is stablized, using mixed Outstanding system, manufactures liquid combination formula suspending system, to effectively disperse main ingredient, guarantees the stable uniformity of preparation.
Summary of the invention
The purpose of the present invention is to provide a kind of in the presence of combined type suspension system with polymolecularity to acetyl ammonia Base phenol liquid preparation.The combination can effectively disperse main ingredient, combined type suspension system auxiliary material have be easy to get, dosage is few, prepared The features such as journey is simple.
What above-mentioned purpose of the invention was achieved through the following technical solutions: a kind of paracetamol with polymolecularity Liquid preparation contains high combined type suspension system in preparation, and combined type suspension system is in paracetamol liquid preparation Mass percent is 15%~20%.
Inventor passes through research discovery: paracetamol coated granule is water-soluble in general hydroxypropyl methylcellulose Suspension effect is poor in liquid, and sinking speed is too fast, and it is slower to restore suspension after settling.Due in production and use process Unavoidable standing, therefore combined type suspension system is used in the formulation, so as to effectively make main ingredient coated granule be suspended, Guarantee the homogeneity of product.
Preferably, combined type suspension system preferred mass percentage 5% in paracetamol liquid preparation ~7%.
The combined type suspension system includes: " hydroxypropyl methylcellulose-sweetener-dimethicone ", " hypromellose Element-sweetener-glycerol ", " hydroxypropyl methylcellulose-sweetener-dimethicone-glycerol ", " hydroxypropyl methylcellulose-sweetener " Deng.
The combined type suspension system proportion are as follows: hydroxypropyl methylcellulose: sweetener: dimethicone=0.01:0.05: 0.01;Hydroxypropyl methylcellulose: sweetener: glycerol=0.02:0.05:0.08;Hydroxypropyl methylcellulose: sweetener: dimethicone: Glycerol=0.01:0.05:0.01:0.08;Hydroxypropyl methylcellulose: sweetener=0.02:0.05.
In example of the present invention, " hydroxypropyl methylcellulose: sweetener: dimethicone " is selected to be used as preparation Combined type suspension system optimum quality percentage be 7%~9%, combined type suspension system proportion be hydroxypropyl methylcellulose: sweet tea Taste agent: dimethicone=0.01:0.05:0.01.
In another specific example of the invention, the group of " hydroxypropyl methylcellulose: sweetener: glycerol " as preparation is selected Box-like suspension system optimum quality percentage is 15%~20%, and combined type suspension system proportion is hydroxypropyl methylcellulose: sweet taste Agent: glycerol=0.02:0.05:0.08.
In another specific example of the invention, select " hydroxypropyl methylcellulose: sweetener: dimethicone: glycerol " Combined type suspension system optimum quality percentage as preparation is 15%~20%, and it is fine that combined type suspension system matches hydroxypropyl first Dimension element: sweetener: dimethicone: glycerol=0.01:0.05:0.01:0.08.
In another specific example of the invention, the combined type of " hydroxypropyl methylcellulose: sweetener " as preparation is selected Suspension system optimum quality percentage is 7%~10%, and combined type suspension system proportion is hydroxypropyl methylcellulose: sweetener= 0.02:0.05。
The present invention have it is following the utility model has the advantages that
(1) effectively disperse granules of main drug, can guarantee the homogeneity of drug content in production and use process.
(2) supplementary material of combined type suspension system is easy to get, cheap, and auxiliary material belongs to water solubility, and liquid preparation is added In it is easy to operate, it is easy to accomplish.The difference between batch will not be caused because of preparation process and environmental factor fluctuation.
Specific embodiment
Hydroxypropyl methylcellulose: sweetener: dimethicone=0.01:0.05:0.01;Hydroxypropyl methylcellulose: sweetener: sweet Oil=0.02:0.05:0.08;Hydroxypropyl methylcellulose: sweetener: dimethicone: glycerol=0.01:0.05:0.01:0.08; Hydroxypropyl methylcellulose: sweetener=0.02:0.05.
The present invention is further explained in the light of specific embodiments, but is not limitation of the invention.
[embodiment 1]
Paracetamol liquid preparation containing " hydroxypropyl methylcellulose: sucrose " combined type suspension system
Paracetamol is used into wet granulation, low viscosity hydroxypropyl methylcellulose aqueous solution is added as adhesive, after It uses organic solvent dissolution as coating solution ethyl cellulose, is coated by the spray of fluidized bed bottom and coated granule (control is made Grain graininess is 40-80 mesh).
It is sequentially added in following ratio into suitable water: hydroxypropyl methylcellulose 1%, sucrose 5%, diformazan base glycerol 1%, Glycerol 8%, ethyl hydroxy benzoate 0.14%, citric acid 0.2%, cherry essence 0.06%, amaranth pigment 0.02% are added to second Acylamino- phenol coated granule is as preparation 1.
The paracetamol liquid preparation of same recipe quantity is prepared, but does not add glycerol, as preparation 2.
The paracetamol liquid preparation of same recipe quantity is prepared, but does not add dimethicone, as preparation 3.
The paracetamol liquid preparation of same recipe quantity is prepared, but does not add glycerol-dimethicone, as preparation 4。
By preparation 1, preparation 2, preparation 3, preparation 4, this 4 kinds of paracetamol liquid preparations carry out physical state observation, As a result such as the following table 1:
Table 1
As shown in table 1: the paracetamol liquid preparation content containing combined type systems stabilisation is most uniform.
[embodiment 2]
Paracetamol liquid preparation containing " hydroxypropyl methylcellulose: sucrose " combined type suspension system
Paracetamol is used into wet granulation, low viscosity hydroxypropyl methylcellulose aqueous solution is added as adhesive, after It uses organic solvent dissolution as coating solution ethyl cellulose, is coated by the spray of fluidized bed bottom and coated granule (control is made Grain graininess is 40-80 mesh).
It is sequentially added in following ratio into suitable water: hydroxypropyl methylcellulose 1%, sucrose 5%, diformazan base glycerol 1%, Glycerol 8%, ethyl hydroxy benzoate 0.14%, citric acid 0.2%, cherry essence 0.06%, amaranth pigment 0.02% are added to second Acylamino- phenol coated granule is as preparation 1.
The paracetamol liquid preparation of same recipe quantity is prepared, but does not add glycerol, as preparation 2.
The paracetamol liquid preparation of same recipe quantity is prepared, but does not add dimethicone, as preparation 3.
The paracetamol liquid preparation of same recipe quantity is prepared, but does not add glycerol-dimethicone, as preparation 4。
By preparation 1, preparation 2, preparation 3, preparation 4, this 4 kinds of paracetamol liquid preparations carry out liquid preparation difference position Assay investigation is set, as a result such as the following table 2:
Table 2
As shown in table 2: the paracetamol liquid preparation content containing combined type systems stabilisation is most uniform.
[embodiment 3]
Paracetamol liquid preparation containing " hydroxypropyl methylcellulose: sucrose " basic combined type suspension system
Paracetamol is used into wet granulation, low viscosity hydroxypropyl methylcellulose aqueous solution is added as adhesive, after It uses organic solvent dissolution as coating solution ethyl cellulose, is coated by the spray of fluidized bed bottom and coated granule (particle is made Granularity control selections are 20-40 mesh, 40-80 mesh, 80-100 mesh).
It is sequentially added in following ratio into suitable water: hydroxypropyl methylcellulose 1%, sucrose 5%, diformazan base glycerol 1%, Glycerol 8%, ethyl hydroxy benzoate 0.14%, citric acid 0.2%, cherry essence 0.06%, amaranth pigment 0.02% are added to second Acylamino- phenol coated granule (20-40 mesh) is used as preparation 1.
The paracetamol liquid preparation of same recipe quantity is prepared, is added particle (40-80 mesh), as preparation 2.
Prepare the paracetamol liquid preparation of same recipe quantity, particle (80-100 mesh), as preparation 3.
By preparation 1, preparation 2, preparation 3, this 3 kinds of paracetamol liquid preparations carry out suspension research, as a result such as The following table 3:
Table 3
As shown in table 3: the paracetamol liquid preparation suspension transition containing 40-80 mesh particle is best.
[embodiment 4]
Paracetamol liquid preparation containing " hydroxypropyl methylcellulose: sucrose " basic combined type suspension system
Paracetamol is used into wet granulation, low viscosity hydroxypropyl methylcellulose aqueous solution is added as adhesive, after It uses organic solvent dissolution as coating solution ethyl cellulose, is coated by the spray of fluidized bed bottom and coated granule (particle is made Granularity control is 40-80 mesh).
It is sequentially added in following ratio into suitable water: hydroxypropyl methylcellulose 0.5%, sucrose 5%, diformazan base glycerol 1%, glycerol 8%, ethyl hydroxy benzoate 0.14%, citric acid 0.2%, cherry essence 0.06%, amaranth pigment 0.02% adds Paracetamol coated granule (40-80 mesh) is used as preparation 1.
The paracetamol liquid preparation of same recipe quantity is prepared, hydroxypropyl methylcellulose concentration is adjusted to 1%, as preparation 2。
The paracetamol liquid preparation of same recipe quantity is prepared, hydroxypropyl methylcellulose concentration is adjusted to 2%, as preparation 3。
By preparation 1, preparation 2, preparation 3, this 3 kinds of paracetamol liquid preparations carry out suspension research, as a result such as The following table 4:
Table 4
As shown in table 4: the paracetamol liquid preparation suspension transition of the hydroxypropyl methylcellulose containing 1% concentration is most It is good.
[embodiment 5]
Paracetamol liquid preparation containing " hydroxypropyl methylcellulose: sucrose " basic combined type suspension system
Paracetamol is used into wet granulation, low viscosity hydroxypropyl methylcellulose aqueous solution is added as adhesive, after It uses organic solvent dissolution as coating solution ethyl cellulose, is coated by the spray of fluidized bed bottom and coated granule (particle is made Granularity control is 40-80 mesh).
It is sequentially added in following ratio into suitable water: hydroxypropyl methylcellulose 1%, sucrose 2.5%, diformazan base glycerol 1%, glycerol 8%, ethyl hydroxy benzoate 0.14%, citric acid 0.2%, cherry essence 0.06%, amaranth pigment 0.02% adds Paracetamol coated granule (40-80 mesh) is used as preparation 1.
The paracetamol liquid preparation of same recipe quantity is prepared, sucrose concentration is adjusted to 5%, as preparation 2.
The paracetamol liquid preparation of same recipe quantity is prepared, sucrose concentration is adjusted to 10%, as preparation 3.
By preparation 1, preparation 2, preparation 3, this 3 kinds of paracetamol liquid preparations carry out suspension research, as a result such as The following table 5:
Table 5
As shown in table 5: the paracetamol liquid preparation suspension transition of the sucrose sweetener containing 5% concentration is best.
[embodiment 6]
Paracetamol liquid preparation containing " hydroxypropyl methylcellulose: sorbierite " basic combined type suspension system
Paracetamol is used into wet granulation, low viscosity hydroxypropyl methylcellulose aqueous solution is added as adhesive, after It uses organic solvent dissolution as coating solution ethyl cellulose, is coated by the spray of fluidized bed bottom and coated granule (particle is made Granularity control is 40-80 mesh).
It is sequentially added in following ratio into suitable water: hydroxypropyl methylcellulose 1%, sorbierite 5%, diformazan base glycerol 1%, glycerol 8%, ethyl hydroxy benzoate 0.14%, citric acid 0.2%, cherry essence 0.06%, amaranth pigment 0.02% adds Paracetamol coated granule (40-80 mesh) is used as preparation 1.
The paracetamol liquid preparation of same recipe quantity is prepared, sweetener is changed to 5% sucrose, as preparation 2.
Preparation 1, preparation 2 this 2 kinds of paracetamol liquid preparations are subjected to suspension researchs, as a result such as the following table 6:
Table 6
As shown in table 6: the paracetamol liquid preparation suspension transition containing sucrose sweetener is relatively preferable.
[embodiment 7]
Paracetamol liquid preparation containing " hydroxypropyl methylcellulose: mannitol " basic combined type suspension system
Paracetamol is used into wet granulation, low viscosity hydroxypropyl methylcellulose aqueous solution is added as adhesive, after It uses organic solvent dissolution as coating solution ethyl cellulose, is coated by the spray of fluidized bed bottom and coated granule (particle is made Granularity control is 40-80 mesh).
It is sequentially added in following ratio into suitable water: hydroxypropyl methylcellulose 1%, mannitol 5%, diformazan base glycerol 1%, glycerol 8%, ethyl hydroxy benzoate 0.14%, citric acid 0.2%, cherry essence 0.06%, amaranth pigment 0.02% adds Paracetamol coated granule (40-80 mesh) is used as preparation 1.
The paracetamol liquid preparation of same recipe quantity is prepared, sweetener is changed to 5% sucrose, as preparation 2.
Preparation 1, preparation 2 this 2 kinds of paracetamol liquid preparations are subjected to suspension researchs, as a result such as the following table 7:
Table 7
As shown in table 7: the paracetamol liquid preparation suspension transition containing sucrose sweetener is relatively preferable.
[embodiment 8]
Paracetamol liquid preparation containing " hydroxypropyl methylcellulose: DEXTROSE ANHYDROUS " basic combined type suspension system
Paracetamol is used into wet granulation, low viscosity hydroxypropyl methylcellulose aqueous solution is added as adhesive, after It uses organic solvent dissolution as coating solution ethyl cellulose, is coated by the spray of fluidized bed bottom and coated granule (particle is made Granularity control is 40-80 mesh).
Sequentially add in following ratio into suitable water: hydroxypropyl methylcellulose 1%, DEXTROSE ANHYDROUS 5%, dimethyl is sweet Oil 1%, glycerol 8%, ethyl hydroxy benzoate 0.14%, citric acid 0.2%, cherry essence 0.06%, amaranth pigment 0.02%, then plus Enter paracetamol coated granule (40-80 mesh) as preparation 1.
The paracetamol liquid preparation of same recipe quantity is prepared, sweetener is changed to 5% sucrose, as preparation 2.
Preparation 1, preparation 2 this 2 kinds of paracetamol liquid preparations are subjected to suspension researchs, as a result such as the following table 8:
Table 8
As shown in table 8: the paracetamol liquid preparation suspension transition containing sucrose sweetener is relatively preferable.
[embodiment 9]
Paracetamol liquid preparation containing " hydroxypropyl methylcellulose: xylitol " basic combined type suspension system
Paracetamol is used into wet granulation, low viscosity hydroxypropyl methylcellulose aqueous solution is added as adhesive, after It uses organic solvent dissolution as coating solution ethyl cellulose, is coated by the spray of fluidized bed bottom and coated granule (particle is made Granularity control is 40-80 mesh).
It is sequentially added in following ratio into suitable water: hydroxypropyl methylcellulose 1%, xylitol 5%, diformazan base glycerol 1%, glycerol 8%, ethyl hydroxy benzoate 0.14%, citric acid 0.2%, cherry essence 0.06%, amaranth pigment 0.02% adds Paracetamol coated granule (40-80 mesh) is used as preparation 1.
The paracetamol liquid preparation of same recipe quantity is prepared, sweetener is changed to 5% sucrose, as preparation 2.
Preparation 1, preparation 2 this 2 kinds of paracetamol liquid preparations are subjected to suspension researchs, as a result such as the following table 9:
Table 9
As shown in table 9: sweetener is that the suspending system situation of xylitol is similar as sweetener situation with sucrose.
[embodiment 10]
Paracetamol liquid preparation containing " hydroxypropyl methylcellulose: xylitol " basic combined type suspension system
Paracetamol is used into wet granulation, low viscosity hydroxypropyl methylcellulose aqueous solution is added as adhesive, after It uses organic solvent dissolution as coating solution ethyl cellulose, is coated by the spray of fluidized bed bottom and coated granule (control is made Grain graininess is 40-80 mesh).
It is sequentially added in following ratio into suitable water: hydroxypropyl methylcellulose 1%, xylitol 5%, diformazan base glycerol 1%, glycerol 8%, ethyl hydroxy benzoate 0.14%, citric acid 0.2%, cherry essence 0.06%, amaranth pigment 0.02% adds Paracetamol coated granule (40-80 mesh) is used as preparation 1.
The paracetamol liquid preparation of same recipe quantity is prepared, but does not add glycerol, as preparation 2.
The paracetamol liquid preparation of same recipe quantity is prepared, but does not add dimethicone, as preparation 3.
The paracetamol liquid preparation of same recipe quantity is prepared, but does not add glycerol-dimethicone, as preparation 4。
By preparation 1, preparation 2, preparation 3, preparation 4, this 4 kinds of paracetamol liquid preparations carry out physical state observation, As a result such as the following table 10:
Table 10
As shown in table 10: the paracetamol liquid preparation content containing combined type systems stabilisation is most uniform.
[embodiment 11]
Paracetamol liquid preparation containing " hydroxypropyl methylcellulose: sucrose " basic combined type suspension system
Paracetamol is used into wet granulation, low viscosity hydroxypropyl methylcellulose aqueous solution is added as adhesive, after It uses organic solvent dissolution as coating solution ethyl cellulose, is coated by the spray of fluidized bed bottom and coated granule (particle is made Granularity control is 40-80 mesh).
It is sequentially added in following ratio into suitable water: hydroxypropyl methylcellulose 1%, sucrose 5%, diformazan base glycerol 1%, Glycerol 4%, ethyl hydroxy benzoate 0.14%, citric acid 0.2%, cherry essence 0.06%, amaranth pigment 0.02% are added to second Acylamino- phenol coated granule (40-80 mesh) is used as preparation 1.
The paracetamol liquid preparation of same recipe quantity is prepared, glycerol dosage is adjusted to 8%, as preparation 2.
The paracetamol liquid preparation of same recipe quantity is prepared, glycerol dosage is adjusted to 12%, as preparation 3.
By preparation 1, preparation 2, preparation 3, this 3 kinds of paracetamol liquid preparations carry out suspension research, as a result such as The following table 11:
Table 11
As shown in table 11: the paracetamol liquid preparation suspension transition of the glycerol containing 8% concentration is best.

Claims (10)

1. a kind of paracetamol liquid preparation with efficient suspension effect, it is characterised in that: contain combined type in preparation Suspending system, mass percent of the combined type suspending system in paracetamol liquid preparation are 7%~10%;Combined type Suspending system includes " hydroxypropyl methylcellulose-sweetener-dimethicone ", " hydroxypropyl methylcellulose-sweetener-glycerol ", " hydroxypropyl Methylcellulose-sweetener-dimethicone-glycerol ", " hydroxypropyl methylcellulose-sweetener " etc..
2. the paracetamol liquid preparation according to claim 1 with efficient suspension effect, it is characterised in that: group Mass percent of the box-like suspending system in paracetamol liquid preparation is preferably 15%~20%.
3. combined type suspending system according to claim 1 or 2, it is characterised in that: the combined type suspending system is selected from " hydroxypropyl methylcellulose-sweetener-dimethicone ", " hydroxypropyl methylcellulose-sweetener-glycerol ", " hydroxypropyl methylcellulose-sweet tea Taste agent-dimethicone-glycerol ", " hydroxypropyl methylcellulose-sweetener " one kind.
4. combined type suspending system according to claim 1 to 3 is 7% " hydroxypropyl methylcellulose-sweetener-dimethyl Silicone oil ", 7% " hydroxypropyl methylcellulose-sweetener-glycerol ", 10% " hydroxypropyl methylcellulose-sweetener-dimethicone-is sweet One of oil ", 5% " hydroxypropyl methylcellulose-sweetener ".
5. combined type suspending system according to claim 4, wherein combined type systems stabilisation matches are as follows: hypromellose Element: sweetener: dimethicone=0.01:0.05:0.01;Hydroxypropyl methylcellulose: sweetener: glycerol=0.02:0.05: 0.08;Hydroxypropyl methylcellulose: sweetener: dimethicone: glycerol=0.01:0.05:0.01:0.08;Hydroxypropyl methylcellulose: sweet tea Taste agent=0.02:0.05.
6. the paracetamol liquid preparation according to claim 1 with efficient suspension effect, it is characterised in that: also Materials described below: essence, pigment, preservative is selected from comprising one or more.
7. the paracetamol liquid preparation according to claim 1 with efficient suspension effect, it is characterised in that: institute State essence pigment proportion 0.1%.
8. the paracetamol liquid preparation according to claim 1 with efficient suspension effect, it is characterised in that: institute Stating preservative includes: sodium benzoate, potassium sorbate, methyl hydroxybenzoate, ethyl hydroxy benzoate, Nipasol.
9. the paracetamol liquid preparation according to claim 1 with efficient suspension effect, it is characterised in that: institute State preservative proportion 0.01%~0.2%.
10. the paracetamol liquid preparation according to claim 1 with efficient suspension effect, it is characterised in that: Contained sweetener includes sucrose, sorbierite, mannitol, DEXTROSE ANHYDROUS, xylitol, Sucralose, antierythrite.
CN201810934330.6A 2018-08-17 2018-08-17 A kind of paracetamol liquid preparation with efficient suspension effect Pending CN108926530A (en)

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