CN110522733A - A kind of arbidol and its salt dry suspensoid agent and preparation method thereof - Google Patents
A kind of arbidol and its salt dry suspensoid agent and preparation method thereof Download PDFInfo
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- CN110522733A CN110522733A CN201910381378.3A CN201910381378A CN110522733A CN 110522733 A CN110522733 A CN 110522733A CN 201910381378 A CN201910381378 A CN 201910381378A CN 110522733 A CN110522733 A CN 110522733A
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Abstract
The invention discloses a kind of arbidols and its salt dry suspensoid agent and preparation method thereof.Including arbidol hydrochloride, suspending agent, filler, corrigent and edible pigment, suspending agent is one or more of Arabic gum, tragacanth, sodium alginate, povidone, hydroxypropyl cellulose, xanthan gum, hydroxypropyl methylcellulose；Filler is one or more of sucrose, mannitol, microcrystalline cellulose；Corrigent includes sweetener and aromatic, and sweetener is one or more of mannitol, sucrose, honey element, aspartame, Sucralose；Aromatic is one or more of peach flavor, flavoring banana essence, lemon extract, strawberry essence, flavoring apple essence；Edible pigment is the one or more of lemon yellow, sunset yellow, Cochineal color.After dry suspensoid agent is made in arbidol and its salt by the present invention, the bitter taste of arbidol and its salt is effectively masked, greatly improves the compliance that patient takes.
Description
Technical field
The present invention relates to medical packaging field, in particular to a kind of arbidol and its salt dry suspensoid agent and its preparation side
Method.
Background technique
Arbidol (Arbidol) is the efficient of a kind of prevention and treatment A type and Type B influenza and other acute respiratory virus infections
Drug.The mechanism of action is different from clinically common antiviral drugs such as Ribavirin, amantadine and Rimantadine etc.；It is logical
Inducement interferon is crossed, enhancing immune function is come to resisiting influenza virus；In addition there is antagonism to A type and Type B influenza virus, than
Adamantane amine antiviral spectrum is wide, also has the function of activated macrophage, effectively treats influenza and other acute respiratories
Virus infection.Recent study shows that the medicine also there is preferable inhibition to make atypia virus under lower safe concentration
With.Arbidol hydrochloride toxicity is very low, and foreign literature report rat and cavy single oral 2000mg/kg, well-tolerated show
Oral Acute Toxicity is very low, estimates LD50 > 3000mg/kg.Mouse oral LD50=340mg/kg.Chronic toxicity test: rat
100~125mg/kg, dog 25mg/kg are administered orally 6 months, do not occur Pathologic changes.To rabbit and cavy long-term administration
It is safer.
Russia and Discussion on Chinese Listed arbidol hydrochloride and its oral solid formulation (piece, capsule, dispersible tablet,
Granula) it is non-nucleosides compound, the mechanism of action is by activation 2,5 '~oligo-adenylate synthetase, and specificity inhibits disease
Malicious lipid cyst membrane is merged with host cell membrane, thus the duplication of blocking virus.Arbidol hydrochloride Russia and China at
Function listing is mainly used for the infection of the upper respiratory tract caused by preventing and treating first, influenza B virus.It has the advantage that and feature: 1,
Infected by influenza A type and it is B-mode effectively.2, existing therapeutic effect, also there is prevention effect.3, it has concurrently and directly inhibits virus and lure
Lead the double action of endogenous interferon.
Arbidol is original by Russia and listed first in 1993, has multinational approval to list later.2005,
The country starts several enterprise's productions, mainly has bulk pharmaceutical chemicals and tablet at present, in addition there are also capsule, dispersible tablet and granules etc..
2006, state approval Tamiflu arbidol hydrochloride listing.Arbidol bitter itself, the compliance that patient takes
It is poor, it is unsuitable for children taking.Therefore, developing a kind of arbidol dry suspensoid agent and preparation method thereof is always urgently to solve
New issue certainly.
Have that some patents disclose some formulation and technologies and preparation technique about arbidol at present.
CN102000030A discloses a kind of arbidol dry suspensoid agent applied in medical and health industry and its preparation
After using wet granulation technology dry suspensoid agent is made in arbidol by the method invention, the hardship of arbidol is effectively masked
Taste greatly improves the compliance that patient takes, but arbidol raw material non-refractory, therefore wet granulation stoving process is to this
The quality of kind is risky.
CN101904826A discloses a kind of arbidol hydrochloride orally disintegrating tablet and preparation method thereof, invented technology control
Simply, it absorbing fastly, bioavailability is high, conveniently takes, but the technique that the technique takes pelleting and is coated, and technique is cumbersome,
The bad control of manufacturing parameter, is unfavorable for industrialization.
CN1572298 discloses a kind of compound preparation of antiviral drugs arbidol, the anti influenza compound system of the invention
Agent contain arbidol hydrochloride on the basis of, also containing brufen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide it is any one
Kind, two or three of composition, add acceptable oral preparation pharmaceutic adjuvant, oral dosage form are made.
CN102091048A discloses the preparation method and its method of quality control of a kind of arbidol hydrochloride piece, the technology
The deficiency for making up existing kind provides a kind of broad-spectrum high efficacy, quality stabilization, simple process, low in cost, patient are easy to receive
The preparation method of arbidol hydrochloride piece, and provide it is a kind of it is simple and efficient, it is quantitative it is accurate, specificity is good, strong applicability hydrochloric acid
The method of quality control of arbidol piece.
CN101653425 discloses a kind of arbidol hydrochloride medicament combination dispersible tablet and preparation method thereof, the invention
Provided its substrate's appearance of arbidol hydrochloride medicament combination dispersible tablet, hardness and dispersing uniformity are all preferable.
CN1535680 discloses the molecular clathrate of a kind of new arbidol and cyclodextrin or its derivative, and
The preparation method of the inclusion compound and their applications in pharmaceutical preparation.The invention is improved by preparing arbidol inclusion compound
Its water-soluble and stability, make this inclusion compound can be used as a kind of starting material or a kind of ingredient be used to prepare intestinal canal administration or
Non-intestinal drug delivery agent.
CN1868470 discloses a kind of arbidol granular agent.The medicine is suspended and good mouthfeel, children and gerontal patient couple
The compliance of the medicine is good.When arbidol hydrochloride accounts for particle total weight 5%, can by the supplementary product consumption in original prescription by
98% drops to 95%, can reduce auxiliary material inventory, reduces production cost.
Country someone is developed at present takes 2 simple sustained release tablets daily.
CN 1589790 disclose it is a kind of be related to the sustained release tablets of antiviral drugs arbidol, invention hydrophilic gel bone
Frame material or wax framework material prepare the sustained release tablets containing arbidol.But sustained-release tablets release is slow, cannot discharge rapidly medicine
Object active constituent keeps maximum plasma concentration lower.
CN100367957C discloses a kind of arbidol and its salt intravenous administration formulation and preparation method thereof, and this method mentions
The high bioavilability of the drug, but the technology salification process is complicated, and domestic without arbidol that meet national standards
Salt raw material, is unfavorable for industrialization.
CN101066248 discloses a kind of arbidol granular and preparation method thereof, and this method uses granule coating technology,
Although improving raw material bring hardship sense, macromolecule packaging technique is used, the release of drug is delayed, reduces drug
Due curative effect of medication is not achieved in bioavilability.
CN101249076, which discloses a kind of arbidol granular formulation and its fluidized-bed coating preparation thereof, this method, to be made
Granulate intermediate is coated with fluidized bed, but particle is coated using fluidized bed, than arbidol hydrochloride and its salt
The dry mixing process of dry suspensoid agent is more cumbersome, more complicated, and parameter is difficult to control, and is unfavorable for the kind industrialization.
Above-mentioned patented technology provides the conventional tablet of arbidol, granule, suspension, dispersible tablet, the system such as inclusion compound
Agent technology only improves the bioavilability of the drug to a certain extent, and fails effectively to cover arbidol and its salt
Bitter, limit clinical application range and practical value；Compared to above-mentioned preparation process, arbidol that the present invention uses and
The preparation method of its salt dry suspensoid agent is to improve the drug to greatest extent in existing preparation process technical foundation
Bioavilability, the corrigent being specifically added, is highly suitable for children taking, expand the medicine application range and practical valence
Value, compares the disclosed technical requirements for crossing 100 mesh of CN102000030A, and the present invention only needs routine to crushed 80 meshes, producing
More succinctly reduce unnecessary cumbersome technique and Quality Control operation in technique, is both conducive to the simplification and quality control of actual production
System, and production cost is reduced, more advantageous industrialized production.
Summary of the invention
The object of the present invention is to provide a kind of arbidol and its salt dry suspensoid agent and preparation method thereof, by arbidol and
Its salt is made after dry suspensoid agent, and Sucralose is used effectively to mask the bitter taste of arbidol and its salt as corrigent,
Greatly improve the compliance that patient's especially child patient is taken.By being controlled greatly raw material particle size in technique
The bioavilability for improving insoluble drug arbidol and its salt makes its drug effect be significantly improved relative to other dosage forms,
Simultaneously using the auxiliary material granulation additional dry-mixed simple process of raw material, avoids preparation quality due to caused by temperature sensitive and ask
Topic, reduces production cost, is conducive to industrialization and product Quality Control.
The object of the present invention is achieved like this: a kind of arbidol and its salt dry suspensoid agent, including arbidol hydrochloride,
Suspending agent, filler, corrigent and edible pigment, each component weight ratio are as follows: arbidol hydrochloride 8%~12%, suspending agent 4%
~8%, filler 60%~90%, corrigent 0.1%~1%, edible pigment 0.00002%~0.00003%.Wherein suspending
Agent is Arabic gum, tragacanth, sodium alginate, povidone, hydroxypropyl cellulose, xanthan gum, one in hydroxypropyl methylcellulose
Kind is several, preferably hydroxypropyl methylcellulose；Filler is one or more of sucrose, mannitol, microcrystalline cellulose, preferably sugarcane
Sugar: mannitol is the mixture of 6-8:1；Corrigent includes sweetener and aromatic, sweetener be mannitol, sucrose, honey element,
One or more of aspartame, Sucralose, preferably Sucralose；Aromatic is peach flavor, flavoring banana essence, lemon
One or more of essence, strawberry essence, flavoring apple essence；Edible pigment be lemon yellow, sunset yellow, Cochineal color one
Kind is several.Arbidol hydrochloride is controlled partial size D90:1~20 by the preparation method of a kind of arbidol and its salt dry suspensoid agent
μm, after filler crushes and 80 meshes are crossed, suspending agent sieves with 100 mesh sieve, and corrigent crushing sieves with 100 mesh sieve, and filler is uniformly mixed,
With 0.03%~0.07% pigment aqueous solution softwood, cross the granulation of 32~40 meshes, 50~70 DEG C drying 60~180 minutes, mistake
Dry particl, arbidol hydrochloride, suspending agent, sweetener, aromatic are sufficiently mixed by 20~40 mesh sieves, after passed examination,
It is fitted into aluminum-plastic composite membrane bag.
The advantage of the invention is that effectively masking arbidol and its salt as corrigent by using Sucralose
Bitter taste, Sucralose sugariness is 400~800 times of sucrose, and sweet taste is pure, and sweet tea sense presentation speed, the impression of maximum sweet taste are strong
The sweet taste characteristics such as degree, sweet taste duration, rear taste are to generally acknowledge in the world at present without any rear bitter taste very similar to sucrose
Intense sweetener.
Compared with prior art, drug effect is made after dry suspensoid agent in arbidol and its salt has obviously relative to other dosage forms
It improves, dissolution in vitro data are shown as sample dissolution in vitro prepared by the present invention and are significantly larger than other dosage forms.The present invention
The bioavilability of insoluble drug arbidol and its salt is greatly improved by carrying out control to raw material particle size；It adopts simultaneously
It is pelletized the additional dry-mixed technique of raw material with auxiliary material, this technique is individually pelletized using auxiliary material, and raw material dry-mixed technique therewith avoids original
Material contact high temperature, reduces the influence of temperature and preparation, avoids preparation quality problems due to caused by temperature sensitive, should
Simple process reduces production cost, is conducive to industrialization and product Quality Control.
Specific embodiment
The following describes the present invention in detail with reference to examples.
Embodiment 1
A kind of arbidol and its salt dry suspensoid agent, take arbidol hydrochloride 200g, hydroxypropyl methylcellulose 40g, trichlorine sugarcane
Sugared 2g, mannitol 200g, sucrose 1540g and peach flavor 10g, 0.03% Cochineal color aqueous solution are appropriate；By hydrochloric acid
Arbidol controls partial size D90:1~20 μm, and Sucralose, peach flavor crushing sieve with 100 mesh sieve；Sucrose, mannitol crush
Cross 80 mesh；Hydroxypropyl methylcellulose sieves with 100 mesh sieve；Sucrose, mannitol are sufficiently mixed, and 0.03% Cochineal color aqueous solution is added
In right amount, softwood processed, 32 meshes granulation, 50 DEG C drying 60 minutes, cross 28 mesh sieves, addition arbidol hydrochloride, Sucralose,
Hydroxypropyl methylcellulose, peach flavor are uniformly mixed, and after passed examination, are fitted into compound membrane bag, are made 1000 bags, every bag of 2g or
2000 bags are made, every bag of 1g.
Embodiment 2
A kind of arbidol and its salt dry suspensoid agent, take arbidol hydrochloride 200g, Arabic gum 20g, hydroxy propyl cellulose
Plain 20g, mannitol 180g, aspartame 2.0g, sucrose 1560g and peach flavor 10g, 0.03% lemon yellow pigment aqueous solution
In right amount；Arbidol hydrochloride is controlled into partial size D90:1~20 μm, sucrose, mannitol crushed 80 mesh；Arabic gum, hydroxypropyl
Cellulose, aspartame, peach flavor smash it through 100 meshes respectively；Sucrose, mannitol are sufficiently mixed, and are added 0.03%
Lemon yellow pigment aqueous solution softwood processed in right amount, the granulation of 32 meshes, 50 DEG C drying 90 minutes, cross 28 mesh sieves, addition hydrochloric acid Ah
It is uniformly mixed than Dorr, aspartame, Arabic gum, peach flavor, after passed examination, is fitted into compound membrane bag, is made
1000 bags, every bag of 2g or 2000 bags are made, every bag of 1g.
Embodiment 3
A kind of arbidol and its salt dry suspensoid agent, take arbidol hydrochloride 100g, hydroxypropyl cellulose 90g, xanthan gum
30g, sucrose 400g, mannitol 350g, aspartame 2.5g, lemon extract 10g, 0.03% lemon yellow pigment aqueous solution are appropriate；
Arbidol hydrochloride is controlled into partial size D90:1~20 μm, sucrose, mannitol crushed 80 mesh；Hydroxypropyl cellulose, xanthan gum,
Aspartame and lemon extract smash it through 100 meshes respectively；Sucrose, mannitol are sufficiently mixed, and 0.03% lemon yellow is added
Plain aqueous solution softwood processed in right amount, the granulation of 32 meshes, 50 DEG C drying 100 minutes, cross 20 mesh sieves, addition arbidol hydrochloride,
Xanthan gum, hydroxypropyl cellulose, aspartame, lemon extract are uniformly mixed, and after passed examination, are fitted into compound membrane bag, are made
1000 bags, every bag of 2g or 2000 bags are made, every bag of 1g.
Embodiment 4
A kind of arbidol and its salt dry suspensoid agent, take arbidol hydrochloride 200g, hydroxypropyl cellulose 90g, hydroxypropyl first
Cellulose 57.5g, sucrose 1000g, mannitol 640g, aspartame 2.5g and lemon extract 10g, 0.05% sunset yellow water
Appropriate solution；Arbidol hydrochloride is controlled into partial size D90:1~20 μm, aspartame, lemon extract crushing sieve with 100 mesh sieve；Sugarcane
Sugar, mannitol crushed 80 mesh；Hydroxypropyl cellulose, hydroxypropyl methylcellulose sieve with 100 mesh sieve；Sucrose, mannitol are sufficiently mixed, and are added
It is appropriate to enter 0.05% sunset yellow aqueous solution, softwood processed, 32 meshes granulation, 50 DEG C drying 180 minutes, mistake 40 mesh sieves,
Arbidol hydrochloride, hydroxypropyl cellulose, hydroxypropyl methylcellulose, aspartame, lemon extract is added to be uniformly mixed, passed examination
Afterwards, it is fitted into compound membrane bag, is made 1000 bags, every bag of 2g or be made 2000 bags, every bag of 1g.
Embodiment 5
A kind of arbidol and its salt dry suspensoid agent, take arbidol hydrochloride 200g, Arabic gum 120g, povidone 55g,
Sucrose 680g, mannitol 1112g, aspartame 3g and flavoring apple essence 10g, 0.07% Cochineal color aqueous solution are appropriate；It will
Arbidol hydrochloride controls partial size D90:1~20 μm, and aspartame, flavoring apple essence crushing sieve with 100 mesh sieve；Sucrose, mannitol powder
Broken 80 mesh of mistake；Arabic gum, povidone cross 80 meshes；Sucrose, mannitol are sufficiently mixed, and 0.07% Cochineal color water is added
Appropriate solution, softwood processed, 40 meshes granulation, 70 DEG C drying 70 minutes, cross 28 mesh sieves, addition arbidol hydrochloride, I
Primary glue, povidone, aspartame, flavoring apple essence are uniformly mixed, and after passed examination, are fitted into compound membrane bag, are made 1000 bags, often
Bag 2g is made 2000 bags, every bag of 1g.
Influence factor test: the arbidol prepared according to embodiment one and its salt dry suspensoid agent are placed in illumination
(4500LX), high temperature (60 DEG C), after high humidity (humidity 75%) 5 days, 10 days, measure respectively its arbidol hydrochloride character, content,
When in relation to substance, test result is shown in Table 1 for dissolution rate, volume sedimentation.
1 arbidol of table and its salt dry suspensoid agent influence factor test result (5 days, 10 days)
By data in table 1 it is found that arbidol provided by the invention and its salt dry suspensoid agent have high stability.
Dissolution in vitro compares: sample prepared by embodiment 1 respectively with other dry suspensoid agents, granule, tablet, capsule
Agent carries out four medium Their Dissolution Test in vitro, and is compared, and test result is shown in Table 2—Table 5.
The hydrochloric acid medium In Vitro Dissolution data (%) of each dosage formulation of 2 arbidol of table
The aqueous medium In Vitro Dissolution data (%) of each dosage formulation of 3 arbidol of table
The acetic aid medium In Vitro Dissolution data (%) of each dosage formulation of 4 arbidol of table
The phosphoric acid medium In Vitro Dissolution data (%) of each dosage formulation of 5 arbidol of table
By above-mentioned data comparison it is found that 1 sample of embodiment relative to other dosage formulations the dissolution rate in each medium
Data are high, and provable 1 sample external biological availability of the embodiment of the present invention is higher than other dosage formulations.Arbidol hydrochloride is
II class of BCS (low dissolution Thief zone drug), dissolution are the rate-limiting steps of drug absorption, and the present invention is dissolved out compared with other dosage formulations
Fastly, have the advantages that both having met formulation characteristic ensures that higher vivo biodistribution availability.
Claims (9)
1. a kind of arbidol and its salt dry suspensoid agent, which is characterized in that including arbidol hydrochloride, suspending agent, filler, rectify
Taste agent and edible pigment.Each component weight ratio are as follows:
The filler is the one or more of sucrose, mannitol.
2. a kind of arbidol as described in claim 1 and its salt dry suspensoid agent, which is characterized in that corrigent includes sweetener
And aromatic, sweetener are the one or more of mannitol, sucrose, aspartame, Sucralose；Aromatic be lemon extract,
The one or more of peach flavor, flavoring apple essence.
3. a kind of arbidol as described in claim 1 and its salt dry suspensoid agent, which is characterized in that suspending agent is Arab
One or more of glue, povidone, hydroxypropyl cellulose, xanthan gum, hydroxypropyl methylcellulose.
4. a kind of arbidol as described in claim 1 and its salt dry suspensoid agent, which is characterized in that edible pigment is lemon
The one or more of Huang, sunset yellow, Cochineal color.
5. the preparation method of a kind of arbidol according to claim 1 and its salt dry suspensoid agent, which is characterized in that including
Following steps:
(1) arbidol hydrochloride, filler and remaining component are pulverized and sieved respectively；
(2) filler is sufficiently mixed, dry then with the aqueous solution softwood containing pigment；
(3) it will be uniformly mixed, pack with pretreated arbidol hydrochloride, suspending agent, corrigent after the particle whole grain after drying
.
6. preparation method according to claim 5, which is characterized in that the preparation step (1) further comprises:
It is D90:250~280 μm that arbidol hydrochloride, which controls partial size,；D50:80~150 μm；D10:5~15 μm；
Preferably, D90:75~100 μm；D50:40~60 μm；D10:1~3 μm；
Preferably, D90:1~20 μm；D50:2~8 μm；D10:0.5~2 μm.
7. preparation method according to claim 5, which is characterized in that the preparation step (1) further comprises:
Filler smashes it through 80 meshes, and suspending agent crushing sieves with 100 mesh sieve, and corrigent crushing sieves with 100 mesh sieve.
8. preparation method according to claim 5, which is characterized in that the preparation step (2) further comprises:
Filler is uniformly mixed, and with 0.03%~0.07% pigment aqueous solution softwood, is crossed 32~40 meshes and is pelletized, and 50~70 DEG C
It is 60~180 minutes dry.
9. preparation method according to claim 5, which is characterized in that the preparation step (3) further comprises:
After particle crosses 20~40 mesh sieves after drying, pretreated arbidol hydrochloride, suspending agent, corrigent is added, mixes
Uniformly, it packs up to the arbidol dry suspensoid agent.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201910381378.3A CN110522733A (en) | 2015-11-06 | 2015-11-06 | A kind of arbidol and its salt dry suspensoid agent and preparation method thereof |
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| CN201510747224.3A CN105250223A (en) | 2015-11-06 | 2015-11-06 | Dry suspension containing Arbidol and salt thereof as well as preparation method of dry suspension |
| CN201910381378.3A CN110522733A (en) | 2015-11-06 | 2015-11-06 | A kind of arbidol and its salt dry suspensoid agent and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115463098A (en) * | 2022-06-28 | 2022-12-13 | 则正(上海)生物科技有限公司 | Arbidol-containing particles, preparation method and application thereof, and arbidol dry suspension |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN112315957A (en) * | 2016-07-29 | 2021-02-05 | 山东金瑞生物科技有限公司 | Compound preparation for preventing and treating chicken respiratory tract mixed infection and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101912368A (en) * | 2010-09-26 | 2010-12-15 | 上海理工大学 | Compound cefaclor suspension and preparation method thereof |
| CN102000030A (en) * | 2010-11-08 | 2011-04-06 | 东北制药（沈阳）科技发展有限公司 | Arbidol dry suspension and preparation method thereof |
| CN103230391A (en) * | 2013-01-24 | 2013-08-07 | 辽宁亿灵科创生物医药科技有限公司 | Bicyclol solid preparation |
-
2015
- 2015-11-06 CN CN201910381378.3A patent/CN110522733A/en active Pending
- 2015-11-06 CN CN201510747224.3A patent/CN105250223A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101912368A (en) * | 2010-09-26 | 2010-12-15 | 上海理工大学 | Compound cefaclor suspension and preparation method thereof |
| CN102000030A (en) * | 2010-11-08 | 2011-04-06 | 东北制药（沈阳）科技发展有限公司 | Arbidol dry suspension and preparation method thereof |
| CN103230391A (en) * | 2013-01-24 | 2013-08-07 | 辽宁亿灵科创生物医药科技有限公司 | Bicyclol solid preparation |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115463098A (en) * | 2022-06-28 | 2022-12-13 | 则正(上海)生物科技有限公司 | Arbidol-containing particles, preparation method and application thereof, and arbidol dry suspension |
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Application publication date: 20191203 |