CN107137394A - Coartem dry suspensoid agent of two-component treatment malaria and preparation method thereof - Google Patents
Coartem dry suspensoid agent of two-component treatment malaria and preparation method thereof Download PDFInfo
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- CN107137394A CN107137394A CN201710341422.9A CN201710341422A CN107137394A CN 107137394 A CN107137394 A CN 107137394A CN 201710341422 A CN201710341422 A CN 201710341422A CN 107137394 A CN107137394 A CN 107137394A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/357—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having two or more oxygen atoms in the same ring, e.g. crown ethers, guanadrel
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Abstract
The present invention discloses a kind of Coartem dry suspensoid agent of two-component treatment malaria and preparation method thereof, it is characterised in that：Preparing raw material includes：Supplementary material：The parts by weight of Artemether 0.05 0.10, the parts by weight of LUMEFANTRINE 0.2 0.8, the parts by weight of sucrose 2.5 4, the parts by weight of lactose 23, the parts by weight of Aspartame 0.05 0.3, the parts by weight of sodium carboxymethylcellulose 0.05 0.15, the parts by weight of 60% ethanol 12；Additional auxiliary material：The parts by weight of xanthans 0.03 0.10, the parts by weight of cocoanut flavour 0.03 0.10, the parts by weight of fresh cream 0.03 0.10, the parts by weight of silica 0.15 0.35.The present invention has the fresh and sweet fragrance of entrance, and children are orally easily accepted by, action effect clear advantage.
Description
Technical field
The present invention relates to the technical field for the treatment of malaria, specially two-component treats the Coartem dry suspensoid agent of malaria
And preparation method thereof.
Background technology
Malaria is the blood through bite by mosquitos or input tape plasmodium person and infects the insect-borne infectious disease caused by plasmodium.
This disease is mainly shown as that periodic regularity breaks out, and goes cold all over, generates heat, hidrosis, after long-term repeatedly breaking-out, can cause anaemia and spleen
Enlargement.Current antimalarial can select qinghaosu, Artemether, Artesunate etc. and prepare.But majority use artemisine or
It is prepared by the single preparationss of ephedrine such as its derivative species of person, although artemisinin derivatives to treatment malaria play the role of it is good, still
Therapeutic effect can sometimes be affected because of single preparations of ephedrine, addition, administration form, stability of transportation etc., special
Be not the undesirable area of Africa contour temperature arid, sanitary condition, with greater need for it is a kind of can suitable children taking and good mouthfeel
Treat the medicine of malaria.
The content of the invention
In view of the deficiencies of the prior art, the present invention provides a kind of fresh and sweet fragrance of entrance, children are orally easily accepted by, action effect
Obvious two-component treats the Coartem dry suspensoid agent of malaria.
In order to solve the above-mentioned technical problem, the technical solution adopted by the present invention is：A kind of two-component treats the compound of malaria
Artemether dry suspensoid agent, preparing raw material includes：Supplementary material：Artemether 0.05-0.10 parts by weight, LUMEFANTRINE (lumefantrine) 0.2-
0.8 parts by weight, sucrose 2.5-4 parts by weight, lactose 2-3 parts by weight, Aspartame 0.05-0.3 parts by weight, sodium carboxymethylcellulose
0.05-0.15 parts by weight, 60% ethanol 1-2 parts by weight；Additional auxiliary material：Xanthans 0.03-0.10 parts by weight, cocoanut flavour
0.03-0.10 parts by weight, fresh cream 0.03-0.10 parts by weight, silica 0.15-0.35 parts by weight.
Preferably, the two-component of the present invention treats the Coartem dry suspensoid agent of malaria, preparing raw material includes：It is former auxiliary
Material：Artemether 0.06-0.09 parts by weight, LUMEFANTRINE 0.4-0.6 parts by weight, sucrose 3-4 parts by weight, lactose 2-3 parts by weight, A Si
Ba Tian 0.15-0.25 parts by weight, sodium carboxymethylcellulose 0.05-0.10 parts by weight, 60% ethanol 1-2 parts by weight；Additional auxiliary material：
Xanthans 0.04-0.06 parts by weight, cocoanut flavour 0.06-0.08 parts by weight, fresh cream 0.06-0.08 parts by weight, silica
0.20-0.30 parts by weight.
The Coartem dry suspensoid agent of malaria, preparing raw material bag are treated as further preferred, of the invention two-component
Include：Supplementary material：Artemether 0.08-0.09 parts by weight, LUMEFANTRINE 0.5-0.6 parts by weight, sucrose 3.5-4 parts by weight, lactose 2-3 weights
Measure part, Aspartame 0.18-0.22 parts by weight, sodium carboxymethylcellulose 0.08-0.10 parts by weight, 60% ethanol 1.5-2 weight
Part；Additional auxiliary material：Xanthans 0.05-0.06 parts by weight, cocoanut flavour 0.07-0.08 parts by weight, fresh cream 0.07-0.08 weight
Part, silica 0.25-0.30 parts by weight.
The present invention realizes that two-component acts synergistically using two kinds of major ingredients of Artemether and LUMEFANTRINE, substantially increases treatment malaria
Curative effect；The two be by add other auxiliary materials, mutually collaboration, interaction obtain dry suspensoid agent mode final drug,
And not the two simple tablet mixing, the final drug performance of acquisition is more stablized, is readily transported, is unlikely to deteriorate, and system
The pharmaceutical property of standby final drug is more efficient, and cure rate even can reach 100%.
The present invention is used as flavor enhancement, filler by sucrose, using lactose as filler, using Aspartame as strong
Taste agent, can make dry suspension rapid split in gastro-intestinal Fluid be broken into the thing of fine particle using sodium carboxymethylcellulose as disintegrant
Matter, so that the rapid solution absorption of functional component, playing a role；Removed using 60% ethanol as wet granular processed, final drying,
Using xanthans as suspending agent, using cocoanut flavour and fresh cream as flavor enhancement, glidant is used as using silica；It is logical
Being mutually mixed, cooperateing with for various raw materials is crossed, a kind of fresh and sweet fragrance of entrance is obtained, children are orally easily accepted by, and action effect is obvious
Two-component treat malaria Coartem dry suspensoid agent.
The present invention also provides a kind of preparation method of the Coartem dry suspensoid agent of above-mentioned two-component treatment malaria, specifically
Preparation process include：
(1) it is with slurry：It is configured to 60% ethanol solution (percent by volume) with purified water, then by Aspartame and carboxylic first fiber
It is standby that plain sodium is added thereto dissolving；
(2) pelletize：Artemether, sucrose were crushed into 80-120 mesh sieves respectively, then with other supplementary material equal increments methods
It is placed in mixer and is well mixed after mixing；Add suitable amount of adhesive stirring and suitable softwood is made, with 15-30 mesh nylon sieve series
Grain；
(3) dry：50-70 DEG C of drying 2~3 hours；
(4) whole grain, total mixed：Add additional auxiliary material and cross mixing after 20 mesh sieve whole grains, pellet moisture is below 2%.
The advantages of the present invention：
1. the two-component of the present invention treats the Coartem dry suspensoid agent of malaria, by rational formula and each composition
The use of specific consumption proportion and component each other, the product of acquisition has character stable, entrance is fresh and sweet fragrance, children mouthful
Clothes are easily accepted by, and action effect is obvious.
2. the two-component of the present invention treats the Coartem dry suspensoid agent of malaria, addition sodium carboxymethylcellulose and dioxy
The components such as SiClx are mutually cooperateed with, and are obtained dry suspensoid agent and are easier the good therapeutic effect that is absorbed by the body and obtains, while may be used also
To ensure the stability of dry suspensoid agent, it is not easy to occur denaturalization phenomenon.
3. the preparation method of the present invention, by reasonably controlling the order of addition of each material and the granularity of material to want
Control asked etc., prepares the Coartem dry suspensoid agent that final two-component treats malaria, what the preparation method was obtained
Final products, which have, to be easy to preserve, conveniently transports and the advantage in good taste for being more suitable for children taking.
Brief description of the drawings
The embodiment process chart of accompanying drawing 1.
Embodiment
The present invention is described in further detail below by specific embodiment, but the present invention is not limited solely to following reality
Apply example.The person skilled in the art in the field according to present invention to some nonessential modifications and adaptations for making of the present invention still
Belong to protection scope of the present invention.
Experimental raw used unless otherwise instructed, can be obtained easily from commercial company in the present embodiment.
Embodiment
Preparing raw material (by every bottle of 180mg containing Artemether, the contained design of 1080mg/60ml/ bottles of prescriptions of LUMEFANTRINE), specifically such as
Shown in table 1 below：
Table 1
Specifically preparation method is：
1. it is with slurry：60% ethanol solution is prepared with purified water, then Aspartame and carmethose is added thereto molten
Solution is standby；
2. granulation：Artemether, sucrose were crushed into 100 mesh sieves respectively, then mixed with other supplementary materials with equal increments method
After be placed in mixer be well mixed；Add suitable amount of adhesive stirring and suitable softwood is made；Pelletized with 20 mesh nylon mesh；It is required that being
Fine powder；
3. dry：60 DEG C of dryings 2~3 hours；
4. it is whole grain, total mixed：Add additional auxiliary material and cross mixing after 20 mesh sieve whole grains；Below pellet moisture 2%；It must dry
It is dry；
The capital equipment of table 2
Crush：Before crushing material, the verification name of an article, specification, lot number, quantity etc. are got by batch production ordering.After confirmation is errorless,
Artemether, sucrose were crushed into 100 mesh sieves respectively.Supplementary material after crushing is stored in the middle turning barrel for being equipped with clean polybag,
Capping.Material label is enclosed, weighing weighing area is transported to.Supplementary material after crushing should be used in 10 days.
Weigh dispensing：Weigh before dispensing by batch the production ordering verification supplementary material name of an article, specification, lot number, quantity etc..Confirm nothing
After by mistake, LUMEFANTRINE, lactose are accurately weighed respectively；Vitamin B12 is by batch weighing.Check it is errorless after, material is equipped with clean plastics
In the middle turning barrel of bag, capping.Enclose material label.Relative recording is filled in production process in time；Production is cleared out a gathering place after terminating, and is filled out
Write script holder's record clearly.Supplementary material after weighing should be used in 10 days.
It is prepared by adhesive：Aspartame, sodium carboxymethylcellulose are first dissolved in appropriate purified water, recipe quantity is added
Ethanol, stir, be configured to 60% ethanol solution and make adhesive.
60% ethanol weight=(95% ethanol weight × 95%)/60%
Adhesive should be stored in the stainless steel cask of cleaning, capping.Bucket outer wall should enclose material label.
Wet granular processed：First by the Artemether of recipe quantity, cane sugar powder with equal increments method mix 3 times, then with remaining sugarcane
Sugar is put in trough type mixing machine, stirring mixing 20 minutes, is added LUMEFANTRINE, lactose, is mixed thoroughly.It is slowly added into adhesive, stirring mixing
5-15 minutes.Obtained softwood is crossed into 18 mesh nylon sieve series wet granulars with oscillating granulator.Wet granular is contained with special stainless steel container
Connect, drying on duty.
Dry whole grain：Wet granular is dispersed evenly on drip pan, is advisable with 1.5-2.0cm thickness.Per car drip pan is all installed
Afterwards, baking oven is pushed into immediately.Open blower fan and start drying, 75 DEG C of drying temperature, about 3 hours drying times.It is every to answer stirring within 1-2 hours
Once.
Additional auxiliary material xanthans, cocoanut flavour, fresh cream, silica are sequentially added in dried particle, is mixed,
Crossing before and after 14 mesh sieve whole grains, whole grain all should check whether screen cloth is broken.
It is total mixed：Particle after whole grain is added and always mixed in V-Mixer, incorporation time 15 minutes, mixer rotating speed：
12rpm。
When being mixed using mixer, material is equipped with the middle turning barrel of clean polybag by QA field samplings after mixing, plus
Lid, encloses material label, is transferred to intermediate station and waits assay.Relative recording is filled in production process in time；After production terminates
Clear out a gathering place, and fill in record of clearing out a gathering place.
Intermediate is examined：Examine qualified, QA supervisors to agree to after letting pass through QC rooms, be transferred to subsequent processing.After always mixed
Grain, should complete granule packaging in 20 days.
All intermediate control methods of table 3 and standard
The yield limit of intermediate products, and material balance computational methods and limit
The process yield that pulverizes and sieves answers >=97%, and calculation formula is as follows：
Weight/otal investment × 100% after yield=crushing
The process material balance that pulverizes and sieves should be 97-100%, and calculation formula is as follows：
Material balance=(weight+waste material weight after crushing)/otal investment × 100%
Mixed processes yield of pelletizing answers >=97%, and calculation formula is as follows：
Yield=total mixed rear particle weight/otal investment × 100%
Granulation mixed processes material balance should be 97-103%, and calculation formula is as follows：
Material balance=(total mixed rear particle weight+tailing weight+waste material weight)/otal investment × 100%
The shelf appeal of product to be packaged, including container, label and particular storage condition intermediate products are in storage, Ying Mi
Close storage；Hold-up vessel cleaning is smooth, and the sterilization of cast easy cleaning, corrosion resistant rustless steel container or cleaning bag bag are not produced
Dress.Material is not adsorbed, does not occur physically or chemically to react with material；Indicate name of product on each container, batch number,
Quantity, product quality state (qualified, unqualified, to be tested, sampled)；Humiture meets D grades of clean area (room) requirements.
The curative effect of the Coartem dry suspensoid agent of two-component treatment malaria prepared by the present invention：Patient is divided into three groups, often
100 people of group；
The Comparison of therapeutic of the product of the embodiment of the present invention of table 4 and single formulation product
| Group | 24 hours protozoon rates of descent | Number when draw protozoon is turned out cloudy | Resume combustion number of cases | Cure rate |
| Two-component of the present invention | 98.6% | 28.5h | 0 | 100% |
| LUMEFANTRINE | 65.0% | 52.2h | 10 | 90% |
| Artemether | 66.8% | 60.5h | 6 | 94% |
Using the two-component medicine of the present invention, exist before administration have a headache, dizzy, nauseous, weak and limb aching pain etc.
Symptom, turns out cloudy with protozoon normally faded away with temperature recovery upon administration, patient does not occur other adverse reactions, blood after medicine
Liquid, blood biochemistry, urinalysis and electrocardiogram etc. are checked has no obvious change upon administration.
Claims (4)
1. a kind of two-component treats the Coartem dry suspensoid agent of malaria, it is characterised in that：Preparing raw material includes：Supplementary material：
Artemether 0.05-0.10 parts by weight, LUMEFANTRINE 0.2-0.8 parts by weight, sucrose 2.5-4 parts by weight, lactose 2-3 parts by weight, A Si
Ba Tian 0.05-0.3 parts by weight, sodium carboxymethylcellulose 0.05-0.15 parts by weight, 60% ethanol 1-2 parts by weight；Additional auxiliary material：
Xanthans 0.03-0.10 parts by weight, cocoanut flavour 0.03-0.10 parts by weight, fresh cream 0.03-0.10 parts by weight, silica
0.15-0.35 parts by weight.
2. two-component according to claim 1 treats the Coartem dry suspensoid agent of malaria, it is characterised in that：Prepare former
Material includes：Supplementary material：Artemether 0.06-0.09 parts by weight, LUMEFANTRINE 0.4-0.6 parts by weight, sucrose 3-4 parts by weight, lactose 2-3
Parts by weight, Aspartame 0.15-0.25 parts by weight, sodium carboxymethylcellulose 0.05-0.10 parts by weight, 60% ethanol 1-2 weight
Part；Additional auxiliary material：Xanthans 0.04-0.06 parts by weight, cocoanut flavour 0.06-0.08 parts by weight, fresh cream 0.06-0.08 weight
Part, silica 0.20-0.30 parts by weight.
3. two-component according to claim 1 treats the Coartem dry suspensoid agent of malaria, it is characterised in that：Prepare former
Material includes：Supplementary material：Artemether 0.08-0.09 parts by weight, LUMEFANTRINE 0.5-0.6 parts by weight, sucrose 3.5-4 parts by weight, lactose
2-3 parts by weight, Aspartame 0.18-0.22 parts by weight, sodium carboxymethylcellulose 0.08-0.10 parts by weight, 60% ethanol 1.5-2
Parts by weight；Additional auxiliary material：Xanthans 0.05-0.06 parts by weight, cocoanut flavour 0.07-0.08 parts by weight, fresh cream 0.07-0.08
Parts by weight, silica 0.25-0.30 parts by weight.
4. a kind of preparation method of the Coartem dry suspensoid agent of two-component treatment malaria, it is characterised in that：It is specific to prepare
Step includes：
(1) it is with slurry：It is configured to 60% ethanol solution (percent by volume) with purified water, then by Aspartame and carmethose
It is added thereto dissolving standby；
(2) pelletize：Artemether, sucrose were crushed into 80-120 mesh sieves respectively, then mixed with other supplementary materials with equal increments method
After be placed in mixer be well mixed；Add suitable amount of adhesive stirring and suitable softwood is made, pelletized with 15-30 mesh nylon mesh；
(3) dry：50-70 DEG C of drying 2~3 hours；
(4) whole grain, total mixed：Add additional auxiliary material and cross mixing after 20 mesh sieve whole grains, pellet moisture is below 2%.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710341422.9A CN107137394A (en) | 2017-05-11 | 2017-05-11 | Coartem dry suspensoid agent of two-component treatment malaria and preparation method thereof |
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| CN201710341422.9A CN107137394A (en) | 2017-05-11 | 2017-05-11 | Coartem dry suspensoid agent of two-component treatment malaria and preparation method thereof |
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| CN201710341422.9A Pending CN107137394A (en) | 2017-05-11 | 2017-05-11 | Coartem dry suspensoid agent of two-component treatment malaria and preparation method thereof |
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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 |
| CN102949348A (en) * | 2012-11-19 | 2013-03-06 | 清远容大生物工程有限公司 | Enramycin dry suspension and preparation method thereof |
| CN104771365A (en) * | 2015-04-20 | 2015-07-15 | 程伟智 | Dexibuprofen dry suspension agent and preparation method thereof |
-
2017
- 2017-05-11 CN CN201710341422.9A patent/CN107137394A/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 |
| CN102949348A (en) * | 2012-11-19 | 2013-03-06 | 清远容大生物工程有限公司 | Enramycin dry suspension and preparation method thereof |
| CN104771365A (en) * | 2015-04-20 | 2015-07-15 | 程伟智 | Dexibuprofen dry suspension agent and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| DAFRA PHARMA INTERNATIONAL NV, BELGIUM: "EU/3/09/702: Public summary of opinion on orphan designation of beta-artemether /lumefantrine (powder for oral suspension) for the treatment of malaria", 《HTTPS://WWW.EMA.EUROPA.EU/EN/SEARCH/SEARCH?SEARCH_API_VIEWS_FULLTEXT=ARTEMETHER+LUMEFANTRINE+SUSPENSION》 * |
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