CN101756982B - Artesunate compound medicine composition with improved mouth feeling and high stability - Google Patents
Artesunate compound medicine composition with improved mouth feeling and high stability Download PDFInfo
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- CN101756982B CN101756982B CN 200810233375 CN200810233375A CN101756982B CN 101756982 B CN101756982 B CN 101756982B CN 200810233375 CN200810233375 CN 200810233375 CN 200810233375 A CN200810233375 A CN 200810233375A CN 101756982 B CN101756982 B CN 101756982B
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Abstract
The invention belongs to the field of preparations, in particular to an artesunate compound medicine composition with improved mouth feeling and high stability. The invention is characterized in that 1) the artesunate compound medicine composition comprises three kinds of granules: artesunate granules, alkaline matter granules and camoquin granules; and 2) the lagging cover is realized through polymer materials, and the artesunate granules are separated from the alkaline matter granules and the camoquin granules. The medicine composition improves the release speed of the artesunate, inhibits the bitterness of the camoquin, and simultaneously maintains the stability of the artesunate.
Description
Technical field
The invention belongs to formulation art, be specifically related to a kind of mouthfeel and stable, pharmaceutical composition of improving, comprise 1) contain three kinds of granules: artesunate granule, alkaline matter granule, Camoquin granule; 2), artesunate granule and alkaline matter granule, Camoquin granule are isolated through the macromolecular material coating.This pharmaceutical composition improves the bitterness of artesunate rate of release and Camoquin, has kept the stability of artesunate simultaneously.
Background of invention:
Malaria is one of the most common disease in the torrid zone, subtropical zone.In many third world countries, the M & M of malaria is still high.Malaria still is distributed in more than 100 countries and regions, the whole world at present.WHO in 1998 estimates that the whole world has 3 one 5 hundred million people to catch malaria every year; Because of these about 3,000,000 people that die that die of illness, 90% dead patient occurs in Africa, and wherein child below 5 years old surpasses 90% in Africa; Malaria is murdered 3000 children every day, murders 1,000,000 children in 1 year in Africa.1999-2002 receives malaria to threaten the population change situation to show in different prevalence rates area: what variation was the fastest, growth is maximum is African area and south east asia.The regional compromised population in Africa rises to 600,000,000 5 thousand ten thousand in 20th century from 6,000,000, lives in the high popular district of malaria and the district of being very popular more than 80%.
Stick up although African malaria is ferocious, because of economy is backward relatively, the cheap chloroquine of the long-term a large amount of uses of people is treated as a line medicine.Because of excessive life-time service chloroquine, more than 80 country produced drug resistance to malaria in the whole world to chloroquine and derivant thereof, Southeast Asia and African most of areas chloroquine to plasmodium oneself invalid [2].It is dead closely related to the increase of chloroquine drug resistance with plasmodium that a large amount of children in Africa suffer from malaria.
Consider African economy bear can be sharp prerequisite under, in order to suppress African malaria epidemic situation, reduce African plasmodial drug resistance, WHO proposes the scheme of reform traditional treatment malaria, recommending to adopt with the artemisinin-based drug is the drug combination on basis, is called for short the ACT therapy.The ACT therapeutic scheme that WHO recommends comprises: Ah not caye/Herba Artemisiae Annuae is bluffed extremely, Artemether/LUMEFANTRINE (Coartem), SP (sulfadoxine/pyrimethamine)/artesunate, mefloquine/artesunate.Existing 40 the national artesunate in the whole world mainly act on the wireless body of plasmodium erythrocytic stage at present, and model of action mainly is to disturb pellicle one mitochondrial function.It has following effect characteristics: (1) is effective to anti-chloroquine pernicious malaria; (2) can kill plasmodium erythrocytic stage phorozoon fast, control malaria symptom; (3) compare with other antimalarial, the effect of paying of this product is little.This product half-life of its shortcoming is short, the treatment short course of treatment (3 days), and parasite killing is not thorough, and the protozoon recrudescence rate is high, and need extend the period of treatment (6-7 days) could thoroughly be killed plasmodium and improve cure rate.Compare with other antimalarial, its price comparison is expensive.
The amodiaquine structure is similar with chloroquine with effect, can effectively kill various plasmodium phorozoons in the erythrocytic stage, and the ripe gametocyte of tertian malaria, quartan malaria and ovale malaria is also had certain effect, but then invalid to the infrared phase plasmodium of the paulospore in the hepatocyte.It has following effect characteristics: (1) is effective to anti-chloroquine pernicious malaria; (2) various plasmodial phorozoons in the blood all there is stronger killing action, can controls clinical symptoms rapidly, the ripe gametocyte and the immature Plasmodium falciparum gametocyte of tertian malaria, quartan malaria and ovale malaria also had killing action; (3) cheap.This product toxicity of its shortcoming is bigger than other antimalarial.Because amodiaquine is cheap, determined curative effect and toleration are good when being used to treat malaria, thus in African area will its as a line malaria medicine for treatment.
What WHO proposed is that basic conventional medicament is united use with the artesunate, is to tackle the chemical sproof effective way of pernicious malaria.Artesunate can reduce the multi-drug resistant plasmodium rapidly, and the nubbin plasmodium just can be killed by the combination medicine of high concentration (for example Ah not caye), and the medication combined use of different effects mechanism has improved curative effect.Simultaneously and since curative effect of medication high with the minimizing of gametocyte quantity, can weaken malaria transmission, and plasmodium is also lower to two kinds of all drug-fast probabilities of medicine, the plasmodium drug resistance should be quite slow due to the drug combination.Therefore the cruel drug combination treatment of amodiaquine and Herba Artemisiae Annuae glass malaria very effectively.
At present, the packing method of drug combination is that two kinds of different drug are pressed on the same bubble cap tray in the world, needs when patient takes two kinds of different pharmaceuticals are taken out, and quantitatively takes, and perhaps is pressed into double-layer tablet.
But tablet all is unfavorable for baby and children taking, poor compliance.In order to improve the compliance of baby and child patient; The inventor attempts developing granule, but the suitable hardship of Camoquin taste is not suitable for taking of baby and child; In order to cover the bitterness of Camoquin, add the bitterness that alkaline matter is covered Camoquin.But, find that but alkaline matter and Camoquin all influence the stability of artesunate.Therefore,, adopt the granule coating technology,, obtained the simultaneously stable again artesunate of existing good mouthfeel and the compositions of amodiaquine artesunate and Camoquin and alkaline matter and artesunate isolation through research.Surprisingly, compare with granule with common artesunate tablet, the dissolution of compositions artesunate of the present invention is greatly improved, and has greatly shortened onset time, has produced unexpected effect.
Artesunate is insoluble in water, and common artesunate tablet need be at 1000ml water, and 100r/min just can reach dissolution preferably under 30 minutes the so very exacting terms.The inventor is unexpected to find compositions of the present invention, artesunate can be at 100ml water, 50r/min, and 5 minutes dissolution reaches more than 80%, shortens clinical onset time more.
Summary of the invention:
This patent relates to a kind of mouthfeel and stable pharmaceutical composition of improving, and comprising:
1) contains three kinds of granules: the granule of the granule of artesunate or its pharmaceutically acceptable salt, alkaline matter granule and amodiaquine hydrochlorate or other pharmaceutically acceptable salt;
2) the macromolecular material sealing coat of suitable coating is arranged between the granule of the granule of artesunate or its pharmaceutically acceptable salt and alkaline matter granule, amodiaquine hydrochlorate or other pharmaceutically acceptable salt.
Pharmaceutical composition of the present invention, the macromolecular material of described suitable coating is selected from one or more in the following material: hydroxypropyl emthylcellulose, hydroxypropyl cellulose, Polyethylene Glycol, polyvinylpyrrolidone, glucosan, HPMCP, cellulose acetate phthalate and ethyl cellulose.
Pharmaceutical composition of the present invention, described macromolecular material is selected from one or more in the following material: HPMC, like HPMCE5; Hydroxypropyl cellulose; Glucosan is like dextran; Polyvinyl alcohol is like OpadryII85F19250 (main component is a polyvinyl alcohol); Polyvinylpyrrolidone is like PVP K29/32.
Macromolecular material of the present invention is HPMC E5, dextran, OpadryII85F19250 (main component is a polyvinyl alcohol) or PVP K29/32 (polyvinylpyrrolidone)
Pharmaceutical composition of the present invention; The macromolecular material sealing coat of described suitable coating is meant uses the macromolecular material coating with the artesunate granule; Perhaps alkaline matter granule and Camoquin granule are used macromolecule coating material coating respectively; Thereby artesunate granule and alkaline matter granule and Camoquin granule are isolated, contact with Camoquin with alkaline matter, influence the stability of artesunate to prevent said composition artesunate during long-term storage; Wherein, coating weightening finish 5-50%, preferred 10-30%, more preferably 20%.
Pharmaceutical composition of the present invention, said alkaline matter are salt of weak acid, preferred sodium bicarbonate, sodium carbonate.In one embodiment; A kind of mouthfeel and stable pharmaceutical composition of improving of the present invention; The alkaline matter granule that comprises artesunate granule, Camoquin granule and salt of weak acid; The macromolecular material sealing coat that suitable coating wherein, is arranged between the alkaline matter granule of artesunate granule and Camoquin granule and salt of weak acid.The alkaline matter of described salt of weak acid is sodium bicarbonate or sodium carbonate.Described macromolecule coating material comprises: hydroxypropyl emthylcellulose, hydroxypropyl cellulose, Polyethylene Glycol, polyvinylpyrrolidone, glucosan, HPMCP, cellulose acetate phthalate or ethyl cellulose; Preferred HPMC, hydroxypropyl cellulose glucosan, polyvinyl alcohol, polyvinylpyrrolidone; HPMC E5; More preferably HPMC E5, dextran, OpadryII85F19250 (main component is a polyvinyl alcohol), PVP K29/32 (polyvinylpyrrolidone).
In a preferred specific embodiments; A kind of mouthfeel and stable pharmaceutical composition of improving of the present invention; Comprise artesunate granule, Camoquin granule and sodium bicarbonate or sodium carbonate particle; Wherein, there is one deck to be suitable for the macromolecular material sealing coat of coating between artesunate granule and Camoquin granule and sodium bicarbonate or the sodium carbonate particle.Described macromolecular material is HPMC, hydroxypropyl cellulose, glucosan, polyvinyl alcohol, polyvinylpyrrolidone; Preferred HPMC E5, dextran, OpadryII85F19250 (main component is a polyvinyl alcohol), PVP K29/32 (polyvinylpyrrolidone).
In above-mentioned specific embodiments; The macromolecular material sealing coat of said suitable coating is meant with macromolecular material sodium bicarbonate particle or sodium carbonate particle (salt of weak acid alkaline matter granule) and Camoquin granule is adopted macromolecule coating material coating respectively, makes it to isolate with the artesunate granule; Perhaps with macromolecular material with the artesunate granule coating, make it to isolate with sodium bicarbonate particle or sodium carbonate particle (salt of weak acid alkaline matter granule) and Camoquin granule.
Pharmaceutical composition of the present invention, described artesunate granule, alkaline matter granule (like sodium bicarbonate particle or sodium carbonate particle) and Camoquin granule granule, its size is the 10-100 order, preferred 24-60 order.
Pharmaceutical composition of the present invention; Wherein, said artesunate granule, alkaline matter granule (like sodium bicarbonate particle or sodium carbonate particle) and Camoquin granule granule can adopt pharmaceutic adjuvant and the manufacturing technology of conventional granule of the routine of ability to prepare.
Coating of the present invention adopts equipment commonly used in the preparation to come coating, for example, and coating pan, high-efficiency coating machine, fluid bed, wherein preferred fluidized bed coating.
Pharmaceutical composition of the present invention can prepare becomes granule, dry suspension, capsule, dosage forms such as tablet.
In order to realize the object of the invention, add filler, lubricant pharmaceutically commonly used in case of necessity, flavouring agent, sweeting agent, plasticizer, color lake etc., said filler is starch, lactose, sucrose, Celluloasun Microcrystallisatum, preferred starch, lactose or sucrose.
Compositions of the present invention realizes by following preparation scheme:
1, earlier artesunate, Camoquin and alkaline matter are mixed with pharmaceutically conventional adjuvant such as starch, lactose, sucrose, Celluloasun Microcrystallisatum and flavouring agent or sweeting agent etc. respectively; The binding agent that adds water or ethanol dilution mixes; Process the granule of 10-100 purpose size; Oven dry makes artesunate granule, Camoquin granule and alkaline matter granule respectively;
2, macromolecule coating material water or ethanol or ethanol water are dissolved into coating solution;
3, the artesunate granule with step 1 gathers 2 coating solution coating with the step, makes grain growth 5-50%, and preferred 10-30% more preferably increases weight 20%, obtains the artesunate coated granule, wherein, and the preferred fluidized bed coating of coating;
4, the artesunate coated granule mixes with the amodiaquine granule and the alkaline matter granule of step 1, and pack promptly gets.
In the step 1 of such scheme, the preferred 24-60 order of artesunate granule, amodiaquine granule and the particulate size of alkaline matter.
Compositions of the present invention also can realize by following another kind of preparation scheme:
1, earlier artesunate, Camoquin and alkaline matter are mixed with pharmaceutically conventional adjuvant such as starch, lactose, sucrose, Celluloasun Microcrystallisatum etc. respectively; The binding agent that adds water or ethanol dilution mixes; Process the granule of 10-100 purpose size; Oven dry makes artesunate granule, Camoquin granule and alkaline matter granule respectively;
2, macromolecule coating material water or ethanol or ethanol water are dissolved into coating solution;
3, Camoquin granule and the alkaline matter granule with step 1 gathers 2 coating solution coating respectively with the step, makes grain growth 5-50%, preferred 10-30%; More preferably increase weight 20%; Obtain amodiaquine coated granule and alkaline matter coated granule, wherein, the preferred fluidized bed coating of coating.
4, amodiaquine hydrochloride coating granule and alkaline matter coated granule mix with the artesunate granule of step 1, and pack promptly gets.
In the step 1 of such scheme, the preferred 24-60 order of artesunate granule, Camoquin granule and the particulate size of alkaline matter.
Prepare in the scheme at above-mentioned two kinds, alkaline matter is a salt of weak acid, preferred sodium carbonate or sodium bicarbonate; The macromolecule coating material comprises: hydroxypropyl emthylcellulose, hydroxypropyl cellulose, Polyethylene Glycol, polyvinylpyrrolidone, glucosan, HPMCP, cellulose acetate phthalate or ethyl cellulose; Preferred HPMC, hydroxypropyl cellulose glucosan, polyvinyl alcohol, polyvinylpyrrolidone; HPMC E5; More preferably HPMC E5, dextran, OpadryII85F19250 (main component is a polyvinyl alcohol), PVP K29/32 (polyvinylpyrrolidone).
Pharmaceutical composition of the present invention, not only stable, and mouthfeel is good, more making us unimaginable is that the rate of release of artesunate is compared with common artesunate tablet or granule and had greatly improved, and dissolution time is short, and onset is faster.
Embodiment:
Below be embodiments of the invention, but do not represent that the present invention is limited to following examples.
Embodiment 1:
Technology:
Granule 1: artesunate, lactose, starch mix homogeneously, 10% starch slurry is granulated, and 50 ℃ of dryings are got 24-60 order granule, and are subsequent use.
Granule 2: Camoquin, lactose, starch mix homogeneously, suitable quantity of water are granulated, and 60 ℃ of dryings are got 24-60 order granule, 50% the ethanol coating weightening finish 20% of 6% HPMC E5.
Granule 3: sodium bicarbonate,, lactose, starch mix homogeneously, 50% alcohol granulation, 40 ℃ of dryings are got 24-60 order granule, 50% the ethanol coating weightening finish 20% of 6% HPMC E5.
Measure the content of granule 1 and granule 2 and granule 3, by every bag of artesunate 25mg, amodiaquine 67.5mg, sodium bicarbonate 32mg pack.
Embodiment 2
Granule 1: artesunate, lactose, starch mix homogeneously, 10% starch slurry is granulated, and 50 ℃ of dryings are got 24-60 order granule, 20% dextran coating, coating weightening finish 20%.
Granule 2: Camoquin, lactose, starch mix homogeneously, suitable quantity of water is granulated, and 60 ℃ of dryings are got 24-60 order granule, and are subsequent use.
Granule 3: sodium bicarbonate, lactose, starch mix homogeneously, 50% alcohol granulation, 40 ℃ of dryings are got 24-60 order granule, and are subsequent use.
Measure the content of granule 1 and granule 2 and granule 3, by every bag of artesunate 25mg, amodiaquine 67.5mg, sodium carbonate particle 20mg pack.
Embodiment 3
Granule 1: artesunate, lactose, starch mix homogeneously, 10% starch slurry is granulated, and 50 ℃ of dryings are got 24-60 order granule
Granule 2: Camoquin, lactose, starch mix homogeneously, suitable quantity of water is granulated, and 60 ℃ of dryings are got 24-60 order granule, 20% PVP K29/32 aqueous solution coating, coating weightening finish 20%.
Granule 3: sodium bicarbonate, lactose, starch mix homogeneously, 50% alcohol granulation, 40 ℃ of dryings are got 24-60 order granule, 20% PVP K29/32 aqueous solution coating, coating weightening finish 20%.
Measure the content of granule 1 and granule 2 and granule 3, by every bag of artesunate 25mg, amodiaquine 67.5mg, sodium bicarbonate 32mg pack.
Embodiment 4:
Granule 1: artesunate, lactose, starch mix homogeneously, 10% starch slurry is granulated, and 50 ℃ of dryings are got 24-60 order granule
Granule 2: Camoquin, lactose, starch mix homogeneously, suitable quantity of water is granulated, and 60 ℃ of dryings are got 24-60 order granule, 20% OpadryII85F19250 aqueous dispersions coating, coating weightening finish 20%.
Granule 3: sodium bicarbonate, lactose, starch mix homogeneously, 50% alcohol granulation, 40 ℃ of dryings are got 24-60 order granule, 20% OpadryII85F19250 aqueous dispersions coating, coating weightening finish 20%.
Measure the content of granule 1 and granule 2 and granule 3, by every bag of artesunate 25mg, amodiaquine 67.5mg, sodium bicarbonate 32mg pack.
Embodiment 5
Granule 1: artesunate, lactose, starch mix homogeneously, 10% starch slurry is granulated, and 50 ℃ of dryings are got 24-60 order granule, 20% OpadryII85F19250 aqueous dispersions coating, coating weightening finish 20%
Granule 2: Camoquin, lactose, starch mix homogeneously, suitable quantity of water is granulated, and 60 ℃ of dryings are got 24-60 order granule.
Granule 3: sodium bicarbonate, lactose, starch mix homogeneously, 50% alcohol granulation, 40 ℃ of dryings are got 24-60 order granule.
Measure the content of granule 1 and granule 2 and granule 3, by every bag of artesunate 25mg, amodiaquine 67.5mg, sodium bicarbonate 32mg pack.
The comparative example 1
Granule 1: artesunate, lactose, starch mix homogeneously, 10% starch slurry is granulated, and 50 ℃ of dryings are subsequent use.
Granule 2: Camoquin, lactose, starch mix homogeneously, suitable quantity of water is granulated, and 60 ℃ of dryings are got 24-60 order granule.
Granule 3: sodium bicarbonate,, lactose, starch mix homogeneously, 50% alcohol granulation, 40 ℃ of dryings are got 24-60 order granule.
Measure the content of granule 1 and granule 2 and granule 3, by every bag of artesunate 25mg, amodiaquine 67.5mg, sodium bicarbonate 32mg pack.
The comparative example 2
Granule 1: artesunate, lactose, starch mix homogeneously, 10% starch slurry is granulated, and 50 ℃ of dryings are subsequent use.
Granule 2: Camoquin, lactose, starch mix homogeneously, suitable quantity of water is granulated, and 60 ℃ of dryings are got 24-60 order granule.
Measure the content of granule 1 and granule 2, by every bag of artesunate 25mg, amodiaquine 67.5mg pack.
With embodiment 1, embodiment 2, and embodiment 3, and embodiment 4 investigates 10 days at 60 ℃, with reference to " result is following for 2005 editions artesunate tablet determination of related substances of Chinese pharmacopoeia method, the related substance of artesunate among mensuration the present invention:
Thus it is clear that, can improve the stability of artesunate through the present invention.
Embodiment 1-5 and contrast are implemented 2 with 100ml, water, 37 ℃, 50r/min, little agar diffusion method do release respectively at different time 5,10,20,30,45,60 minutes release degree.The result is following:
Thus it is clear that, the release degree of artesunate was reached more than 80% at 5 minutes through the present invention.
Embodiment 1-5 is implemented 2 with contrast be dissolved in the 20ml warm water, the volunteer attempts mouthfeel.The result is following:
| Mouthfeel | |
| Embodiment 1 | Sweetness, the back is not bitter |
| Embodiment 2 | Sweetness, the back is not bitter |
| Embodiment 3 | Sweetness, the back is not bitter |
| Embodiment 4 | Sweetness, the back is not bitter |
| Embodiment 5 | Sweetness, the back is not bitter |
| Comparison example 2 | Earlier pleasantly sweet, the back is bitter serious, can not accept |
Thus it is clear that, can cover the bitterness of Camoquin through the present invention.
Claims (6)
1. one kind is improved mouthfeel and stable pharmaceutical composition, comprising:
1) contains three kinds of granules: the granule of the granule of artesunate or its pharmaceutically acceptable salt, alkaline matter granule and amodiaquine hydrochlorate or other pharmaceutically acceptable salt;
2) the macromolecular material sealing coat of suitable coating is arranged between the granule of the granule of artesunate or its pharmaceutically acceptable salt and alkaline matter granule, amodiaquine hydrochlorate or other pharmaceutically acceptable salt; With macromolecular material coating artesunate granule; Artesunate granule and alkaline matter granule and Camoquin granule are isolated; Or with macromolecular material with alkaline matter granule and Camoquin granule coating, make it and artesunate is isolated, wherein; Said suitable macromolecular material is HPMC, hydroxypropyl cellulose, glucosan, polyvinyl alcohol or polyvinylpyrrolidone, and said alkaline matter is sodium bicarbonate or sodium carbonate.
2. pharmaceutical composition according to claim 1, said macromolecular material, wherein, said HPMC is that HPMC E5, said glucosan are that dextran, said polyvinyl alcohol are that Opadry II 85F19250 or said polyvinylpyrrolidone are PVP K29/32.
3. pharmaceutical composition according to claim 1 and 2 is characterized in that: the coating weightening finish is 5-50%.
4. pharmaceutical composition according to claim 3 is characterized in that: the coating weightening finish is 10-40%.
5. pharmaceutical composition according to claim 4 is characterized in that: the coating weightening finish is 30%.
6. pharmaceutical composition according to claim 1, the dosage form of said composition are granule, dry suspension, capsule, tablet.
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| CN 200810233375 CN101756982B (en) | 2008-12-17 | 2008-12-17 | Artesunate compound medicine composition with improved mouth feeling and high stability |
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| CN 200810233375 CN101756982B (en) | 2008-12-17 | 2008-12-17 | Artesunate compound medicine composition with improved mouth feeling and high stability |
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| CN101756982B true CN101756982B (en) | 2012-07-04 |
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| CN102397262B (en) * | 2010-09-15 | 2015-07-15 | 重庆医药工业研究院有限责任公司 | Amoxicillin sustained release solid medicinal composition and preparation method thereof |
| CN103463120B (en) * | 2013-09-03 | 2015-10-28 | 福州闽海药业有限公司 | A kind of stable type compound vitamin B tablet and preparation method thereof |
| CN105380948A (en) * | 2015-11-27 | 2016-03-09 | 浙江华立南湖制药有限公司 | Dihydroartemisinin piperaquine dry suspension agent and preparation process thereof |
| CN112263550A (en) * | 2020-10-27 | 2021-01-26 | 福元药业有限公司 | Artesunate granules and preparation method thereof |
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| CH696229A5 (en) * | 2006-05-13 | 2007-02-28 | Professeur Dr Achille Benakis | Antimalarial composition in geometrical solid tablet form obtained by the compression of a medicine powder and excipients, useful to treat malaria, comprises three separate layers |
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| WO2005023304A2 (en) * | 2003-09-04 | 2005-03-17 | Cipla Limited | Antimalarial compositions and manufacturing process thereof |
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| CN101756982A (en) | 2010-06-30 |
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