CN102283829B - Anti-malarial medicinal composition and preparation method and application thereof - Google Patents
Anti-malarial medicinal composition and preparation method and application thereof Download PDFInfo
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- CN102283829B CN102283829B CN2011101738461A CN201110173846A CN102283829B CN 102283829 B CN102283829 B CN 102283829B CN 2011101738461 A CN2011101738461 A CN 2011101738461A CN 201110173846 A CN201110173846 A CN 201110173846A CN 102283829 B CN102283829 B CN 102283829B
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- 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
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- 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 invention discloses an anti-malarial medicinal composition and a preparation method and application thereof. In the medicinal composition, artemether and lumefantrine are respectively pelletized and then are prepared into a double-layer sheet, so that the process of mixing the artemether and the lumefantrine is prevented, and the safety in the compound preparation process is ensured. In addition, the double-layer sheet can be quickly disintegrated by screening auxiliary materials in a specific preparation mode; and compared with the conventional compound tablet, the invention has the advantages that: the dissolution rate of the active ingredient of the medicinal composition is obviously improved, so that the medicinal composition has a better release behavior, contributes to the absorption of medicines better and has a better curative effect.
Description
Technical field
The present invention relates to a kind of antimalarial pharmaceutical composition and preparation method and purposes, belong to drug world.
Background technology
Malaria is a kind of parasitic disease by killing propagation, has very high M ﹠ M.At present, artemisinin-based drug is antimalarial agent the most commonly used.Artemether (Artemether), (3R, 5aS, 6R, 8aS, 9R, 10S, 12R, 12aR)-decahydro-10-methoxyl group-3,6,9-trimethyl-3,12-oxo bridge-12H-pyrans also [4,3-j]-1,2-benzo two plugs are flat, and the plasmodium schizont is had stronger kill activity, and are evident in efficacy for multiple resistant malaria and anti-chloroquine pernicious malaria.But it exists action time short again, shortcomings such as relapse rate height.And benflumetol (Lumefantrine), (9Z)-2,7-two chloro-9-[(4-chlorphenyls) methylene]-α-[(two n-butyl amine bases) methyl]-9H-fluorenes-4-methanol, it is totally thorough to kill plasmodium, the effective percentage height, relapse rate is low, but onset is slow.Therefore, antimalarial agent that both are used in combination has appearred on the market.
WO92/02217 provides a kind of new anti-malaria composition, and it has very effective malaria drug effect by the collaborative antimalarial agent that benflumetol and Artemether are formed.At present, in commercially available Artemether/benflumetol compound solid preparation, tablet form is the most common, mostly is the tablet of 20mg Artemether and 120mg benflumetol, as the medicine Coartem/Riamet of Novartis.Then, also there is the people that such compound solid preparation is improved, as number of patent application: 200780024023.4, prepared plurality of active ingredients different content tablet in this application, make things convenient for the patient to use.
But, because Artemether and benflumetol water solublity extreme difference have caused the active component absorbance of compound product lower, making that the drug effect of compound solid preparation is stable inadequately, its use is restricted.Moreover, in the production process of this compound solid preparation, also find, in benflumetol and Artemether mixed process, may produce blast, make to have certain potential safety hazard in the production process.
Summary of the invention
The object of the invention has provided a kind of antimalarial pharmaceutical composition; Another object of the present invention has provided this preparation of drug combination method and purposes.
The invention provides a kind of antimalarial pharmaceutical composition, it is the double-layer tablet that the supplementary material by the following weight proportioning is prepared from:
The Artemether layer:
20 parts of Artemether, A diluent 12-30 part, A binding agent 10-28 part, 0.5 part of lubricant;
The benflumetol layer:
120 parts of benflumetol, B diluent 40-60 part, B binding agent 8-28 part, 1.5 parts of lubricants;
Wherein, the A diluent is lactose, mannitol or carboxymethyl starch sodium, and the A binding agent is 30 POVIDONE K 30 BP/USP 30, ethyl cellulose or hyprolose, and the B diluent is pregelatinized Starch, dextrin or corn starch, the B binding agent is HANSHENGJIAO or cane sugar powder, and lubricant is magnesium stearate or polyethylene glycol 6000.
Further, Artemether layer and benflumetol layer are prepared from by the supplementary material of following weight proportion respectively:
The Artemether layer:
20 parts of Artemether, lactose 12-20 part, 30 POVIDONE K 30 BP/USP 30 20-28 parts, 0.5 part of magnesium stearate;
The benflumetol layer:
120 parts of benflumetol, pregelatinized Starch 40-60 part, HANSHENGJIAO 8-28 part, 1.5 parts of magnesium stearate.
Further preferably, Artemether layer and benflumetol layer are prepared from by the supplementary material of following weight proportion respectively:
The Artemether layer:
20 parts of Artemether, 12 parts of lactose, 30 28 parts of 30 POVIDONE K 30 BP/USPs, 0.5 part of magnesium stearate;
The benflumetol layer:
120 parts of benflumetol, 60 parts of pregelatinized Starch, 8 parts of HANSHENGJIAO, 1.5 parts of magnesium stearate.
Wherein, this preparation of drug combination method is as follows:
(1) takes by weighing supplementary material by weight ratio;
(2) get 80% of 30 POVIDONE K 30 BP/USP 30 gross masses, with Artemether, lactose mixing, other gets remaining 30 POVIDONE K 30 BP/USP 30 and adds behind the water as binding agent, granulate, and drying, the gained granule is standby behind the granulate;
(3) with benflumetol, pregelatinized Starch mixing, HANSHENGJIAO adds behind the water as binding agent, granulate, and drying, the gained granule is standby behind the granulate;
(4) with step (2), step (3) gained granule respectively with the magnesium stearate mixing after, adopt bi-layer tablet press to carry out tabletting, namely.
The present invention also provides the method for preparing above-mentioned pharmaceutical composition, and it comprises the steps:
(1) takes by weighing supplementary material by weight ratio;
(2) 50-80% of taking adhesive gross mass with Artemether, diluent mixing, after other gets remaining binding agent and adds the water mixing, granulates, drying, and the gained granule is standby behind the granulate;
(3) 0-60% of taking adhesive gross mass with benflumetol, diluent mixing, after remaining binding agent adds the water mixing, granulates, drying, and the gained granule is standby behind the granulate;
(4) with step (2), step (3) gained granule respectively with the magnesium stearate mixing after, adopt bi-layer tablet press to carry out tabletting, namely.
Further, it comprises the steps:
(1) take by weighing supplementary material by following weight proportion:
The Artemether layer:
20 parts of Artemether, 12 parts of lactose, 30 28 parts of 30 POVIDONE K 30 BP/USPs, 0.5 part of magnesium stearate;
The benflumetol layer:
120 parts of benflumetol, 60 parts of pregelatinized Starch, 8 parts of HANSHENGJIAO, 1.5 parts of magnesium stearate;
(2) get 80% of 30 POVIDONE K 30 BP/USP 30 gross masses, with Artemether, lactose mixing, other gets remaining 30 POVIDONE K 30 BP/USP 30 and adds behind the water as binding agent, granulate, and drying, the gained granule is standby behind the granulate;
(3) with benflumetol, pregelatinized Starch mixing, HANSHENGJIAO adds behind the water as binding agent, granulate, and drying, the gained granule is standby behind the granulate;
(4) with step (2), step (3) gained granule respectively with the magnesium stearate mixing after, adopt bi-layer tablet press to carry out tabletting, namely.
The present invention also provides the above-mentioned purposes of pharmaceutical composition in the antimalarial medicine of preparation treatment.
Pharmaceutical composition of the present invention is prepared into double-layer tablet after Artemether and benflumetol are granulated respectively, has avoided the mixed process of Artemether and benflumetol, has guaranteed the safety in the compound recipe preparation process; And the present invention is by screening and specific preparation method to adjuvant, and the disintegrate of gained double-layer tablet is rapid, and compare with existing compound tablet, its effective ingredient dissolution significantly improves, and illustrates that pharmaceutical composition release behavior of the present invention is better, more be conducive to the absorption of medicine, curative effect is better.
Obviously, according to foregoing of the present invention, according to ordinary skill knowledge and the customary means of this area, not breaking away under the above-mentioned basic fundamental thought of the present invention prerequisite, can also make modification, replacement or the change of other various ways.
The specific embodiment of form is described in further detail foregoing of the present invention again by the following examples.But this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following example.All technology that realizes based on foregoing of the present invention all belong to scope of the present invention.
The specific embodiment
Embodiment 1 preparation of drug combination of the present invention
Take by weighing supplementary material by the described weight proportion of table 1:
Table 1
Used supplementary material all can obtain by buying the commercial goods among the present invention, wherein, Artemether, benflumetol after measured, purity is 98-102%.
Operating procedure:
1, the manufacture method of Artemether layer granule: with Artemether, lactose, 80% 30 POVIDONE K 30 BP/USP, 30 mixings, aqueous solution is made in all the other 20% 30 POVIDONE K 30 BP/USP, 30 usefulness suitable quantity of water dissolvings, does to granulate and uses binding agent, make soft material, wave granulator and make granule, 50-60 ℃ of drying, behind the 20 eye mesh screen granulate, standby;
2, the manufacture method of benflumetol layer granule: with benflumetol, pregelatinized Starch mixing, HANSHENGJIAO adds suitable quantity of water and makes aqueous solution, and wet method is made granule, and 50-60 ℃ of drying is standby behind the 20 eye mesh screen granulate:
3, tabletting method: adopt the bi-layer tablet press tabletting, add the A hopper after will Artemether layer granule adding the magnesium stearate mixing, and regulate A face punch die loading amount specification be total sheet heavy 24.2%; Benflumetol layer granule granule adds the B hopper after adding the magnesium stearate mixing, and adjusting B face granule punch die loading amount specification is that 75.8% tabletting gets final product.
The disintegration time of embodiment 1 gained double-layer tablet is 6～8min, and the average dissolution of Artemether is 95%, and the average dissolution of benflumetol is 90%.
The screening of embodiment 2 pharmaceutical composition prescriptions of the present invention
Because in Artemether and the benflumetol mixed process, might blast, therefore, the present invention is prepared into double-layer tablet with Artemether, benflumetol compound recipe, avoiding both mixing, thereby avoid the generation of accident.Because Artemether, benflumetol dissolubility in water are low, therefore, when being prepared into tablet, the high request of dissolution is seemed very necessary.In this screening experiment, main is index by disintegration and dissolution to tablet, and the supplementary product kind of pharmaceutical composition of the present invention, consumption etc. are screened.
No. 1 preparation prescription: see embodiment 1.
No. 2 preparation prescriptions:
Table 2
Operating procedure:
1, the manufacture method of Artemether layer granule: with Artemether, mannitol, 80% ethyl cellulose mixing, all the other 20% ethyl celluloses are made aqueous solution with the suitable quantity of water dissolving, do to granulate and use binding agent, make soft material, wave granulator and make granule, 50-60 ℃ of drying, behind the 20 eye mesh screen granulate, standby;
2, the manufacture method of benflumetol layer granule: with the cane sugar powder mixing of benflumetol, dextrin and 50%, other 50% cane sugar powder adds the suitable quantity of water heating and makes water slurry, does to granulate and uses binding agent, and wet method is made granule, and 50-60 ℃ of drying is standby behind the 20 eye mesh screen granulate:
3, tabletting method: adopt the bi-layer tablet press tabletting, add the A hopper after will Artemether layer granule adding the magnesium stearate mixing, and regulate A face punch die loading amount specification be total sheet heavy 24.2%; Benflumetol layer granule adds the B hopper after adding the magnesium stearate mixing, and adjusting B face granule punch die loading amount specification is that 75.8% tabletting gets final product.
Making Artemether/LUMEFANTRINE double-layer tablet disintegration time by this operating condition is 20～25min, and the average dissolution of Artemether is 88%, and the average dissolution of benflumetol is 85%.
No. 3 preparation prescriptions:
Table 3
Operating process:
1, the manufacture method of Artemether layer granule: with Artemether, lactose, 50% 30 POVIDONE K 30 BP/USP, 30 mixings, aqueous solution is made in all the other 50% 30 POVIDONE K 30 BP/USP, 30 usefulness suitable quantity of water dissolvings, does to granulate and uses binding agent, make soft material, wave granulator and make granule, 50-60 ℃ of drying, behind the 20 eye mesh screen granulate, standby;
2, the manufacture method of benflumetol layer granule: with benflumetol, pregelatinized Starch, 60% HANSHENGJIAO mixing, 40% HANSHENGJIAO adds suitable quantity of water and makes aqueous solution, and wet method is made granule, and 50-60 ℃ of drying is standby behind the 20 eye mesh screen granulate:
3, tabletting method: adopt the bi-layer tablet press tabletting, add the A hopper after will Artemether layer granule adding the magnesium stearate mixing, and regulate A face punch die loading amount specification be total sheet heavy 24.2%; Benflumetol layer granule adds the B hopper after adding the magnesium stearate mixing, and adjusting B face granule punch die loading amount specification is that 75.8% tabletting gets final product.
Making Artemether/LUMEFANTRINE double-layer tablet disintegration time by this operating condition is 8～10min, and the average dissolution of double-layer tablet preparation Artemether is 91%, and the average dissolution of benflumetol is 89%.
No. 4 preparation prescriptions:
Table 4
Operating procedure:
1, the manufacture method of Artemether layer granule: with Artemether, mannitol, 80% ethyl cellulose mixing, all the other 20% ethyl celluloses are made aqueous solution with the suitable quantity of water dissolving, do to granulate and use binding agent, make soft material, wave granulator and make granule, 50-60 ℃ of drying, behind the 20 eye mesh screen granulate, standby;
2, the manufacture method of benflumetol layer granule: with the cane sugar powder mixing of benflumetol, dextrin and 50%, other 50% cane sugar powder adds the suitable quantity of water heating and makes water slurry, does to granulate and uses binding agent, and wet method is made granule, and 50-60 ℃ of drying is standby behind the 20 eye mesh screen granulate:
3, tabletting method: adopt the bi-layer tablet press tabletting, add the A hopper after will Artemether layer granule adding the magnesium stearate mixing, and regulate A face punch die loading amount specification be total sheet heavy 24.2%; Benflumetol layer granule adds the B hopper after adding the magnesium stearate mixing, and adjusting B face granule punch die loading amount specification is that 75.8% tabletting gets final product.
Making Artemether/LUMEFANTRINE double-layer tablet disintegration time by this operating condition is 18～24min, and the average dissolution of Artemether is 88%, and the average dissolution of benflumetol is 85%.
No. 5 preparation prescriptions:
Table 5
Operating procedure:
1, the manufacture method of Artemether layer granule: with Artemether, mannitol, 50% ethyl cellulose mixing, all the other 50% ethyl celluloses are made aqueous solution with the suitable quantity of water dissolving, do to granulate and use binding agent, make soft material, wave granulator and make granule, 50-60 ℃ of drying, behind the 20 eye mesh screen granulate, standby;
2, the manufacture method of benflumetol layer granule: with benflumetol, dextrin mixing, cane sugar powder adds the suitable quantity of water heating and makes water slurry, does to granulate and uses binding agent, and wet method is made granule, and 50-60 ℃ of drying is standby behind the 20 eye mesh screen granulate:
3, tabletting method: adopt the bi-layer tablet press tabletting, add the A hopper after will Artemether layer granule adding the magnesium stearate mixing, and regulate A face punch die loading amount specification be total sheet heavy 24.2%; Benflumetol layer granule adds the B hopper after adding the magnesium stearate mixing, and adjusting B face granule punch die loading amount specification is that 75.8% tabletting gets final product.
Making Artemether/LUMEFANTRINE double-layer tablet disintegration time by this operating condition is 22～26min, and the average dissolution of Artemether is 90%, and the average dissolution of benflumetol is 87%.
Above The selection result shows, No. 1 preparation prescription gained Artemether/the shortest about 6～8min of its disintegration time of LUMEFANTRINE double-layer tablet, and the average dissolution of its preparation Artemether is 95%, and the average dissolution of benflumetol is 90%, and this writes out a prescription best.
Below by concrete test example beneficial effect of the present invention is described.
Test example 1 dissolution, the contrast of disintegration
(number of patent application: the conventional tablet 200780024023.4) compares with products obtained therefrom of the present invention and prior art.
Number of patent application: 200780024023.4, the tablet formulation in this application sees Table 6, presses the conventional tablet of its prescription preparation, and itself and double-layer tablet of the present invention are carried out the contrast of dissolution and disintegration, the results are shown in Table 7,8.
Table 6
| Composition | The mg/ sheet |
| In the granule | |
| Artemether | 40.0 |
| Benflumetol | 240.0 |
| Microcrystalline Cellulose | 42.6 |
| Cross-linking sodium carboxymethyl cellulose | 56.0 |
| Hydroxypropyl emthylcellulose | 8.0 |
| Silica sol | 10.0 |
| Outside the granule | |
| Microcrystalline Cellulose | 20.0 |
| Polyoxyethylene sorbitan monoleate | 1.0 |
| Microcrystalline Cellulose | 56.4 |
| Silica sol | 6.0 |
| Magnesium stearate | 20.0 |
| Total amount | 500 |
Dissolution determination:
With reference to " the Chinese pharmacopoeia dissolution determination method carries out the dissolution comparative test to this double-layer tablet preparation and ordinary tablet preparation, and wherein, the used solution of dissolution is: dilute hydrochloric acid 16.4ml, add water 800ml, and after shaking up with pepsin 10g, add water to 1000ml.Measurement result is as follows:
Table 7
More than in the experiment, the dissolution of the inventive method gained double-layer tablet all is better than conventional tablet, wherein, and with embodiment 1 optimum.
Disintegration time mensuration:
With reference to " Chinese pharmacopoeia disintegration time mensuration method is carried out test disintegration to this double-layer tablet preparation and ordinary tablet preparation, and the result is as follows:
Table 8
| Prescription | 2010 editions " the Chinese pharmacopoeia method is measured the disintegration time result |
| The present invention 1 (embodiment 1) of writing out a prescription | 6.8 minute |
| The present invention 2 (embodiment 2) of writing out a prescription | 20-25 minute |
| The present invention 3 (embodiment 2) of writing out a prescription | 8-10 minute |
| The present invention 4 (embodiment 2) of writing out a prescription | 18-24 minute |
| The present invention 5 (embodiment 2) of writing out a prescription | 22-26 minute |
| Conventional tablet prescription (table 2) | 28.2 minute |
More than in the experiment, all be better than conventional tablet the disintegration of the inventive method gained double-layer tablet, wherein, and with embodiment 1 optimum.
By table 7,8 as can be known, existing conventional tablet, disintegration time is 27-29min, and the average dissolution of Artemether is 80.1%, and the average dissolution of benflumetol is 71.2%; And embodiment 1 gained double-layer tablet, disintegration time is 6～8min, the average dissolution of Artemether is 95%, improved more than 18%, the average dissolution of benflumetol is 90%, has improved more than 26%, show, pharmaceutical composition release behavior of the present invention significantly improves, and is conducive to the absorption of effective ingredient, and curative effect is better.
In sum, after pharmaceutical composition of the present invention was granulated Artemether and benflumetol respectively, refabrication became double-layer tablet, has avoided the mixed process of Artemether and benflumetol, has guaranteed the safety in the compound recipe preparation process; And the present invention is by screening and specific preparation method to adjuvant, and the disintegrate of gained double-layer tablet is rapid, and compare with existing compound tablet, its effective ingredient dissolution significantly improves, and illustrates that pharmaceutical composition release behavior of the present invention is better, more be conducive to the absorption of medicine, curative effect is better.
Claims (5)
1. antimalarial pharmaceutical composition is characterized in that: it is the double-layer tablet that the supplementary material by the following weight proportioning is prepared from:
The Artemether layer:
20 parts of Artemether, lactose 12-20 part, 30 POVIDONE K 30 BP/USP 30 20-28 parts, 0.5 part of magnesium stearate;
The benflumetol layer:
120 parts of benflumetol, pregelatinized Starch 40-60 part, HANSHENGJIAO 8-28 part, 1.5 parts of magnesium stearate.
2. pharmaceutical composition according to claim 1, it is characterized in that: Artemether layer and benflumetol layer are prepared from by the supplementary material of following weight proportion respectively:
The Artemether layer:
20 parts of Artemether, 12 parts of lactose, 30 28 parts of 30 POVIDONE K 30 BP/USPs, 0.5 part of magnesium stearate;
The benflumetol layer:
120 parts of benflumetol, 60 parts of pregelatinized Starch, 8 parts of HANSHENGJIAO, 1.5 parts of magnesium stearate.
3. pharmaceutical composition according to claim 1 and 2, it is characterized in that: this preparation of drug combination method is as follows:
(1) takes by weighing supplementary material by weight ratio;
(2) get 80% of 30 POVIDONE K 30 BP/USP 30 gross masses, with Artemether, lactose mixing, other gets remaining 30 POVIDONE K 30 BP/USP 30 and adds behind the water as binding agent, granulate, and drying, the gained granule is standby behind the granulate;
(3) with benflumetol, pregelatinized Starch mixing, HANSHENGJIAO adds behind the water as binding agent, granulate, and drying, the gained granule is standby behind the granulate;
(4) with step (2), step (3) gained granule respectively with the magnesium stearate mixing after, adopt bi-layer tablet press to carry out tabletting, namely.
4. prepare the method for the described pharmaceutical composition of claim 1, it is characterized in that: it comprises the steps:
(1) takes by weighing supplementary material by weight ratio;
(2) get 80% of 30 POVIDONE K 30 BP/USP 30 gross masses, with Artemether, lactose mixing, other gets remaining 30 POVIDONE K 30 BP/USP 30 and adds behind the water as binding agent, granulate, and drying, the gained granule is standby behind the granulate;
(3) with benflumetol, pregelatinized Starch mixing, HANSHENGJIAO adds behind the water as binding agent, granulate, and drying, the gained granule is standby behind the granulate;
(4) with step (2), step (3) gained granule respectively with the magnesium stearate mixing after, adopt bi-layer tablet press to carry out tabletting, namely.
5. preparation method according to claim 4, it is characterized in that: it comprises the steps:
(1) take by weighing supplementary material by following weight proportion:
The Artemether layer:
20 parts of Artemether, 12 parts of lactose, 30 28 parts of 30 POVIDONE K 30 BP/USPs, 0.5 part of magnesium stearate;
The benflumetol layer:
120 parts of benflumetol, 60 parts of pregelatinized Starch, 8 parts of HANSHENGJIAO, 1.5 parts of magnesium stearate;
(2) get 80% of 30 POVIDONE K 30 BP/USP 30 gross masses, with Artemether, lactose mixing, other gets remaining 30 POVIDONE K 30 BP/USP 30 and adds behind the water as binding agent, granulate, and drying, the gained granule is standby behind the granulate;
(3) with benflumetol, pregelatinized Starch mixing, HANSHENGJIAO adds behind the water as binding agent, granulate, and drying, the gained granule is standby behind the granulate;
(4) with step (2), step (3) gained granule respectively with the magnesium stearate mixing after, adopt bi-layer tablet press to carry out tabletting, namely.
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| Application Number | Priority Date | Filing Date | Title |
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| CN2011101738461A CN102283829B (en) | 2011-06-24 | 2011-06-24 | Anti-malarial medicinal composition and preparation method and application thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011101738461A CN102283829B (en) | 2011-06-24 | 2011-06-24 | Anti-malarial medicinal composition and preparation method and application thereof |
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|---|---|---|---|---|
| CN100998569A (en) * | 2006-12-30 | 2007-07-18 | 桂林制药有限责任公司 | Compound antimalarial three-layered tablets containing artemisinin or its derivatives and its preparing method |
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| CN100998569A (en) * | 2006-12-30 | 2007-07-18 | 桂林制药有限责任公司 | Compound antimalarial three-layered tablets containing artemisinin or its derivatives and its preparing method |
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