CN1543973A - Highly effective sustained release breviscapine compositions and its granule capsule - Google Patents
Highly effective sustained release breviscapine compositions and its granule capsule Download PDFInfo
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- CN1543973A CN1543973A CNA2003101085719A CN200310108571A CN1543973A CN 1543973 A CN1543973 A CN 1543973A CN A2003101085719 A CNA2003101085719 A CN A2003101085719A CN 200310108571 A CN200310108571 A CN 200310108571A CN 1543973 A CN1543973 A CN 1543973A
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- breviscapine
- instant granular
- release compositions
- efficiency sustained
- enteric material
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- 239000000203 mixture Substances 0.000 title claims abstract description 22
- 239000002775 capsule Substances 0.000 title claims abstract description 19
- 239000008187 granular material Substances 0.000 title claims abstract description 18
- DJSISFGPUUYILV-UHFFFAOYSA-N UNPD161792 Natural products O1C(C(O)=O)C(O)C(O)C(O)C1OC(C(=C1O)O)=CC2=C1C(=O)C=C(C=1C=CC(O)=CC=1)O2 DJSISFGPUUYILV-UHFFFAOYSA-N 0.000 title claims description 74
- DJSISFGPUUYILV-ZFORQUDYSA-N scutellarin Chemical compound O1[C@H](C(O)=O)[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1OC(C(=C1O)O)=CC2=C1C(=O)C=C(C=1C=CC(O)=CC=1)O2 DJSISFGPUUYILV-ZFORQUDYSA-N 0.000 title claims description 74
- 238000013268 sustained release Methods 0.000 title claims description 17
- 239000012730 sustained-release form Substances 0.000 title claims description 17
- 239000000463 material Substances 0.000 claims abstract description 18
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- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 9
- 238000002360 preparation method Methods 0.000 claims description 8
- 239000004925 Acrylic resin Substances 0.000 claims description 6
- 229920000178 Acrylic resin Polymers 0.000 claims description 6
- 239000011248 coating agent Substances 0.000 claims description 6
- 238000000576 coating method Methods 0.000 claims description 6
- 229920003132 hydroxypropyl methylcellulose phthalate Polymers 0.000 claims description 6
- 229940031704 hydroxypropyl methylcellulose phthalate Drugs 0.000 claims description 6
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 4
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 4
- 239000008101 lactose Substances 0.000 claims description 4
- 239000004094 surface-active agent Substances 0.000 claims description 4
- 229920000623 Cellulose acetate phthalate Polymers 0.000 claims description 3
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 3
- 229930195725 Mannitol Natural products 0.000 claims description 3
- 229930006000 Sucrose Natural products 0.000 claims description 3
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 3
- 230000002378 acidificating effect Effects 0.000 claims description 3
- 229940081734 cellulose acetate phthalate Drugs 0.000 claims description 3
- 239000000594 mannitol Substances 0.000 claims description 3
- 235000010355 mannitol Nutrition 0.000 claims description 3
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims description 3
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 3
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 3
- 239000002904 solvent Substances 0.000 claims description 3
- 239000005720 sucrose Substances 0.000 claims description 3
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims description 2
- 239000002202 Polyethylene glycol Substances 0.000 claims description 2
- 238000007796 conventional method Methods 0.000 claims description 2
- 238000001035 drying Methods 0.000 claims description 2
- 229920001223 polyethylene glycol Polymers 0.000 claims description 2
- 230000001105 regulatory effect Effects 0.000 claims description 2
- 239000011780 sodium chloride Substances 0.000 claims description 2
- 235000002639 sodium chloride Nutrition 0.000 claims description 2
- 230000000968 intestinal effect Effects 0.000 description 12
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 6
- 239000012530 fluid Substances 0.000 description 6
- 239000003814 drug Substances 0.000 description 5
- 210000002429 large intestine Anatomy 0.000 description 5
- 239000008280 blood Substances 0.000 description 4
- 210000004369 blood Anatomy 0.000 description 4
- 210000001198 duodenum Anatomy 0.000 description 4
- 238000000034 method Methods 0.000 description 4
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 3
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 description 3
- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 description 3
- 229920003171 Poly (ethylene oxide) Polymers 0.000 description 3
- 239000004359 castor oil Substances 0.000 description 3
- 235000019438 castor oil Nutrition 0.000 description 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 3
- 238000005516 engineering process Methods 0.000 description 3
- ZEMPKEQAKRGZGQ-XOQCFJPHSA-N glycerol triricinoleate Natural products CCCCCC[C@@H](O)CC=CCCCCCCCC(=O)OC[C@@H](COC(=O)CCCCCCCC=CC[C@@H](O)CCCCCC)OC(=O)CCCCCCCC=CC[C@H](O)CCCCCC ZEMPKEQAKRGZGQ-XOQCFJPHSA-N 0.000 description 3
- 238000001727 in vivo Methods 0.000 description 3
- -1 polyoxyethylene Polymers 0.000 description 3
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- 238000010521 absorption reaction Methods 0.000 description 2
- 239000007931 coated granule Substances 0.000 description 2
- 239000011246 composite particle Substances 0.000 description 2
- 238000002425 crystallisation Methods 0.000 description 2
- 230000008025 crystallization Effects 0.000 description 2
- 238000004090 dissolution Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 230000002496 gastric effect Effects 0.000 description 2
- 239000004531 microgranule Substances 0.000 description 2
- 238000004806 packaging method and process Methods 0.000 description 2
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 description 2
- 229920000053 polysorbate 80 Polymers 0.000 description 2
- 239000000243 solution Substances 0.000 description 2
- IIZPXYDJLKNOIY-JXPKJXOSSA-N 1-palmitoyl-2-arachidonoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCC\C=C/C\C=C/C\C=C/C\C=C/CCCCC IIZPXYDJLKNOIY-JXPKJXOSSA-N 0.000 description 1
- 206010002383 Angina Pectoris Diseases 0.000 description 1
- 206010008132 Cerebral thrombosis Diseases 0.000 description 1
- 235000008495 Chrysanthemum leucanthemum Nutrition 0.000 description 1
- 235000000604 Chrysanthemum parthenium Nutrition 0.000 description 1
- 201000001429 Intracranial Thrombosis Diseases 0.000 description 1
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 description 1
- 239000004141 Sodium laurylsulphate Substances 0.000 description 1
- 240000004460 Tanacetum coccineum Species 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- 208000029078 coronary artery disease Diseases 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- 230000000916 dilatatory effect Effects 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000000284 extract Substances 0.000 description 1
- 235000008384 feverfew Nutrition 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 210000004051 gastric juice Anatomy 0.000 description 1
- 230000005764 inhibitory process Effects 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 230000031891 intestinal absorption Effects 0.000 description 1
- 239000000787 lecithin Substances 0.000 description 1
- 235000010445 lecithin Nutrition 0.000 description 1
- 229940067606 lecithin Drugs 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 239000002075 main ingredient Substances 0.000 description 1
- 208000031225 myocardial ischemia Diseases 0.000 description 1
- TZBAVQKIEKDGFH-UHFFFAOYSA-N n-[2-(diethylamino)ethyl]-1-benzothiophene-2-carboxamide;hydrochloride Chemical compound [Cl-].C1=CC=C2SC(C(=O)NCC[NH+](CC)CC)=CC2=C1 TZBAVQKIEKDGFH-UHFFFAOYSA-N 0.000 description 1
- 239000003921 oil Substances 0.000 description 1
- 239000003960 organic solvent Substances 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 230000036581 peripheral resistance Effects 0.000 description 1
- 229920000136 polysorbate Polymers 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 238000007613 slurry method Methods 0.000 description 1
- 235000019333 sodium laurylsulphate Nutrition 0.000 description 1
- 239000007962 solid dispersion Substances 0.000 description 1
- 208000010110 spontaneous platelet aggregation Diseases 0.000 description 1
- 238000005507 spraying Methods 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 239000003826 tablet Substances 0.000 description 1
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
A breviscapini high performance slow release composition and its granule capsule comprises, breviscanpini promptly soluble granule 20-40% coated by pH=5.5-6.5 enteric-coated material, breviscanpini promptly soluble granule 10-30% coated by pH=6.5-6.8 enteric-coated material, breviscanpini promptly soluble granule 10-30% coated by pH=7.2-7.5 enteric-coated material, pH=6.8-7.2 breviscanpini promptly soluble granule 20-40%, wherein the breviscanpini promptly soluble granule includes breviscanpini and crystal of water-soluble articles.
Description
Technical field
The present invention relates to a kind of Breviscapine slow release compositions, relate in particular to Breviscapine slow release combination particle capsule.
Background technology
Breviscapine is the oil lamp cycle of sixty years element that extracts from the feverfew HERBA ERIGERONTIS, the mixture of second element, and wherein the second element is a Main Ingredients and Appearance.Breviscapine has blood vessel dilating, increase arterial flow, blood viscosity lowering, reduction Peripheral resistance, reduces the effect of platelet and inhibition platelet aggregation, is mainly used in treatment coronary heart disease, angina pectoris, myocardial ischemia and cerebral thrombosis etc. clinically.
Breviscapine injection, injectable powder, granule, tablet are arranged at present.Because its oral administration biaavailability low (about 16%), half-life short (about 2 hours),, repeatedly take so need strengthen the treatment dose when treating.For overcoming these shortcomings, domestic have various slow releasing preparation (CN1364516A, CN1383817A, patent application CN1385162A).Generally, adopt blocker to reach the purpose of prolongation effect more all by making solid dispersion, clathrate, fused matter to improve bioavailability.Above-mentioned technology is not considered the difference of pH in the interior duodenum of body, small intestinal upper end, small intestinal lower end, the large intestine, thereby can not guarantee all has the absorbable medicine of soluble granule at duodenum, small intestinal upper end, small intestinal lower end, large intestine, thereby guarantees to have the sufficiently long time to keep enough blood concentrations in vivo.
Summary of the invention
The technical issues that need to address of the present invention are to disclose a kind of breviscapine high-efficiency sustained-release compositions and granule capsule thereof, to overcome the above-mentioned defective that prior art exists.
Technical conceive of the present invention is such:
The present invention is according to the breviscapine characteristics of intestinal absorption entirely in vivo, designed the composite particles capsule that a kind of can be under several pH conditions dissolved coated granule is formed, so that it respectively has soluble granule at duodenum, small intestinal upper end, small intestinal lower end, large intestine, thereby guarantee the internal energy blood concentration of keeping the sufficiently long time of body.Simple, the easy row of this preparation method, but dissolution rate flexible.
Its two, the present invention has adopted the crystallization packaging technique for improving its bioavailability, promptly at the plane of crystal of water solublity thing, with granulating after the organic solvent of this product and the surfactant solution spraying again.Oral back is because crystalline dissolving, makes to coat its surperficial breviscapine and also strengthened absorption thereupon being dispersed into microgranule.
The component and the content of breviscapine high-efficiency sustained-release compositions of the present invention comprise:
PH is the breviscapine instant granular 20～40% of 5.5～6.5 enteric material parcel
PH is the breviscapine instant granular 10～30% of 6.5～6.8 enteric material parcel
PH is the breviscapine instant granular 10～30% of 7.2～7.5 enteric material parcel
PH is 6.8～7.2 breviscapine instant granular 20～40%.
Said enteric material comprise a kind of in hydroxypropyl methylcellulose phthalate, acrylic resin or the Cellulose Acetate Phthalate etc., the breviscapine instant granular of its parcel can in the gastric juice of pH=1～2, place 2 hours broken;
Said breviscapine instant granular comprises the crystal of breviscapine and water solublity thing;
Wherein:
Breviscapine 5～30%
The crystal 70～95% of water solublity thing;
More than be weight percentage.
The water solublity thing of being addressed comprises one or more in lactose, NaCl, mannitol, polyvinylpyrrolidone, Polyethylene Glycol or the sucrose.
The present invention also comprises the capsule of above-mentioned composition.
Breviscapine high-efficiency sustained-release compositions of the present invention and the capsular preparation method of granule thereof comprise the steps:
(1) preparation of breviscapine instant granular:
With the breviscapine dissolution with solvents, regulating pH with acidic materials is 6.8～7.2, adds an amount of surfactant, this solution is sprayed on the crystal of water solublity thing, and drying promptly gets the Herba Erigerontis grain of crystal coating;
The solvent of being addressed comprises a kind of in ethanol, acetone or the dichloromethane;
The surfactant of being addressed comprises one or more in tween 80, sodium lauryl sulphate, lecithin or the polyoxyethylene castor oil;
The acidic materials of being addressed comprise a kind of in citric acid, acetic acid or the hydrochloric acid;
Adopt conventional method to granulate then, sieve is got 18-40 order granule, i.e. breviscapine instant granular;
(2) the breviscapine instant granular with step (1) places air-flow coating machine, respectively with above-mentioned pH be 5.5～6.5, pH be 6.5～6.8 and pH be 7.2～7.5 enteric material parcel, mixed then, promptly obtain breviscapine high-efficiency sustained-release compositions of the present invention;
(3) the breviscapine high-efficiency sustained-release compositions with step (2) pours in the capsule, promptly obtains to contain the capsule of breviscapine high-efficiency sustained-release compositions.
Breviscapine high-efficiency sustained-release compositions of the present invention and capsule, can under several pH conditions, dissolve respectively, so that it respectively has soluble granule at duodenum, small intestinal upper end, small intestinal lower end, large intestine, thereby guaranteeing that body is internal energy keeps enough blood concentrations for a long time, simultaneously, owing to adopted the crystallization packaging technique, oral back is because crystalline dissolving, make and coat its surperficial breviscapine and also be dispersed into microgranule thereupon, improved its bioavailability, strengthened absorption, this product can reach one day purpose of taking medicine once.
Description of drawings
Fig. 1 is the external release curve chart of breviscapine high-efficiency sustained-release composition capsule.
The specific embodiment
Embodiment 1
Contain breviscapine 60mg in every capsules
PH is 7.0 breviscapine instant granular (in breviscapine) 18mg, pH is breviscapine instant granular (in the breviscapine) 18mg of 5.5 hydroxypropyl methylcellulose phthalate parcel, pH is breviscapine instant granular (in the breviscapine) 12mg of 6.5 hydroxypropyl methylcellulose phthalate parcel, and pH is breviscapine instant granular (in the breviscapine) 12mg of 7.5 hydroxypropyl methylcellulose phthalate parcel; Wherein:
The prescription of breviscapine instant granular is: breviscapine 60mg, lactose 300mg, tween 80 2mg;
After breviscapine usefulness ethanol and tween dissolving, adopt Fructus Citri Limoniae acid for adjusting pH to 7.0 to sparge on the lactose fluid bed of 100 mesh sieves, dry back is taken out and is divided into 4 parts, and 3 parts of PMCP that use three kinds of different pH respectively are in fluid bed behind the coating, mix, irritate in No. 0 capsule.
Contain breviscapine 60mg in every capsules
PH is 7.0 breviscapine instant granular (in breviscapine) 24mg, pH is breviscapine instant granular (in the breviscapine) 6mg of 6.0 acrylic resin parcel, pH is breviscapine instant granular (in the breviscapine) 6mg of 6.8 acrylic resin parcel, and pH is breviscapine instant granular (in the breviscapine) 24mg of 7.5 acrylic resin parcel; Wherein:
The prescription of breviscapine instant granular is: breviscapine 60mg, mannitol 300mg, polyoxyethylene castor oil 2mg, polyvinylpyrrolidone 5mg;
Preparation process such as embodiment 1.
Embodiment 3
Every capsules contains breviscapine 60mg
Coating material and consumption such as embodiment 1, the prescription of breviscapine instant granular is: breviscapine 60mg, sucrose 300mg, polyoxyethylene castor oil 5mg, Macrogol 4000 60mg; Preparation technology such as embodiment 1.
The capsule extracorporeal releasing test of embodiment 1
Press Chinese Pharmacopoeia version in 2000, the slurry method.Get a capsules and be positioned in the 1000ml simulated gastric fluid, stir hypsokinesis in 2 hours and remove simulated gastric fluid, pour the simulated intestinal fluid of 1000ml pH5.5 into, pour the simulated intestinal fluid of pH6.5, pH7.5 after 2 hours again into method, each 2 hours, sampling and measuring discharged the medication amount in the liquid, the results are shown in Figure 1.
From scheming as seen, various different coated granules all can discharge under corresponding pH condition.Therefore, in vivo, this composite particles capsule can shift to intestinal from stomach successively along with food, again by small intestinal to large intestine, discharge medicine simultaneously.Because this process was generally 16-24 hour, therefore, this product can reach one day purpose of taking medicine once.
Claims (6)
1. breviscapine high-efficiency sustained-release compositions is characterized in that component and weight percent content comprise:
PH is the breviscapine instant granular 20～40% of 5.5～6.5 enteric material parcel
PH is the breviscapine instant granular 10～30% of 6.5～6.8 enteric material parcel
PH is the breviscapine instant granular 10～30% of 7.2～7.5 enteric material parcel
PH is 6.8～7.2 breviscapine instant granular 20～40%.
Said breviscapine instant granular comprises the crystal of breviscapine and water solublity thing;
Wherein:
Breviscapine 5～30%
The crystal 70～95% of water solublity thing;
More than be weight percentage.
2. breviscapine high-efficiency sustained-release compositions according to claim 1 is characterized in that the water solublity thing of being addressed comprises one or more in lactose, NaCl, mannitol, polyvinylpyrrolidone, Polyethylene Glycol or the sucrose.
3. breviscapine high-efficiency sustained-release compositions according to claim 1 is characterized in that, said enteric material comprises a kind of in hydroxypropyl methylcellulose phthalate, acrylic resin or the Cellulose Acetate Phthalate.
4. breviscapine high-efficiency sustained-release compositions according to claim 2 is characterized in that, said enteric material comprises a kind of in hydroxypropyl methylcellulose phthalate, acrylic resin or the Cellulose Acetate Phthalate.
5. capsule that contains each described breviscapine high-efficiency sustained-release compositions of claim 1～4.
6. each described breviscapine high-efficiency sustained-release compositions of claim 1～4 and the capsular preparation method of granule thereof is characterized in that, comprise the steps:
(1) preparation of breviscapine instant granular:
Breviscapine is dissolved with The suitable solvent, and regulating pH with acidic materials is 6.8～7.2, adds an amount of surfactant, this solution is sprayed on the crystal of water solublity thing, and drying promptly gets the Herba Erigerontis grain of crystal coating;
Adopt conventional method to granulate then, i.e. the breviscapine instant granular;
(2) the breviscapine instant granular with step (1) places air-flow coating machine, respectively with above-mentioned pH be 5.5～6.5, pH be 6.5～6.8 and pH be 7.2～7.5 enteric material parcel, mixed then, promptly obtain breviscapine high-efficiency sustained-release compositions.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200310108571 CN1233327C (en) | 2003-11-13 | 2003-11-13 | Highly effective sustained release breviscapine compositions and its granule capsule |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200310108571 CN1233327C (en) | 2003-11-13 | 2003-11-13 | Highly effective sustained release breviscapine compositions and its granule capsule |
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| Publication Number | Publication Date |
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| CN1543973A true CN1543973A (en) | 2004-11-10 |
| CN1233327C CN1233327C (en) | 2005-12-28 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104906160B (en) * | 2015-05-25 | 2018-07-24 | 昆明理工大学 | A kind of enteric coated preparations of erigeron breviscapus extract |
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2003
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104906160B (en) * | 2015-05-25 | 2018-07-24 | 昆明理工大学 | A kind of enteric coated preparations of erigeron breviscapus extract |
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