CN102772390B - Venlafaxine hydrochloride sustained release capsule and preparation method thereof - Google Patents
Venlafaxine hydrochloride sustained release capsule and preparation method thereof Download PDFInfo
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- CN102772390B CN102772390B CN201210291863.XA CN201210291863A CN102772390B CN 102772390 B CN102772390 B CN 102772390B CN 201210291863 A CN201210291863 A CN 201210291863A CN 102772390 B CN102772390 B CN 102772390B
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- 239000002775 capsule Substances 0.000 title claims abstract description 24
- 238000013268 sustained release Methods 0.000 title claims abstract description 19
- 239000012730 sustained-release form Substances 0.000 title claims abstract description 19
- QYRYFNHXARDNFZ-UHFFFAOYSA-N venlafaxine hydrochloride Chemical compound [H+].[Cl-].C1=CC(OC)=CC=C1C(CN(C)C)C1(O)CCCCC1 QYRYFNHXARDNFZ-UHFFFAOYSA-N 0.000 title claims abstract description 14
- 229960002416 venlafaxine hydrochloride Drugs 0.000 title claims abstract description 12
- 238000002360 preparation method Methods 0.000 title claims abstract description 10
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 claims abstract description 16
- 239000000203 mixture Substances 0.000 claims abstract description 15
- 239000006187 pill Substances 0.000 claims abstract description 15
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 15
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 10
- 229920003081 Povidone K 30 Polymers 0.000 claims abstract description 10
- 239000000725 suspension Substances 0.000 claims abstract description 9
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 7
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 claims abstract description 5
- 229960004688 venlafaxine Drugs 0.000 claims description 14
- 239000001856 Ethyl cellulose Substances 0.000 claims description 12
- 229920001249 ethyl cellulose Polymers 0.000 claims description 12
- 235000019325 ethyl cellulose Nutrition 0.000 claims description 12
- 239000007788 liquid Substances 0.000 claims description 11
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims description 8
- 229960000935 dehydrated alcohol Drugs 0.000 claims description 8
- 238000007789 sealing Methods 0.000 claims description 8
- 239000000945 filler Substances 0.000 claims description 7
- 238000000034 method Methods 0.000 claims description 5
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims description 4
- 229920001030 Polyethylene Glycol 4000 Polymers 0.000 claims description 4
- 239000011230 binding agent Substances 0.000 claims description 4
- 235000012343 cottonseed oil Nutrition 0.000 claims description 4
- 239000011812 mixed powder Substances 0.000 claims description 4
- 238000003756 stirring Methods 0.000 claims description 4
- 238000000576 coating method Methods 0.000 claims description 3
- 238000013265 extended release Methods 0.000 claims description 3
- 239000008188 pellet Substances 0.000 claims description 3
- 229920002472 Starch Polymers 0.000 claims description 2
- 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 2
- 229930006000 Sucrose Natural products 0.000 claims description 2
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical group [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 2
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 2
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims description 2
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims description 2
- 239000007921 spray Substances 0.000 claims description 2
- 239000008107 starch Substances 0.000 claims description 2
- 235000019698 starch Nutrition 0.000 claims description 2
- 239000005720 sucrose Substances 0.000 claims description 2
- 239000000463 material Substances 0.000 abstract description 4
- 239000000470 constituent Substances 0.000 abstract 3
- 238000012856 packing Methods 0.000 abstract 2
- 239000004698 Polyethylene Substances 0.000 abstract 1
- 230000015572 biosynthetic process Effects 0.000 abstract 1
- 239000004067 bulking agent Substances 0.000 abstract 1
- 239000000825 pharmaceutical preparation Substances 0.000 abstract 1
- -1 polyethylene Polymers 0.000 abstract 1
- 229920000573 polyethylene Polymers 0.000 abstract 1
- PNVNVHUZROJLTJ-UHFFFAOYSA-N venlafaxine Chemical compound C1=CC(OC)=CC=C1C(CN(C)C)C1(O)CCCCC1 PNVNVHUZROJLTJ-UHFFFAOYSA-N 0.000 description 12
- 239000000243 solution Substances 0.000 description 8
- 238000012360 testing method Methods 0.000 description 5
- 239000003814 drug Substances 0.000 description 4
- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 description 3
- ZMANZCXQSJIPKH-UHFFFAOYSA-N Triethylamine Chemical compound CCN(CC)CC ZMANZCXQSJIPKH-UHFFFAOYSA-N 0.000 description 3
- 239000000047 product Substances 0.000 description 3
- 239000013558 reference substance Substances 0.000 description 3
- 239000004925 Acrylic resin Substances 0.000 description 2
- QUSNBJAOOMFDIB-UHFFFAOYSA-N Ethylamine Chemical compound CCN QUSNBJAOOMFDIB-UHFFFAOYSA-N 0.000 description 2
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 239000003960 organic solvent Substances 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- SFLSHLFXELFNJZ-QMMMGPOBSA-N (-)-norepinephrine Chemical compound NC[C@H](O)C1=CC=C(O)C(O)=C1 SFLSHLFXELFNJZ-QMMMGPOBSA-N 0.000 description 1
- 208000019901 Anxiety disease Diseases 0.000 description 1
- 208000020401 Depressive disease Diseases 0.000 description 1
- 208000011688 Generalised anxiety disease Diseases 0.000 description 1
- 241001597008 Nomeidae Species 0.000 description 1
- OAICVXFJPJFONN-UHFFFAOYSA-N Phosphorus Chemical compound [P] OAICVXFJPJFONN-UHFFFAOYSA-N 0.000 description 1
- PVDVPOZEJCXUAM-UHFFFAOYSA-N acetonitrile;n,n-diethylethanamine Chemical compound CC#N.CCN(CC)CC PVDVPOZEJCXUAM-UHFFFAOYSA-N 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 229940125713 antianxiety drug Drugs 0.000 description 1
- 239000000935 antidepressant agent Substances 0.000 description 1
- 229940005513 antidepressants Drugs 0.000 description 1
- 230000036506 anxiety Effects 0.000 description 1
- 239000002249 anxiolytic agent Substances 0.000 description 1
- 239000007853 buffer solution Substances 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- HPXRVTGHNJAIIH-UHFFFAOYSA-N cyclohexanol Chemical compound OC1CCCCC1 HPXRVTGHNJAIIH-UHFFFAOYSA-N 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 238000010790 dilution Methods 0.000 description 1
- 239000012895 dilution Substances 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 238000011978 dissolution method Methods 0.000 description 1
- 230000000857 drug effect Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 230000007613 environmental effect Effects 0.000 description 1
- 125000001495 ethyl group Chemical group [H]C([H])([H])C([H])([H])* 0.000 description 1
- 238000010812 external standard method Methods 0.000 description 1
- 239000000706 filtrate Substances 0.000 description 1
- 208000029364 generalized anxiety disease Diseases 0.000 description 1
- 238000004128 high performance liquid chromatography Methods 0.000 description 1
- 230000008676 import Effects 0.000 description 1
- 239000003112 inhibitor Substances 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 238000004811 liquid chromatography Methods 0.000 description 1
- 229960002748 norepinephrine Drugs 0.000 description 1
- SFLSHLFXELFNJZ-UHFFFAOYSA-N norepinephrine Natural products NCC(O)C1=CC=C(O)C(O)=C1 SFLSHLFXELFNJZ-UHFFFAOYSA-N 0.000 description 1
- 230000000966 norepinephrine reuptake Effects 0.000 description 1
- YTJSFYQNRXLOIC-UHFFFAOYSA-N octadecylsilane Chemical compound CCCCCCCCCCCCCCCCCC[SiH3] YTJSFYQNRXLOIC-UHFFFAOYSA-N 0.000 description 1
- 239000011574 phosphorus Substances 0.000 description 1
- 229910052698 phosphorus Inorganic materials 0.000 description 1
- 230000000697 serotonin reuptake Effects 0.000 description 1
- 239000000377 silicon dioxide Substances 0.000 description 1
- 239000002002 slurry Substances 0.000 description 1
- 239000013589 supplement Substances 0.000 description 1
Landscapes
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention belongs to the field of pharmaceutical preparations, and discloses a venlafaxine hydrochloride sustained release capsule and a preparation method thereof. The content of the sustained release capsule is a sustained release micro pill, wherein the sustained release pill is successively provided with a pill core, an isolating layer and a sustained release layer from the interior to the exterior, the pill core is prepared from the following constituents according to weight percentage composition: 45-48% of venlafaxine hydrochloride, 15-18% of bulking agent, 3-3.5% of disintegrating agent, 4-6% of povidone K 30, 24-26% of absolute ethyl alcohol and the balance being water; the isolating layer is prepared from the following constituents according to weight percentage composition: 11-13% povidone K30, 83-86% of absolute ethyl alcohol and the balance being talcum powder; the sustained release layer is prepared from the following constituents according to weight percentage composition: 38-42% of ethocel suspension, 0.1-1.0% of polyethylene glycol-60000 and the balance being water, wherein the ethocel accounts for 20-30% of the ethocel suspension in mass; and the preparation method provided by the invention has the following steps of preparing the pill core, packing the isolating layer, packing the sustained release layer and filling a capsule, thus obtaining the sustained release capsule. The venlafaxine hydrochloride sustained release capsule provided by the invention adopts the ethocel, the flammability is low, the hygroscopicity is small, good film formation property can be achieved, the material is stable and is easy to control, and the venlafaxine hydrochloride sustained release capsule is safe and environment-friendly.
Description
Technical field
The invention belongs to technical field of medicine, be specifically related to a kind of venlafaxine hydrochloride sustained-release capsule and preparation method thereof.
Background technology
VENLAFAXINE HCL is a kind of effective antianxiety drugs and antidepressants, and the form with hydrochlorate in medicament exists, its chemical name: (±)-1-[2-(dimethylamino)-1-(4-anisyl) ethyl] the Hexalin hydrochlorate, the chemical structural formula formula is as follows:
Venlafaxine belongs to the ethylamine derivant, is norepinephrine and serotonin reuptake transporter double inhibitor, always for the first-line treatment of depression, is mainly used in all kinds depression, comprises depression and generalized anxiety disorder with anxiety.
U.S. Wyeth number of patent application: 97109594.9, patent name: slow releasing preparation, wherein use the organic solvents such as dichloromethane.Patent 200910162006.8, patent name: Venlafaxine hydrochloride sustained-release pellet capsules extended release coatings film adopts polyacrylic resin, and this slow-release material price is expensive, and the pharmaceutical production cost is high.
Summary of the invention
For overcoming the deficiencies in the prior art part, the object of the present invention is to provide a kind of venlafaxine hydrochloride sustained-release capsule and preparation method thereof.
For achieving the above object, the technical scheme that the present invention takes is as follows:
A kind of venlafaxine hydrochloride sustained-release capsule, the content of this slow releasing capsule is slow-release micro-pill, this slow-release micro-pill is followed successively by ball core, sealing coat, slow release layer from the inside to the outside, wherein, the ball core is made by the composition of following weight percent: VENLAFAXINE HCL 45-48%, filler 15-18%, disintegrating agent 3-3.5%, PVP K30 4-6%, dehydrated alcohol 24-26%, and surplus is water; Sealing coat is made by the composition of following weight percent: PVP K30 11-13%, dehydrated alcohol 83-86%, and surplus is Pulvis Talci; Slow release layer is made by the composition of following weight percent: ethylcellulose mixed suspension liquid 38-42%, PEG-4000 0.1-1.0%, and surplus is water, the ethyl cellulose mass content of described ethylcellulose mixed suspension liquid is 20-30%.
Described filler is starch, sucrose or both combinations.
Described disintegrating agent is sodium carboxymethyl cellulose.
Preparation method is characterized in that step is as follows:
(1) prepare the ball core: after VENLAFAXINE HCL, filler, disintegrating agent are pulverized respectively, by the recipe quantity mix homogeneously, obtain mixed powder; The PVP K30 of recipe quantity is added in dehydrated alcohol and makes its even expansion, and the limit edged stirs, then adds water and stir, and room temperature is standing to be dissolved it to obtain binding agent fully; Mixed powder adds in pellet processing machine, sprays into the wet ball of binding agent preparation simultaneously, dries, and obtains the ball core;
(2) bag sealing coat: will be after the PVP K30 of recipe quantity, dehydrated alcohol and Pulvis Talci mix homogeneously contagion gown liquid, the ball core of step (1) is carried out to Cotton seeds;
(3) bag slow release layer: will be after the ethylcellulose mixed suspension liquid of recipe quantity, PEG-4000 and water mix homogeneously extended release coatings liquid, the ball core of step (2) is carried out to Cotton seeds, obtain slow-release micro-pill;
(4) filled capsules: the slow-release micro-pill of step (3) is filled in Capsules, obtains slow releasing capsule.
The slow-release material that the present invention adopts is ethyl cellulose, on the one hand in the situation that guarantee the slow release drug effect, avoided the residual of organic solvent to become to produce cost (domestic 380 yuan/kilogram of ethyl cellulose with having reduced, 526/ kilogram of imported from America, polyacrylic resin is mainly used 900/ kilogram of German import); The combustibility of ethyl cellulose is low on the other hand, and hygroscopicity is little, has good film property, and the ethyl cellulose suspension stable material quality of using in production process is easily controlled, and water slurry is safer and environmental protection.
The specific embodiment
Embodiment 1
A kind of venlafaxine sustained-release capsule, the content of this slow releasing capsule is slow-release micro-pill, this slow-release micro-pill is followed successively by ball core, sealing coat, slow release layer from the inside to the outside, ball core, sealing coat, slow release layer prescription as table 1-1, table 1-2, table 1-3.
drug release determination
Get embodiment 1 product, according to drug release determination method (two appendix X D first methods of Chinese Pharmacopoeia version in 2010), adopt the device of dissolution method (two appendix X C first methods of Chinese Pharmacopoeia version in 2010), take water 900ml as release medium, rotating speed is per minute 100 to turn, operation in accordance with the law, in the time of 2,4,8,12,24 hours, get respectively solution 5ml, filter, and the instant water that supplements the uniform temp equal volume in process container, get subsequent filtrate as need testing solution; Another precision takes the VENLAFAXINE HCL reference substance, accurately weighed, makes in every 1ml and approximately contains venlafaxine 70 μ g(specifications with water dissolution quantitative dilution: solution 75mg), product solution in contrast.According to high performance liquid chromatography (two appendix V D of Chinese Pharmacopoeia version in 2010), measure: with octadecylsilane chemically bonded silica, be filler, (get triethylamine 10ml with acetonitrile-triethylamine buffer solution, be diluted with water to 1000ml, with phosphorus acid for adjusting pH to 3.0) (20:80) be mobile phase, the detection wavelength is 225nm, number of theoretical plate calculates and should be not less than 1000 by the venlafaxine peak, and tailing factor should be not more than 2.0.Precision measures test sample liquid and each 20 μ l injection liquid chromatographies of contrast solution, records chromatogram, by external standard method, with calculated by peak area, obtains.Calculate respectively every burst size at different time.Computing formula:
In formula:
A
sample: need testing solution collection of illustrative plates Venlafaxine peak area;
A
right: reference substance solution collection of illustrative plates Venlafaxine peak area;
C
right: reference substance solution concentration;
0.8838: the conversion coefficient of VENLAFAXINE HCL and venlafaxine.
Repeat 6 tests, result of the test is in Table 4, and the burst size of this product in the time of 2,4,8,12,24 hours should be respectively below 30% of corresponding labelled amount, 30%～55%, 55%～80%, more than 65%～90% and 80%, all should be up to specification.
Claims (2)
1. a venlafaxine hydrochloride sustained-release capsule, it is characterized in that: the content of this slow releasing capsule is slow-release micro-pill, this slow-release micro-pill is followed successively by ball core, sealing coat, slow release layer from the inside to the outside, wherein, the ball core is made by the composition of following weight percent: VENLAFAXINE HCL 45-48%, filler 15-18%, disintegrating agent 3-3.5%, PVP K30 4-6%, dehydrated alcohol 24-26%, and surplus is water; Sealing coat is made by the composition of following weight percent: PVP K30 11-13%, dehydrated alcohol 83-86%, and surplus is Pulvis Talci; Slow release layer is made by the composition of following weight percent: ethylcellulose mixed suspension liquid 38-42%, PEG-4000 0.1-1.0%, and surplus is water, the ethyl cellulose mass content of described ethylcellulose mixed suspension liquid is 20-30%; Wherein, described filler is starch, sucrose or both combinations, and described disintegrating agent is sodium carboxymethyl cellulose.
2. a method for preparing venlafaxine hydrochloride sustained-release capsule as claimed in claim 1 is characterized in that step is as follows:
(1) prepare the ball core: after VENLAFAXINE HCL, filler, disintegrating agent are pulverized respectively, by the recipe quantity mix homogeneously, obtain mixed powder; The PVP K30 of recipe quantity is added in dehydrated alcohol and makes its even expansion, and the limit edged stirs, then adds water and stir, and room temperature is standing to be dissolved it to obtain binding agent fully; Mixed powder adds in pellet processing machine, sprays into the wet ball of binding agent preparation simultaneously, dries, and obtains the ball core;
(2) bag sealing coat: will be after the PVP K30 of recipe quantity, dehydrated alcohol and Pulvis Talci mix homogeneously contagion gown liquid, the ball core of step (1) is carried out to Cotton seeds;
(3) bag slow release layer: will be after the ethylcellulose mixed suspension liquid of recipe quantity, PEG-4000 and water mix homogeneously extended release coatings liquid, the ball core of step (2) is carried out to Cotton seeds, obtain slow-release micro-pill;
(4) filled capsules: the slow-release micro-pill of step (3) is filled in Capsules, obtains slow releasing capsule.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210291863.XA CN102772390B (en) | 2012-08-16 | 2012-08-16 | Venlafaxine hydrochloride sustained release capsule and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201210291863.XA CN102772390B (en) | 2012-08-16 | 2012-08-16 | Venlafaxine hydrochloride sustained release capsule and preparation method thereof |
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| CN102772390B true CN102772390B (en) | 2014-01-08 |
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Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103006618A (en) * | 2012-12-14 | 2013-04-03 | 中国药科大学 | Anti-depression slow-release capsule |
| CN104873477A (en) * | 2015-05-20 | 2015-09-02 | 南京正大天晴制药有限公司 | Venlafaxine hydrochloride sustained-release capsule and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101204380A (en) * | 2006-12-19 | 2008-06-25 | 北京德众万全药物技术开发有限公司 | Sustained-release coated pellets for 24 hours |
| CN101584674A (en) * | 2008-05-21 | 2009-11-25 | 上海医药科技发展有限公司 | Venlafaxine hydrochloride sustained-release tablet preparation and preparation method thereof |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| UA77145C2 (en) * | 1997-11-05 | 2006-11-15 | Wyeth Corp | Extended release dosage formulation |
| AU2006252394A1 (en) * | 2005-06-02 | 2006-12-07 | Biovail Laboratories International S.R.L. | Modified-release composition of at least one form of venlafaxine |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101204380A (en) * | 2006-12-19 | 2008-06-25 | 北京德众万全药物技术开发有限公司 | Sustained-release coated pellets for 24 hours |
| CN101584674A (en) * | 2008-05-21 | 2009-11-25 | 上海医药科技发展有限公司 | Venlafaxine hydrochloride sustained-release tablet preparation and preparation method thereof |
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