CN1977845A - 盐酸丁螺环酮缓/控释微丸 - Google Patents
盐酸丁螺环酮缓/控释微丸 Download PDFInfo
- Publication number
- CN1977845A CN1977845A CN 200510126198 CN200510126198A CN1977845A CN 1977845 A CN1977845 A CN 1977845A CN 200510126198 CN200510126198 CN 200510126198 CN 200510126198 A CN200510126198 A CN 200510126198A CN 1977845 A CN1977845 A CN 1977845A
- Authority
- CN
- China
- Prior art keywords
- slow
- controlled release
- buspirone hydrochloride
- buspirone
- coating
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- QWCRAEMEVRGPNT-UHFFFAOYSA-N buspirone Chemical compound C1C(=O)N(CCCCN2CCN(CC2)C=2N=CC=CN=2)C(=O)CC21CCCC2 QWCRAEMEVRGPNT-UHFFFAOYSA-N 0.000 title claims abstract description 116
- 229960001768 buspirone hydrochloride Drugs 0.000 title claims abstract description 84
- 239000006187 pill Substances 0.000 title claims abstract description 13
- 238000013270 controlled release Methods 0.000 title claims description 57
- 239000003814 drug Substances 0.000 claims abstract description 75
- 239000002775 capsule Substances 0.000 claims abstract description 39
- 238000002360 preparation method Methods 0.000 claims abstract description 25
- 239000011247 coating layer Substances 0.000 claims abstract description 21
- 239000010410 layer Substances 0.000 claims abstract description 17
- 238000000576 coating method Methods 0.000 claims description 62
- 239000011248 coating agent Substances 0.000 claims description 56
- 229960002495 buspirone Drugs 0.000 claims description 34
- 239000008188 pellet Substances 0.000 claims description 31
- 238000007789 sealing Methods 0.000 claims description 30
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 26
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 26
- 238000013268 sustained release Methods 0.000 claims description 24
- 239000012730 sustained-release form Substances 0.000 claims description 23
- 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 description 20
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 17
- 229960003943 hypromellose Drugs 0.000 claims description 17
- 239000000463 material Substances 0.000 claims description 15
- 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 description 12
- 239000002202 Polyethylene glycol Substances 0.000 claims description 8
- 239000012530 fluid Substances 0.000 claims description 8
- 229920001223 polyethylene glycol Polymers 0.000 claims description 8
- 239000001856 Ethyl cellulose Substances 0.000 claims description 6
- 235000019325 ethyl cellulose Nutrition 0.000 claims description 6
- 229920001249 ethyl cellulose Polymers 0.000 claims description 6
- 239000004925 Acrylic resin Substances 0.000 claims description 4
- 229920000178 Acrylic resin Polymers 0.000 claims description 4
- 239000002671 adjuvant Substances 0.000 claims description 4
- 239000000203 mixture Substances 0.000 claims description 4
- 238000012856 packing Methods 0.000 claims description 4
- 239000007888 film coating Substances 0.000 claims description 3
- 238000009501 film coating Methods 0.000 claims description 3
- 238000012946 outsourcing Methods 0.000 claims description 2
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims 1
- 230000015572 biosynthetic process Effects 0.000 claims 1
- 229920002523 polyethylene Glycol 1000 Polymers 0.000 claims 1
- 208000019901 Anxiety disease Diseases 0.000 abstract description 5
- 229940079593 drug Drugs 0.000 description 27
- 239000003826 tablet Substances 0.000 description 22
- 239000000243 solution Substances 0.000 description 21
- 241000282472 Canis lupus familiaris Species 0.000 description 19
- 229920001030 Polyethylene Glycol 4000 Polymers 0.000 description 18
- MTHSVFCYNBDYFN-UHFFFAOYSA-N diethylene glycol Chemical compound OCCOCCO MTHSVFCYNBDYFN-UHFFFAOYSA-N 0.000 description 18
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 18
- 238000002156 mixing Methods 0.000 description 17
- 210000004369 blood Anatomy 0.000 description 16
- 239000008280 blood Substances 0.000 description 16
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- 239000003405 delayed action preparation Substances 0.000 description 13
- 229940023488 pill Drugs 0.000 description 9
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- 238000000889 atomisation Methods 0.000 description 6
- 230000000694 effects Effects 0.000 description 6
- 239000000935 antidepressant agent Substances 0.000 description 5
- 239000006185 dispersion Substances 0.000 description 5
- 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 5
- 210000002381 plasma Anatomy 0.000 description 5
- 230000008569 process Effects 0.000 description 5
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 4
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 4
- 238000010521 absorption reaction Methods 0.000 description 4
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- 238000005516 engineering process Methods 0.000 description 3
- 238000013265 extended release Methods 0.000 description 3
- 238000011049 filling Methods 0.000 description 3
- 239000007789 gas Substances 0.000 description 3
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- 239000013563 matrix tablet Substances 0.000 description 3
- 239000002207 metabolite Substances 0.000 description 3
- 229920000642 polymer Polymers 0.000 description 3
- KHWTYGFHPHRQMP-UHFFFAOYSA-N (4-propan-2-ylcyclohexyl)methanol Chemical compound CC(C)C1CCC(CO)CC1 KHWTYGFHPHRQMP-UHFFFAOYSA-N 0.000 description 2
- TVYLLZQTGLZFBW-ZBFHGGJFSA-N (R,R)-tramadol Chemical compound COC1=CC=CC([C@]2(O)[C@H](CCCC2)CN(C)C)=C1 TVYLLZQTGLZFBW-ZBFHGGJFSA-N 0.000 description 2
- AZUVBPVDRHGGEP-UHFFFAOYSA-N 6a,9a-dimethyl-4,5,7,8,9,9a-hexahydro-6aH-dipyrrolo(2,3-b;3',2',1'-hi)indole Natural products CC(=C)C1CCC(C)=CCCC(C)=CCCC(C)=CC1O AZUVBPVDRHGGEP-UHFFFAOYSA-N 0.000 description 2
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
- XDTMQSROBMDMFD-UHFFFAOYSA-N Cyclohexane Chemical compound C1CCCCC1 XDTMQSROBMDMFD-UHFFFAOYSA-N 0.000 description 2
- WSTYNZDAOAEEKG-UHFFFAOYSA-N Mayol Natural products CC1=C(O)C(=O)C=C2C(CCC3(C4CC(C(CC4(CCC33C)C)=O)C)C)(C)C3=CC=C21 WSTYNZDAOAEEKG-UHFFFAOYSA-N 0.000 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 description 2
- 229930006000 Sucrose Natural products 0.000 description 2
- 238000005349 anion exchange Methods 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 239000011230 binding agent Substances 0.000 description 2
- 150000001768 cations Chemical class 0.000 description 2
- 238000006243 chemical reaction Methods 0.000 description 2
- 239000002131 composite material Substances 0.000 description 2
- 238000013461 design Methods 0.000 description 2
- 238000010790 dilution Methods 0.000 description 2
- 239000012895 dilution Substances 0.000 description 2
- 238000000132 electrospray ionisation Methods 0.000 description 2
- 238000000605 extraction Methods 0.000 description 2
- 238000010579 first pass effect Methods 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 238000001294 liquid chromatography-tandem mass spectrometry Methods 0.000 description 2
- 239000000314 lubricant Substances 0.000 description 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical group [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 2
- 230000000144 pharmacologic effect Effects 0.000 description 2
- -1 polyethylene Polymers 0.000 description 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 2
- 150000003839 salts Chemical class 0.000 description 2
- 239000003772 serotonin uptake inhibitor Substances 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 239000005720 sucrose Substances 0.000 description 2
- 229960004380 tramadol Drugs 0.000 description 2
- TVYLLZQTGLZFBW-GOEBONIOSA-N tramadol Natural products COC1=CC=CC([C@@]2(O)[C@@H](CCCC2)CN(C)C)=C1 TVYLLZQTGLZFBW-GOEBONIOSA-N 0.000 description 2
- PPKXEPBICJTCRU-XMZRARIVSA-N (R,R)-tramadol hydrochloride Chemical compound Cl.COC1=CC=CC([C@]2(O)[C@H](CCCC2)CN(C)C)=C1 PPKXEPBICJTCRU-XMZRARIVSA-N 0.000 description 1
- 206010002869 Anxiety symptoms Diseases 0.000 description 1
- 206010013654 Drug abuse Diseases 0.000 description 1
- 206010059866 Drug resistance Diseases 0.000 description 1
- 229920003134 Eudragit® polymer Polymers 0.000 description 1
- 208000011688 Generalised anxiety disease Diseases 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- CERQOIWHTDAKMF-UHFFFAOYSA-M Methacrylate Chemical compound CC(=C)C([O-])=O CERQOIWHTDAKMF-UHFFFAOYSA-M 0.000 description 1
- VVQNEPGJFQJSBK-UHFFFAOYSA-N Methyl methacrylate Chemical compound COC(=O)C(C)=C VVQNEPGJFQJSBK-UHFFFAOYSA-N 0.000 description 1
- RCEAADKTGXTDOA-UHFFFAOYSA-N OS(O)(=O)=O.CCCCCCCCCCCC[Na] Chemical compound OS(O)(=O)=O.CCCCCCCCCCCC[Na] RCEAADKTGXTDOA-UHFFFAOYSA-N 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- 229920003081 Povidone K 30 Polymers 0.000 description 1
- 206010039897 Sedation Diseases 0.000 description 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 1
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical class [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 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
- 238000002835 absorbance Methods 0.000 description 1
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 230000032683 aging Effects 0.000 description 1
- 239000002249 anxiolytic agent Substances 0.000 description 1
- 230000000949 anxiolytic effect Effects 0.000 description 1
- 229940049706 benzodiazepine Drugs 0.000 description 1
- 150000001557 benzodiazepines Chemical class 0.000 description 1
- 230000004071 biological effect Effects 0.000 description 1
- 238000010241 blood sampling Methods 0.000 description 1
- 125000000484 butyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
- 239000001768 carboxy methyl cellulose Substances 0.000 description 1
- 229920002678 cellulose Polymers 0.000 description 1
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- 235000010980 cellulose Nutrition 0.000 description 1
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- 238000011161 development Methods 0.000 description 1
- 230000018109 developmental process Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000012377 drug delivery Methods 0.000 description 1
- 230000000857 drug effect Effects 0.000 description 1
- 125000001495 ethyl group Chemical group [H]C([H])([H])C([H])([H])* 0.000 description 1
- 239000003925 fat Substances 0.000 description 1
- AOQKTXNIXJZEJT-UHFFFAOYSA-N formic acid;methanol;hydrate Chemical group O.OC.OC=O AOQKTXNIXJZEJT-UHFFFAOYSA-N 0.000 description 1
- 238000012395 formulation development Methods 0.000 description 1
- 208000029364 generalized anxiety disease Diseases 0.000 description 1
- 230000035876 healing Effects 0.000 description 1
- 238000004128 high performance liquid chromatography Methods 0.000 description 1
- 238000003475 lamination Methods 0.000 description 1
- 210000003141 lower extremity Anatomy 0.000 description 1
- 235000019359 magnesium stearate Nutrition 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 230000002503 metabolic effect Effects 0.000 description 1
- 230000004060 metabolic process Effects 0.000 description 1
- 239000003094 microcapsule Substances 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 229910052757 nitrogen Inorganic materials 0.000 description 1
- 229940126701 oral medication Drugs 0.000 description 1
- 239000007935 oral tablet Substances 0.000 description 1
- 229940096978 oral tablet Drugs 0.000 description 1
- 238000007427 paired t-test Methods 0.000 description 1
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- 229920000573 polyethylene Polymers 0.000 description 1
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- 208000012201 sexual and gender identity disease Diseases 0.000 description 1
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- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 description 1
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 description 1
- 235000019333 sodium laurylsulphate Nutrition 0.000 description 1
- 230000003595 spectral effect Effects 0.000 description 1
- 201000009032 substance abuse Diseases 0.000 description 1
- 208000011117 substance-related disease Diseases 0.000 description 1
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- 230000001839 systemic circulation Effects 0.000 description 1
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- 230000001988 toxicity Effects 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- 229960003107 tramadol hydrochloride Drugs 0.000 description 1
- MEYZYGMYMLNUHJ-UHFFFAOYSA-N tunicamycin Natural products CC(C)CCCCCCCCCC=CC(=O)NC1C(O)C(O)C(CC(O)C2OC(C(O)C2O)N3C=CC(=O)NC3=O)OC1OC4OC(CO)C(O)C(O)C4NC(=O)C MEYZYGMYMLNUHJ-UHFFFAOYSA-N 0.000 description 1
- 238000000870 ultraviolet spectroscopy Methods 0.000 description 1
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Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
动力学参数 | 普通片 | 缓释胶囊 | P值 |
Cmax(ng·ml-1)Tmax(h)t1/2β(h)MRT(h)AUC0-24(ng.h·ml-1)AUC0-∞(ng·h·ml-1) | 6.93±1.730.8±0.34.83±3.632.76±0.9411.07±2.791135±2.98 | 1.80±0.754.70±1.604.00±1.457.18±1.3214.45±7.3014.90±7.54 | 0.0003*0.0024*0.66880.0004*0.24330.2331 |
Claims (10)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CNB2005101261989A CN100551373C (zh) | 2005-12-01 | 2005-12-01 | 盐酸丁螺环酮缓/控释微丸 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CNB2005101261989A CN100551373C (zh) | 2005-12-01 | 2005-12-01 | 盐酸丁螺环酮缓/控释微丸 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN1977845A true CN1977845A (zh) | 2007-06-13 |
CN100551373C CN100551373C (zh) | 2009-10-21 |
Family
ID=38129265
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CNB2005101261989A Active CN100551373C (zh) | 2005-12-01 | 2005-12-01 | 盐酸丁螺环酮缓/控释微丸 |
Country Status (1)
Country | Link |
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CN (1) | CN100551373C (zh) |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101829045A (zh) * | 2010-03-05 | 2010-09-15 | 南京海陵中药制药工艺技术研究有限公司 | 一种阿奇霉素缓释干混悬剂及其制备方法 |
US9763884B2 (en) | 2011-05-13 | 2017-09-19 | Eb Ip Hybritabs B.V. | Drug delivery system |
-
2005
- 2005-12-01 CN CNB2005101261989A patent/CN100551373C/zh active Active
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101829045A (zh) * | 2010-03-05 | 2010-09-15 | 南京海陵中药制药工艺技术研究有限公司 | 一种阿奇霉素缓释干混悬剂及其制备方法 |
US9763884B2 (en) | 2011-05-13 | 2017-09-19 | Eb Ip Hybritabs B.V. | Drug delivery system |
US10966933B2 (en) | 2011-05-13 | 2021-04-06 | Eb Ip Hybritabs B.V. | Drug delivery system |
Also Published As
Publication number | Publication date |
---|---|
CN100551373C (zh) | 2009-10-21 |
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C14 | Grant of patent or utility model | ||
GR01 | Patent grant | ||
C53 | Correction of patent for invention or patent application | ||
CB03 | Change of inventor or designer information |
Inventor after: Dong Guoming Inventor after: Long Yongpeng Inventor after: Chen Yan Inventor after: Wang Jin Inventor before: Long Yongpeng Inventor before: Chen Yan Inventor before: Wang Jin |
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COR | Change of bibliographic data |
Free format text: CORRECT: INVENTOR; FROM: LONG YONGPENG CHEN YAN WANG JIN TO: DONG GUOMING LONG YONGPENG CHEN YAN WANG JIN |
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EE01 | Entry into force of recordation of patent licensing contract |
Assignee: Huaxia Pharmaceutical Group Co., Ltd. Assignor: Beijing Hwells Pharmaceutical Co., Ltd. Contract record no.: 2012370000015 Denomination of invention: Buspirone hydrochloride slow/controlled release micro pill Granted publication date: 20091021 License type: Exclusive License Open date: 20070613 Record date: 20120313 |
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EC01 | Cancellation of recordation of patent licensing contract |
Assignee: Huaxia Pharmaceutical Group Co., Ltd. Assignor: Beijing Hwells Pharmaceutical Co., Ltd. Contract record no.: 2012370000015 Date of cancellation: 20130624 |
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LICC | Enforcement, change and cancellation of record of contracts on the licence for exploitation of a patent or utility model | ||
EE01 | Entry into force of recordation of patent licensing contract | ||
EE01 | Entry into force of recordation of patent licensing contract |
Application publication date: 20070613 Assignee: Zhongguancun Pharmaceutical (Hainan) Co., Ltd. Assignor: Beijing Hwells Pharmaceutical Co., Ltd. Contract record no.: X2019990000035 Denomination of invention: Buspirone hydrochloride slow/controlled release micro pill Granted publication date: 20091021 License type: Common License Record date: 20190822 |