CN101756971A - 一种盐酸二甲双胍瑞格列奈的口服固体药物组合物 - Google Patents
一种盐酸二甲双胍瑞格列奈的口服固体药物组合物 Download PDFInfo
- Publication number
- CN101756971A CN101756971A CN200810224002A CN200810224002A CN101756971A CN 101756971 A CN101756971 A CN 101756971A CN 200810224002 A CN200810224002 A CN 200810224002A CN 200810224002 A CN200810224002 A CN 200810224002A CN 101756971 A CN101756971 A CN 101756971A
- Authority
- CN
- China
- Prior art keywords
- repaglinide
- pharmaceutical composition
- metformin hydrochloride
- pharmaceutically acceptable
- acceptable carrier
- 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
- FAEKWTJYAYMJKF-QHCPKHFHSA-N GlucoNorm Chemical compound C1=C(C(O)=O)C(OCC)=CC(CC(=O)N[C@@H](CC(C)C)C=2C(=CC=CC=2)N2CCCCC2)=C1 FAEKWTJYAYMJKF-QHCPKHFHSA-N 0.000 title claims abstract description 31
- 229960002354 repaglinide Drugs 0.000 title claims abstract description 31
- XZWYZXLIPXDOLR-UHFFFAOYSA-N metformin hydrochloride Natural products CN(C)C(=N)NC(N)=N XZWYZXLIPXDOLR-UHFFFAOYSA-N 0.000 title claims abstract description 25
- OETHQSJEHLVLGH-UHFFFAOYSA-N metformin hydrochloride Chemical group Cl.CN(C)C(=N)N=C(N)N OETHQSJEHLVLGH-UHFFFAOYSA-N 0.000 title claims abstract description 23
- 229960004329 metformin hydrochloride Drugs 0.000 title claims abstract description 23
- 239000003814 drug Substances 0.000 title claims abstract description 14
- 239000007787 solid Substances 0.000 title claims abstract description 14
- 239000000203 mixture Substances 0.000 title abstract description 18
- 229940079593 drug Drugs 0.000 title abstract description 6
- 239000003937 drug carrier Substances 0.000 claims abstract description 9
- 239000008194 pharmaceutical composition Substances 0.000 claims description 14
- 229920002472 Starch Polymers 0.000 claims description 8
- 239000008107 starch Substances 0.000 claims description 8
- 235000019698 starch Nutrition 0.000 claims description 8
- 239000002131 composite material Substances 0.000 claims description 7
- 239000011230 binding agent Substances 0.000 claims description 6
- 239000003795 chemical substances by application Substances 0.000 claims description 5
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 5
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 4
- 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 claims description 4
- 239000000945 filler Substances 0.000 claims description 4
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 4
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 4
- 239000008213 purified water Substances 0.000 claims description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 4
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 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
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims description 3
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims description 3
- 229930195725 Mannitol Natural products 0.000 claims description 3
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 3
- FUFJGUQYACFECW-UHFFFAOYSA-L calcium hydrogenphosphate Chemical compound [Ca+2].OP([O-])([O-])=O FUFJGUQYACFECW-UHFFFAOYSA-L 0.000 claims description 3
- 235000019700 dicalcium phosphate Nutrition 0.000 claims description 3
- 239000000594 mannitol Substances 0.000 claims description 3
- 235000010355 mannitol Nutrition 0.000 claims description 3
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 3
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 3
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 3
- 229960000540 polacrilin potassium Drugs 0.000 claims description 3
- WVWZXTJUCNEUAE-UHFFFAOYSA-M potassium;1,2-bis(ethenyl)benzene;2-methylprop-2-enoate Chemical group [K+].CC(=C)C([O-])=O.C=CC1=CC=CC=C1C=C WVWZXTJUCNEUAE-UHFFFAOYSA-M 0.000 claims description 3
- 239000011734 sodium Substances 0.000 claims description 3
- 229910052708 sodium Inorganic materials 0.000 claims description 3
- 239000000600 sorbitol Substances 0.000 claims description 3
- 235000010356 sorbitol Nutrition 0.000 claims description 3
- 229920002785 Croscarmellose sodium Polymers 0.000 claims description 2
- 229940063834 carboxymethylcellulose sodium Drugs 0.000 claims description 2
- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 claims description 2
- 239000000314 lubricant Substances 0.000 claims description 2
- 238000002156 mixing Methods 0.000 claims description 2
- 239000002245 particle Substances 0.000 claims description 2
- 239000008188 pellet Substances 0.000 claims description 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 2
- 238000002360 preparation method Methods 0.000 abstract description 17
- 238000004090 dissolution Methods 0.000 abstract description 6
- 208000001072 type 2 diabetes mellitus Diseases 0.000 abstract description 4
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 8
- 239000000243 solution Substances 0.000 description 8
- 238000004519 manufacturing process Methods 0.000 description 6
- 239000002671 adjuvant Substances 0.000 description 5
- 238000005516 engineering process Methods 0.000 description 5
- 206010013786 Dry skin Diseases 0.000 description 4
- 230000001476 alcoholic effect Effects 0.000 description 4
- 239000007864 aqueous solution Substances 0.000 description 4
- 239000011248 coating agent Substances 0.000 description 4
- 238000000576 coating method Methods 0.000 description 4
- 230000000052 comparative effect Effects 0.000 description 4
- 238000001035 drying Methods 0.000 description 4
- 239000008187 granular material Substances 0.000 description 4
- 235000019359 magnesium stearate Nutrition 0.000 description 4
- 239000007779 soft material Substances 0.000 description 4
- 238000003756 stirring Methods 0.000 description 4
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- 239000001768 carboxy methyl cellulose Substances 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 238000004132 cross linking Methods 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 229960003105 metformin Drugs 0.000 description 2
- 239000002002 slurry Substances 0.000 description 2
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 description 2
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 description 2
- 238000005303 weighing Methods 0.000 description 2
- CTKXFMQHOOWWEB-UHFFFAOYSA-N Ethylene oxide/propylene oxide copolymer Chemical compound CCCOC(C)COCCO CTKXFMQHOOWWEB-UHFFFAOYSA-N 0.000 description 1
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 1
- MBBZMMPHUWSWHV-BDVNFPICSA-N N-methylglucamine Chemical compound CNC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO MBBZMMPHUWSWHV-BDVNFPICSA-N 0.000 description 1
- 229920003080 Povidone K 25 Polymers 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 239000013078 crystal Substances 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 238000007922 dissolution test Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000005469 granulation Methods 0.000 description 1
- 230000003179 granulation Effects 0.000 description 1
- 238000010237 hybrid technique Methods 0.000 description 1
- 238000010348 incorporation Methods 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 210000003734 kidney Anatomy 0.000 description 1
- 229960003194 meglumine Drugs 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 229920001993 poloxamer 188 Polymers 0.000 description 1
- 229940044519 poloxamer 188 Drugs 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 239000007921 spray Substances 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
- 238000005550 wet granulation Methods 0.000 description 1
Landscapes
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Description
A+1.80S | 压片过程及外观 | |
实施例1 | 3.4 | 硬度为120N无裂片现象,片面光洁 |
实施例2 | 4.1 | 硬度为110N无裂片现象,片面光洁 |
实施例3 | 2.8 | 硬度为123N无裂片现象,片面光洁 |
Claims (10)
Priority Applications (1)
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---|---|---|---|
CN 200810224002 CN101756971B (zh) | 2008-10-09 | 2008-10-09 | 一种盐酸二甲双胍瑞格列奈的口服固体药物组合物 |
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CN 200810224002 CN101756971B (zh) | 2008-10-09 | 2008-10-09 | 一种盐酸二甲双胍瑞格列奈的口服固体药物组合物 |
Publications (2)
Publication Number | Publication Date |
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CN101756971A true CN101756971A (zh) | 2010-06-30 |
CN101756971B CN101756971B (zh) | 2013-09-18 |
Family
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CN 200810224002 Active CN101756971B (zh) | 2008-10-09 | 2008-10-09 | 一种盐酸二甲双胍瑞格列奈的口服固体药物组合物 |
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102218064A (zh) * | 2011-04-20 | 2011-10-19 | 海南锦瑞制药股份有限公司 | 瑞格列奈和二甲双胍为活性成份的药用组合物及制备方法 |
CN103070864A (zh) * | 2012-12-06 | 2013-05-01 | 华润赛科药业有限责任公司 | 一种瑞格列奈和盐酸二甲双胍药物组合物及其制备方法 |
CN103181923A (zh) * | 2011-12-29 | 2013-07-03 | 北京韩美药品有限公司 | 包含瑞格列奈的药物制剂及其制备方法 |
Family Cites Families (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
ES2159184T3 (es) * | 1997-06-13 | 2001-09-16 | Novo Nordisk As | Nueva posologia para la dmni. |
AU1133901A (en) * | 1999-10-08 | 2001-04-23 | Novartis Ag | Method of treating metabolic disorders |
EP2026787B1 (en) * | 2006-05-13 | 2013-12-25 | Novo Nordisk A/S | Tablet formulation comprising repaglinide and metformin |
US20100029721A1 (en) * | 2006-09-29 | 2010-02-04 | Novo Nordisk A/S | Pharmaceutical Formulation Comprising Metformin and Repaglinide |
-
2008
- 2008-10-09 CN CN 200810224002 patent/CN101756971B/zh active Active
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102218064A (zh) * | 2011-04-20 | 2011-10-19 | 海南锦瑞制药股份有限公司 | 瑞格列奈和二甲双胍为活性成份的药用组合物及制备方法 |
CN102218064B (zh) * | 2011-04-20 | 2012-07-18 | 海南锦瑞制药股份有限公司 | 瑞格列奈和二甲双胍为活性成份的药用组合物及制备方法 |
CN103181923A (zh) * | 2011-12-29 | 2013-07-03 | 北京韩美药品有限公司 | 包含瑞格列奈的药物制剂及其制备方法 |
CN103070864A (zh) * | 2012-12-06 | 2013-05-01 | 华润赛科药业有限责任公司 | 一种瑞格列奈和盐酸二甲双胍药物组合物及其制备方法 |
CN103070864B (zh) * | 2012-12-06 | 2015-04-15 | 华润赛科药业有限责任公司 | 一种瑞格列奈和盐酸二甲双胍药物组合物及其制备方法 |
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Publication number | Publication date |
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CN101756971B (zh) | 2013-09-18 |
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C06 | Publication | ||
PB01 | Publication | ||
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SE01 | Entry into force of request for substantive examination | ||
C14 | Grant of patent or utility model | ||
GR01 | Patent grant | ||
ASS | Succession or assignment of patent right |
Owner name: HAINAN SHENGKE LIFE SCIENTIFIC RESEARCH INSTITUTE Free format text: FORMER OWNER: DEZHONG WANQUAN PHARMACEUTICALS TECH. DEV. CO., LTD., BEIJING Effective date: 20150519 |
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C41 | Transfer of patent application or patent right or utility model | ||
C53 | Correction of patent of invention or patent application | ||
CB03 | Change of inventor or designer information |
Inventor after: Wang Shifeng Inventor after: Shang Lixia Inventor before: Shang Lixia |
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COR | Change of bibliographic data |
Free format text: CORRECT: ADDRESS; FROM: 100097 HAIDIAN, BEIJING TO: 570000 HAIKOU, HAINAN PROVINCE Free format text: CORRECT: INVENTOR; FROM: SHANG LIXIA TO: WANG SHIFENG SHANG LIXIA |
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TR01 | Transfer of patent right |
Effective date of registration: 20150519 Address after: 570000 Hainan Province, Haikou City Xiuying District Road No. 17 Yu Department of science and technology building on the third floor Patentee after: Hainan Shengke Life Scientific Research Institute Address before: 100097 Beijing city Haidian District Sijiqing Wanquan Zhuang 3 Building Patentee before: Beijing D-Venturepharm Technology Development Co.,Ltd. |
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TR01 | Transfer of patent right |
Effective date of registration: 20190829 Address after: Haicang Xinyang Industrial Zone District of Xiamen City, Fujian province 361022 Yang Road No. 6 Patentee after: WANQUAN WANTE PHARMACEUTICAL (XIAMEN) CO.,LTD. Address before: Third Floor of Yuke Building, 17 Science and Technology Avenue, Xiuying District, Haikou City Patentee before: Hainan Shengke Life Scientific Research Institute |
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TR01 | Transfer of patent right | ||
DD01 | Delivery of document by public notice |
Addressee: Hainan Shengke Life Scientific Research Institute Document name: Notification of Passing Examination on Formalities |
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DD01 | Delivery of document by public notice | ||
PE01 | Entry into force of the registration of the contract for pledge of patent right | ||
PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: An oral solid drug combination of metformin hydrochloride and regaglandine hydrochloride Granted publication date: 20130918 Pledgee: Agricultural Bank of China Limited Xiamen Siming Sub branch Pledgor: WANQUAN WANTE PHARMACEUTICAL (XIAMEN) CO.,LTD. Registration number: Y2024980006640 |