CN103396328A - Meclofenoxate hydrochloride compound and pharmaceutical composition thereof - Google Patents
Meclofenoxate hydrochloride compound and pharmaceutical composition thereof Download PDFInfo
- Publication number
- CN103396328A CN103396328A CN2013103658460A CN201310365846A CN103396328A CN 103396328 A CN103396328 A CN 103396328A CN 2013103658460 A CN2013103658460 A CN 2013103658460A CN 201310365846 A CN201310365846 A CN 201310365846A CN 103396328 A CN103396328 A CN 103396328A
- Authority
- CN
- China
- Prior art keywords
- meclofenoxate hydrochloride
- hydrochloride compound
- preparation
- meclofenoxate
- drug combination
- 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
- 229960001637 meclofenoxate hydrochloride Drugs 0.000 title claims abstract description 168
- -1 Meclofenoxate hydrochloride compound Chemical class 0.000 title claims abstract description 87
- 239000008194 pharmaceutical composition Substances 0.000 title abstract description 6
- 239000000843 powder Substances 0.000 claims abstract description 41
- 239000002775 capsule Substances 0.000 claims abstract description 25
- 238000000634 powder X-ray diffraction Methods 0.000 claims abstract description 7
- 239000013078 crystal Substances 0.000 claims abstract description 4
- XZTYGFHCIAKPGJ-UHFFFAOYSA-N Meclofenoxate Chemical compound CN(C)CCOC(=O)COC1=CC=C(Cl)C=C1 XZTYGFHCIAKPGJ-UHFFFAOYSA-N 0.000 claims description 84
- 238000002360 preparation method Methods 0.000 claims description 65
- 238000003756 stirring Methods 0.000 claims description 34
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 31
- 229910052799 carbon Inorganic materials 0.000 claims description 25
- 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 24
- 229930195725 Mannitol Natural products 0.000 claims description 24
- 239000000594 mannitol Substances 0.000 claims description 24
- 235000010355 mannitol Nutrition 0.000 claims description 24
- 239000000706 filtrate Substances 0.000 claims description 22
- 238000012856 packing Methods 0.000 claims description 22
- 239000000470 constituent Substances 0.000 claims description 20
- 239000000890 drug combination Substances 0.000 claims description 18
- 239000000243 solution Substances 0.000 claims description 18
- 238000010792 warming Methods 0.000 claims description 18
- 239000008215 water for injection Substances 0.000 claims description 17
- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 claims description 16
- 239000007919 dispersible tablet Substances 0.000 claims description 13
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 12
- 239000003814 drug Substances 0.000 claims description 12
- 239000000203 mixture Substances 0.000 claims description 12
- 206010013786 Dry skin Diseases 0.000 claims description 11
- 229920000881 Modified starch Polymers 0.000 claims description 11
- 238000001035 drying Methods 0.000 claims description 11
- 238000001914 filtration Methods 0.000 claims description 10
- 238000005374 membrane filtration Methods 0.000 claims description 10
- HEDRZPFGACZZDS-UHFFFAOYSA-N Chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 claims description 8
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 8
- 229960001701 chloroform Drugs 0.000 claims description 8
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 8
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 8
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 8
- 239000002994 raw material Substances 0.000 claims description 8
- 238000002156 mixing Methods 0.000 claims description 7
- 238000005262 decarbonization Methods 0.000 claims description 6
- 238000004821 distillation Methods 0.000 claims description 6
- 238000004108 freeze drying Methods 0.000 claims description 6
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 4
- 239000012065 filter cake Substances 0.000 claims description 4
- 238000011068 loading method Methods 0.000 claims description 4
- 230000001105 regulatory effect Effects 0.000 claims description 4
- 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 3
- 239000008101 lactose Substances 0.000 claims description 3
- 239000003826 tablet 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
- 229920002307 Dextran Polymers 0.000 claims description 2
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 2
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims description 2
- 239000008103 glucose Substances 0.000 claims description 2
- FZWBNHMXJMCXLU-BLAUPYHCSA-N isomaltotriose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1OC[C@@H]1[C@@H](O)[C@H](O)[C@@H](O)[C@@H](OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C=O)O1 FZWBNHMXJMCXLU-BLAUPYHCSA-N 0.000 claims description 2
- 238000002347 injection Methods 0.000 abstract description 16
- 239000007924 injection Substances 0.000 abstract description 16
- 239000002552 dosage form Substances 0.000 abstract 1
- 239000012535 impurity Substances 0.000 abstract 1
- 238000001228 spectrum Methods 0.000 abstract 1
- 238000000034 method Methods 0.000 description 16
- 238000012360 testing method Methods 0.000 description 10
- 238000011835 investigation Methods 0.000 description 6
- 238000003556 assay Methods 0.000 description 5
- 229940079593 drug Drugs 0.000 description 4
- 239000000463 material Substances 0.000 description 4
- 230000007062 hydrolysis Effects 0.000 description 3
- 238000006460 hydrolysis reaction Methods 0.000 description 3
- 239000007864 aqueous solution Substances 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 230000007774 longterm Effects 0.000 description 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 2
- 238000011160 research Methods 0.000 description 2
- SODPIMGUZLOIPE-UHFFFAOYSA-N (4-chlorophenoxy)acetic acid Chemical compound OC(=O)COC1=CC=C(Cl)C=C1 SODPIMGUZLOIPE-UHFFFAOYSA-N 0.000 description 1
- 208000007848 Alcoholism Diseases 0.000 description 1
- 206010012289 Dementia Diseases 0.000 description 1
- 208000008967 Enuresis Diseases 0.000 description 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 1
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 1
- 206010039987 Senile psychosis Diseases 0.000 description 1
- 229920002472 Starch Polymers 0.000 description 1
- 208000010513 Stupor Diseases 0.000 description 1
- 230000001133 acceleration Effects 0.000 description 1
- 201000007930 alcohol dependence Diseases 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 210000004958 brain cell Anatomy 0.000 description 1
- 150000001720 carbohydrates Chemical class 0.000 description 1
- 235000014633 carbohydrates Nutrition 0.000 description 1
- 239000002131 composite material Substances 0.000 description 1
- 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 description 1
- 150000002148 esters Chemical class 0.000 description 1
- 230000005284 excitation Effects 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 description 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 1
- 235000019359 magnesium stearate Nutrition 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 230000004060 metabolic process Effects 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 229920003109 sodium starch glycolate Polymers 0.000 description 1
- 229940079832 sodium starch glycolate Drugs 0.000 description 1
- 239000008109 sodium starch glycolate Substances 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 229940032147 starch Drugs 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 230000000472 traumatic effect Effects 0.000 description 1
Abstract
Description
Claims (10)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201310365846.0A CN103396328B (en) | 2013-08-21 | 2013-08-21 | Meclofenoxate hydrochloride compound and pharmaceutical composition thereof |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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CN201310365846.0A CN103396328B (en) | 2013-08-21 | 2013-08-21 | Meclofenoxate hydrochloride compound and pharmaceutical composition thereof |
Publications (2)
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CN103396328A true CN103396328A (en) | 2013-11-20 |
CN103396328B CN103396328B (en) | 2014-10-15 |
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CN201310365846.0A Active CN103396328B (en) | 2013-08-21 | 2013-08-21 | Meclofenoxate hydrochloride compound and pharmaceutical composition thereof |
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Cited By (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN104058979A (en) * | 2014-07-02 | 2014-09-24 | 江苏汉斯通药业有限公司 | Purification process of meclofenoxate hydrochloride |
CN105106190A (en) * | 2015-10-09 | 2015-12-02 | 杨献美 | Central stimulant meclofenoxate hydrochloride composition |
CN105106189A (en) * | 2015-09-30 | 2015-12-02 | 杨献美 | Meclofenoxate hydrochloride pharmaceutical composition capable of promoting brain energy metabolism |
CN105287409A (en) * | 2015-12-01 | 2016-02-03 | 青岛华之草医药科技有限公司 | Medicinal meclofenoxate hydrochloride composition freeze-dried powder injection for treating senile dementia |
CN105287410A (en) * | 2015-12-01 | 2016-02-03 | 青岛华之草医药科技有限公司 | Medicinal meclofenoxate hydrochloride composition freeze-dried powder injection for treating traumatic coma |
CN105434384A (en) * | 2016-01-05 | 2016-03-30 | 濮阳市仲亿药业有限公司 | Aceclofenac dispersible tablets and preparation method |
CN113133975A (en) * | 2021-04-22 | 2021-07-20 | 海南通用三洋药业有限公司 | Preparation method of meclofenoxate hydrochloride freeze-dried powder injection |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS61171460A (en) * | 1985-01-23 | 1986-08-02 | Dainippon Pharmaceut Co Ltd | Production of i-type crystal of meclofenoxate hydrochloride |
JPS61246123A (en) * | 1985-04-22 | 1986-11-01 | Dainippon Pharmaceut Co Ltd | Freeze-drying of highly concentrated aqueous solution of meclofenoxate hydrochloride |
CN101747215A (en) * | 2008-12-11 | 2010-06-23 | 重庆药友制药有限责任公司 | Method for preparing meclofenoxate hydrochloride sterile bulk drug |
CN103214382A (en) * | 2013-04-24 | 2013-07-24 | 四川省惠达药业有限公司 | Meclofenoxate hydrochloride compound and pharmaceutical composition thereof |
-
2013
- 2013-08-21 CN CN201310365846.0A patent/CN103396328B/en active Active
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS61171460A (en) * | 1985-01-23 | 1986-08-02 | Dainippon Pharmaceut Co Ltd | Production of i-type crystal of meclofenoxate hydrochloride |
JPS61246123A (en) * | 1985-04-22 | 1986-11-01 | Dainippon Pharmaceut Co Ltd | Freeze-drying of highly concentrated aqueous solution of meclofenoxate hydrochloride |
CN101747215A (en) * | 2008-12-11 | 2010-06-23 | 重庆药友制药有限责任公司 | Method for preparing meclofenoxate hydrochloride sterile bulk drug |
CN103214382A (en) * | 2013-04-24 | 2013-07-24 | 四川省惠达药业有限公司 | Meclofenoxate hydrochloride compound and pharmaceutical composition thereof |
Cited By (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN104058979A (en) * | 2014-07-02 | 2014-09-24 | 江苏汉斯通药业有限公司 | Purification process of meclofenoxate hydrochloride |
CN105106189A (en) * | 2015-09-30 | 2015-12-02 | 杨献美 | Meclofenoxate hydrochloride pharmaceutical composition capable of promoting brain energy metabolism |
CN105106190A (en) * | 2015-10-09 | 2015-12-02 | 杨献美 | Central stimulant meclofenoxate hydrochloride composition |
CN105287409A (en) * | 2015-12-01 | 2016-02-03 | 青岛华之草医药科技有限公司 | Medicinal meclofenoxate hydrochloride composition freeze-dried powder injection for treating senile dementia |
CN105287410A (en) * | 2015-12-01 | 2016-02-03 | 青岛华之草医药科技有限公司 | Medicinal meclofenoxate hydrochloride composition freeze-dried powder injection for treating traumatic coma |
CN105434384A (en) * | 2016-01-05 | 2016-03-30 | 濮阳市仲亿药业有限公司 | Aceclofenac dispersible tablets and preparation method |
CN113133975A (en) * | 2021-04-22 | 2021-07-20 | 海南通用三洋药业有限公司 | Preparation method of meclofenoxate hydrochloride freeze-dried powder injection |
Also Published As
Publication number | Publication date |
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CN103396328B (en) | 2014-10-15 |
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Legal Events
Date | Code | Title | Description |
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C06 | Publication | ||
PB01 | Publication | ||
C10 | Entry into substantive examination | ||
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: HUNAN WUZHOUTONG PHARMACEUTICAL CO., LTD. Free format text: FORMER OWNER: HUBEI MERRYCLIN PHARMACEUTICALS CO., LTD. Effective date: 20150316 |
|
C41 | Transfer of patent application or patent right or utility model | ||
COR | Change of bibliographic data |
Free format text: CORRECT: ADDRESS; FROM: 430014 WUHAN, HUBEI PROVINCE TO: 411200 XIANGTAN, HUNAN PROVINCE |
|
TR01 | Transfer of patent right |
Effective date of registration: 20150316 Address after: 411200 Fenghuang Road, easy Town, Xiangtan County, Xiangtan, Hunan Patentee after: HUNAN WUZHOUTONG PHARMACEUTICAL CO., LTD. Address before: 430014, Zhenghe Plaza, 707 Zhongshan Avenue, Jiang'an District, Hubei, Wuhan, 1506 Patentee before: Hubei Merryclin Pharmaceutical Co., Ltd. |
|
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: Meclofenoxate hydrochloride compound and pharmaceutical composition thereof Effective date of registration: 20200629 Granted publication date: 20141015 Pledgee: China Construction Bank Corporation Xiangtan County sub branch Pledgor: HUNAN WUZHOUTONG PHARMACEUTICAL Co.,Ltd. Registration number: Y2020980003555 |
|
CP03 | Change of name, title or address |
Address after: No. 219, biquantan Road, Tianyi Economic Development Zone, Xiangtan City, Hunan Province Patentee after: Hunan wuzhoutong Pharmaceutical Co., Ltd Address before: 411200 Fenghuang Road, Yisuhe Town, Xiangtan County, Hunan Province Patentee before: HUNAN WUZHOUTONG PHARMACEUTICAL Co.,Ltd. |
|
CP03 | Change of name, title or address |