CN101766615B - 泮托拉唑钠的组合药物 - Google Patents
泮托拉唑钠的组合药物 Download PDFInfo
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- CN101766615B CN101766615B CN2010100458276A CN201010045827A CN101766615B CN 101766615 B CN101766615 B CN 101766615B CN 2010100458276 A CN2010100458276 A CN 2010100458276A CN 201010045827 A CN201010045827 A CN 201010045827A CN 101766615 B CN101766615 B CN 101766615B
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- pantoprazole sodium
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- medicinal liquid
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- 239000003814 drug Substances 0.000 title claims abstract description 113
- YNWDKZIIWCEDEE-UHFFFAOYSA-N pantoprazole sodium Chemical compound [Na+].COC1=CC=NC(CS(=O)C=2[N-]C3=CC=C(OC(F)F)C=C3N=2)=C1OC YNWDKZIIWCEDEE-UHFFFAOYSA-N 0.000 title claims abstract description 82
- 229960004048 pantoprazole sodium Drugs 0.000 title claims abstract description 82
- 229940079593 drug Drugs 0.000 title abstract description 22
- 238000002360 preparation method Methods 0.000 claims abstract description 35
- 108010058907 Tiopronin Proteins 0.000 claims abstract description 18
- 229960004402 tiopronin Drugs 0.000 claims abstract description 18
- YTGJWQPHMWSCST-UHFFFAOYSA-N Tiopronin Chemical compound CC(S)C(=O)NCC(O)=O YTGJWQPHMWSCST-UHFFFAOYSA-N 0.000 claims abstract description 17
- 235000013921 calcium diglutamate Nutrition 0.000 claims abstract description 17
- UMVAYAXXQSFULN-QHTZZOMLSA-L calcium;(2s)-2-aminopentanedioate;hydron Chemical compound [Ca+2].[O-]C(=O)[C@@H](N)CCC(O)=O.[O-]C(=O)[C@@H](N)CCC(O)=O UMVAYAXXQSFULN-QHTZZOMLSA-L 0.000 claims abstract description 17
- ZGTMUACCHSMWAC-UHFFFAOYSA-L EDTA disodium salt (anhydrous) Chemical compound [Na+].[Na+].OC(=O)CN(CC([O-])=O)CCN(CC(O)=O)CC([O-])=O ZGTMUACCHSMWAC-UHFFFAOYSA-L 0.000 claims abstract description 16
- 239000004480 active ingredient Substances 0.000 claims abstract description 8
- 239000000203 mixture Substances 0.000 claims description 70
- 239000007788 liquid Substances 0.000 claims description 44
- 238000002347 injection Methods 0.000 claims description 37
- 239000007924 injection Substances 0.000 claims description 37
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 24
- 229910052799 carbon Inorganic materials 0.000 claims description 22
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 21
- 239000002131 composite material Substances 0.000 claims description 21
- 239000000243 solution Substances 0.000 claims description 16
- 238000005374 membrane filtration Methods 0.000 claims description 15
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 14
- 208000007107 Stomach Ulcer Diseases 0.000 claims description 14
- 201000005917 gastric ulcer Diseases 0.000 claims description 14
- 238000000034 method Methods 0.000 claims description 14
- 230000001954 sterilising effect Effects 0.000 claims description 14
- 238000004659 sterilization and disinfection Methods 0.000 claims description 14
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 10
- 239000007921 spray Substances 0.000 claims description 8
- 239000000470 constituent Substances 0.000 claims description 7
- 239000012530 fluid Substances 0.000 claims description 7
- 238000003756 stirring Methods 0.000 claims description 7
- 239000008215 water for injection Substances 0.000 claims description 7
- 238000009472 formulation Methods 0.000 claims description 4
- 230000000694 effects Effects 0.000 abstract description 5
- 230000006378 damage Effects 0.000 abstract description 3
- 230000008901 benefit Effects 0.000 abstract description 2
- 206010067484 Adverse reaction Diseases 0.000 abstract 1
- 230000006838 adverse reaction Effects 0.000 abstract 1
- 229940124274 edetate disodium Drugs 0.000 abstract 1
- 210000004185 liver Anatomy 0.000 abstract 1
- 238000004108 freeze drying Methods 0.000 description 25
- 238000006243 chemical reaction Methods 0.000 description 13
- 239000007787 solid Substances 0.000 description 13
- 238000011082 depyrogenation Methods 0.000 description 9
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 8
- WSFSSNUMVMOOMR-UHFFFAOYSA-N Formaldehyde Chemical compound O=C WSFSSNUMVMOOMR-UHFFFAOYSA-N 0.000 description 7
- 239000002510 pyrogen Substances 0.000 description 7
- 238000012360 testing method Methods 0.000 description 7
- JGSARLDLIJGVTE-UHFFFAOYSA-N 3,3-dimethyl-7-oxo-6-[(2-phenylacetyl)amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid Chemical compound O=C1N2C(C(O)=O)C(C)(C)SC2C1NC(=O)CC1=CC=CC=C1 JGSARLDLIJGVTE-UHFFFAOYSA-N 0.000 description 6
- 229910000831 Steel Inorganic materials 0.000 description 6
- 239000010959 steel Substances 0.000 description 6
- 210000002784 stomach Anatomy 0.000 description 6
- 241001465754 Metazoa Species 0.000 description 5
- 229940083646 famotidine 20 mg Drugs 0.000 description 5
- 239000000546 pharmaceutical excipient Substances 0.000 description 5
- -1 iron ion Chemical class 0.000 description 4
- 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 description 4
- 208000008469 Peptic Ulcer Diseases 0.000 description 3
- 229960000583 acetic acid Drugs 0.000 description 3
- 229940119744 dextran 40 Drugs 0.000 description 3
- 229910001385 heavy metal Inorganic materials 0.000 description 3
- 150000002500 ions Chemical class 0.000 description 3
- XEEYBQQBJWHFJM-UHFFFAOYSA-N iron Substances [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 description 3
- 229910052742 iron Inorganic materials 0.000 description 3
- 230000003647 oxidation Effects 0.000 description 3
- 238000007254 oxidation reaction Methods 0.000 description 3
- 208000011906 peptic ulcer disease Diseases 0.000 description 3
- 206010002198 Anaphylactic reaction Diseases 0.000 description 2
- 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 description 2
- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 description 2
- 229930195725 Mannitol Natural products 0.000 description 2
- 208000025865 Ulcer Diseases 0.000 description 2
- 210000000683 abdominal cavity Anatomy 0.000 description 2
- 230000009471 action Effects 0.000 description 2
- 239000002671 adjuvant Substances 0.000 description 2
- 230000036783 anaphylactic response Effects 0.000 description 2
- 208000003455 anaphylaxis Diseases 0.000 description 2
- 239000003638 chemical reducing agent Substances 0.000 description 2
- 239000010419 fine particle Substances 0.000 description 2
- 239000000594 mannitol Substances 0.000 description 2
- 235000010355 mannitol Nutrition 0.000 description 2
- 238000007539 photo-oxidation reaction Methods 0.000 description 2
- 230000002980 postoperative effect Effects 0.000 description 2
- 231100000397 ulcer Toxicity 0.000 description 2
- 206010002091 Anaesthesia Diseases 0.000 description 1
- 229920000742 Cotton Polymers 0.000 description 1
- 229920002307 Dextran Polymers 0.000 description 1
- 241000590002 Helicobacter pylori Species 0.000 description 1
- 206010020751 Hypersensitivity Diseases 0.000 description 1
- 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 description 1
- 206010067125 Liver injury Diseases 0.000 description 1
- IQPSEEYGBUAQFF-UHFFFAOYSA-N Pantoprazole Chemical compound COC1=CC=NC(CS(=O)C=2NC3=CC=C(OC(F)F)C=C3N=2)=C1OC IQPSEEYGBUAQFF-UHFFFAOYSA-N 0.000 description 1
- 102000057297 Pepsin A Human genes 0.000 description 1
- 108090000284 Pepsin A Proteins 0.000 description 1
- NINIDFKCEFEMDL-UHFFFAOYSA-N Sulfur Chemical group [S] NINIDFKCEFEMDL-UHFFFAOYSA-N 0.000 description 1
- 230000004913 activation Effects 0.000 description 1
- 238000001467 acupuncture Methods 0.000 description 1
- 230000037005 anaesthesia Effects 0.000 description 1
- 238000010171 animal model Methods 0.000 description 1
- 210000001367 artery Anatomy 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- 230000037396 body weight Effects 0.000 description 1
- 239000002738 chelating agent Substances 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 210000001198 duodenum Anatomy 0.000 description 1
- 230000003628 erosive effect Effects 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 210000004211 gastric acid Anatomy 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 239000012362 glacial acetic acid Substances 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 229940037467 helicobacter pylori Drugs 0.000 description 1
- 231100000753 hepatic injury Toxicity 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 239000003112 inhibitor Substances 0.000 description 1
- 230000002045 lasting effect Effects 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 229910021645 metal ion Inorganic materials 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 210000004877 mucosa Anatomy 0.000 description 1
- 230000007935 neutral effect Effects 0.000 description 1
- 239000000041 non-steroidal anti-inflammatory agent Substances 0.000 description 1
- 229940021182 non-steroidal anti-inflammatory drug Drugs 0.000 description 1
- 235000021590 normal diet Nutrition 0.000 description 1
- 229960005019 pantoprazole Drugs 0.000 description 1
- 229940111202 pepsin Drugs 0.000 description 1
- 230000003285 pharmacodynamic effect Effects 0.000 description 1
- 238000001556 precipitation Methods 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 229940126409 proton pump inhibitor Drugs 0.000 description 1
- 239000000612 proton pump inhibitor Substances 0.000 description 1
- 210000001187 pylorus Anatomy 0.000 description 1
- 229940044551 receptor antagonist Drugs 0.000 description 1
- 239000002464 receptor antagonist Substances 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 238000001179 sorption measurement Methods 0.000 description 1
- 241000894007 species Species 0.000 description 1
- 230000000638 stimulation Effects 0.000 description 1
- 210000003462 vein Anatomy 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
项目 | 大鼠数量只 | 2.1法每只胃溃疡面积平均值mm2 | 2.2法每只胃溃疡面积平均值mm2 | 含量均匀度提高率% | 热原反应率% | 不良反应率% |
法莫替丁20mg/kg口服 | 10 | 34 | 49 | - | 10% | 10% |
注射用泮托拉唑 钠20mg/kg注射 | 10 | 32 | 45 | - | 10% | 10% |
本发明组合药物20mg/kg口服 | 10 | 21 | 46 | 23% | 0 | 0 |
本发明组合药物冻干针 剂20mg/kg注射 | 10 | 13 | 45 | - | 0 | 0 |
项目 | 大鼠数量只 | 2.1法每只胃溃疡面积平均值mm2 | 2.2法每只胃溃疡面积平均值mm2 | 含量均匀度提高率% | 热原反应率% | 不良反应率% |
法莫替丁20mg/kg口服 | 10 | 38 | 50 | - | 10% | 10% |
注射用泮托拉唑 钠20mg/kg注射 | 10 | 36 | 47 | - | 10% | 10% |
本发明组合药物20mg/kg口服 | 10 | 23 | 48 | 26% | 0 | 0 |
本发明组合药物冻干针 剂20mg/kg注射 | 10 | 16 | 45 | - | 0 | 0 |
项目 | 大鼠数量只 | 2.1法每只胃溃疡面积平均值mm2 | 2.2法每只胃溃疡面积平均值mm2 | 含量均匀度提高率% | 热原反应率% | 不良反应率% |
法莫替丁20mg/kg口服 | 10 | 38 | 51 | - | 10% | 10% |
注射用泮托拉唑 钠20mg/kg注射 | 10 | 36 | 47 | - | 10% | 10% |
本发明组合药物20mg/kg口服 | 10 | 23 | 46 | 24% | 0 | 0 |
本发明组合药物冻干针 剂20mg/kg注射 | 10 | 14 | 45 | - | 0 | 0 |
项目 | 大鼠数量只 | 2.1法每只胃溃疡面积平均值mm2 | 2.2法每只胃溃疡面积平均值mm2 | 含量均匀度提高率% | 热原反应率% | 不良反应率% |
法莫替丁20mg/kg口服 | 10 | 39 | 47 | - | 10% | 10% |
注射用泮托拉唑 钠20mg/kg注射 | 10 | 38 | 48 | - | 10% | 10% |
本发明组合药物20mg/kg口服 | 10 | 23 | 46 | 25% | 0 | 0 |
本发明组合药物冻干针 剂20mg/kg注射 | 10 | 13 | 46 | - | 0 | 0 |
项目 | 大鼠数量只 | 2.1法每只胃溃疡面积平均值mm2 | 2.2法每只胃溃疡面积平均值mm2 | 含量均匀度提高率% | 热原反应率% | 不良反应率% |
法莫替丁20mg/kg口服 | 10 | 40 | 49 | - | 10% | 10% |
注射用泮托拉唑 钠20mg/kg注射 | 10 | 37 | 47 | - | 10% | 10% |
本发明组合药物20mg/kg口服 | 10 | 23 | 47 | 26% | 0 | 0 |
本发明组合药物冻干针 剂20mg/kg注射 | 10 | 15 | 48 | - | 0 | 0 |
Claims (4)
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CN2010100458276A CN101766615B (zh) | 2010-01-12 | 2010-01-12 | 泮托拉唑钠的组合药物 |
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CN2010100458276A CN101766615B (zh) | 2010-01-12 | 2010-01-12 | 泮托拉唑钠的组合药物 |
Publications (2)
Publication Number | Publication Date |
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CN101766615A CN101766615A (zh) | 2010-07-07 |
CN101766615B true CN101766615B (zh) | 2011-06-08 |
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CN2010100458276A Active CN101766615B (zh) | 2010-01-12 | 2010-01-12 | 泮托拉唑钠的组合药物 |
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CN (1) | CN101766615B (zh) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN102225063B (zh) * | 2011-05-10 | 2012-10-10 | 江苏奥赛康药业股份有限公司 | 一种供注射用的泮托拉唑钠组合物 |
Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101011397A (zh) * | 2006-12-31 | 2007-08-08 | 丽珠医药集团股份有限公司 | 泮托拉唑钠冻干粉针剂及其制备方法 |
-
2010
- 2010-01-12 CN CN2010100458276A patent/CN101766615B/zh active Active
Patent Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101011397A (zh) * | 2006-12-31 | 2007-08-08 | 丽珠医药集团股份有限公司 | 泮托拉唑钠冻干粉针剂及其制备方法 |
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Publication number | Publication date |
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CN101766615A (zh) | 2010-07-07 |
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Assignee: Ocean University of China LAN Tai Pharmaceutical Co., Ltd. Assignor: Deng Xuefeng Contract record no.: 2011530000011 Denomination of invention: Pantoprazole sodium combined medicament and preparation method thereof License type: Exclusive License Open date: 20100707 Record date: 20110329 |
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Application publication date: 20100707 Assignee: Louhe Kangzhiyuan Medicine Co., Ltd. Assignor: Deng Xuefeng Contract record no.: 2014530000082 Denomination of invention: Pantoprazole sodium combined medicament and preparation method thereof Granted publication date: 20110608 License type: Common License Record date: 20140623 |
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Effective date of registration: 20210111 Address after: No.6, Qimen Road, Shitai County, Chizhou City, Anhui Province 247000 Patentee after: ANHUI YANSHOUTANG PHARMACEUTICAL Co.,Ltd. Address before: 330009 Jiangxi Lu Lin County of Guangfeng Province Road No. 156 Yongfeng Street Office Patentee before: Deng Xuefeng |