CN102274233A - 一种头孢哌酮钠他唑巴坦钠药物组合物 - Google Patents
一种头孢哌酮钠他唑巴坦钠药物组合物 Download PDFInfo
- Publication number
- CN102274233A CN102274233A CN 201110260244 CN201110260244A CN102274233A CN 102274233 A CN102274233 A CN 102274233A CN 201110260244 CN201110260244 CN 201110260244 CN 201110260244 A CN201110260244 A CN 201110260244A CN 102274233 A CN102274233 A CN 102274233A
- Authority
- CN
- China
- Prior art keywords
- sodium
- tazobactam
- pharmaceutical composition
- cefoperazone
- solution
- 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
- NCFTXMQPRQZFMZ-WERGMSTESA-M Cefoperazone sodium Chemical group [Na+].O=C1C(=O)N(CC)CCN1C(=O)N[C@H](C=1C=CC(O)=CC=1)C(=O)N[C@@H]1C(=O)N2C(C([O-])=O)=C(CSC=3N(N=NN=3)C)CS[C@@H]21 NCFTXMQPRQZFMZ-WERGMSTESA-M 0.000 title claims abstract description 47
- 229960002417 cefoperazone sodium Drugs 0.000 title claims abstract description 47
- NDIURPSCHWTXDC-UHFFFAOYSA-N 2-(4,5-dimethoxy-2-nitrophenyl)acetohydrazide Chemical compound COC1=CC(CC(=O)NN)=C([N+]([O-])=O)C=C1OC NDIURPSCHWTXDC-UHFFFAOYSA-N 0.000 title claims abstract description 42
- 229960000373 tazobactam sodium Drugs 0.000 title claims abstract description 42
- 239000000203 mixture Substances 0.000 title claims abstract description 29
- 238000000634 powder X-ray diffraction Methods 0.000 claims abstract description 10
- 229960003865 tazobactam Drugs 0.000 claims description 60
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 claims description 55
- 239000003814 drug Substances 0.000 claims description 38
- 238000002360 preparation method Methods 0.000 claims description 36
- 239000008194 pharmaceutical composition Substances 0.000 claims description 25
- 239000000843 powder Substances 0.000 claims description 17
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims description 15
- 239000012046 mixed solvent Substances 0.000 claims description 14
- 235000015424 sodium Nutrition 0.000 claims description 12
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 10
- 229940079593 drug Drugs 0.000 claims description 10
- 239000012065 filter cake Substances 0.000 claims description 10
- 229960004682 cefoperazone Drugs 0.000 claims description 9
- GCFBRXLSHGKWDP-XCGNWRKASA-N cefoperazone Chemical compound O=C1C(=O)N(CC)CCN1C(=O)N[C@H](C=1C=CC(O)=CC=1)C(=O)N[C@@H]1C(=O)N2C(C(O)=O)=C(CSC=3N(N=NN=3)C)CS[C@@H]21 GCFBRXLSHGKWDP-XCGNWRKASA-N 0.000 claims description 9
- 238000000605 extraction Methods 0.000 claims description 9
- XDTMQSROBMDMFD-UHFFFAOYSA-N Cyclohexane Chemical compound C1CCCCC1 XDTMQSROBMDMFD-UHFFFAOYSA-N 0.000 claims description 8
- GEHJYWRUCIMESM-UHFFFAOYSA-L sodium sulfite Chemical compound [Na+].[Na+].[O-]S([O-])=O GEHJYWRUCIMESM-UHFFFAOYSA-L 0.000 claims description 8
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 6
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 claims description 6
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 6
- 239000003963 antioxidant agent Substances 0.000 claims description 6
- 230000003078 antioxidant effect Effects 0.000 claims description 6
- 235000006708 antioxidants Nutrition 0.000 claims description 6
- 239000013081 microcrystal Substances 0.000 claims description 6
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 5
- 230000002421 anti-septic effect Effects 0.000 claims description 5
- 238000001035 drying Methods 0.000 claims description 5
- 238000005406 washing Methods 0.000 claims description 5
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 claims description 4
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims description 4
- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 claims description 4
- 235000010234 sodium benzoate Nutrition 0.000 claims description 4
- 239000004299 sodium benzoate Substances 0.000 claims description 4
- 235000010265 sodium sulphite Nutrition 0.000 claims description 4
- CHHHXKFHOYLYRE-UHFFFAOYSA-M 2,4-Hexadienoic acid, potassium salt (1:1), (2E,4E)- Chemical compound [K+].CC=CC=CC([O-])=O CHHHXKFHOYLYRE-UHFFFAOYSA-M 0.000 claims description 2
- 239000004471 Glycine Substances 0.000 claims description 2
- XUJNEKJLAYXESH-REOHCLBHSA-N L-Cysteine Chemical compound SC[C@H](N)C(O)=O XUJNEKJLAYXESH-REOHCLBHSA-N 0.000 claims description 2
- 235000010323 ascorbic acid Nutrition 0.000 claims description 2
- 239000011668 ascorbic acid Substances 0.000 claims description 2
- 229960005070 ascorbic acid Drugs 0.000 claims description 2
- 235000018417 cysteine Nutrition 0.000 claims description 2
- XUJNEKJLAYXESH-UHFFFAOYSA-N cysteine Natural products SCC(N)C(O)=O XUJNEKJLAYXESH-UHFFFAOYSA-N 0.000 claims description 2
- 235000019441 ethanol Nutrition 0.000 claims description 2
- BEFDCLMNVWHSGT-UHFFFAOYSA-N ethenylcyclopentane Chemical compound C=CC1CCCC1 BEFDCLMNVWHSGT-UHFFFAOYSA-N 0.000 claims description 2
- 235000011187 glycerol Nutrition 0.000 claims description 2
- XAEFZNCEHLXOMS-UHFFFAOYSA-M potassium benzoate Chemical compound [K+].[O-]C(=O)C1=CC=CC=C1 XAEFZNCEHLXOMS-UHFFFAOYSA-M 0.000 claims description 2
- 235000010235 potassium benzoate Nutrition 0.000 claims description 2
- 239000004300 potassium benzoate Substances 0.000 claims description 2
- 229940103091 potassium benzoate Drugs 0.000 claims description 2
- 235000010241 potassium sorbate Nutrition 0.000 claims description 2
- 239000004302 potassium sorbate Substances 0.000 claims description 2
- 229940069338 potassium sorbate Drugs 0.000 claims description 2
- 235000013772 propylene glycol Nutrition 0.000 claims description 2
- HRZFUMHJMZEROT-UHFFFAOYSA-L sodium disulfite Chemical compound [Na+].[Na+].[O-]S(=O)S([O-])(=O)=O HRZFUMHJMZEROT-UHFFFAOYSA-L 0.000 claims description 2
- 235000010262 sodium metabisulphite Nutrition 0.000 claims description 2
- JXKPEJDQGNYQSM-UHFFFAOYSA-M sodium propionate Chemical compound [Na+].CCC([O-])=O JXKPEJDQGNYQSM-UHFFFAOYSA-M 0.000 claims description 2
- 235000010334 sodium propionate Nutrition 0.000 claims description 2
- 239000004324 sodium propionate Substances 0.000 claims description 2
- 229960003212 sodium propionate Drugs 0.000 claims description 2
- AKHNMLFCWUSKQB-UHFFFAOYSA-L sodium thiosulfate Chemical compound [Na+].[Na+].[O-]S([O-])(=O)=S AKHNMLFCWUSKQB-UHFFFAOYSA-L 0.000 claims description 2
- 235000019345 sodium thiosulphate Nutrition 0.000 claims description 2
- 235000010199 sorbic acid Nutrition 0.000 claims description 2
- 239000004334 sorbic acid Substances 0.000 claims description 2
- 229940075582 sorbic acid Drugs 0.000 claims description 2
- 238000000034 method Methods 0.000 abstract description 11
- 239000000126 substance Substances 0.000 abstract description 11
- 239000000243 solution Substances 0.000 description 26
- 239000000047 product Substances 0.000 description 15
- 238000012360 testing method Methods 0.000 description 12
- 230000003115 biocidal effect Effects 0.000 description 8
- 239000011521 glass Substances 0.000 description 7
- 238000002156 mixing Methods 0.000 description 7
- 238000012856 packing Methods 0.000 description 7
- 238000005303 weighing Methods 0.000 description 7
- 238000002474 experimental method Methods 0.000 description 6
- 239000011734 sodium Substances 0.000 description 6
- 229930186147 Cephalosporin Natural products 0.000 description 4
- 239000002671 adjuvant Substances 0.000 description 4
- 229940124587 cephalosporin Drugs 0.000 description 4
- 150000001780 cephalosporins Chemical class 0.000 description 4
- 229910052708 sodium Inorganic materials 0.000 description 4
- 229910017488 Cu K Inorganic materials 0.000 description 3
- 229910017541 Cu-K Inorganic materials 0.000 description 3
- 230000005260 alpha ray Effects 0.000 description 3
- 230000000844 anti-bacterial effect Effects 0.000 description 3
- 238000004587 chromatography analysis Methods 0.000 description 3
- 239000013078 crystal Substances 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 238000002347 injection Methods 0.000 description 3
- 239000007924 injection Substances 0.000 description 3
- 239000007791 liquid phase Substances 0.000 description 3
- 238000001953 recrystallisation Methods 0.000 description 3
- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 description 2
- 229930182555 Penicillin Natural products 0.000 description 2
- 238000004458 analytical method Methods 0.000 description 2
- 239000012296 anti-solvent Substances 0.000 description 2
- 239000003782 beta lactam antibiotic agent Substances 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 238000002425 crystallisation Methods 0.000 description 2
- 230000008025 crystallization Effects 0.000 description 2
- 238000000921 elemental analysis Methods 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 239000002502 liposome Substances 0.000 description 2
- 230000007774 longterm Effects 0.000 description 2
- 239000004005 microsphere Substances 0.000 description 2
- 150000002960 penicillins Chemical class 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- 239000002904 solvent Substances 0.000 description 2
- 238000001228 spectrum Methods 0.000 description 2
- 238000013112 stability test Methods 0.000 description 2
- 238000000108 ultra-filtration Methods 0.000 description 2
- HVUMOYIDDBPOLL-UHFFFAOYSA-N 2-(3,4-Dihydroxyoxolan-2-yl)-2-hydroxyethyl octadecanoate Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)C1OCC(O)C1O HVUMOYIDDBPOLL-UHFFFAOYSA-N 0.000 description 1
- 241000588624 Acinetobacter calcoaceticus Species 0.000 description 1
- 206010002198 Anaphylactic reaction Diseases 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- 101710116957 D-alanyl-D-alanine carboxypeptidase Proteins 0.000 description 1
- 108090000204 Dipeptidase 1 Proteins 0.000 description 1
- 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 description 1
- 241000588656 Neisseriaceae Species 0.000 description 1
- 206010034133 Pathogen resistance Diseases 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 230000036783 anaphylactic response Effects 0.000 description 1
- 208000003455 anaphylaxis Diseases 0.000 description 1
- 230000000843 anti-fungal effect Effects 0.000 description 1
- 229940088710 antibiotic agent Drugs 0.000 description 1
- 229940121375 antifungal agent Drugs 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 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 description 1
- 102000006635 beta-lactamase Human genes 0.000 description 1
- 238000004364 calculation method Methods 0.000 description 1
- 210000002421 cell wall Anatomy 0.000 description 1
- 239000007957 coemulsifier Substances 0.000 description 1
- 239000002131 composite material Substances 0.000 description 1
- MSQDVGOEBXMPRF-UHFFFAOYSA-N cyclohexane;propan-2-one Chemical compound CC(C)=O.C1CCCCC1 MSQDVGOEBXMPRF-UHFFFAOYSA-N 0.000 description 1
- 201000003146 cystitis Diseases 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 238000004042 decolorization Methods 0.000 description 1
- 239000003995 emulsifying agent Substances 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 229940075507 glyceryl monostearate Drugs 0.000 description 1
- 238000004128 high performance liquid chromatography Methods 0.000 description 1
- 239000012535 impurity Substances 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000002844 melting Methods 0.000 description 1
- 230000008018 melting Effects 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 239000011259 mixed solution Substances 0.000 description 1
- 239000001788 mono and diglycerides of fatty acids Substances 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 230000000704 physical effect Effects 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 238000000746 purification Methods 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 159000000000 sodium salts Chemical class 0.000 description 1
- 238000001694 spray drying Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 230000002195 synergetic effect Effects 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
- 239000002132 β-lactam antibiotic Substances 0.000 description 1
- 229940124586 β-lactam antibiotics Drugs 0.000 description 1
Images
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
制剂 | N,N-二甲基甲酰胺 | 丙酮 | 环己烷 | 其它有关物质 |
实施例1 | 符合规定 | 符合规定 | 符合规定 | 符合规定 |
实施例2 | 符合规定 | 符合规定 | 符合规定 | 符合规定 |
实施例3 | 符合规定 | 符合规定 | 符合规定 | 符合规定 |
Claims (9)
Priority Applications (1)
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CN201110260244A CN102274233B (zh) | 2011-09-05 | 2011-09-05 | 一种头孢哌酮钠他唑巴坦钠药物组合物 |
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CN201110260244A CN102274233B (zh) | 2011-09-05 | 2011-09-05 | 一种头孢哌酮钠他唑巴坦钠药物组合物 |
Publications (2)
Publication Number | Publication Date |
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CN102274233A true CN102274233A (zh) | 2011-12-14 |
CN102274233B CN102274233B (zh) | 2012-07-18 |
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CN201110260244A Expired - Fee Related CN102274233B (zh) | 2011-09-05 | 2011-09-05 | 一种头孢哌酮钠他唑巴坦钠药物组合物 |
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102512374A (zh) * | 2011-12-16 | 2012-06-27 | 苏州二叶制药有限公司 | 一种注射用头孢哌酮钠他唑巴坦钠的制备工艺 |
CN104382907A (zh) * | 2014-09-21 | 2015-03-04 | 四川制药制剂有限公司 | 注射用头孢哌酮钠他唑巴坦钠的加工工艺 |
CN105748482A (zh) * | 2016-03-18 | 2016-07-13 | 海南通用三洋药业有限公司 | 一种注射用头孢哌酮钠他唑巴坦钠药物组合物 |
CN107281187A (zh) * | 2017-07-11 | 2017-10-24 | 苏州二叶制药有限公司 | 一种注射用头孢哌酮钠他唑巴坦钠及其制备方法 |
Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1868478A (zh) * | 2005-05-26 | 2006-11-29 | 广东诺康药业有限公司 | 注射用头孢哌酮钠和他唑巴坦钠复方制剂 |
-
2011
- 2011-09-05 CN CN201110260244A patent/CN102274233B/zh not_active Expired - Fee Related
Patent Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1868478A (zh) * | 2005-05-26 | 2006-11-29 | 广东诺康药业有限公司 | 注射用头孢哌酮钠和他唑巴坦钠复方制剂 |
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102512374A (zh) * | 2011-12-16 | 2012-06-27 | 苏州二叶制药有限公司 | 一种注射用头孢哌酮钠他唑巴坦钠的制备工艺 |
CN104382907A (zh) * | 2014-09-21 | 2015-03-04 | 四川制药制剂有限公司 | 注射用头孢哌酮钠他唑巴坦钠的加工工艺 |
CN105748482A (zh) * | 2016-03-18 | 2016-07-13 | 海南通用三洋药业有限公司 | 一种注射用头孢哌酮钠他唑巴坦钠药物组合物 |
CN107281187A (zh) * | 2017-07-11 | 2017-10-24 | 苏州二叶制药有限公司 | 一种注射用头孢哌酮钠他唑巴坦钠及其制备方法 |
CN107281187B (zh) * | 2017-07-11 | 2020-11-17 | 苏州二叶制药有限公司 | 一种注射用头孢哌酮钠他唑巴坦钠及其制备方法 |
Also Published As
Publication number | Publication date |
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CN102274233B (zh) | 2012-07-18 |
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