CN103432078B - 盐酸头孢甲肟的药物组合物 - Google Patents
盐酸头孢甲肟的药物组合物 Download PDFInfo
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- CN103432078B CN103432078B CN201310383089.XA CN201310383089A CN103432078B CN 103432078 B CN103432078 B CN 103432078B CN 201310383089 A CN201310383089 A CN 201310383089A CN 103432078 B CN103432078 B CN 103432078B
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- abbott
- sodium carbonate
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- ethylenediamine
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- MPTNDTIREFCQLK-UNVJPQNDSA-N cefmenoxime hydrochloride Chemical group [H+].[Cl-].S([C@@H]1[C@@H](C(N1C=1C(O)=O)=O)NC(=O)\C(=N/OC)C=2N=C(N)SC=2)CC=1CSC1=NN=NN1C.S([C@@H]1[C@@H](C(N1C=1C(O)=O)=O)NC(=O)\C(=N/OC)C=2N=C(N)SC=2)CC=1CSC1=NN=NN1C MPTNDTIREFCQLK-UNVJPQNDSA-N 0.000 title claims abstract description 61
- 239000000203 mixture Substances 0.000 title abstract description 26
- 229960003791 cefmenoxime Drugs 0.000 title abstract description 16
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims abstract description 75
- 229910000029 sodium carbonate Inorganic materials 0.000 claims abstract description 36
- PIICEJLVQHRZGT-UHFFFAOYSA-N Ethylenediamine Chemical compound NCCN PIICEJLVQHRZGT-UHFFFAOYSA-N 0.000 claims abstract description 28
- 239000000843 powder Substances 0.000 claims abstract description 11
- 239000008194 pharmaceutical composition Substances 0.000 claims description 25
- 150000001875 compounds Chemical class 0.000 claims description 13
- 238000012360 testing method Methods 0.000 abstract description 41
- HJJDBAOLQAWBMH-YCRCPZNHSA-N cefmenoxime Chemical compound S([C@@H]1[C@@H](C(N1C=1C(O)=O)=O)NC(=O)\C(=N/OC)C=2N=C(N)SC=2)CC=1CSC1=NN=NN1C HJJDBAOLQAWBMH-YCRCPZNHSA-N 0.000 abstract description 12
- 239000007924 injection Substances 0.000 abstract description 11
- 238000002347 injection Methods 0.000 abstract description 11
- 229920000642 polymer Polymers 0.000 abstract description 11
- 239000012535 impurity Substances 0.000 abstract description 8
- 238000004090 dissolution Methods 0.000 abstract description 6
- 238000012216 screening Methods 0.000 abstract description 4
- 239000003814 drug Substances 0.000 abstract 2
- 229940079593 drug Drugs 0.000 abstract 1
- 238000013112 stability test Methods 0.000 abstract 1
- 239000000243 solution Substances 0.000 description 29
- 238000002360 preparation method Methods 0.000 description 22
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 14
- 239000002671 adjuvant Substances 0.000 description 10
- 230000000844 anti-bacterial effect Effects 0.000 description 10
- 229940090044 injection Drugs 0.000 description 10
- 238000004811 liquid chromatography Methods 0.000 description 10
- 239000000047 product Substances 0.000 description 9
- 239000013558 reference substance Substances 0.000 description 9
- 239000011812 mixed powder Substances 0.000 description 8
- 239000002994 raw material Substances 0.000 description 8
- 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 7
- 239000011261 inert gas Substances 0.000 description 7
- 229910052757 nitrogen Inorganic materials 0.000 description 7
- 238000004806 packaging method and process Methods 0.000 description 7
- 239000008363 phosphate buffer Substances 0.000 description 7
- 238000010298 pulverizing process Methods 0.000 description 7
- 230000001954 sterilising effect Effects 0.000 description 7
- 238000004659 sterilization and disinfection Methods 0.000 description 7
- XOHZHMUQBFJTNH-UHFFFAOYSA-N 1-methyl-2h-tetrazole-5-thione Chemical compound CN1N=NN=C1S XOHZHMUQBFJTNH-UHFFFAOYSA-N 0.000 description 6
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 6
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 6
- 230000014759 maintenance of location Effects 0.000 description 6
- 229920002307 Dextran Polymers 0.000 description 5
- FLKYBGKDCCEQQM-WYUVZMMLSA-M cefazolin sodium Chemical compound [Na+].S1C(C)=NN=C1SCC1=C(C([O-])=O)N2C(=O)[C@@H](NC(=O)CN3N=NN=C3)[C@H]2SC1 FLKYBGKDCCEQQM-WYUVZMMLSA-M 0.000 description 5
- 229960003408 cefazolin sodium Drugs 0.000 description 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 5
- 241000894006 Bacteria Species 0.000 description 4
- QYQDKDWGWDOFFU-IUODEOHRSA-N Cefotiam Chemical compound CN(C)CCN1N=NN=C1SCC1=C(C(O)=O)N2C(=O)[C@@H](NC(=O)CC=3N=C(N)SC=3)[C@H]2SC1 QYQDKDWGWDOFFU-IUODEOHRSA-N 0.000 description 4
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 4
- 238000010790 dilution Methods 0.000 description 4
- 239000012895 dilution Substances 0.000 description 4
- 229930186147 Cephalosporin Natural products 0.000 description 3
- 241000192125 Firmicutes Species 0.000 description 3
- RQBBFKINEJYDOB-UHFFFAOYSA-N acetic acid;acetonitrile Chemical compound CC#N.CC(O)=O RQBBFKINEJYDOB-UHFFFAOYSA-N 0.000 description 3
- 229940124587 cephalosporin Drugs 0.000 description 3
- 150000001780 cephalosporins Chemical class 0.000 description 3
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 description 3
- 229910000397 disodium phosphate Inorganic materials 0.000 description 3
- 235000019800 disodium phosphate Nutrition 0.000 description 3
- 238000010812 external standard method Methods 0.000 description 3
- 239000000945 filler Substances 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- HZAXFHJVJLSVMW-UHFFFAOYSA-N 2-Aminoethan-1-ol Chemical compound NCCO HZAXFHJVJLSVMW-UHFFFAOYSA-N 0.000 description 2
- 241000193830 Bacillus <bacterium> Species 0.000 description 2
- 241000606125 Bacteroides Species 0.000 description 2
- 241000588923 Citrobacter Species 0.000 description 2
- 108090000204 Dipeptidase 1 Proteins 0.000 description 2
- 241000588724 Escherichia coli Species 0.000 description 2
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 description 2
- 241000206591 Peptococcus Species 0.000 description 2
- 241000191992 Peptostreptococcus Species 0.000 description 2
- 241000588769 Proteus <enterobacteria> Species 0.000 description 2
- 241000607720 Serratia Species 0.000 description 2
- 241000193996 Streptococcus pyogenes Species 0.000 description 2
- 102000006635 beta-lactamase Human genes 0.000 description 2
- 210000002421 cell wall Anatomy 0.000 description 2
- 230000002950 deficient Effects 0.000 description 2
- 238000001514 detection method Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 238000004128 high performance liquid chromatography Methods 0.000 description 2
- 238000005286 illumination Methods 0.000 description 2
- 206010022000 influenza Diseases 0.000 description 2
- YTJSFYQNRXLOIC-UHFFFAOYSA-N octadecylsilane Chemical compound CCCCCCCCCCCCCCCCCC[SiH3] YTJSFYQNRXLOIC-UHFFFAOYSA-N 0.000 description 2
- 239000000825 pharmaceutical preparation Substances 0.000 description 2
- 238000005070 sampling Methods 0.000 description 2
- 239000000377 silicon dioxide Substances 0.000 description 2
- 239000001509 sodium citrate Substances 0.000 description 2
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 description 2
- 238000010998 test method Methods 0.000 description 2
- WFIYPADYPQQLNN-UHFFFAOYSA-N 2-[2-(4-bromopyrazol-1-yl)ethyl]isoindole-1,3-dione Chemical compound C1=C(Br)C=NN1CCN1C(=O)C2=CC=CC=C2C1=O WFIYPADYPQQLNN-UHFFFAOYSA-N 0.000 description 1
- 0 CNC(*C(CS[C@]1[C@]2NC(C(C3=CSC(N)N3C)=NOC)=O)=C(C(O)=O)N1C2=O)=NN=N Chemical compound CNC(*C(CS[C@]1[C@]2NC(C(C3=CSC(N)N3C)=NOC)=O)=C(C(O)=O)N1C2=O)=NN=N 0.000 description 1
- 101710116957 D-alanyl-D-alanine carboxypeptidase Proteins 0.000 description 1
- 208000005189 Embolism Diseases 0.000 description 1
- 241000588914 Enterobacter Species 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Chemical compound OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- ODKSFYDXXFIFQN-BYPYZUCNSA-N L-arginine Chemical compound OC(=O)[C@@H](N)CCCN=C(N)N ODKSFYDXXFIFQN-BYPYZUCNSA-N 0.000 description 1
- 229930064664 L-arginine Natural products 0.000 description 1
- 235000014852 L-arginine Nutrition 0.000 description 1
- 241000589516 Pseudomonas Species 0.000 description 1
- 241000193998 Streptococcus pneumoniae Species 0.000 description 1
- 208000001435 Thromboembolism Diseases 0.000 description 1
- 206010047115 Vasculitis Diseases 0.000 description 1
- 125000000738 acetamido group Chemical group [H]C([H])([H])C(=O)N([H])[*] 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 150000001412 amines Chemical class 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 230000003115 biocidal effect Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 229960001242 cefotiam Drugs 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 229940121657 clinical drug Drugs 0.000 description 1
- 239000002131 composite material Substances 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 239000006184 cosolvent Substances 0.000 description 1
- 238000002425 crystallisation Methods 0.000 description 1
- 230000008025 crystallization Effects 0.000 description 1
- 238000010828 elution Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000002270 exclusion chromatography Methods 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 229940093181 glucose injection Drugs 0.000 description 1
- 229960002885 histidine Drugs 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 230000005764 inhibitory process Effects 0.000 description 1
- 230000000968 intestinal effect Effects 0.000 description 1
- 238000001990 intravenous administration Methods 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 description 1
- 239000004531 microgranule Substances 0.000 description 1
- 239000000178 monomer Substances 0.000 description 1
- 229910000403 monosodium phosphate Inorganic materials 0.000 description 1
- 235000019799 monosodium phosphate Nutrition 0.000 description 1
- QQVIHTHCMHWDBS-UHFFFAOYSA-N perisophthalic acid Natural products OC(=O)C1=CC=CC(C(O)=O)=C1 QQVIHTHCMHWDBS-UHFFFAOYSA-N 0.000 description 1
- 230000035699 permeability Effects 0.000 description 1
- 230000000144 pharmacologic effect Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 239000008354 sodium chloride injection Substances 0.000 description 1
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 description 1
- 239000001488 sodium phosphate Substances 0.000 description 1
- 229940031000 streptococcus pneumoniae Drugs 0.000 description 1
- 229910052717 sulfur Inorganic materials 0.000 description 1
- 239000011593 sulfur Substances 0.000 description 1
- 239000008215 water for injection Substances 0.000 description 1
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- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
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CN201310383089.XA CN103432078B (zh) | 2013-08-28 | 2013-08-28 | 盐酸头孢甲肟的药物组合物 |
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Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1121691A (zh) * | 1993-04-28 | 1996-05-01 | 吉富制药株式会社 | 稳定的注射剂及注射剂的稳定方法 |
CN1526396A (zh) * | 2003-03-03 | 2004-09-08 | 中国医药集团总公司四川抗菌素工业研 | 一种可注射给药的盐酸头孢甲肟新剂型 |
CN101569628A (zh) * | 2009-06-19 | 2009-11-04 | 山东罗欣药业股份有限公司 | 一种盐酸头孢甲肟组合物粉针及其制备方法 |
CN102499922A (zh) * | 2011-10-20 | 2012-06-20 | 桂林澳林制药有限责任公司 | 一种注射用盐酸头孢甲肟组合物及其制剂 |
CN102552181A (zh) * | 2012-01-20 | 2012-07-11 | 江苏吴中医药集团有限公司 | 一种兰索拉唑冻干粉针制剂及其制备方法 |
CN103145735A (zh) * | 2013-03-21 | 2013-06-12 | 四川省惠达药业有限公司 | 一种注射用盐酸头孢甲肟化合物及其药物组合物 |
-
2013
- 2013-08-28 CN CN201310383089.XA patent/CN103432078B/zh active Active
Patent Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1121691A (zh) * | 1993-04-28 | 1996-05-01 | 吉富制药株式会社 | 稳定的注射剂及注射剂的稳定方法 |
CN1526396A (zh) * | 2003-03-03 | 2004-09-08 | 中国医药集团总公司四川抗菌素工业研 | 一种可注射给药的盐酸头孢甲肟新剂型 |
CN101569628A (zh) * | 2009-06-19 | 2009-11-04 | 山东罗欣药业股份有限公司 | 一种盐酸头孢甲肟组合物粉针及其制备方法 |
CN102499922A (zh) * | 2011-10-20 | 2012-06-20 | 桂林澳林制药有限责任公司 | 一种注射用盐酸头孢甲肟组合物及其制剂 |
CN102552181A (zh) * | 2012-01-20 | 2012-07-11 | 江苏吴中医药集团有限公司 | 一种兰索拉唑冻干粉针制剂及其制备方法 |
CN103145735A (zh) * | 2013-03-21 | 2013-06-12 | 四川省惠达药业有限公司 | 一种注射用盐酸头孢甲肟化合物及其药物组合物 |
Non-Patent Citations (1)
Title |
---|
李捷玮,等.乙二胺.《常用药物辅料手册》.2000, * |
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