CN102718693A - 一种卡络磺钠化合物及其组合物 - Google Patents
一种卡络磺钠化合物及其组合物 Download PDFInfo
- Publication number
- CN102718693A CN102718693A CN2012102221226A CN201210222122A CN102718693A CN 102718693 A CN102718693 A CN 102718693A CN 2012102221226 A CN2012102221226 A CN 2012102221226A CN 201210222122 A CN201210222122 A CN 201210222122A CN 102718693 A CN102718693 A CN 102718693A
- Authority
- CN
- China
- Prior art keywords
- sodium sulfonate
- carbazochrome sodium
- bullion
- carbazochrome
- sulfonate compound
- 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
- 229960004353 carbazochrome sodium sulfonate Drugs 0.000 title claims abstract description 108
- -1 Carbazochrome sodium sulfonate compound Chemical class 0.000 title claims abstract description 25
- 239000000203 mixture Substances 0.000 title claims abstract description 4
- 239000003814 drug Substances 0.000 claims abstract description 14
- 238000000634 powder X-ray diffraction Methods 0.000 claims abstract description 12
- 229940079593 drug Drugs 0.000 claims abstract description 9
- HLFCZZKCHVSOAP-WXIWBVQFSA-M sodium;(5e)-5-(carbamoylhydrazinylidene)-1-methyl-6-oxo-2,3-dihydroindole-2-sulfonate Chemical compound [Na+].NC(=O)N\N=C/1C(=O)C=C2N(C)C(S([O-])(=O)=O)CC2=C\1 HLFCZZKCHVSOAP-WXIWBVQFSA-M 0.000 claims description 83
- 239000000243 solution Substances 0.000 claims description 34
- 238000003756 stirring Methods 0.000 claims description 22
- 238000002156 mixing Methods 0.000 claims description 20
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 18
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 17
- HEDRZPFGACZZDS-UHFFFAOYSA-N Chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 claims description 14
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 14
- 238000002347 injection Methods 0.000 claims description 12
- 239000007924 injection Substances 0.000 claims description 12
- 239000000843 powder Substances 0.000 claims description 12
- 238000001035 drying Methods 0.000 claims description 11
- 238000000034 method Methods 0.000 claims description 9
- 238000005406 washing Methods 0.000 claims description 9
- 238000013019 agitation Methods 0.000 claims description 7
- 238000010792 warming Methods 0.000 claims description 7
- 238000003556 assay Methods 0.000 claims description 5
- 239000007788 liquid Substances 0.000 claims description 5
- 239000008176 lyophilized powder Substances 0.000 claims description 4
- 238000000691 measurement method Methods 0.000 abstract 1
- 229910052799 carbon Inorganic materials 0.000 description 11
- 238000004108 freeze drying Methods 0.000 description 10
- 239000000047 product Substances 0.000 description 10
- 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 9
- 229930195725 Mannitol Natural products 0.000 description 9
- 239000000594 mannitol Substances 0.000 description 9
- 235000010355 mannitol Nutrition 0.000 description 9
- 238000002360 preparation method Methods 0.000 description 9
- 238000012360 testing method Methods 0.000 description 8
- 239000008215 water for injection Substances 0.000 description 8
- 238000005303 weighing Methods 0.000 description 6
- 208000032843 Hemorrhage Diseases 0.000 description 4
- 235000019846 buffering salt Nutrition 0.000 description 4
- 238000004128 high performance liquid chromatography Methods 0.000 description 4
- 238000009413 insulation Methods 0.000 description 4
- 239000000126 substance Substances 0.000 description 4
- 238000000108 ultra-filtration Methods 0.000 description 4
- 238000005261 decarburization Methods 0.000 description 3
- 239000003937 drug carrier Substances 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 238000005516 engineering process Methods 0.000 description 3
- 230000007774 longterm Effects 0.000 description 3
- 238000005374 membrane filtration Methods 0.000 description 3
- 230000001954 sterilising effect Effects 0.000 description 3
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- 239000003708 ampul Substances 0.000 description 2
- 238000006243 chemical reaction Methods 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 239000012528 membrane Substances 0.000 description 2
- 238000012856 packing Methods 0.000 description 2
- 239000002994 raw material Substances 0.000 description 2
- 238000011160 research Methods 0.000 description 2
- 239000011780 sodium chloride Substances 0.000 description 2
- 238000004659 sterilization and disinfection Methods 0.000 description 2
- 238000003860 storage Methods 0.000 description 2
- UMGDCJDMYOKAJW-UHFFFAOYSA-N thiourea Chemical compound NC(N)=S UMGDCJDMYOKAJW-UHFFFAOYSA-N 0.000 description 2
- 230000002485 urinary effect Effects 0.000 description 2
- 239000003981 vehicle Substances 0.000 description 2
- RPHLQSHHTJORHI-UHFFFAOYSA-N Adrenochrome Chemical compound O=C1C(=O)C=C2N(C)CC(O)C2=C1 RPHLQSHHTJORHI-UHFFFAOYSA-N 0.000 description 1
- 229910019142 PO4 Inorganic materials 0.000 description 1
- 206010071229 Procedural haemorrhage Diseases 0.000 description 1
- 206010051373 Wound haemorrhage Diseases 0.000 description 1
- DPDMMXDBJGCCQC-UHFFFAOYSA-N [Na].[Cl] Chemical compound [Na].[Cl] DPDMMXDBJGCCQC-UHFFFAOYSA-N 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 1
- CUBCNYWQJHBXIY-UHFFFAOYSA-N benzoic acid;2-hydroxybenzoic acid Chemical compound OC(=O)C1=CC=CC=C1.OC(=O)C1=CC=CC=C1O CUBCNYWQJHBXIY-UHFFFAOYSA-N 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 230000004856 capillary permeability Effects 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 239000013078 crystal Substances 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 208000002173 dizziness Diseases 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 230000023597 hemostasis Effects 0.000 description 1
- 230000002439 hemostatic effect Effects 0.000 description 1
- 239000003112 inhibitor Substances 0.000 description 1
- 238000010255 intramuscular injection Methods 0.000 description 1
- 239000007927 intramuscular injection Substances 0.000 description 1
- 238000001990 intravenous administration Methods 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 229910052757 nitrogen Inorganic materials 0.000 description 1
- 230000003647 oxidation Effects 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- 229910052760 oxygen Inorganic materials 0.000 description 1
- 239000001301 oxygen Substances 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 230000035699 permeability Effects 0.000 description 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 1
- 239000010452 phosphate Substances 0.000 description 1
- 238000001953 recrystallisation Methods 0.000 description 1
- 210000002345 respiratory system Anatomy 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- VYGBQXDNOUHIBZ-UHFFFAOYSA-L sodium formaldehyde sulphoxylate Chemical compound [Na+].[Na+].O=C.[O-]S[O-] VYGBQXDNOUHIBZ-UHFFFAOYSA-L 0.000 description 1
- PAYGMRRPBHYIMA-UHFFFAOYSA-N sodium;trihydrate Chemical compound O.O.O.[Na] PAYGMRRPBHYIMA-UHFFFAOYSA-N 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- XPFJYKARVSSRHE-UHFFFAOYSA-K trisodium;2-hydroxypropane-1,2,3-tricarboxylate;2-hydroxypropane-1,2,3-tricarboxylic acid Chemical compound [Na+].[Na+].[Na+].OC(=O)CC(O)(C(O)=O)CC(O)=O.[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O XPFJYKARVSSRHE-UHFFFAOYSA-K 0.000 description 1
- 210000002700 urine Anatomy 0.000 description 1
Images
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
Description
1个月 | 2个月 | 3个月 | 6个月 | 12个月 | |
1 | 99.75% | 99.53% | 99.16% | 98.96% | 96.25% |
2 | 99.72% | 99.25% | 99.03% | 98.78% | 95.84% |
3 | 99.70% | 99.13% | 97.35% | 95.04% | 87.87% |
4 | 99.71% | 99.05% | 97.16% | 94.54% | 86.96% |
3个月 | 6个月 | 9个月 | 12个月 | 18个月 | |
1 | 99.75% | 99.61% | 99.48% | 98.92% | 97.45% |
2 | 99.70% | 99.56% | 99.28% | 98.45% | 96.91% |
3 | 99.68% | 99.20% | 98.60% | 96.21% | 90.55% |
4 | 99.60% | 99.13% | 97.85% | 95.45% | 89.35% |
Claims (9)
Priority Applications (1)
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CN2012102221226A CN102718693B (zh) | 2012-06-29 | 2012-06-29 | 一种卡络磺钠化合物及其组合物 |
Applications Claiming Priority (1)
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CN2012102221226A CN102718693B (zh) | 2012-06-29 | 2012-06-29 | 一种卡络磺钠化合物及其组合物 |
Publications (2)
Publication Number | Publication Date |
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CN102718693A true CN102718693A (zh) | 2012-10-10 |
CN102718693B CN102718693B (zh) | 2013-12-04 |
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN103145603A (zh) * | 2013-03-15 | 2013-06-12 | 湖北济生医药有限公司 | 卡络磺钠化合物及其药物组合物 |
CN107382818A (zh) * | 2017-08-03 | 2017-11-24 | 江苏汉斯通药业有限公司 | 一种高纯净度卡络磺钠的合成方法 |
CN108938626A (zh) * | 2018-07-27 | 2018-12-07 | 四川联成迅康医药股份有限公司 | 一种稳定性好和安全性高的卡络磺钠药物组合物及其制备方法和应用 |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1759832A (zh) * | 2005-09-09 | 2006-04-19 | 王海燕 | 卡络磺钠注射液及其制备方法 |
JP4310820B2 (ja) * | 1998-05-28 | 2009-08-12 | 田辺三菱製薬株式会社 | カルバゾクロムスルホン酸誘導体の製法 |
CN102018675A (zh) * | 2009-11-11 | 2011-04-20 | 海南利能康泰制药有限公司 | 一种卡络磺钠冻干粉针及其制备方法 |
-
2012
- 2012-06-29 CN CN2012102221226A patent/CN102718693B/zh active Active
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP4310820B2 (ja) * | 1998-05-28 | 2009-08-12 | 田辺三菱製薬株式会社 | カルバゾクロムスルホン酸誘導体の製法 |
CN1759832A (zh) * | 2005-09-09 | 2006-04-19 | 王海燕 | 卡络磺钠注射液及其制备方法 |
CN102018675A (zh) * | 2009-11-11 | 2011-04-20 | 海南利能康泰制药有限公司 | 一种卡络磺钠冻干粉针及其制备方法 |
Non-Patent Citations (1)
Title |
---|
周伯庭; 徐平声; 李新中: "大孔树脂法纯化卡络磺钠", 《中国医院药学杂志》 * |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN103145603A (zh) * | 2013-03-15 | 2013-06-12 | 湖北济生医药有限公司 | 卡络磺钠化合物及其药物组合物 |
CN103145603B (zh) * | 2013-03-15 | 2014-12-17 | 湖北济生医药有限公司 | 卡络磺钠化合物及其药物组合物 |
CN107382818A (zh) * | 2017-08-03 | 2017-11-24 | 江苏汉斯通药业有限公司 | 一种高纯净度卡络磺钠的合成方法 |
CN108938626A (zh) * | 2018-07-27 | 2018-12-07 | 四川联成迅康医药股份有限公司 | 一种稳定性好和安全性高的卡络磺钠药物组合物及其制备方法和应用 |
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Publication number | Publication date |
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CN102718693B (zh) | 2013-12-04 |
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C06 | Publication | ||
PB01 | Publication | ||
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C14 | Grant of patent or utility model | ||
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EE01 | Entry into force of recordation of patent licensing contract |
Application publication date: 20121010 Assignee: Hainan Yi Shun Pharmaceutical Co.,Ltd. Assignor: Xia Zhihong Contract record no.: 2014360000046 Denomination of invention: Carbazochrome sodium sulfonate compound and composition thereof Granted publication date: 20131204 License type: Common License Record date: 20140304 |
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LICC | Enforcement, change and cancellation of record of contracts on the licence for exploitation of a patent or utility model | ||
TR01 | Transfer of patent right | ||
TR01 | Transfer of patent right |
Effective date of registration: 20220808 Address after: H1708-1711, Mingzhu Square, Jiefang West Road, Qingyunpu, Nanchang City, Jiangxi Province 334000 Patentee after: JIANGXI XINXIANFENG MEDICINE SCIENTIFIC RESEARCH MARKETING CO.,LTD. Address before: Room 1709, Block H, Mingzhu Plaza, Jiefang West Road, Nanchang City, Jiangxi Province, 330002 Patentee before: Xia Zhihong |