CN101856333B - 头孢孟多酯钠冻干粉针制剂及其制备方法 - Google Patents
头孢孟多酯钠冻干粉针制剂及其制备方法 Download PDFInfo
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- CN101856333B CN101856333B CN2010101999749A CN201010199974A CN101856333B CN 101856333 B CN101856333 B CN 101856333B CN 2010101999749 A CN2010101999749 A CN 2010101999749A CN 201010199974 A CN201010199974 A CN 201010199974A CN 101856333 B CN101856333 B CN 101856333B
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- Prior art keywords
- freeze
- dried powder
- cefamandole nafate
- cefamandole
- powder injection
- 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.)
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- 239000000843 powder Substances 0.000 title claims abstract description 48
- RRJHESVQVSRQEX-SUYBPPKGSA-N O-formylcefamandole Chemical compound CN1N=NN=C1SCC1=C(C(O)=O)N2C(=O)[C@@H](NC(=O)[C@H](OC=O)C=3C=CC=CC=3)[C@H]2SC1 RRJHESVQVSRQEX-SUYBPPKGSA-N 0.000 title claims abstract description 30
- 229960002440 cefamandole nafate Drugs 0.000 title claims abstract description 30
- 238000002347 injection Methods 0.000 title claims abstract description 15
- 239000007924 injection Substances 0.000 title claims abstract description 15
- 238000002360 preparation method Methods 0.000 title description 18
- 238000004108 freeze drying Methods 0.000 claims abstract description 30
- 238000000034 method Methods 0.000 claims abstract description 15
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 12
- 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 claims description 32
- 229910052708 sodium Inorganic materials 0.000 claims description 32
- 239000011734 sodium Substances 0.000 claims description 32
- ICZOIXFFVKYXOM-YCLOEFEOSA-M cefamandole nafate Chemical compound [Na+].CN1N=NN=C1SCC1=C(C([O-])=O)N2C(=O)[C@@H](NC(=O)[C@H](OC=O)C=3C=CC=CC=3)[C@H]2SC1 ICZOIXFFVKYXOM-YCLOEFEOSA-M 0.000 claims description 31
- 239000003814 drug Substances 0.000 claims description 21
- 229940079593 drug Drugs 0.000 claims description 18
- 238000004090 dissolution Methods 0.000 claims description 12
- 238000005374 membrane filtration Methods 0.000 claims description 8
- 239000012528 membrane Substances 0.000 claims description 6
- 238000012856 packing Methods 0.000 claims description 5
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 abstract description 14
- 229960003012 cefamandole Drugs 0.000 abstract description 11
- OLVCFLKTBJRLHI-AXAPSJFSSA-N cefamandole Chemical compound CN1N=NN=C1SCC1=C(C(O)=O)N2C(=O)[C@@H](NC(=O)[C@H](O)C=3C=CC=CC=3)[C@H]2SC1 OLVCFLKTBJRLHI-AXAPSJFSSA-N 0.000 abstract description 11
- 229910000029 sodium carbonate Inorganic materials 0.000 abstract description 7
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 abstract description 6
- 239000001569 carbon dioxide Substances 0.000 abstract description 3
- 229910002092 carbon dioxide Inorganic materials 0.000 abstract description 3
- 238000001914 filtration Methods 0.000 abstract description 3
- 238000004806 packaging method and process Methods 0.000 abstract description 2
- 239000000243 solution Substances 0.000 abstract description 2
- 239000000126 substance Substances 0.000 abstract description 2
- 238000005303 weighing Methods 0.000 description 4
- 239000002994 raw material Substances 0.000 description 3
- 239000008215 water for injection Substances 0.000 description 3
- 206010001526 Air embolism Diseases 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- LSBDFXRDZJMBSC-UHFFFAOYSA-N Amide-Phenylacetic acid Natural products NC(=O)CC1=CC=CC=C1 LSBDFXRDZJMBSC-UHFFFAOYSA-N 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- 206010061695 Biliary tract infection Diseases 0.000 description 1
- 229930186147 Cephalosporin Natural products 0.000 description 1
- 206010011951 Decompression Sickness Diseases 0.000 description 1
- 208000005189 Embolism Diseases 0.000 description 1
- 206010019280 Heart failures Diseases 0.000 description 1
- 206010022678 Intestinal infections Diseases 0.000 description 1
- AYDQIZKZTQHYIY-UHFFFAOYSA-N OC(=O)C1(C)CC(C(O)=O)=CC=C1 Chemical compound OC(=O)C1(C)CC(C(O)=O)=CC=C1 AYDQIZKZTQHYIY-UHFFFAOYSA-N 0.000 description 1
- 206010040047 Sepsis Diseases 0.000 description 1
- 102000004377 Thiopurine S-methyltransferases Human genes 0.000 description 1
- 108090000958 Thiopurine S-methyltransferases Proteins 0.000 description 1
- 208000001435 Thromboembolism Diseases 0.000 description 1
- 210000003445 biliary tract Anatomy 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 210000000988 bone and bone Anatomy 0.000 description 1
- 229940124587 cephalosporin Drugs 0.000 description 1
- 150000001780 cephalosporins Chemical class 0.000 description 1
- 230000035606 childbirth Effects 0.000 description 1
- 208000003167 cholangitis Diseases 0.000 description 1
- 239000006184 cosolvent Substances 0.000 description 1
- 230000006837 decompression Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 238000007710 freezing Methods 0.000 description 1
- 230000008014 freezing Effects 0.000 description 1
- 210000003128 head Anatomy 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 210000004072 lung Anatomy 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 210000003205 muscle Anatomy 0.000 description 1
- 210000003739 neck Anatomy 0.000 description 1
- 239000013618 particulate matter Substances 0.000 description 1
- 206010034674 peritonitis Diseases 0.000 description 1
- 210000003800 pharynx Anatomy 0.000 description 1
- 239000013558 reference substance Substances 0.000 description 1
- 210000002345 respiratory system Anatomy 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 208000013223 septicemia Diseases 0.000 description 1
- 210000003491 skin Anatomy 0.000 description 1
- 210000004872 soft tissue Anatomy 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 238000010254 subcutaneous injection Methods 0.000 description 1
- 239000007929 subcutaneous injection Substances 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 210000000779 thoracic wall Anatomy 0.000 description 1
- 210000002229 urogenital system Anatomy 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Cephalosporin Compounds (AREA)
Abstract
Description
溶解速度 | |
本发明制备样品 | 30s |
市售原料药 | 大于30min |
市售原料药+碳酸钠 | 57s |
Claims (2)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN2010101999749A CN101856333B (zh) | 2010-06-10 | 2010-06-10 | 头孢孟多酯钠冻干粉针制剂及其制备方法 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN2010101999749A CN101856333B (zh) | 2010-06-10 | 2010-06-10 | 头孢孟多酯钠冻干粉针制剂及其制备方法 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN101856333A CN101856333A (zh) | 2010-10-13 |
CN101856333B true CN101856333B (zh) | 2012-02-22 |
Family
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Family Applications (1)
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CN2010101999749A Expired - Fee Related CN101856333B (zh) | 2010-06-10 | 2010-06-10 | 头孢孟多酯钠冻干粉针制剂及其制备方法 |
Country Status (1)
Country | Link |
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CN (1) | CN101856333B (zh) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN106511281A (zh) * | 2016-09-30 | 2017-03-22 | 华北制药河北华民药业有限责任公司 | 一种注射用头孢孟多酯钠粉针制剂的制备方法 |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101219117A (zh) * | 2007-08-14 | 2008-07-16 | 山东罗欣药业股份有限公司 | 一种头孢孟多酯钠粉针及其粉针、原料药的制备方法 |
CN101279979A (zh) * | 2008-06-03 | 2008-10-08 | 海南本创医药科技有限公司 | 头孢孟多酯钠的分离纯化方法及冻干粉针制剂的制备方法 |
CN101637456A (zh) * | 2009-08-18 | 2010-02-03 | 海南永田药物研究院有限公司 | 一种头孢孟多酯钠混悬粉针剂及其新应用 |
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2010
- 2010-06-10 CN CN2010101999749A patent/CN101856333B/zh not_active Expired - Fee Related
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101219117A (zh) * | 2007-08-14 | 2008-07-16 | 山东罗欣药业股份有限公司 | 一种头孢孟多酯钠粉针及其粉针、原料药的制备方法 |
CN101279979A (zh) * | 2008-06-03 | 2008-10-08 | 海南本创医药科技有限公司 | 头孢孟多酯钠的分离纯化方法及冻干粉针制剂的制备方法 |
CN101637456A (zh) * | 2009-08-18 | 2010-02-03 | 海南永田药物研究院有限公司 | 一种头孢孟多酯钠混悬粉针剂及其新应用 |
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Publication number | Publication date |
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CN101856333A (zh) | 2010-10-13 |
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Owner name: HUBEI MERRYCLIN PHARMACEUTICALS CO., LTD. Free format text: FORMER OWNER: HUBEI NEO-TREATION PHARMACEUTICAL CO., LTD. Effective date: 20150211 |
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Effective date of registration: 20150211 Address after: 432500 Yunmeng Economic Development Zone, Hubei, Xiaogan Patentee after: Hubei Merryclin Pharmaceutical Co., Ltd. Address before: 430014, B2B5, room 15, Zhenghe Plaza, 707 Zhongshan Avenue, Jiang'an District, Hubei, Wuhan Patentee before: Hubei Neo-Treation Pharmaceutical Co., Ltd. |
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Effective date of registration: 20171207 Address after: 432800 Xiaogan City, Hubei Province town of Chengguan Dawu County Han market No. 126 Patentee after: Hubei Yuan Yuan medical science and Technology Co., Ltd. Address before: 432500 Yunmeng Economic Development Zone, Hubei, Xiaogan Patentee before: Hubei Merryclin Pharmaceutical Co., Ltd. |
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Effective date of registration: 20181109 Address after: 432500 Yunmeng County Economic Development Zone, Xiaogan, Hubei Patentee after: Hubei Merryclin Pharmaceutical Co., Ltd. Address before: 432800 126, Han Da market, Chengguan Town, Dawu County, Xiaogan, Hubei Patentee before: Hubei Yuan Yuan medical science and Technology Co., Ltd. |
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