CN101143133A - Sodium fusidate freezing-dried powder injection - Google Patents
Sodium fusidate freezing-dried powder injection Download PDFInfo
- Publication number
- CN101143133A CN101143133A CNA2007100502224A CN200710050222A CN101143133A CN 101143133 A CN101143133 A CN 101143133A CN A2007100502224 A CNA2007100502224 A CN A2007100502224A CN 200710050222 A CN200710050222 A CN 200710050222A CN 101143133 A CN101143133 A CN 101143133A
- Authority
- CN
- China
- Prior art keywords
- sodium fusidate
- dried powder
- powder injection
- freezing
- clarification
- 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
- 229960004675 fusidic acid Drugs 0.000 title claims abstract description 44
- 239000000843 powder Substances 0.000 title claims abstract description 24
- 239000007924 injection Substances 0.000 title claims abstract description 20
- 238000002347 injection Methods 0.000 title claims abstract description 20
- IECPWNUMDGFDKC-MZJAQBGESA-N fusidic acid Chemical compound O[C@@H]([C@@H]12)C[C@H]3\C(=C(/CCC=C(C)C)C(O)=O)[C@@H](OC(C)=O)C[C@]3(C)[C@@]2(C)CC[C@@H]2[C@]1(C)CC[C@@H](O)[C@H]2C IECPWNUMDGFDKC-MZJAQBGESA-N 0.000 title claims abstract 15
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims abstract description 24
- 239000004475 Arginine Substances 0.000 claims abstract description 12
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims abstract description 12
- 239000004471 Glycine Substances 0.000 claims description 11
- 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 claims description 6
- 229930195725 Mannitol Natural products 0.000 claims description 6
- 239000000594 mannitol Substances 0.000 claims description 6
- 235000010355 mannitol Nutrition 0.000 claims description 6
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 4
- 239000008101 lactose Substances 0.000 claims description 4
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 4
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims description 3
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims description 2
- 239000000600 sorbitol Substances 0.000 claims description 2
- 229940079593 drug Drugs 0.000 abstract description 6
- 239000003814 drug Substances 0.000 abstract description 6
- 239000003381 stabilizer Substances 0.000 abstract description 4
- 238000005352 clarification Methods 0.000 description 31
- HJHVQCXHVMGZNC-JCJNLNMISA-M sodium;(2z)-2-[(3r,4s,5s,8s,9s,10s,11r,13r,14s,16s)-16-acetyloxy-3,11-dihydroxy-4,8,10,14-tetramethyl-2,3,4,5,6,7,9,11,12,13,15,16-dodecahydro-1h-cyclopenta[a]phenanthren-17-ylidene]-6-methylhept-5-enoate Chemical compound [Na+].O[C@@H]([C@@H]12)C[C@H]3\C(=C(/CCC=C(C)C)C([O-])=O)[C@@H](OC(C)=O)C[C@]3(C)[C@@]2(C)CC[C@@H]2[C@]1(C)CC[C@@H](O)[C@H]2C HJHVQCXHVMGZNC-JCJNLNMISA-M 0.000 description 29
- 239000007788 liquid Substances 0.000 description 26
- 239000000126 substance Substances 0.000 description 12
- 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 10
- 229940090044 injection Drugs 0.000 description 10
- 229940093181 glucose injection Drugs 0.000 description 9
- 239000008354 sodium chloride injection Substances 0.000 description 8
- 239000013618 particulate matter Substances 0.000 description 7
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 6
- 238000005286 illumination Methods 0.000 description 5
- 238000001514 detection method Methods 0.000 description 4
- 238000002360 preparation method Methods 0.000 description 4
- 239000000872 buffer Substances 0.000 description 3
- 239000002932 luster Substances 0.000 description 3
- 239000000203 mixture Substances 0.000 description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 3
- 239000008215 water for injection Substances 0.000 description 3
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 2
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- 230000003115 biocidal effect Effects 0.000 description 2
- 239000000337 buffer salt Substances 0.000 description 2
- 208000015181 infectious disease Diseases 0.000 description 2
- 230000007774 longterm Effects 0.000 description 2
- 239000000243 solution Substances 0.000 description 2
- 239000002904 solvent Substances 0.000 description 2
- 238000003756 stirring Methods 0.000 description 2
- 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 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical group 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
- 241000191940 Staphylococcus Species 0.000 description 1
- 230000001580 bacterial effect Effects 0.000 description 1
- 210000000988 bone and bone Anatomy 0.000 description 1
- 238000005262 decarbonization Methods 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 description 1
- 229910000397 disodium phosphate Inorganic materials 0.000 description 1
- 235000019800 disodium phosphate Nutrition 0.000 description 1
- 206010014665 endocarditis Diseases 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 238000004108 freeze drying Methods 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 239000007791 liquid phase Substances 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 125000002345 steroid group Chemical group 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
Abstract
Description
Prescription | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 |
Sodium fusidate | 500mg | 500mg | 500mg | 500mg | 125mg | 125mg | 125mg | 125mg |
Glycine | 60mg | 100mg | 120mg | 200mg | 50mg | 70mg | 35mg | 30mg |
Arginine | 100mg | 150mg | 180mg | 100mg | 30mg | 85mg | 40mg | 30mg |
Lactose | 0mg | 50mg | 0mg | 50mg | 45mg | 0mg | 0mg | 40mg |
Mannitol | 50mg | 0mg | 0mg | 0mg | 0mg | 20mg | 20mg | 0mg |
Buffer | 10ml | 10ml | 10ml | 10ml | 10ml | 10ml | 10ml | 10ml |
The redissolution phenomenon | Dissolving | Insoluble | Dissolving | Dissolving | Dissolving | Dissolving | Insoluble | Dissolving |
5% glucose injection compatibility | Particulate matter is arranged | —— | Clarification | Particulate matter is arranged | Particulate matter is arranged | Clarification | —— | Particulate matter is arranged |
0.9% sodium chloride injection compatibility | Clarification | —— | Clarification | Particulate matter is arranged | Particulate matter is arranged | Clarification | —— | Particulate matter is arranged |
Condition | Time (my god) | Character | PH value | Clarity | Clarity | Color and luster | Moisture (%) | Related substance (%) | Content (%) |
High temperature (40 ℃) | 0 | White lyophilizing block | 8.51 | Up to specification | Clarification | Colourless | 1.45 | 0.83 | 99.84 |
5 | White lyophilizing block | 8.48 | Up to specification | Clarification | Colourless | 1.38 | 0.88 | 99.60 | |
10 | White lyophilizing block | 8.47 | Up to specification | Clarification | Colourless | 1.35 | 0.91 | 99.25 | |
High temperature (60 ℃) | 0 | White lyophilizing block | 8.51 | Up to specification | Clarification | Colourless | 1.45 | 0.83 | 99.84 |
5 | White lyophilizing block | 8.45 | Up to specification | Clarification | Colourless | 1.33 | 1.24 | 98.97 | |
10 | Pale yellow lyophilizing block | 8.43 | Up to specification | Clarification | Little Huang | 1.29 | 1.59 | 98.18 | |
Illumination 45001 X | 0 | White lyophilizing block | 8.51 | Up to specification | Clarification | Colourless | 1.45 | 0.83 | 99.84 |
5 | White lyophilizing block | 8.50 | Up to specification | Clarification | Colourless | 1.48 | 0.79 | 99.76 | |
10 | White lyophilizing block | 8.50 | Up to specification | Clarification | Colourless | 1.40 | 0.88 | 99.79 | |
Kept sample 90 days | White lyophilizing block | 8.48 | Up to specification | Clarification | Colourless | 1.56 | 0.85 | 99.68 |
Condition | Time (my god) | Character | PH value | Clarity | Clarity | Color and luster | Moisture (%) | Related substance (%) | Content (%) |
High temperature (40 ℃) | 0 | White lyophilizing block | 8.63 | Up to specification | Clarification | Colourless | 1.65 | 0.71 | 100.17 |
5 | White lyophilizing block | 8.58 | Up to specification | Clarification | Colourless | 1.49 | 0.82 | 99.99 | |
10 | White lyophilizing block | 8.55 | Up to specification | Clarification | Colourless | 1.42 | 0.84 | 99.68 | |
High temperature (60 ℃) | 0 | White lyophilizing block | 8.63 | Up to specification | Clarification | Colourless | 1.65 | 0.71 | 100.17 |
5 | White lyophilizing block | 8.55 | Up to specification | Clarification | Colourless | 1.38 | 1.16 | 99.64 | |
10 | Pale yellow lyophilizing block | 8.46 | Up to specification | Clarification | Little Huang | 1.26 | 1.49 | 98.78 | |
Illumination 45001 X | 0 | White lyophilizing block | 8.63 | Up to specification | Clarification | Colourless | 1.65 | 0.71 | 100.17 |
5 | White lyophilizing block | 8.61 | Up to specification | Clarification | Colourless | 1.68 | 0.73 | 99.96 | |
10 | White lyophilizing block | 8.66 | Up to specification | Clarification | Colourless | 1.80 | 0.77 | 99.89 | |
Kept sample 90 days | White lyophilizing block | 8.52 | Up to specification | Clarification | Colourless | 1.78 | 0.72 | 99.98 |
Detection time | 0 hour | 2 hours | 4 hours | 6 hours | 8 hours | 24 hours |
Character | Colourless clear liquid | Colourless clear liquid | Colourless clear liquid | Colourless clear liquid | Colourless clear liquid | Colourless clear liquid |
PH value | 7.55 | 7.53 | 7.54 | 7.53 | 7.52 | 7.50 |
Content | 99.84% | 99.73% | 99.62% | 99.48% | 99.25% | 98.68% |
Related substance | 0.83% | 0.92% | 0.99% | 1.15% | 1.41% | 1.88% |
Detection time | 0 hour | 2 hours | 4 hours | 6 hours | 8 hours | 24 hours |
Character | Colourless clear liquid | Colourless clear liquid | Colourless clear liquid | Colourless clear liquid | Colourless clear liquid | Colourless clear liquid |
PH value | 7.38 | 7.39 | 7.38 | 7.37 | 7.36 | 7.34 |
Content | 100.17% | 100.03% | 99.87% | 99.59% | 99.38% | 99.01% |
Related substance | 0.71% | 0.87% | 1.01% | 1.38% | 1.51% | 1.97% |
Detection time | 0 hour | 2 hours | 4 hours | 6 hours | 8 hours | 24 hours |
Character | Colourless clear liquid | Colourless clear liquid | Colourless clear liquid | Colourless clear liquid | Colourless clear liquid | Colourless clear liquid |
PH value | 7.53 | 7.51 | 7.52 | 7.52 | 7.50 | 7.48 |
Content | 99.84% | 99.69% | 99.53% | 99.32% | 99.10% | 98.84% |
Related substance | 0.83% | 0.92% | 0.99% | 1.15% | 1.41% | 1.88% |
Detection time | 0 hour | 2 hours | 4 hours | 6 hours | 8 hours | 24 hours |
Character | Colourless clear liquid | Colourless clear liquid | Colourless clear liquid | Colourless clear liquid | Colourless clear liquid | Colourless clear liquid |
PH value | 7.38 | 7.39 | 7.38 | 7.37 | 7.36 | 7.34 |
Content | 100.17% | 100.04% | 99.87% | 99.49% | 99.26% | 98.76% |
Related substance | 0.71% | 0.87% | 1.01% | 1.38% | 1.51% | 1.97% |
The check product batches | The date of inspection | Content | Related substance | PH value | The compatibility result | |
Sodium fusidate freezing-dried powder injection of the present invention | 20060701 | 2007.2.26 | 99.83% | 1.38% | 8.05 | Clarification |
20060702 | 2007.2.26 | 100.57% | 1.35% | 7.99 | Clarification | |
20060801 | 2007.2.26 | 98.56% | 1.42% | 7.93 | Clarification | |
20061001 | 2007.2.26 | 99.32% | 1.13% | 8.02 | Clarification | |
20061201 | 2007.2.26 | 101.60% | 1.20% | 7.98 | Clarification | |
The listing like product | 2007.2.26 | 94.21% | 5.10% | 7.87 | Muddy rapidly |
Claims (6)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CNB2007100502224A CN100566704C (en) | 2007-10-12 | 2007-10-12 | Sodium fusidate freezing-dried powder injection |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CNB2007100502224A CN100566704C (en) | 2007-10-12 | 2007-10-12 | Sodium fusidate freezing-dried powder injection |
Publications (2)
Publication Number | Publication Date |
---|---|
CN101143133A true CN101143133A (en) | 2008-03-19 |
CN100566704C CN100566704C (en) | 2009-12-09 |
Family
ID=39205990
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CNB2007100502224A Active CN100566704C (en) | 2007-10-12 | 2007-10-12 | Sodium fusidate freezing-dried powder injection |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN100566704C (en) |
Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102743342A (en) * | 2012-04-11 | 2012-10-24 | 江苏奥赛康药业股份有限公司 | Sodium fusidate lyophilized composition for injection |
CN103169673A (en) * | 2013-04-11 | 2013-06-26 | 山东罗欣药业股份有限公司 | Sodium fusidate freeze-dried powder injection and preparation method thereof |
CN104352454A (en) * | 2014-11-15 | 2015-02-18 | 成都天台山制药有限公司 | Sodium fusidate powder-injection pharmaceutical composition for injection and preparation method |
CN106924194A (en) * | 2015-12-31 | 2017-07-07 | 深圳翰宇药业股份有限公司 | A kind of long-acting Pharmaceutical composition and preparation method |
US20200030448A1 (en) * | 2011-05-23 | 2020-01-30 | Arrevus, Inc. | Compositions comprising fusidic acid and packages therefor |
CN111012747A (en) * | 2018-10-10 | 2020-04-17 | 四川海思科制药有限公司 | Sodium fusidate pharmaceutical composition for injection and preparation method thereof |
-
2007
- 2007-10-12 CN CNB2007100502224A patent/CN100566704C/en active Active
Cited By (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20200030448A1 (en) * | 2011-05-23 | 2020-01-30 | Arrevus, Inc. | Compositions comprising fusidic acid and packages therefor |
US20220233699A1 (en) * | 2011-05-23 | 2022-07-28 | Arrevus, Inc. | Compositions comprising fusidic acid and packages therefor |
CN102743342A (en) * | 2012-04-11 | 2012-10-24 | 江苏奥赛康药业股份有限公司 | Sodium fusidate lyophilized composition for injection |
CN102743342B (en) * | 2012-04-11 | 2014-04-02 | 江苏奥赛康药业股份有限公司 | Sodium fusidate lyophilized composition for injection |
CN103169673A (en) * | 2013-04-11 | 2013-06-26 | 山东罗欣药业股份有限公司 | Sodium fusidate freeze-dried powder injection and preparation method thereof |
CN103169673B (en) * | 2013-04-11 | 2014-08-20 | 山东罗欣药业股份有限公司 | Sodium fusidate freeze-dried powder injection and preparation method thereof |
CN104352454A (en) * | 2014-11-15 | 2015-02-18 | 成都天台山制药有限公司 | Sodium fusidate powder-injection pharmaceutical composition for injection and preparation method |
CN104352454B (en) * | 2014-11-15 | 2017-06-16 | 成都天台山制药有限公司 | Sodium fusidafe as injection powder-injection pharmaceutical composition and preparation method |
CN106924194A (en) * | 2015-12-31 | 2017-07-07 | 深圳翰宇药业股份有限公司 | A kind of long-acting Pharmaceutical composition and preparation method |
CN111012747A (en) * | 2018-10-10 | 2020-04-17 | 四川海思科制药有限公司 | Sodium fusidate pharmaceutical composition for injection and preparation method thereof |
Also Published As
Publication number | Publication date |
---|---|
CN100566704C (en) | 2009-12-09 |
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Change date: 20190410 Contract record no.: 2016510000027 Assignor after: HAISCO PHARMACEUTICAL Group Inc. Assignor before: LIAONING HAISCO PHARMACEUTICAL Co.,Ltd. |
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EM01 | Change of recordation of patent licensing contract |