CN100566704C - Sodium fusidate freezing-dried powder injection - Google Patents
Sodium fusidate freezing-dried powder injection Download PDFInfo
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- CN100566704C CN100566704C CNB2007100502224A CN200710050222A CN100566704C CN 100566704 C CN100566704 C CN 100566704C CN B2007100502224 A CNB2007100502224 A CN B2007100502224A CN 200710050222 A CN200710050222 A CN 200710050222A CN 100566704 C CN100566704 C CN 100566704C
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- sodium fusidate
- freezing
- dried powder
- hours
- sodium
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- 229960004675 fusidic acid Drugs 0.000 title claims abstract description 36
- 239000000843 powder Substances 0.000 title claims abstract description 16
- 239000007924 injection Substances 0.000 title claims abstract description 14
- 238000002347 injection Methods 0.000 title claims abstract description 14
- 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 8
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims abstract description 20
- 239000004475 Arginine Substances 0.000 claims abstract description 10
- 239000004471 Glycine Substances 0.000 claims abstract description 10
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims abstract 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 claims description 5
- 229930195725 Mannitol Natural products 0.000 claims description 5
- 239000000594 mannitol Substances 0.000 claims description 5
- 235000010355 mannitol Nutrition 0.000 claims description 5
- 229940079593 drug Drugs 0.000 abstract description 6
- 239000003814 drug Substances 0.000 abstract description 6
- 239000003381 stabilizer Substances 0.000 abstract description 4
- 230000007774 longterm Effects 0.000 abstract description 3
- 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 28
- 239000007788 liquid Substances 0.000 description 26
- 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
- 229940093181 glucose injection Drugs 0.000 description 9
- 229940090044 injection Drugs 0.000 description 9
- 239000000126 substance Substances 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
- 238000005352 clarification Methods 0.000 description 6
- 238000001514 detection method Methods 0.000 description 4
- 238000002360 preparation method Methods 0.000 description 4
- 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 description 3
- 239000000872 buffer Substances 0.000 description 3
- 238000005286 illumination Methods 0.000 description 3
- 239000008101 lactose 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
- 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 description 2
- 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
- 239000000546 pharmaceutical excipient Substances 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
- 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 description 1
- 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
- 239000007791 liquid phase Substances 0.000 description 1
- 239000002932 luster 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
- 239000000600 sorbitol Substances 0.000 description 1
- 125000002345 steroid group Chemical group 0.000 description 1
Abstract
The invention discloses a kind of sodium fusidate freezing-dried powder injection.It comprises following component and content (weight portion): sodium fusidate 450～550, glycine 30～500, arginine 40～600.This sodium fusidate freezing-dried powder injection is owing to added certain amount of stabilizer, and its long-term stability is good, and the safety when having improved patient's medication has reduced drug risk.
Description
Technical field
The present invention relates to the lyophilized injectable powder of sodium fusidate.
Background technology
Sodium fusidate is a kind of antibiotic with steroid backbone, is mainly used in staphy lococcus infection, and is particularly suitable to anti-other antibiotic bacterial strains, is usually used in skin, site infection such as osseous tissue and joint and endocarditis etc.
Owing to insoluble floccule can occur when sodium fusidate and 5% glucose or 0.9% sodium chloride compatibility, and sodium fusidate is placed unstable in solution, therefore the sodium fusidate product of listing is freeze-dried powder at present, adopt the alkaline buffer salt solvent dissolving of incidental special use during use, solve the product compatibility problems.But long-time stability are relatively poor after this product lyophilizing, and long term store has related substance easily and exceeds standard, and compatibility phenomenon such as become turbid easily when using, and directly cause and can not use.
Chinese patent application CN1817340A discloses a kind of composition of sodium fusidafe as injection, and it is solvent that this sodium fusidate adopts water for injection, and citric acid buffer salt and sodium fusidate are directly made lyophilized formulations.We carry out study on the stability to it, sedimentary problem occurs though said preparation can better solve compatibility, its long-time stability are very poor, and related substance exceeds standard in 3 months even shorter time, cause product quality defective, thereby have a strong impact on patient's drug safety.Therefore, the sodium fusidate freeze-dried powder preparation of stability is badly in need of in this area.
Summary of the invention
Technical problem to be solved by this invention provides a kind of stable sodium fusidate freezing-dried powder injection.
Sodium fusidate freezing-dried powder injection of the present invention comprises following component and content (weight portion):
Sodium fusidate 450～550
Glycine 30～500
Arginine 40～600.
The preferred sodium fusidate 470～530 of said components and content, glycine 50～350, arginine 100～400; More preferably sodium fusidate 500, glycine 120, arginine 180; More preferably sodium fusidate 125, glycine 70, arginine 85, mannitol 20 again.
Above-mentioned lyophilized injectable powder also can further comprise at least a in excipient such as lactose, mannitol, the sorbitol.Consumption is 1～10% of a described lyophilized injectable powder percentage by weight.
The present invention is in conjunction with knowhow and clinical handling characteristics, add certain amount of stabilizer glycine and arginine, sodium fusidate is made stable injection freeze-dried composition, its long-term stability is good, safety when having improved patient's medication has reduced drug risk.
The present invention is further detailed explanation below in conjunction with the specific embodiment.
The specific embodiment
Embodiment 1
Get water for injection, put and be chilled to 30 ℃, press the described recipe quantity of table 1 and add glycine, arginine, lactose and mannitol, stirring and dissolving.Adjusting pH value of solution is 8.0～9.0, adds the sodium fusidate of the described recipe quantity of table 1, and stirring and dissolving adds to the full amount of water for injection.Add the injection special-purpose activated charcoal to medicinal liquid, stirred decarbonization filtering 15 minutes.0.22～0.45 μ m microporous filter membrane fine straining degerming, liquid drug is partly rolled plug, lyophilization, and lid is rolled in the outlet tamponade.Redissolve, select stabilizing agent and the final consumption of excipient by buffer (component and content are: sodium hydrogen phosphate 196mg, citric acid 10mg, EDTA-2Na 5mg, 10ml altogether) with 5% glucose injection and 0.9% sodium chloride injection compatibility result.Result of study sees Table 1:
Table 1 stabilizing agent dosage selection result
| 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 |
To put respectively under high temperature (60 ℃), high temperature (40 ℃) and illumination (4500lx) condition by the fusidic acid sodium freeze dry of the present invention of prescription 3, prescription 6 preparations and place 10 days, respectively at sampling in 5,10 days, other three months storage requirement keeps sample and takes a sample to check, and every quality index the results are shown in Table 2 and table 3.
The result shows: fusidic acid sodium freeze dry of the present invention was placed 10 days in high temperature (60 ℃), high temperature (40 ℃), illumination (4500lx) environment, and finished product was being stipulated the storage requirement reserved sample observing 90 days, checking every quality index and relatively removing high temperature (60 ℃) related substance in 0 day increases, content descends, color and luster changes, outside illumination (4500lx) related substance slightly increased, all other indexs had no significant change.
Table 2 prescription 3 influence factor's result of the tests
Table 3 prescription 6 influence factor's result of the tests
The compatibility test
To join by the fusidic acid sodium freeze dries of the present invention of prescription 3, prescription 6 preparations in 5% glucose injection of 0.9% sodium chloride injection, 250ml of 250ml, detect 24 hours in the mass change situation, the results are shown in Table 4, table 5, table 6 and table 7.
Table 4 prescription 3 and 0.9% sodium chloride injection compatibility result of the test
| 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％ |
Table 5 prescription 6 and 0.9% sodium chloride injection compatibility result of the test
| 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％ |
The result shows: fusidic acid sodium freeze dry of the present invention is in the test of 24 hours compatibilities, and every quality index all meets the requirements, and illustrates that quality is reliable and stable in this product and the 0.9% sodium chloride injection compatibility 24 hours.
Table 6 prescription 3 and 5% glucose injection compatibility result of the test
| 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％ |
Table 7 prescription 6 and 5% glucose injection compatibility result of the test
| 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 result shows: fusidic acid sodium freeze dry of the present invention is in " 24 hours compatibility test ", and every quality index all meets the requirements, and illustrates that quality is reliable and stable in this product and the 5% glucose injection compatibility 24 hours.
In addition sodium fusidate freezing-dried powder injection of the present invention (prescription 3) is carried out the compatibility experimental control with listing like product (only containing sodium fusidate 500mg), be followed successively by 0h, 2h, 4h, 6h, 8h, 24h observing time, temperature is a room temperature, wherein content and determination of related substances adopt high-efficient liquid phase technique according to statutory standards, it is to record after dried frozen aquatic products adds the buffer redissolution that pH value is measured, the compatibility subjects is 0.9% sodium chloride injection of 250ml, 5% glucose injection of 250ml, the results are shown in Table 8.
Table 8 sodium fusidate freezing-dried powder injection of the present invention and listing like product compatibility experimental control table
The result shows that the similar fusidic acid sodium freeze dry that goes on the market no matter joins sodium chloride injection or glucose injection all becomes turbid rapidly, adds in glucose injection and insoluble floccule just occurs; And sodium fusidate freezing-dried powder injection compatibility result of the present invention is clarification.
Claims (2)
1, a kind of sodium fusidate freezing-dried powder injection is characterized in that, it is made up of following component (weight portion): sodium fusidate 500, glycine 120, arginine 180.
2, a kind of sodium fusidate freezing-dried powder injection is characterized in that, it is made up of following component (weight portion): sodium fusidate 125, glycine 70, arginine 85, mannitol 20.
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 |
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| Publication Number | Publication Date |
|---|---|
| CN101143133A CN101143133A (en) | 2008-03-19 |
| CN100566704C true CN100566704C (en) | 2009-12-09 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2007100502224A Active CN100566704C (en) | 2007-10-12 | 2007-10-12 | Sodium fusidate freezing-dried powder injection |
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Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP6072778B2 (en) * | 2011-05-23 | 2017-02-01 | シーイーエム—１０２ ファーマシューティカルズ，インコーポレイテッド | Compositions containing fusidic acid and packages therefor |
| 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 |
| 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 |
| 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 |
| CN111012747B (en) * | 2018-10-10 | 2022-11-25 | 四川海思科制药有限公司 | Sodium fusidate pharmaceutical composition for injection and preparation method thereof |
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| CN101143133A (en) | 2008-03-19 |
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Application publication date: 20080319 Assignee: CHENGDU TIANTAISHAN PHARMACEUTICAL Co.,Ltd. Assignor: LIAONING HAISCO PHARMACEUTICAL Co.,Ltd. Contract record no.: 2016510000027 Denomination of invention: Sodium fusidate freeze-dried powder injection and preparation method thereof Granted publication date: 20091209 License type: Common License Record date: 20161111 |
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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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