CN1864666A - Lyophilized powder injection of levofloxacin mesylate and preparation method thereof - Google Patents
Lyophilized powder injection of levofloxacin mesylate and preparation method thereof Download PDFInfo
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- CN1864666A CN1864666A CN 200610019305 CN200610019305A CN1864666A CN 1864666 A CN1864666 A CN 1864666A CN 200610019305 CN200610019305 CN 200610019305 CN 200610019305 A CN200610019305 A CN 200610019305A CN 1864666 A CN1864666 A CN 1864666A
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- levofloxacin
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- glucose
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- 239000007924 injection Substances 0.000 title claims abstract description 49
- 238000002347 injection Methods 0.000 title claims abstract description 49
- ZSPLOATUDIRNAS-PPHPATTJSA-N levofloxacin mesylate Chemical compound CS(O)(=O)=O.C([C@@H](N1C2=C(C(C(C(O)=O)=C1)=O)C=C1F)C)OC2=C1N1CCN(C)CC1 ZSPLOATUDIRNAS-PPHPATTJSA-N 0.000 title claims abstract description 30
- 238000002360 preparation method Methods 0.000 title claims abstract description 18
- 239000008176 lyophilized powder Substances 0.000 title claims description 23
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 34
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims abstract description 28
- 239000000546 pharmaceutical excipient Substances 0.000 claims abstract description 26
- 238000001914 filtration Methods 0.000 claims abstract description 19
- 239000008215 water for injection Substances 0.000 claims abstract description 17
- 239000000843 powder Substances 0.000 claims abstract description 9
- 238000010438 heat treatment Methods 0.000 claims abstract description 7
- 229910052799 carbon Inorganic materials 0.000 claims abstract description 6
- 238000005406 washing Methods 0.000 claims abstract description 6
- 238000001816 cooling Methods 0.000 claims abstract description 3
- GSDSWSVVBLHKDQ-JTQLQIEISA-N Levofloxacin Chemical compound C([C@@H](N1C2=C(C(C(C(O)=O)=C1)=O)C=C1F)C)OC2=C1N1CCN(C)CC1 GSDSWSVVBLHKDQ-JTQLQIEISA-N 0.000 claims description 60
- 229960003376 levofloxacin Drugs 0.000 claims description 60
- 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 claims description 44
- 239000008103 glucose Substances 0.000 claims description 40
- 239000000243 solution Substances 0.000 claims description 23
- 239000000706 filtrate Substances 0.000 claims description 12
- 238000005262 decarbonization Methods 0.000 claims description 11
- 238000011082 depyrogenation Methods 0.000 claims description 5
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 4
- 238000005374 membrane filtration Methods 0.000 claims description 4
- 238000001291 vacuum drying Methods 0.000 claims description 4
- 239000002994 raw material Substances 0.000 claims description 2
- 125000002791 glucosyl group Chemical group C1([C@H](O)[C@@H](O)[C@H](O)[C@H](O1)CO)* 0.000 claims 1
- 238000004108 freeze drying Methods 0.000 abstract description 4
- 230000001105 regulatory effect Effects 0.000 abstract 3
- 238000001035 drying Methods 0.000 abstract 2
- 239000002510 pyrogen Substances 0.000 abstract 2
- 238000009835 boiling Methods 0.000 abstract 1
- 229940090044 injection Drugs 0.000 description 32
- 239000003978 infusion fluid Substances 0.000 description 9
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 8
- 239000007788 liquid Substances 0.000 description 8
- 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 7
- 229930195725 Mannitol Natural products 0.000 description 7
- 239000000594 mannitol Substances 0.000 description 7
- 235000010355 mannitol Nutrition 0.000 description 7
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 6
- 239000000126 substance Substances 0.000 description 6
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 5
- 239000012528 membrane Substances 0.000 description 5
- 238000012360 testing method Methods 0.000 description 4
- 239000011780 sodium chloride Substances 0.000 description 3
- DDRJAANPRJIHGJ-UHFFFAOYSA-N creatinine Chemical compound CN1CC(=O)NC1=N DDRJAANPRJIHGJ-UHFFFAOYSA-N 0.000 description 2
- 239000008121 dextrose Substances 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 230000005496 eutectics Effects 0.000 description 2
- 230000003203 everyday effect Effects 0.000 description 2
- 229940093181 glucose injection Drugs 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 238000001556 precipitation Methods 0.000 description 2
- 239000008354 sodium chloride injection Substances 0.000 description 2
- 238000010998 test method Methods 0.000 description 2
- 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 1
- GSDSWSVVBLHKDQ-UHFFFAOYSA-N 9-fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid Chemical compound FC1=CC(C(C(C(O)=O)=C2)=O)=C3N2C(C)COC3=C1N1CCN(C)CC1 GSDSWSVVBLHKDQ-UHFFFAOYSA-N 0.000 description 1
- AFVFQIVMOAPDHO-UHFFFAOYSA-N Methanesulfonic acid Chemical compound CS(O)(=O)=O AFVFQIVMOAPDHO-UHFFFAOYSA-N 0.000 description 1
- 241000589517 Pseudomonas aeruginosa Species 0.000 description 1
- 239000003708 ampul Substances 0.000 description 1
- 230000000844 anti-bacterial effect Effects 0.000 description 1
- 230000002924 anti-infective effect Effects 0.000 description 1
- 230000000845 anti-microbial effect Effects 0.000 description 1
- 229960005475 antiinfective agent Drugs 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000003115 biocidal effect Effects 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 229940109239 creatinine Drugs 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 229940124307 fluoroquinolone Drugs 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 238000005286 illumination Methods 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 238000001990 intravenous administration Methods 0.000 description 1
- 230000003907 kidney function Effects 0.000 description 1
- 238000011031 large-scale manufacturing process Methods 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 229960001699 ofloxacin Drugs 0.000 description 1
- 244000052769 pathogen Species 0.000 description 1
- 230000001717 pathogenic effect Effects 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- 210000003462 vein Anatomy 0.000 description 1
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The freeze dried levofloxacin mesilate powder for injection consists of levofloxacin mesilate as active component and pharmaceutically acceptable excipient. The preparation process of the freeze dried levofloxacin mesilate powder for injection includes the following steps: dissolving excipient in water for injection, regulating pH value to 3.8-4.0, adding injection purpose active carbon and boiling through steam heating, cooling and filtering to eliminating active carbon, adding levofloxacin mesilate, regulating pH value to 3.0-4.5, adding water for injection, eliminating pyrogen, filtering, washing, drying, and freeze drying to obtain the freeze dried levofloxacin mesilate powder for injection. Or, The preparation process includes the following steps: dissolving excipient and levofloxacin mesilate in water for injection, regulating pH value to 3.0-4.5, eliminating pyrogen, filtering, washing, drying, and freeze drying to obtain the freeze dried levofloxacin mesilate powder for injection. The present invention has high stability and use convenience.
Description
Technical field
The present invention relates to lyophilized powder injection of levofloxacin mesylate and preparation method thereof, belong to medical technical field.
Background technology
Levofloxacin M. S. A is the fluoroquinolones anti-infectives, its molecular formula: C
18H
20FN
3O
4CH
3SO
3HH
2O, molecular weight: 475.49 chemical structural formulas are:
Levofloxacin M. S. A is the mesylate of levofloxacin, and its clinical efficacy and levofloxacin are close, and its antimicrobial spectrum is identical with ofloxacin, but antibacterial action is strong 1 times, and toxicity is lower, and its clinical practice is wide, untoward reaction is little, is subjected to doctor and patient's welcome deeply.The Levofloxacin M. S. A water solublity is better, is fit to make ejection preparation.At present, there is the little pin and the infusion solutions listing of Levofloxacin M. S. A in market, but the Levofloxacin M. S. A aqueous stability is poor, meets auroral poles and easily decomposes variable color, and its little pin and infusion solutions all need keep in Dark Place.
Summary of the invention
The present invention provides a kind of lyophilized powder injection of levofloxacin mesylate and preparation method thereof at the problems referred to above exactly, and the obtained freeze-drying powder needle injection can improve stability of formulation with solid form storage transportation, extends the expiration date.The method technology that provides is simple, is suitable for large-scale production.
Technical scheme provided by the invention is: lyophilized powder injection of levofloxacin mesylate, form by active component Levofloxacin M. S. A and pharmaceutically-acceptable excipients.
Described excipient is selected from one or more in glucide, mannitol, the sodium chloride; Weight ratio between Levofloxacin M. S. A (in levofloxacin) and the excipient is 1: 1-20: 1.
The preferred glucose of excipient wherein.Weight ratio 1 between Levofloxacin M. S. A and the glucose: 1-10: 1.Weight ratio between Levofloxacin M. S. A and the glucose 5: 1.
The present invention also provides the preparation method of above-mentioned lyophilized powder injection of levofloxacin mesylate, getting excipient earlier is dissolved in the water for injection, make into the excipient solution of 50～70wt%, regulate pH to 3.8～4.0, add 0.3～1.0g needle-use activated carbon by the 100ml excipient solution, Steam Heating was boiled 30～120 minutes, cooling, and filtering decarbonization gets excipient filtrate; The Levofloxacin M. S. A raw material is added in the above-mentioned excipient filtrate, regulate pH to 3.0～4.5, adding the injection water is the Levofloxacin M. S. A solution of 10～20wt% to forming in levofloxacin concentration; Active carbon depyrogenation, membrane filtration degerming, absolute ethanol washing, vacuum drying, lyophilizing promptly get lyophilized powder injection of levofloxacin mesylate.
The present invention also can prepare as follows: excipient, Levofloxacin M. S. A are added the dissolving of injection water, regulate pH to 3.0～4.5, adding the injection water is the Levofloxacin M. S. A solution of 10～20wt% to forming in levofloxacin concentration; Active carbon depyrogenation, membrane filtration degerming, absolute ethanol washing, vacuum drying, lyophilizing promptly get lyophilized powder injection of levofloxacin mesylate.
When lyophilized powder injection of levofloxacin mesylate of the present invention uses, can add 5% glucose injection, 0.9% sodium chloride injection or 5% Dextrose and Sodium Chloride Inj. 100ml iv drip more earlier with after 5% glucose injection, 0.9% sodium chloride injection or 5% Dextrose and Sodium Chloride Inj., the 5～10ml dissolving.Lyophilized powder injection of levofloxacin mesylate of the present invention can supply intravenous drip, and the instillation time is every 100ml at least 60 minutes.This preparation should not mix quiet with bottle with other medicines, or carries out quiet in same radicular vein tube for transfusion.Recommended dose: adult 400mg every day (in levofloxacin), divide 1-2 time quiet.Severe infection patient and pathogen are to this product sensitivity chump (as bacillus pyocyaneus), and every day, maximal dose can increase to 600mg (in levofloxacin), divide 1-2 time quiet.The renal function person of going down determines dosage according to creatinine clearance rate.
Lyophilized powder injection of levofloxacin mesylate of the present invention has good stability, and characteristics easy to use have better stability than little pin and infusion solutions.
The specific embodiment
Further specify the present invention by the following examples, therefore do not limit the present invention in the described scope of embodiments.
Embodiment 1:
Get the 40g glucose and be dissolved in the water for injection (30 ℃), make into the glucose concentrated solution of 50wt%, regulate pH to 3.8～4.0 with 1mol/L hydrochloric acid, add the 0.3g needle-use activated carbon by 100ml glucose concentrated solution, Steam Heating was boiled 30 minutes, was chilled to 50 ℃, filtering decarbonization gets glucose filtrate.
With 200g (with C
18H
20FN
3O
4Meter) Levofloxacin M. S. A (C
18H
20FN
3O
4CH
3SO
3HH
2O) add in the glucose filtrate, add injection water to Levofloxacin M. S. A and dissolve, regulate pH to 3.5～4.5, add the injection water to 2000g; Add the 10g needle-use activated carbon, 60 ℃ were stirred filtering decarbonization 30 minutes; Through 0.22um filter membrane coarse filtration and fine straining.By 1000 bottles of fills, lyophilizing, tamponade, Zha Gai.
Embodiment 2:
Get the 60g glucose and be dissolved in the hot water for injection (60 ℃), make into the glucose concentrated solution of 60wt%, regulate pH to 3.8～4.0 with 1mol/L hydrochloric acid, add the 0.3g needle-use activated carbon by 100ml glucose concentrated solution, Steam Heating was boiled 30 minutes, was chilled to 50 ℃, filtering decarbonization gets glucose filtrate.
With 300g (with C
18H
20FN
3O
4Meter) Levofloxacin M. S. A (C
18H
20FN
3O
4CH
3SO
3HH
2O) add in the glucose filtrate, add injection water to Levofloxacin M. S. A and dissolve, regulate pH to 3.5～4.5, add the injection water to 3000g; Add the 15g needle-use activated carbon, 60 ℃ were stirred filtering decarbonization 30 minutes; Through 0.22um filter membrane coarse filtration and fine straining.By 1000 bottles of fills, lyophilizing, tamponade, Zha Gai.
Embodiment 3:
Get the 30g glucose and be dissolved in the hot water for injection (100 ℃), make into the glucose concentrated solution of 70wt%, regulate pH to 3.8～4.0 with 1mol/L hydrochloric acid, add the 0.3g needle-use activated carbon by 100ml glucose concentrated solution, Steam Heating was boiled 30 minutes, was chilled to 50 ℃, filtering decarbonization gets glucose filtrate.
With 300g (with C
18H
20FN
3O
4Meter) Levofloxacin M. S. A (C
18H
20FN
3O
4CH
3SO
3HH
2O) add in the glucose filtrate, add injection water to Levofloxacin M. S. A and dissolve, regulate pH to 3.5～4.5, add the injection water to 3000g; Add the 15g needle-use activated carbon, 60 ℃ were stirred filtering decarbonization 30 minutes; Through 0.22um filter membrane coarse filtration and fine straining.By 1000 bottles of fills, lyophilizing, tamponade, Zha Gai.
Embodiment 4:
A. preparating liquid: with 150g glucose, 300g Levofloxacin M. S. A (with C
18H
20FN
3O
4Meter) adds the dissolving of injection water, regulate pH to 3.0～4.5, add the injection water to 3000g.
B. depyrogenation: get the 15g needle-use activated carbon and add in the solution that step a makes, 60 ℃ were stirred filtering decarbonization 30 minutes.
C. degerming: the medicinal liquid that obtains through step b is through 0.22um filter membrane coarse filtration and fine straining.
D. fill: with the fill of 1000 bottles of control cillin bottles.
E. lyophilizing: under-20～-50 ℃, vacuum, carry out lyophilization.Tamponade, Zha Gai promptly get lyophilized powder injection of levofloxacin mesylate.
Embodiment 5:
1000 bottles of inventorys
Levofloxacin M. S. A (C
18H
20FN
3O
4CH
3SO
3HH
2O) 450g is (with C
18H
20FN
3O
4Meter)
Glucose 30g
Water for injection adds to 3000g
Get the 30g glucose and be dissolved in the hot water for injection (60 ℃), make into the glucose concentrated solution of 70wt%, regulate pH to 3.8～4.0 with 1mol/L hydrochloric acid, add the 1.0g needle-use activated carbon by 100ml glucose concentrated solution, Steam Heating was boiled 120 minutes, was chilled to 50 ℃, filtering decarbonization gets glucose filtrate.
With 450g (with C
18H
20FN
3O
4Meter) Levofloxacin M. S. A (C
18H
20FN
3O
4CH
3SO
3HH
2O) add in the glucose filtrate, add injection water to Levofloxacin M. S. A and dissolve, regulate pH to 3.5～4.5, add the injection water to 3000g; Add the 15g needle-use activated carbon, 60 ℃ were stirred filtering decarbonization 30 minutes; Through 0.22um filter membrane coarse filtration and fine straining.By 1000 bottles of fills, lyophilizing, tamponade, Zha Gai.
Embodiment 6:
1000 bottles of inventorys
Levofloxacin M. S. A (C
18H
20FN
3O
4CH
3SO
3HH
2O) 450g is (with C
18H
20FN
3O
4Meter)
Glucose 60g
Water for injection adds to 3000g
Preparation method is with embodiment 2.
Embodiment 7:
1000 bottles of inventorys
Levofloxacin M. S. A (C
18H
20FN
3O
4CH
3SO
3HH
2O) 450g is (with C
18H
20FN
3O
4Meter)
Glucose 150g
Water for injection adds to 3000g
Preparation method is with embodiment 2.
Embodiment 8:
1000 bottles of inventorys
Levofloxacin M. S. A (C
18H
20FN
3O
4CH
3SO
3HH
2O) 600g is (with C
18H
20FN
3O
4Meter)
Glucose 30g
Water for injection adds to 3000g
Preparation method is with embodiment 2.
Embodiment 9:
1000 bottles of inventorys
Levofloxacin M. S. A (C
18H
20FN
3O
4CH
3SO
3HH
2O) 600g is (with C
18H
20FN
3O
4Meter)
Glucose 600g
Water for injection adds to 3000g
Preparation method is with embodiment 2.
Embodiment 10:
1000 bottles of inventorys
Levofloxacin M. S. A (C
18H
20FN
3O
4CH
3SO
3HH
2O) 600g is (with C
18H
20FN
3O
4Meter)
Glucose 150g
Water for injection adds to 3000g
Preparation method is with embodiment 2.
The present invention illustrates beneficial effect of the present invention by following test:
A. the comparison of excipient
1. test objective:
Mannitol, glucose are lyophilizing pin excipient commonly used, and the eutectic point of mannitol is-1.0 ℃, and the eutectic point of glucose is-3 ℃, respectively with mannitol, glucose and Levofloxacin M. S. A compatibility, investigate compatibility stability.
2. test method
Mannitol is mixed with 20% solution, adds Levofloxacin M. S. A, make into 0.5g/L, placed 7 days under-5 ℃ of conditions.
In addition glucose is mixed with 20% solution, adds Levofloxacin M. S. A, make into 0.5g/L, placed 7 days under-5 ℃ of conditions.
3. result of the test
Produce precipitation behind 20% mannitol solution and the Levofloxacin M. S. A compatibility.Still be settled solution behind glucose solution and the Levofloxacin M. S. A compatibility, do not produce precipitation.
4. conclusion
There are not obvious incompatibility in glucose and Levofloxacin M. S. A between the two, and glucose more is applicable in the lyophilized powder injection of levofloxacin mesylate prescription than mannitol as excipient.
B. lyophilized powder injection of levofloxacin mesylate, the little pin of Levofloxacin M. S. A, Levofloxacin M. S. A infusion solutions stability are relatively
1. sample: lyophilized powder injection of levofloxacin mesylate, lot number: 030609, specification: 0.2g, control antibiotic glass bottle dress, Hubei KeYi Pharmacentic Co., Ltd. produces.
The little pin of Levofloxacin M. S. A, lot number: 031030470, specification: 2ml:0.2g, colourless ampoule is bottled, and He'nan Tianfang Pharmaceutical Co., Ltd produces.
The Levofloxacin M. S. A infusion solutions, lot number: 0310152, specification: 100ml:0.2g, colourless transfusion bottle, the Beijing Double-Crane Pharmaceutical Co., Ltd produces.
2. experimental condition:
Light: illumination 4500 ± 5001x, sample put in 4500 ± 5001x light cupboard.
3. test method: sample was placed experimental condition following ten days, investigate, its result comparison during with 0 day in sampling in 5,10 days.
4. result of the test the results are shown in Table 1.
Table 1 stability test result
| The sample title | Freezing-dried powder injection | Little pin | Infusion solutions | |
| 0 day | Character indicates content (%) related substance (%) | Off-white color, block 101.1 0.09 | Yellow green clear liquid 101.6 0.13 | Yellow green clear liquid 102.2 0.11 |
| 5 days | Outward appearance indicates content (%) related substance (%) | Off-white color, block 99.83 0.31 | Yellow clear liquid 99.20 0.51 | Yellow green clear liquid 101.0 0.45 |
| 10 days | Outward appearance indicates content (%) related substance (%) | Off-white color, block 99.47 0.35 | Yellow clear liquid 99.85 0.83 | Yellow clear liquid 100.9 0.81 |
Lyophilized powder injection of levofloxacin mesylate, little pin, infusion solutions under the 45001x condition 10 days, content there is no significant change, but related substance all increases, and the lyophilized powder injection of levofloxacin mesylate related substance increases less than Levofloxacin M. S. A infusion solutions and the little pin of Levofloxacin M. S. A.
5. conclusion
Lyophilized powder injection of levofloxacin mesylate has better stability than its little pin and infusion solutions.
Claims (7)
1. lyophilized powder injection of levofloxacin mesylate is made up of active component Levofloxacin M. S. A and pharmaceutically-acceptable excipients.
2. according to the described freezing-dried powder injection of claim 1, it is characterized in that: described excipient is a glucose; In levofloxacin, the weight ratio between Levofloxacin M. S. A and the excipient is 1: 1-20: 1.
3. according to the described freezing-dried powder injection of claim 2, it is characterized in that: in levofloxacin, the weight ratio 1 between Levofloxacin M. S. A and the glucose: 1-10: 1.
4. according to the described freezing-dried powder injection of claim 2, it is characterized in that: in levofloxacin, the weight ratio between Levofloxacin M. S. A and the glucose 5: 1.
5. the preparation method of claim 1 or 2 described lyophilized powder injection of levofloxacin mesylate, it is characterized in that: get excipient earlier and be dissolved in the water for injection, make into the excipient solution of 50～70wt%, regulate pH to 3.8～4.0, add 0.3～1.0g needle-use activated carbon by the 100ml excipient solution, Steam Heating was boiled 30～120 minutes, cooling, and filtering decarbonization gets excipient filtrate; The Levofloxacin M. S. A raw material is added in the above-mentioned excipient filtrate, regulate pH to 3.0～4.5, adding the injection water is the Levofloxacin M. S. A solution of 10～20wt% to forming in levofloxacin concentration; Active carbon depyrogenation, membrane filtration degerming, absolute ethanol washing, vacuum drying, lyophilizing promptly get lyophilized powder injection of levofloxacin mesylate.
6. preparation method according to claim 5 is characterized in that: the used water for injection of preparation excipient solution is 30 ℃～100 ℃ water for injection.
7. the preparation method of claim 1 or 2 described lyophilized powder injection of levofloxacin mesylate, it is characterized in that: excipient, Levofloxacin M. S. A are added the dissolving of injection water, regulate pH to 3.0～4.5, adding the injection water is the Levofloxacin M. S. A solution of 10～20wt% to forming in levofloxacin concentration; Active carbon depyrogenation, membrane filtration degerming, absolute ethanol washing, vacuum drying, lyophilizing promptly get lyophilized powder injection of levofloxacin mesylate.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102018678A (en) * | 2010-12-20 | 2011-04-20 | 蚌埠丰原涂山制药有限公司 | Preparation method of antofloxacin hydrochloride powder injection |
| CN101991546B (en) * | 2009-08-21 | 2012-02-22 | 华北制药集团制剂有限公司 | Methanesulfonic acid levofloxacin freeze-dried powder injection and preparation method thereof |
| CN105232480A (en) * | 2015-11-27 | 2016-01-13 | 湖南科伦制药有限公司 | Preparation method of ofloxacin freeze-dried powder injection |
| CN106491529A (en) * | 2016-12-08 | 2017-03-15 | 广东彼迪药业有限公司 | A kind of levofloxacin hydrochloride sodium chloride injection and preparation method thereof |
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2006
- 2006-06-09 CN CN 200610019305 patent/CN1864666A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101991546B (en) * | 2009-08-21 | 2012-02-22 | 华北制药集团制剂有限公司 | Methanesulfonic acid levofloxacin freeze-dried powder injection and preparation method thereof |
| CN102018678A (en) * | 2010-12-20 | 2011-04-20 | 蚌埠丰原涂山制药有限公司 | Preparation method of antofloxacin hydrochloride powder injection |
| CN105232480A (en) * | 2015-11-27 | 2016-01-13 | 湖南科伦制药有限公司 | Preparation method of ofloxacin freeze-dried powder injection |
| CN105232480B (en) * | 2015-11-27 | 2019-02-19 | 湖南科伦制药有限公司 | A kind of preparation method of Ofloxacin freeze drying powder injection |
| CN106491529A (en) * | 2016-12-08 | 2017-03-15 | 广东彼迪药业有限公司 | A kind of levofloxacin hydrochloride sodium chloride injection and preparation method thereof |
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