CN101822681A - Cefoxitin sodium drug combination - Google Patents
Cefoxitin sodium drug combination Download PDFInfo
- Publication number
- CN101822681A CN101822681A CN201010104298A CN201010104298A CN101822681A CN 101822681 A CN101822681 A CN 101822681A CN 201010104298 A CN201010104298 A CN 201010104298A CN 201010104298 A CN201010104298 A CN 201010104298A CN 101822681 A CN101822681 A CN 101822681A
- Authority
- CN
- China
- Prior art keywords
- medicine
- cefoxitin
- cefoxitin sodium
- sodium
- composition
- 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.)
- Pending
Links
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses a cefoxitin sodium drug combination, which consists of the following effective ingredients in part by weight: 1000 to 2000 parts of cefoxitin sodium, 100 to 200 parts of lidocaine, 50 to 120 parts of reduced glutathione and 80 to 120 parts of diammonium glycyrrhizinate. The drug combination cannot cause adverse reactions, and has a high curative effect, and moreover, the preparation method is simple and environment-friendly.
Description
Technical field
The present invention relates to a kind of cefoxitin sodium drug combination and preparation method thereof.
Background technology
Cefoxitin and cefoxitin sodium are the antimicrobial drugs of current clinical practice.Cefoxitin calls second generation cephalosporin to it traditionally.English name Cefoxitin.Its has a broad antifungal spectrum, antibacterial action is strong, does not orally absorb, and vein and administered intramuscular absorb good.
But, existing cefoxitin sodium injection is at room temperature preserved also unstable, and may produce following untoward reaction when using: drug allergy has harmful effect to gastrointestinal tract, liver, kidney, blood, nervous system etc., the drug fever reaction, intravenous drip pain and generation phlebitis etc.
Summary of the invention
In order to overcome the defective of the above-mentioned untoward reaction that existing cefoxitin or cefoxitin sodium exist in as the medicinal application process, improve the curative effect of medicine simultaneously, the invention provides a kind of cefoxitin sodium drug combination and preparation method thereof that is used for.
A kind of cefoxitin sodium drug combination provided by the invention comprises effective active ingredient of following portions by weight:
Cefoxitin sodium 1000～2000;
Lignocaine 100～200;
Reduced glutathion 50～120;
Diammonium glycyrrhizinate 80～200.
As further selection, above-mentioned cefoxitin sodium can replace by cefoxitin.
The present invention also provides a kind of preparation method of combinations thereof medicine, may further comprise the steps:
(1). get 50～200 times water for injection of described cefoxitin sodium weight, stir down, the cefoxitin sodium of described amount, lignocaine, reduced glutathion and diammonium glycyrrhizinate dissolving fully, make the solution of medicine respectively.
(2). the solution elder generation that step (1) obtains is through the membrane ultrafiltration of molecular cut off 8000D, get filtrate again through the membrane ultrafiltration of the molecular weight 2000D that dams, get filtrate, sodium hydrate aqueous solution liquid adjust pH to 8.0～9.0 with 8%, with the membrane filtration mistake of 0.22 μ m, obtain the medicinal liquid of composition of medicine.
(3). the content of cefoxitin sodium in the composition of medicine medicinal liquid that determination step (2) obtains.
(4). the medicinal liquid of described composition of medicine is made acceptable forms on the pharmaceutics:
According to the cefoxitin sodium dosage that pharmaceutics allows, the medicinal liquid of combinations thereof medicine is aseptic subpackaged in cillin bottle, and lyophilization makes in the lyophilized solid moisture according to a conventional method lyophilized solid be made lyophilized injection or spray again below 2%.
As further selection, cefoxitin sodium can replace by cefoxitin in the above-mentioned steps.
The present invention can reach following technique effect:
1. composition of medicine of the present invention has improved the antibacterial effect of cefoxitin sodium or cefoxitin medicine.
2. protect cefoxitin sodium or cefoxitin in manufacturing, storage, transportation, use, intravital oxidation and peroxidating with the antioxidant reduced glutathion, untoward reaction is alleviated greatly, and reduced glutathion have protection liver, kidney again not by the medicine detrimental effect;
3. lignocaine and diammonium glycyrrhizinate are the excipient of combination, the pain untoward reaction when lignocaine can alleviate intravenous drip again;
4. diammonium glycyrrhizinate is the cosolvent of cefoxitin sodium or cefoxitin, again can anti-cefoxitin sodium or the phlebitis that causes when intravenous drip of cefoxitin;
5. among the preparation technology of the present invention, remove pyrogen and the pyrogen segment of molecular weight, can alleviate the drug fever reaction of cefoxitin sodium or cefoxitin greatly greater than 2000D with the ultrafilter membrane continuous ultrafiltration of molecular cut off 8000D and molecular cut off 2000D;
6. the present invention is after ultrafiltration, adjust pH 8.0～9.0, and, remove sedimentary heavy metal ion and high volence metal ion again through the membrane filtration of 0.22 μ m, and degerming, make composition of medicine of the present invention more stable.
7. because the present invention has added antioxidant, depyrogenation, degerming at normal temperatures at normal temperatures, that avoids prior art adds the active carbon high-temp depyrogenation, avoid heavy metal ion that activated carbon process is brought into and active carbon fine particle in medicinal liquid, the present invention can thoroughly remove heavy metal ion in the medicinal liquid, pyrogen and mushroom, medicine quality height, steady quality;
8. preparation method energy-conserving and environment-protective of the present invention.
The specific embodiment
The invention will be further described below in conjunction with specific embodiment, can be implemented so that those skilled in the art can better understand the present invention also, but illustrated embodiment is not as a limitation of the invention.
Embodiment 1
The cefoxitin sodium drug combination that present embodiment provides comprises effective active ingredient of following portions by weight:
Cefoxitin sodium 1000;
Lignocaine 100;
Reduced glutathion 50;
Diammonium glycyrrhizinate 80.
Above-mentioned cefoxitin sodium can replace by cefoxitin.
The preparation method of combinations thereof medicine comprises the steps:
(1). get 50～200 times water for injection of described cefoxitin sodium weight, stir down, the cefoxitin sodium of described amount, lignocaine, reduced glutathion and diammonium glycyrrhizinate dissolving fully, make the solution of medicine respectively.
In manufacturing, storage, transportation, use, intravital oxidation and peroxidating, untoward reaction is alleviated with antioxidant reduced glutathion protection cefoxitin sodium greatly, and reduced glutathion have protection liver, kidney again not by the medicine detrimental effect; Lignocaine and diammonium glycyrrhizinate are the excipient of combination, the pain untoward reaction when lignocaine can alleviate intravenous drip again; Diammonium glycyrrhizinate is the phlebitis that the cosolvent of cefoxitin sodium again can anti-cefoxitin causes when intravenous drip.
(2). the solution elder generation that step (1) obtains is through the membrane ultrafiltration of molecular cut off 8000D, get filtrate again through the membrane ultrafiltration of the molecular weight 2000D that dams, get filtrate, sodium hydrate aqueous solution liquid adjust pH to 8.0～9.0 with 8%, with the membrane filtration mistake of 0.22 μ m, obtain the medicinal liquid of composition of medicine.
Remove pyrogen and the pyrogen segment of molecular weight with the ultrafilter membrane continuous ultrafiltration of molecular cut off 8000D and molecular cut off 2000D, can alleviate the drug fever reaction of cefoxitin sodium greatly greater than 2000D; After ultrafiltration, adjust pH 8.0～9.0, and, remove sedimentary heavy metal ion and high volence metal ion again through the membrane filtration of 0.22 μ m, and degerming, make composition of medicine more stable.
(3). cefoxitin sodium content in the composition of medicine medicinal liquid that determination step (2) obtains.
(4). the medicinal liquid of described composition of medicine is made acceptable forms on the pharmaceutics:
According to the cefoxitin sodium dosage that pharmaceutics allows, the medicinal liquid of combinations thereof medicine is aseptic subpackaged in cillin bottle, and lyophilization makes in the lyophilized solid moisture according to a conventional method lyophilized solid be made lyophilized injection or spray again below 2%.
Cefoxitin sodium can replace by cefoxitin in the above-mentioned steps.
Stability test:
At room temperature, medicine was deposited 360 days, measured the wherein content of cefoxitin sodium, calculate the content reduction rate.
The pharmacodynamics demonstration test:
(1) animal is selected: select the mice by the infection animal experimental model of Experimental Animal Center preparation, body weight 18～22g, male and female half and half, random packet, 10 of every treated animals.
(2) infection bacteria species: staphylococcus aureus causes the model mice of pneumonia, four groups of model mice, Ke Shi pneumobacillus, hemophilus influenza that streptococcus pneumoniae causes pneumonia.
(3) infection dosage: measure 100% minimum lethal dose (100%MLD) of the bacterial strain that tries by Experimental Animal Center, as infection dosage.
(4) route of infection: bacterium stock solution is diluted to desired concn (Experimental Animal Center is determined) with 5% gastric Mucin, through tail vein injection.
(5) test method: with the mice branch: the A. staphylococcus aureus causes the model mice group of pneumonia, model mice group, C. Ke Shi pneumobacillus group, four groups of D. hemophilus influenza group that the B. streptococcus pneumoniae causes pneumonia.Carry out the cefoxitin for inj contrast of not administration contrast, prior art for preparing, medicine of the present invention contrast.10 of every group model animals.Quiet immediately notes administration after the infection is later on every administration in 6 hours.Note observing reaction of animals, continuous 7 days, record dead mouse number.
The result of the test contrast:
| Project | A strain infected group mortality rate % | B strain infected group mortality rate % | C strain infected group mortality rate % | D strain infected group mortality rate % | Drug fever response rate % | Stomach and liver untoward reaction rate % | Content rate of descent % |
| Drug treatment not | ??100 | ??100 | ??100 | ??100 | ??-- | ??-- | ??-- |
| The administration of 20mg/kg cefoxitin sodium for injection | ??50 | ??60 | ??60 | ??40 | ??20 | ??10 | ??30 |
| 20mg/kg composition of medicine administration of the present invention | ??20 | ??30 | ??20 | ??10 | ??0 | ??0 | ??10 |
Embodiment 2
The cefoxitin sodium drug combination that present embodiment provides comprises effective active ingredient of following portions by weight:
Cefoxitin sodium 2000;
Lignocaine 100;
Reduced glutathion 120;
Diammonium glycyrrhizinate 200.
Above-mentioned cefoxitin sodium can replace by cefoxitin.
The preparation method of combinations thereof medicine comprises the steps:
(1). get 50～200 times water for injection of described cefoxitin sodium weight, stir down, the cefoxitin sodium of described amount, lignocaine, reduced glutathion and diammonium glycyrrhizinate dissolving fully, make the solution of medicine respectively.
In manufacturing, storage, transportation, use, intravital oxidation and peroxidating, untoward reaction is alleviated with antioxidant reduced glutathion protection cefoxitin sodium greatly, and reduced glutathion have protection liver, kidney again not by the medicine detrimental effect; Lignocaine and diammonium glycyrrhizinate are the excipient of combination, the pain untoward reaction when lignocaine can alleviate intravenous drip again; Diammonium glycyrrhizinate is the phlebitis that the cosolvent of cefoxitin sodium again can anti-cefoxitin sodium causes when intravenous drip.
(2). the solution elder generation that step (1) obtains is through the membrane ultrafiltration of molecular cut off 8000D, get filtrate again through the membrane ultrafiltration of the molecular weight 2000D that dams, get filtrate, sodium hydrate aqueous solution liquid adjust pH to 8.0～9.0 with 8%, with the membrane filtration mistake of 0.22 μ m, obtain the medicinal liquid of composition of medicine.
Remove pyrogen and the pyrogen segment of molecular weight with the ultrafilter membrane continuous ultrafiltration of molecular cut off 8000D and molecular cut off 2000D, can alleviate the drug fever reaction of cefoxitin greatly greater than 2000D; After ultrafiltration, adjust pH 8.0～9.0, and, remove sedimentary heavy metal ion and high volence metal ion again through the membrane filtration of 0.22 μ m, and degerming, make composition of medicine more stable.
(3). cefoxitin sodium content in the composition of medicine medicinal liquid that determination step (2) obtains.
(4). the medicinal liquid of described composition of medicine is made acceptable forms on the pharmaceutics:
According to the cefoxitin sodium dosage that pharmaceutics allows, the medicinal liquid of combinations thereof medicine is aseptic subpackaged in cillin bottle, and lyophilization makes in the lyophilized solid moisture according to a conventional method lyophilized solid be made lyophilized injection or spray again below 2%.
Can replace by cefoxitin in the above-mentioned cefoxitin sodium step.
Stability test:
At room temperature, medicine was deposited 360 days, measured the wherein content of cefoxitin, calculate the content reduction rate.
The pharmacodynamics demonstration test:
(1) animal is selected: select the mice by the infection animal experimental model of Experimental Animal Center preparation, body weight 18～22g, male and female half and half, random packet, 10 of every treated animals.
(2) infection bacteria species: staphylococcus aureus causes the model mice of pneumonia, four groups of model mice, Ke Shi pneumobacillus, hemophilus influenza that streptococcus pneumoniae causes pneumonia.
(3) infection dosage: measure 100% minimum lethal dose (100%MLD) of the bacterial strain that tries by Experimental Animal Center, as infection dosage.
(4) route of infection: bacterium stock solution is diluted to desired concn (Experimental Animal Center is determined) with 5% gastric Mucin, through tail vein injection.
(5) test method: with the mice branch: the A. staphylococcus aureus causes the model mice group of pneumonia, model mice group, C. Ke Shi pneumobacillus group, four groups of D. hemophilus influenza group that the B. streptococcus pneumoniae causes pneumonia.Carry out the cefoxitin for inj contrast of not administration contrast, prior art for preparing, medicine of the present invention contrast.10 of every group model animals.Quiet immediately notes administration after the infection is later on every administration in 6 hours.Note observing reaction of animals, continuous 7 days, record dead mouse number.
The result of the test contrast:
| Project | A strain infected group mortality rate % | B strain infected group mortality rate % | C strain infected group mortality rate % | D strain infected group mortality rate % | Drug fever response rate % | Stomach and liver untoward reaction rate % | Content rate of descent % |
| Drug treatment not | ??100 | ??100 | ??100 | ??100 | ??-- | ??-- | ??-- |
| The administration of 20mg/kg cefoxitin sodium for injection | ??60 | ??60 | ??60 | ??50 | ??20 | ??30 | ??10 |
| 20mg/kg composition of medicine administration of the present invention | ??20 | ??30 | ??20 | ??10 | ??0 | ??10 | ??0 |
Embodiment 3
The cefoxitin sodium drug combination that present embodiment provides comprises effective active ingredient of following portions by weight:
Cefoxitin sodium 1550;
Lignocaine 135;
Reduced glutathion 90;
Diammonium glycyrrhizinate 173.
Above-mentioned cefoxitin sodium can replace by cefoxitin.
The preparation method of combinations thereof medicine comprises the steps:
(1). get 50～200 times water for injection of described cefoxitin sodium weight, stir down, respectively the cefoxitin sodium of described amount or its pharmaceutically acceptable salt, lignocaine, reduced glutathion and diammonium glycyrrhizinate are dissolved fully, make the solution of medicine.
In manufacturing, storage, transportation, use, intravital oxidation and peroxidating, untoward reaction is alleviated with antioxidant reduced glutathion protection cefoxitin sodium greatly, and reduced glutathion have protection liver, kidney again not by the medicine detrimental effect; Lignocaine and diammonium glycyrrhizinate are the excipient of combination, the pain untoward reaction when lignocaine can alleviate intravenous drip again; Diammonium glycyrrhizinate is the phlebitis that the cosolvent of cefoxitin sodium again can anti-cefoxitin causes when intravenous drip.
(2). the solution elder generation that step (1) obtains is through the membrane ultrafiltration of molecular cut off 8000D, get filtrate again through the membrane ultrafiltration of the molecular weight 2000D that dams, get filtrate, sodium hydrate aqueous solution liquid adjust pH to 8.0～9.0 with 8%, with the membrane filtration mistake of 0.22 μ m, obtain the medicinal liquid of composition of medicine.
Remove pyrogen and the pyrogen segment of molecular weight with the ultrafilter membrane continuous ultrafiltration of molecular cut off 8000D and molecular cut off 2000D, can alleviate the drug fever reaction of cefoxitin greatly greater than 2000D; After ultrafiltration, adjust pH 8.0～9.0, and, remove sedimentary heavy metal ion and high volence metal ion again through the membrane filtration of 0.22 μ m, and degerming, make composition of medicine more stable.
(3). cefoxitin sodium content in the composition of medicine medicinal liquid that determination step (2) obtains.
(4). the medicinal liquid of described composition of medicine is made acceptable forms on the pharmaceutics:
According to the cefoxitin sodium dosage that pharmaceutics allows, the medicinal liquid of combinations thereof medicine is aseptic subpackaged in cillin bottle, and lyophilization makes in the lyophilized solid moisture according to a conventional method lyophilized solid be made lyophilized injection or spray again below 2%.
Cefoxitin sodium can replace by cefoxitin in the above-mentioned steps.
Stability test:
At room temperature, medicine was deposited 360 days, measured the content of cefoxitin sodium wherein or cefoxitin, calculate the content reduction rate.
The pharmacodynamics demonstration test:
(1) animal is selected: select the mice by the infection animal experimental model of Experimental Animal Center preparation, body weight 18～22g, male and female half and half, random packet, 10 of every treated animals.
(2) infection bacteria species: staphylococcus aureus causes the model mice of pneumonia, four groups of model mice, Ke Shi pneumobacillus, hemophilus influenza that streptococcus pneumoniae causes pneumonia.
(3) infection dosage: measure 100% minimum lethal dose (100%MLD) of the bacterial strain that tries by Experimental Animal Center, as infection dosage.
(4) route of infection: bacterium stock solution is diluted to desired concn (Experimental Animal Center is determined) with 5% gastric Mucin, through tail vein injection.
(5) test method: with the mice branch: the A. staphylococcus aureus causes the model mice group of pneumonia, model mice group, C. Ke Shi pneumobacillus group, four groups of D. hemophilus influenza group that the B. streptococcus pneumoniae causes pneumonia.Carry out the cefoxitin for inj contrast of not administration contrast, prior art for preparing, medicine of the present invention contrast.10 of every group model animals.Quiet immediately notes administration after the infection is later on every administration in 6 hours.Note observing reaction of animals, continuous 7 days, record dead mouse number.
The result of the test contrast:
| Project | A strain infected group mortality rate % | B strain infected group mortality rate % | C strain infected group mortality rate % | D strain infected group mortality rate % | Drug fever response rate % | Stomach and liver untoward reaction rate % | Content rate of descent % |
| Drug treatment not | ??100 | ??100 | ??100 | ??100 | ??-- | ??-- | ??-- |
| The administration of 20mg/kg cefoxitin sodium for injection | ??50 | ??60 | ??60 | ??40 | ??20 | ??30 | ??10 |
| Project | A strain infected group mortality rate % | B strain infected group mortality rate % | C strain infected group mortality rate % | D strain infected group mortality rate % | Drug fever response rate % | Stomach and liver untoward reaction rate % | Content rate of descent % |
| 20mg/kg composition of medicine administration of the present invention | ??20 | ??30 | ??20 | ??10 | ??0 | ??10 | ??0 |
Embodiment 4
The cefoxitin sodium drug combination that present embodiment provides comprises effective active ingredient of following portions by weight:
Cefoxitin sodium 2000;
Lignocaine 100;
Reduced glutathion 120;
Diammonium glycyrrhizinate 80.
Above-mentioned cefoxitin sodium can replace by cefoxitin.
The preparation method of combinations thereof medicine comprises the steps:
(1). get 50～200 times water for injection of described cefoxitin sodium weight, stir down, the cefoxitin sodium of described amount, lignocaine, reduced glutathion and diammonium glycyrrhizinate dissolving fully, make the solution of medicine respectively.
In manufacturing, storage, transportation, use, intravital oxidation and peroxidating, untoward reaction is alleviated with antioxidant reduced glutathion protection cefoxitin sodium greatly, and reduced glutathion have protection liver, kidney again not by the medicine detrimental effect; Lignocaine and diammonium glycyrrhizinate are the excipient of combination, the pain untoward reaction when lignocaine can alleviate intravenous drip again; Diammonium glycyrrhizinate is the phlebitis that the cosolvent of cefoxitin again can anti-cefoxitin causes when intravenous drip.
(2). the solution elder generation that step (1) obtains is through the membrane ultrafiltration of molecular cut off 8000D, get filtrate again through the membrane ultrafiltration of the molecular weight 2000D that dams, get filtrate, sodium hydrate aqueous solution liquid adjust pH to 8.0～9.0 with 8%, with the membrane filtration mistake of 0.22 μ m, obtain the medicinal liquid of composition of medicine.
Remove pyrogen and the pyrogen segment of molecular weight with the ultrafilter membrane continuous ultrafiltration of molecular cut off 8000D and molecular cut off 2000D, can alleviate the drug fever reaction of cefoxitin sodium greatly greater than 2000D; After ultrafiltration, adjust pH 8.0～9.0, and, remove sedimentary heavy metal ion and high volence metal ion again through the membrane filtration of 0.22 μ m, and degerming, make composition of medicine more stable.
(3). cefoxitin sodium content in the composition of medicine medicinal liquid that determination step (2) obtains.
(4). the medicinal liquid of described composition of medicine is made acceptable forms on the pharmaceutics:
According to the cefoxitin sodium dosage that pharmaceutics allows, the medicinal liquid of combinations thereof medicine is aseptic subpackaged in cillin bottle, and lyophilization makes in the lyophilized solid moisture according to a conventional method lyophilized solid be made lyophilized injection or spray again below 2%.
Cefoxitin sodium can replace by cefoxitin in the above-mentioned steps.
Stability test:
At room temperature, medicine was deposited 360 days, measured the content of cefoxitin sodium wherein or cefoxitin, calculate the content reduction rate.
The pharmacodynamics demonstration test:
(1) animal is selected: select the mice by the infection animal experimental model of Experimental Animal Center preparation, body weight 18～22g, male and female half and half, random packet, 10 of every treated animals.
(2) infection bacteria species: staphylococcus aureus causes the model mice of pneumonia, four groups of model mice, Ke Shi pneumobacillus, hemophilus influenza that streptococcus pneumoniae causes pneumonia.
(3) infection dosage: measure 100% minimum lethal dose (100%MLD) of the bacterial strain that tries by Experimental Animal Center, as infection dosage.
(4) route of infection: bacterium stock solution is diluted to desired concn (Experimental Animal Center is determined) with 5% gastric Mucin, through tail vein injection.
(5) test method: with the mice branch: the A. staphylococcus aureus causes the model mice group of pneumonia, model mice group, C. Ke Shi pneumobacillus group, four groups of D. hemophilus influenza group that the B. streptococcus pneumoniae causes pneumonia.Carry out the cefoxitin for inj contrast of not administration contrast, prior art for preparing, medicine of the present invention contrast.10 of every group model animals.Quiet immediately notes administration after the infection is later on every administration in 6 hours.Note observing reaction of animals, continuous 7 days, record dead mouse number.
The result of the test contrast:
| Project | A strain infected group mortality rate % | B strain infected group mortality rate % | C strain infected group mortality rate % | D strain infected group mortality rate % | Drug fever response rate % | Stomach and liver untoward reaction rate % | Content rate of descent % |
| Drug treatment not | ??100 | ??100 | ??100 | ??100 | ??-- | ??-- | ??-- |
| The administration of 20mg/kg cefoxitin sodium for injection | ??50 | ??60 | ??60 | ??40 | ??20 | ??30 | ??10 |
| 20mg/kg composition of medicine administration of the present invention | ??20 | ??30 | ??20 | ??10 | ??0 | ??10 | ??0 |
Embodiment 5
The cefoxitin sodium drug combination that present embodiment provides comprises effective active ingredient of following portions by weight:
Cefoxitin sodium 1000;
Lignocaine 100;
Reduced glutathion 50;
Diammonium glycyrrhizinate 80.
Above-mentioned cefoxitin sodium can replace by cefoxitin.
The preparation method of combinations thereof medicine comprises the steps:
(1). get 50～200 times water for injection of described cefoxitin sodium weight, stir down, the cefoxitin sodium of described amount, lignocaine, reduced glutathion and diammonium glycyrrhizinate dissolving fully, make the solution of medicine respectively.
In manufacturing, storage, transportation, use, intravital oxidation and peroxidating, untoward reaction is alleviated with antioxidant reduced glutathion protection cefoxitin sodium greatly, and reduced glutathion have protection liver, kidney again not by the medicine detrimental effect; Lignocaine and diammonium glycyrrhizinate are the excipient of combination, the pain untoward reaction when lignocaine can alleviate intravenous drip again; Diammonium glycyrrhizinate is the phlebitis that the cosolvent of cefoxitin sodium again can anti-cefoxitin causes when intravenous drip.
(2). the solution elder generation that step (1) obtains is through the membrane ultrafiltration of molecular cut off 8000D, get filtrate again through the membrane ultrafiltration of the molecular weight 2000D that dams, get filtrate, sodium hydrate aqueous solution liquid adjust pH to 8.0～9.0 with 8%, with the membrane filtration mistake of 0.22 μ m, obtain the medicinal liquid of composition of medicine.
Remove pyrogen and the pyrogen segment of molecular weight with the ultrafilter membrane continuous ultrafiltration of molecular cut off 8000D and molecular cut off 2000D, can alleviate the drug fever reaction of cefoxitin sodium greatly greater than 2000D; After ultrafiltration, adjust pH 8.0～9.0, and, remove sedimentary heavy metal ion and high volence metal ion again through the membrane filtration of 0.22 μ m, and degerming, make composition of medicine more stable.
(3). cefoxitin sodium content in the composition of medicine medicinal liquid that determination step (2) obtains.
(4). the medicinal liquid of described composition of medicine is made acceptable forms on the pharmaceutics:
According to the cefoxitin sodium dosage that pharmaceutics allows, the medicinal liquid of combinations thereof medicine is aseptic subpackaged in cillin bottle, and lyophilization makes in the lyophilized solid moisture according to a conventional method lyophilized solid be made lyophilized injection or spray again below 2%.
Cefoxitin sodium can replace by cefoxitin in the above-mentioned steps.
Stability test:
At room temperature, medicine was deposited 360 days, measured the content of cefoxitin sodium wherein or cefoxitin, calculate the content reduction rate.
The pharmacodynamics demonstration test:
(1) animal is selected: select the mice by the infection animal experimental model of Experimental Animal Center preparation, body weight 18～22g, male and female half and half, random packet, 10 of every treated animals.
(2) infection bacteria species: staphylococcus aureus causes the model mice of pneumonia, four groups of model mice, Ke Shi pneumobacillus, hemophilus influenza that streptococcus pneumoniae causes pneumonia.
(3) infection dosage: measure 100% minimum lethal dose (100%MLD) of the bacterial strain that tries by Experimental Animal Center, as infection dosage.
(4) route of infection: bacterium stock solution is diluted to desired concn (Experimental Animal Center is determined) with 5% gastric Mucin, through tail vein injection.
(5) test method: with the mice branch: the A. staphylococcus aureus causes the model mice group of pneumonia, model mice group, C. Ke Shi pneumobacillus group, four groups of D. hemophilus influenza group that the B. streptococcus pneumoniae causes pneumonia.Carry out the cefoxitin for inj contrast of not administration contrast, prior art for preparing, medicine of the present invention contrast.10 of every group model animals.Quiet immediately notes administration after the infection is later on every administration in 6 hours.Note observing reaction of animals, continuous 7 days, record dead mouse number.
The result of the test contrast:
| Project | A strain infected group mortality rate % | B strain infected group mortality rate % | C strain infected group mortality rate % | D strain infected group mortality rate % | Drug fever response rate % | Stomach and liver untoward reaction rate % | Content rate of descent % |
| Drug treatment not | ??100 | ??100 | ??100 | ??100 | ??-- | ??-- | ??-- |
| The administration of 20mg/kg cefoxitin sodium for injection | ??50 | ??60 | ??60 | ??40 | ??20 | ??30 | ??10 |
| 20mg/kg composition of medicine administration of the present invention | ??20 | ??30 | ??20 | ??10 | ??0 | ??10 | ??0 |
The above embodiment is the preferred embodiment that proves absolutely that the present invention lifts, and protection scope of the present invention is not limited thereto.Being equal to that those skilled in the art are done on basis of the present invention substitutes or conversion, all within protection scope of the present invention.Protection scope of the present invention is as the criterion with claims.
Claims (5)
1. a cefoxitin sodium drug combination is characterized in that, comprises effective active ingredient of following portions by weight:
Cefoxitin sodium 1000～2000;
Lignocaine 100～200;
Reduced glutathion 50～120;
Diammonium glycyrrhizinate 80～200.
2. composition of medicine according to claim 1, described cefoxitin sodium can replace by cefoxitin.
3. the preparation method of the described composition of medicine of claim 1 is characterized in that, may further comprise the steps:
(1). get 50～200 times water for injection of described cefoxitin sodium weight, stir down, the cefoxitin sodium of described amount, lignocaine, reduced glutathion and diammonium glycyrrhizinate dissolving fully, make the solution of medicine respectively;
(2). the solution elder generation that step (1) obtains is through the membrane ultrafiltration of molecular cut off 8000D, get filtrate again through the membrane ultrafiltration of the molecular weight 2000D that dams, get filtrate, sodium hydrate aqueous solution liquid adjust pH to 8.0～9.0 with 8%, with the membrane filtration mistake of 0.22 μ m, obtain the medicinal liquid of composition of medicine;
(3). the content of cefoxitin sodium in the composition of medicine medicinal liquid that determination step (2) obtains;
(4). the medicinal liquid of described composition of medicine is made acceptable forms on the pharmaceutics.
4. preparation method according to claim 3 is characterized in that, acceptable forms is lyophilized injection or spray on the described pharmaceutics of step (4).
5. the preparation of the described composition of medicine of claim 1 is used for antimicrobial medicine.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201010104298A CN101822681A (en) | 2010-02-02 | 2010-02-02 | Cefoxitin sodium drug combination |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201010104298A CN101822681A (en) | 2010-02-02 | 2010-02-02 | Cefoxitin sodium drug combination |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101822681A true CN101822681A (en) | 2010-09-08 |
Family
ID=42686985
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201010104298A Pending CN101822681A (en) | 2010-02-02 | 2010-02-02 | Cefoxitin sodium drug combination |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN101822681A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102895182A (en) * | 2012-10-22 | 2013-01-30 | 四川制药制剂有限公司 | Method for preparing cefoxitin sodium for injection |
-
2010
- 2010-02-02 CN CN201010104298A patent/CN101822681A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102895182A (en) * | 2012-10-22 | 2013-01-30 | 四川制药制剂有限公司 | Method for preparing cefoxitin sodium for injection |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| EP1902712B1 (en) | Use of levo-ornidazole for preparing antiparasitic infection drug | |
| CN102008490B (en) | Compound florfenicol injection for animal | |
| JP2013523830A (en) | Methods of treatment with 3-bromopyruvate and other selective inhibitors of ATP production | |
| CN101822679B (en) | Cefepime hydrochloride combined medicament | |
| KR101667535B1 (en) | An anti-microbial peptide Scolopendrasin-6 isolated from the Scolopendra subspinipes mutilans and its synthetic peptide | |
| CN101822680B (en) | Cefpiramide drug combination | |
| CN103920137B (en) | A kind of pharmaceutical composition with the effect of anti-drug resistance gram-positive bacteria | |
| CN101874808A (en) | Azithromycin compound medicament | |
| CN101822681A (en) | Cefoxitin sodium drug combination | |
| CN101822686B (en) | Cefpirome sulfate combined drug | |
| CN107714678B (en) | Application of pterostilbene in preparation of MCR-1 enzyme inhibitor | |
| HU198472B (en) | Process for producing adduct comprising norfloxacin and pharmaceutical composition comprising such adduct | |
| CN101850104B (en) | Clindamycin hydrochloride composition medicine | |
| CN101850105B (en) | Cefuroxime sodium composite medicine | |
| EP3733176B1 (en) | Composition comprising piperacillin, pharmaceutical preparation thereof and use thereof | |
| CN101849948A (en) | Cefuroxime axetil composite medicine | |
| CN101822678B (en) | Cefamandole nafate combined drug | |
| CN114146082A (en) | Application of methylparaben and sodium salt thereof in resisting coronavirus | |
| CN101850103B (en) | Clindamycin phosphate composite medicine | |
| CN107875154A (en) | Composition containing Piperacillin, its pharmaceutical preparation and its application | |
| JPS6383022A (en) | Vetrinary remedy | |
| CN117264910B (en) | Phage resistant to Gao Wenan spectrum salmonella and clinical application thereof | |
| CN104971342A (en) | Pharmaceutical composition for resisting methicillin-resistant staphylococcus aureus (mrsa) | |
| CN113332328A (en) | Medicine for diseases of respiratory and endocrinology departments | |
| CN106673989A (en) | Pharmaceutical composition as well as preparation method and application thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| AD01 | Patent right deemed abandoned |
Effective date of abandoning: 20100908 |
|
| C20 | Patent right or utility model deemed to be abandoned or is abandoned |