CN1843354A - Injectable pharmaceutical composition containing faropenem - Google Patents
Injectable pharmaceutical composition containing faropenem Download PDFInfo
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- CN1843354A CN1843354A CN 200610043933 CN200610043933A CN1843354A CN 1843354 A CN1843354 A CN 1843354A CN 200610043933 CN200610043933 CN 200610043933 CN 200610043933 A CN200610043933 A CN 200610043933A CN 1843354 A CN1843354 A CN 1843354A
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- pharmaceutical composition
- faropenem
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Abstract
Disclosed is an antibiotic medicament of faropenem, which is a broad-spectrum antimicrobial capable of repressing Staphylococcus aureus, streptococcus and gram-negative bacteria including Bacillus influenzae, N.gonorrhoeae, especially for anaerobic bacteria.
Description
Affiliated technical field
The invention belongs to the medicine new technique, be characterized in a kind of efficient broad-spectrum antibacterial combination, the infection effect that specially refers to it will significantly be better than oral administration.
Background technology
Faropenem is an atypia beta-lactam antibiotic that both can supply oral also injectable to use, and belongs to the derivant of penems.Carbapenems and penems two big compounds have attracted the great interest of people, and penems more has unique advantage, and existing five malicious vinyl derivatives of green grass or young crops are among exploitation, and faropenem is one of them.Except that more weak to the inhibition bacillus pyocyaneus, its has a broad antifungal spectrum, effective especially to anaerobe surpasses carbapenem antibiotic.
Faropenem sodium is the exploitation of Japanese Suntory company, patents in Japan in 1986.Nineteen ninety and 1992 Japanese Yamanouchi drugmaker and U.S. Wyeth-Ayerst company obtain the clinical licence of these product respectively, carry out its clinical research jointly.And at first got permission listing in Japan in 1997, commodity are called Farom.
This product can suppress staphylococcus, streptococcus and a lot of gram negative bacteria, comprises hemophilus influenza, gonococcus, blue mucositis cloth Chinese Salmonella, and very strong biological activity is arranged.It is effective especially to anaerobe, and its external antibacterial action compares research with a lot of antibiotic, as cefteram, cefixime, cefaclor, amoxicillin, cefotaxime, Zinacef, clindamycin, imipenum, cefpodoxime, ciprofloxacin, Piperacil, Amoxicillin/potassium Clavulanat, metronidazole, tobramycin, vancomycin etc., it is all stronger than the antibiotic that participates in test that it suppresses the anaerobe effect, and up to the present, it is the strongest antibiotic of anaerobe resistant.In addition, it to staphylococcus, streptococcus pneumoniae, streptococcus and a lot of gram negative bacteria than cefteram, cefixime, cefaclor, the amoxicillin is effective, than the strong 5-10 of third generation cephalosporin doubly.
This product is 0.78 μ g/ml to the MIC of clinical isolating all strains, and it is more much effective than erythromycin, clarithromycin, Roxithromycin, ofloxacin to Campylobacter; It suppresses streptococcus, clostridium difficile is very effective, MIC90≤1 μ g/ml; To bacteroides fragilis MIC90≤4 μ g/ml.The influence of antibacterial action unable to take food thing, this product has bactericidal action.Stable to various beta-lactamase, also very stable to kidney peptidase (DHP-1).Medicine is higher for injection back this product concentration in serum and interstitial fluid, in vivo it by carrier mediated transmission system by little intestinal absorption.
Summary of the invention
We are at self physics and chemistry characteristic of logical faropenem, carried out galenic pharmacy research, we have carried out experiment repeatedly and have finally selected water for injection in the selection of solvent for injection and adjuvant, ethanol, glycerol, propylene glycol, Polyethylene Glycol, dimethyl acetylamide (DMA), pyrosulfite, thiourea, ascorbic acid, proglumide, cysteine, thioglycerol, disodium edetate, methyl hydroxybenzoate, propylparaben, benzoic acid, chlorobutanol, bromo geramine, hyamine 1622, chlorocresol, cresol, phenol, phenylmercuric acetate, thimerosal, wherein one or more of phenethanol have been prepared the faropenem injection.
The present invention has following feature through a large amount of pharmacological testing proofs: (1) antimicrobial spectrum is wider, and antibacterial activity is strong, and aerobe and anaerobe are had good antibacterial action; (2) antibacterial to resting state also has killing action; (3) highly stable to beta-lactamase, and inhibitory action is arranged; Extended spectrum (ESBL) is produced beta-lactamase height generation bacterium such as bacterium, citrobacter genus, Enterobacter good antibacterial action is also arranged.And better curative effect is arranged at following disease; (1) pustular acne, acne agminata, furuncle, furuncle and phyma disease, carbuncle, infective pustule, erysipelas, cellulitis, lymphangitis, panaris, pyogenic paronychia, subcutaneous abscess, hidradenitis, the swollen cyst sebaceous cyst of infectious skin, chronic pyodermia; (2) mastitis, perianal abscess, wound, scald, operation wound (shallow-layer) superinfection; (3) laryngitis, acute bronchitis, tonsil, pneumonia, pulmonary suppuration; (4) pyelonephritis, cystitis, prostatitis, epididymitis; (5) adnexitis, intrauterine infection, bartholinitis; (6) periodontal tissue's inflammation, pericoronitis, ganathitis; (7) blepharitis, hordeolum, dacryocystisis, meibomitis, corneal ulcer; (8) external otitis, otitis media, sinusitis.
Find by zoopery, the infection effect of faropenem drug administration by injection significantly is better than oral administration, and prior art thinks that this product is a beta-Lactam antibiotic that both can supply oral also injectable to use, medicine is verified for research, faropenem can be by carrier mediated transmission system by little intestinal absorption in vivo, and faropenem is by drug administration by injection and do not have significant difference by oral administration on pharmacodynamics.And our pharmacodynamic experiment by has repeatedly confirmed that the infection effect of faropenem drug administration by injection will significantly be better than oral administration.
The present invention receives the form of salt and hydrate with faropenem to be present in the pharmaceutical composition, and it has very high stability.
The specific embodiment
Embodiment 1
The faropenem injection
Faropenem sodium 55g
Sodium pyrosulfite 1.0g
Methyl hydroxybenzoate 1.5g
Water for injection adds to 1000ml
Preparation technology:
80% water for injection that adds amount of preparation in the preparation container adds the Faropenem sodium of recipe quantity then, pyrosulfite, and methyl hydroxybenzoate stirs and makes its dissolving, and hydrochloric acid is regulated pH value 5 ~ 6, adds an amount of needle-use activated carbon, stirs, and circulation was taken off charcoal 20 minutes.Add water to full dose, be filtered to clear and bright.Embedding under carbon dioxide or nitrogen current, the sterilization in 15 minutes of 100 ℃ of flowing steams, promptly.
Embodiment 2
The faropenem injection
Faropenem sodium 55g
Sodium sulfite 1.0g
Propylparaben 1.5g
Water for injection adds to 1000ml
Preparation technology:
80% water for injection that in the preparation container, adds amount of preparation, addition method faropenem then, sodium sulfite, propylparaben stirs and makes its dissolving, and sodium bicarbonate is regulated pH value 5 ~ 6, adds an amount of needle-use activated carbon, stirs, and circulation was taken off charcoal 20 minutes.Add water to full dose, be filtered to clear and bright.Embedding under carbon dioxide or nitrogen current, the sterilization in 15 minutes of 100 ℃ of flowing steams, promptly.
Embodiment 3
The faropenem injection
Faropenem sodium 55g
Ascorbic acid 1.0g
Disodium edetate 0.2g
Benzoic acid 10g
Water for injection adds to 1000ml
Preparation technology:
Earlier with a spot of water dissolution disodium edetate and ascorbic acid, 80% water for injection that in the preparation container, adds amount of preparation, addition method faropenem then, benzoic acid, stir and make its dissolving, add disodium edetate solution and ascorbic acid solution, regulate pH value 5 ~ 6, add an amount of needle-use activated carbon, stir, circulation was taken off charcoal 20 minutes, added water to full dose, was filtered to clear and bright.Embedding under carbon dioxide or nitrogen current, the sterilization in 15 minutes of 100 ℃ of flowing steams, promptly.
Embodiment 4
The faropenem long-acting injection
Faropenem sodium 55g
Ethanol 100ml
Propylene glycol 300
Glycerol 200ml
Cysteine 1g
Disodium edetate 0.2g
Water for injection adds to 1000ml
Preparation technology:
Earlier with a spot of water dissolution disodium edetate and cysteine, in the preparation container, add a spot of water for injection, addition method faropenem stirring and dissolving, add ethanol, glycerol, propylene glycol successively, add disodium edetate and the cysteine solution for preparing in advance then, stir, regulate pH value 5 ~ 6, add water to full dose, be filtered to clear and bright.Embedding under carbon dioxide or nitrogen current, the sterilization in 15 minutes of 100 ℃ of flowing steams, promptly.
Embodiment 5
The faropenem long-acting injection
Faropenem sodium 55g
Ethanol 100ml
Propylene glycol 400ml
Thiourea 1g
Chlorobutanol 1.5g
Disodium edetate 0.2g
Water for injection adds to 1000ml
Preparation technology:
Earlier with a spot of water dissolution disodium edetate and thiourea, 80% water for injection that in the preparation container, adds amount of preparation, addition method faropenem stirring and dissolving, ethanol, propylene glycol add disodium edetate and the thiourea for preparing in advance then successively, add chlorobutanol at last, stir, regulate pH value 5 ~ 6, add water to full dose, be filtered to clear and bright.Embedding under carbon dioxide or nitrogen current, the sterilization in 15 minutes of 100 ℃ of flowing steams, promptly.
Embodiment 6
The faropenem long-acting injection
Faropenem sodium 55g
DMA 100ml
Polyethylene Glycol 500ml
Proglumide 1g
Disodium edetate 0.2g
Propylparaben 1.5g
Water for injection adds to 1000ml
Preparation technology:
Earlier with a spot of water dissolution disodium edetate and proglumide, 80% water for injection that in the preparation container, adds amount of preparation, addition method faropenem stirring and dissolving, DMA, Polyethylene Glycol add the proglumide that preliminary election prepares then successively, disodium edetate solution, add propylparaben at last, stir, regulate pH value 5 ~ 6, add water to full dose, be filtered to clear and bright.Embedding under carbon dioxide or nitrogen current, the sterilization in 15 minutes of 100 ℃ of flowing steams, promptly.
Pharmacodynamic study
Embodiment 7
Experiment purpose:
Observe faropenem injection drug administration by injection and oral formulations gastric infusion to infecting the Cavia porcellus therapeutic effect of golden Portugal bacterium.
Experimental technique:
At first obtain golden Portugal bacterium strong virus force bacterial strain, in culture medium, cultivate fresh antibacterial with animal interior generation method.
Measure earlier before the infection the bacterial strain that tries in the internal energy all dead minimum lethal doses (100%MLD) of infection animal that make of 1 ~ 2d, as infection dosage.
The foundation of model:
Get the fresh new bacterium of cultivation, be mixed with suitable solution, with entry needle Cavia porcellus is carried out back leg intravenous injection inoculation, injection volume is 0.5ml, makes it to infect golden Portugal bacterium.And Cavia porcellus carried out metainfective observation.
Concrete grouping:
Get the Cavia porcellus about 60, male and female half and half are divided into six groups at random;
Normal control group: give normal saline and irritate stomach every day three times and give intramuscular injection normal saline every day three times.
Model group: the Cavia porcellus of using above-mentioned modeling to infect gives normal saline and irritates stomach every day three times and give intramuscular injection normal saline every day three times.
The gastric infusion group: the Cavia porcellus of using above-mentioned modeling to infect, irritate stomach and be equivalent to faropenem 10mg/kg solid preparation, every day three times.
The drug administration by injection group: the Cavia porcellus of using above-mentioned modeling to infect, intramuscular injection is equivalent to faropenem 10mg/kg ejection preparation, every day three times.
Experimental result:
Each group Cavia porcellus is carried out different route of administration administrations, discovery drug administration by injection group can well be brought into play therapeutical effect than gastric infusion group, can obviously reduce the dead quantity of Cavia porcellus and the life span of prolonged guinea pig, drug administration by injection has significant therapeutical effect than gastric infusion.
Concrete experimental data sees Table 1
The dead quantity of table 1. drug administration by injection and gastric infusion Cavia porcellus (/ day) and survival rate relatively
| Group | n | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 3 days survival rates | 9 days survival rates | |
| Matched group | Gastric infusion | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 100％ | 100％ |
| Drug administration by injection | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 100％ | 100％ | |
| Model group | Gastric infusion | 10 | 4 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0％ | 0％ |
| Drug administration by injection | 10 | 3 | 7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0％ | 0％ | |
| The gastric infusion group | 10 | 2 | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 70％ * | 50％ * | |
| The drug administration by injection group | 10 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 100％ **★ | 90％ **★ |
*Compare p＜0.05 with model group,
*Compare p＜0.01. with model group
★Compare p＜0.05. with the gastric infusion group
Embodiment 8
Experiment purpose:
Observe faropenem injection drug administration by injection and oral formulations gastric infusion to pneumonia infection streptococcus Cavia porcellus therapeutic effect.
Experimental technique:
With embodiment 7.
The foundation of model:
With embodiment 7.
Concrete grouping:
Get the Cavia porcellus about 60, male and female half and half are divided into six groups at random;
Normal control group: give normal saline every day three times that normal saline is irritated stomach every day three times and given intramuscular injection.
Model group: the Cavia porcellus of using above-mentioned modeling to infect gives normal saline and irritates stomach every day three times and give intramuscular injection normal saline every day three times.
The gastric infusion group: the Cavia porcellus of using above-mentioned modeling to infect, irritate stomach and be equivalent to faropenem 10mg/kg solid preparation, every day three times.
The drug administration by injection group: the Cavia porcellus of using above-mentioned modeling to infect, intramuscular injection is equivalent to faropenem 10mg/kg ejection preparation, every day three times.
Experimental result:
Each group Cavia porcellus is carried out different route of administration administrations, discovery drug administration by injection group can well be brought into play therapeutical effect than gastric infusion group, can obviously reduce the dead quantity of Cavia porcellus and the life span of prolonged guinea pig, drug administration by injection has significant therapeutical effect than gastric infusion.
Concrete experimental data sees Table 2.
The dead quantity of table 2. drug administration by injection and oral administration Cavia porcellus (/ day) and survival rate relatively
| Group | n | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 3 days survival rates | 9 days survival rates | |
| Matched group | Gastric infusion | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 100％ | 100％ |
| Drug administration by injection | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 100％ | 100％ | |
| Model group | Gastric infusion | 10 | 6 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | .0％ | .0％ |
| Drug administration by injection | 10 | 5 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0％ | 0％ | |
| The gastric infusion group | 10 | 2 | 2 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 60％ * | 30％ * | |
| The drug administration by injection group | 10 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 90％ **★ | 90％ **★★ |
*Compare p＜0.05 with model group,
*Compare p＜0.01. with model group
★Compare p＜0.05. with the gastric infusion group
★ ★Compare p＜0.01. with the gastric infusion group
Embodiment 9
Experiment purpose:
Observe the faropenem injection and irritate the stomach solid preparation the Cavia porcellus leukocyte of sense escherichia coli and the different inhibitory action of neutrophilic granulocyte.
Experimental technique:
The foundation of model:
At first obtain escherichia coli strong virus force bacterial strain with animal interior generation method, in culture medium, cultivate fresh antibacterial, measure the bacterial strain that tries make infection animal fraction (20 ~ 30%) death in 1 ~ 2d is internal energy, the minimum infection dosage of fraction in 8 ~ 14d (20 ~ 30%) survival is as infection dosage.Then Cavia porcellus is carried out the back leg intravenous inoculation, make it to infect, get in the Cavia porcellus auricular vein in infecting 1 ~ 14d that blood carries out numeration of leukocyte (WBC) and neutrophilic granulocyte is counted blood test.
Concrete grouping:
Get the Cavia porcellus about 60, male and female half and half are divided into six groups at random;
Normal control group: give normal saline and irritate stomach every day three times and give intramuscular injection normal saline every day three times.
Model group: the Cavia porcellus of using above-mentioned modeling to infect gives normal saline and irritates stomach every day three times and give intramuscular injection normal saline every day three times.
The gastric infusion group: the Cavia porcellus of using above-mentioned modeling to infect, irritate stomach and be equivalent to faropenem 10mg/kg solid preparation, every day three times.
The drug administration by injection group: modeling is the same, and intramuscular injection is equivalent to faropenem 10mg/kg ejection preparation, every day three times.
Experimental result:
Each group Cavia porcellus is carried out different route of administration administrations, and discovery drug administration by injection group can well be brought into play the effect that suppresses leukocyte and neutrophilic granulocyte than gastric infusion group, and drug administration by injection has significant therapeutical effect than gastric infusion, and concrete experimental result sees Table 3.
The inhibition leukocyte that table 3. drug administration by injection is different with gastric infusion and the effect of neutrophilic granulocyte
| Group | n | Total white blood cells (* 10 9/L) | Neutrophilic granulocyte (* 10 9/L) | |
| Matched group | Gastric infusion | 10 | 9.49±0.16 | 4.31±0.26 |
| Drug administration by injection | 10 | 10.13±0.09 | 4.69±0.39 | |
| Model group | Gastric infusion | 10 | 21.69±0.19 | 12.73±0.36 |
| Drug administration by injection | 10 | 22.61±0.28 | 13.39±0.69 | |
| The gastric infusion group | 10 | 16.46±3.13 ** | 8.58±1.87 ** | |
| The drug administration by injection group | 10 | 12.23±1.76 **※※ | 5.05±2.09 **※※ |
*Compare p＜0.01 with model group.
※ ※With gastric infusion group p＜0.01.
Claims (8)
1. one kind contains physiologically active faropenem or its acceptable salt or its medicinal compound of hydrate, is characterized in a kind of injection.
2. pharmaceutical composition as claimed in claim 1 is characterized in that described injection is water for injection injection or long-acting injection injection.
3. pharmaceutical composition as claimed in claim 1 is characterized in that it contains in antioxidant, metal chelating agent, antibacterial, pH value regulator or the adsorbent one or more.
4. pharmaceutical composition as claimed in claim 3 is characterized in that described metal chelating agent is the edetic acid sodium salt.
5. pharmaceutical composition as claimed in claim 3 is characterized in that described antioxidant is sodium pyrosulfite, sodium sulfite, sodium sulfite, thiourea, ascorbic acid, proglumide, cysteine, thioglycerol.
6. pharmaceutical composition as claimed in claim 3 is characterized in that described pH value regulator is hydrochloric acid, citric acid or sodium bicarbonate.
7. pharmaceutical composition as claimed in claim 3 is characterized in that described adsorbent is a needle-use activated carbon.
8. pharmaceutical composition as claimed in claim 1 or 2 is characterized in that it contains in ethanol, glycerol, propylene glycol, Polyethylene Glycol, the dimethyl acetylamide (DMA) one or more.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610043933 CN1843354A (en) | 2006-05-10 | 2006-05-10 | Injectable pharmaceutical composition containing faropenem |
| CNB200610145902XA CN100536843C (en) | 2006-05-10 | 2006-11-28 | Pharmaceutical composition for injection containing faropenem |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610043933 CN1843354A (en) | 2006-05-10 | 2006-05-10 | Injectable pharmaceutical composition containing faropenem |
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| Publication Number | Publication Date |
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| CN1843354A true CN1843354A (en) | 2006-10-11 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200610043933 Pending CN1843354A (en) | 2006-05-10 | 2006-05-10 | Injectable pharmaceutical composition containing faropenem |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102018960A (en) * | 2010-12-01 | 2011-04-20 | 安徽省皖北药业股份有限公司 | Method for keeping quality stability of clindamycin phosphate injection |
| CN101904822B (en) * | 2009-06-04 | 2011-11-09 | 鲁南制药集团股份有限公司 | Faropenem sodium freeze-drying powder and preparation method thereof |
| CN101744782B (en) * | 2010-01-24 | 2012-03-21 | 鲁南贝特制药有限公司 | Tablet containing faropenem sodium |
| CN102038638B (en) * | 2009-10-26 | 2012-12-26 | 海口市制药厂有限公司 | Clindamycin hydrochloride injection and preparation method thereof |
-
2006
- 2006-05-10 CN CN 200610043933 patent/CN1843354A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101904822B (en) * | 2009-06-04 | 2011-11-09 | 鲁南制药集团股份有限公司 | Faropenem sodium freeze-drying powder and preparation method thereof |
| CN102038638B (en) * | 2009-10-26 | 2012-12-26 | 海口市制药厂有限公司 | Clindamycin hydrochloride injection and preparation method thereof |
| CN101744782B (en) * | 2010-01-24 | 2012-03-21 | 鲁南贝特制药有限公司 | Tablet containing faropenem sodium |
| CN102018960A (en) * | 2010-12-01 | 2011-04-20 | 安徽省皖北药业股份有限公司 | Method for keeping quality stability of clindamycin phosphate injection |
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