CN102462683A - Antibiotic composition and preparation method and application thereof - Google Patents
Antibiotic composition and preparation method and application thereof Download PDFInfo
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- CN102462683A CN102462683A CN2010105319636A CN201010531963A CN102462683A CN 102462683 A CN102462683 A CN 102462683A CN 2010105319636 A CN2010105319636 A CN 2010105319636A CN 201010531963 A CN201010531963 A CN 201010531963A CN 102462683 A CN102462683 A CN 102462683A
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Abstract
The invention provides an antibiotic composition and a preparation method and an application thereof. The antibiotic composition provided by the invention comprises a component (A), i.e., cefoxitin or a salt thereof and a component (B), i.e., tazobactam or a salt thereof, and preferably comprises a component (A), i.e. cefoxitin, and a component (B), i.e., tazobactam, and the mass ratio of component (A) to the component (B) is (1-16):1. The invention further provides a preparation method and an application of the composition. The antibiotic composition provided by invention has a remarkable coordinated antibacterial action, contributes to increasing the antibacterial activity of the cefoxitin and suppressing the generation of the medicament tolerance of bacteria simultaneously, can be prepared into a powder injection or a parenteral solution for injection, and has high stability and high infusion compatibility stability simultaneously.
Description
Technical field
The invention belongs to field of medicaments, be specifically related to a kind of antibiotic composite, Preparation Method And The Use that comprises cefoxitin and Tazobactam Sodium.
Background technology
Cefoxitin belongs to second generation cephalosporin class medicine, is to be derived by the cephamycin C chemical modification, is a kind of semi-synthetic broad-spectrum sterilization medicine, and its bactericidal action is because suppressed the synthetic of bacteria cell wall.With respect to first generation cephalosporin, drug-fast most gram-negative bacteria effects obviously strengthen cefoxitin to first generation cephalosporin, and anaerobe is had efficiently; More stable to multiple beta-lactamase; Toxicity to kidney also decreases.The chemical constitution of cefoxitin is unique, and the methoxyl group in its structure is in " trans ", can hinder beta-lactamase near beta-lactam nucleus, and the attenuating enzyme is affine to medicine, thereby the protection beta-lactam nucleus is not destroyed.Making its stability to multiple beta-lactamase is strong than most cephalosporins, has high stability; Especially highly stable to the beta-lactamase of numerous plasmids or chromosome mediation, be difficult for by the beta-lactam enzyme hydrolysis.
It is reported that use cefoxitin and treat various infection, its total effective rate is 74%.The effective percentage of respiratory tract infection such as medical patient's mesobronchus inflammation, pneumonia, pulmonary abscess is 72.6%; The effective percentage of acute and chronic urinary tract infection is respectively 99.5% and 77.8%.The effective percentage of suppurative osteoarthritis, osteomyelitis, subcutaneous abscess etc. is 66.7%.Pathogen is main with gram negative bacilli, and treatment back bacteria clearance is 71.6%; The clearance rate of escherichia coli and pneumobacillus is respectively 89.6% and 65.7%.The removing effect of GPCs such as staphylococcus aureus is satisfied.Surgery, urology department and gynecologic and obstetric disease philtrum clinical effective rate are respectively 71.6%, 71.0% and 85.2%; Total bacteria clearance of 3 groups of patients is 75.2%; Wherein the clearance rate of escherichia coli, pneumobacillus and Serratia is respectively 79.2%, 82.1% and 60.0%, and the bacteria clearance of Grain-positive and negative cocci is 83.3%.Because cefoxitin all has effect to aerobic and anaerobe (especially bacteroides fragilis), so the clinical effective rate that is used to treat intraperitoneal and female genital tract infection is above 85%.Use cefoxitin treatment immunodeficiency person infection and also obtain good efficacy, and seldom untoward reaction takes place.
Compare with other cephalosporins, the cefoxitin antimicrobial spectrum is wider, and is more balanced, Gram-positive and feminine gender, anaerobe or aerobe all had strong active.Its antimicrobial spectrum further enlarges than first generation cephalosporin, and the gram-negative bacteria of many anti-first generation cephalosporins (like enterobacteria, the positive Bacillus proteus of indole etc.) is responsive to cefoxitin.Cefoxitin all has stronger active characteristic to aerobe and anaerobe, makes it in clinical treatment anaerobic infection or mixed infection, possibly become a kind of selection promising and the alternative present drug combination of conduct.
Tazobactam Sodium (tazobactam) is the novel penicillanic acid sulfones beta-lactamase inhibitor of Japanese roc drugmaker exploitation.Chemical name 3a-methyl-7-oxo-3 β-(1H-1,2,3;-triazole-1-methylene)-and 4-thia-1-azabicyclo [3.2.0] heptane-2a-carboxylic acid 4, the 4-dioxide, it is the earliest from 6-amino-penicillanic acid (6-aminopenicillianicaicd; 6-APA) set out and make, its structure is on the basis of sulbactam, to increase a triazole ring, presses down the enzyme effect to improve; It is the best beta-lactamase inhibitor of present clinical effectiveness, and it is high to have stability; Active low; Toxicity is low; Press down characteristics such as enzymatic activity is strong.1992, the compound medicine Tazobactam Sodium/piperacillin (1: 8) of Tazobactam Sodium was used to treat various bacteria and infects first in France's listing.Because all beta-Lactam antibiotics all have a typical case or an atypical beta-lactam nucleus, this ring is antibiotic main active site, in a single day this ring is hydrolyzed destruction, and antibiotic just will lose antibacterial activity.And antibacterial is to destroy this mechanism of beta-lactam nucleus and realize through producing the beta-lactam enzyme hydrolysis to the drug resistance about 80% of beta-Lactam antibiotic.Stop the hydrolysis of beta-lactamase to have two approach to select: the one, improve the stability of beta-lactam antibiotic to beta-lactamase, it is not destroyed.The second approach is that a kind of beta-lactam enzyme antibiotic and beta-lactamase inhibitor are formed compound formulation, resists and suppresses beta-lactamase with enzyme inhibitor, and the protection beta-lactam antibiotic is not damaged, and continues the performance antibacterial action.
In recent years, along with antibiotic extensive use clinically, genovariation has taken place in antibacterial, and Resistant strain day by day increases, and the microbial hospital infection number of drug resistance has accounted for about 30% of HOI patient total number of persons.Therefore, have the expert to foretell, China might rate be introduced into " back antibiotic epoch ", that is gets back to antibiotic and find the epoch before.
In order to solve bacterial drug resistance, pharmaceutical researchers tries hard to seek new antibiotic compound preparation. and comparatively speaking, the compound preparation that beta-lactam antibiotic and beta-lactamase inhibitor are formed is used more general clinically.What gone on the market both at home and abroad has kinds such as cefoperazone sodium and tazobactam sodium, ceftriaxone sodium and tazobactam sodium, piperacillin sodium-tazobactam, ceftazidime and tazobactam.But, still be necessary to develop and have synergetic antibacterial effect, can suppress the new antibiotic composite that bacterial drug resistance produces.
Summary of the invention
Therefore, the purpose of this invention is to provide a kind of new antibiotic composite.
Another object of the present invention provides the method for preparing and the purposes of above-mentioned antibiotic composite.
The objective of the invention is to adopt following technical scheme to realize.On the one hand, the present invention provides a kind of antibiotic composite, and said antibiotic composite contains: component A) cefoxitin or its salt; And B component) Tazobactam Sodium or its salt.
Preferably, said antibiotic composite contains: MK-306 component A); And B component) sodium-tazobactam.
Preferably, in the described antibiotic composite,, said component A) in the weight of cefoxitin and Tazobactam Sodium and B component) weight ratio be 0.5～30: 1; More preferably, said component A) and B component) weight ratio be 1～16: 1; More preferably, said component A) and B component) weight ratio be 4～12: 1; Further preferably, said component A) and B component) weight ratio be 4～10: 1; Most preferably, said component A) and B component) weight ratio be 4: 1.
Preferably, said antibiotic composite is the power for intravenous injection agent.
On the other hand, the invention provides the method for the above-mentioned antibiotic composite of manufacturing right, said method is included under the aseptic condition, with component A) and B component) mix homogeneously and packing.
Another aspect the invention provides the purposes of above-mentioned antibiotic composite in the preparation anti-bacterial drug; Preferably; Said antibacterial comprises gram positive bacteria and gram negative bacteria, is selected from escherichia coli, pneumobacillus, Serratia, the positive Bacillus proteus of indole, staphylococcus aureus, bacteroides fragilis, large intestine dust alkene bacterium, Klebsiella Pneumoniae, hemophilus influenza, salmonella, shigella dysenteriae, Pseudomonas aeruginosa and streptococcus etc.; More preferably, said antibacterial is a Resistant strain.
Concrete, the concentration that above-mentioned antibiotic composite suppresses staphylococcus aureus growth is 4-16 μ g/mg; Be preferably 4-8 μ g/mg.
The concentration that above-mentioned antibiotic composite suppresses the Klebsiella Pneumoniae growth is 16-64 μ g/mg; Be preferably 16-32 μ g/mg.
The concentration that above-mentioned antibiotic composite suppresses the Pseudomonas aeruginosa growth is 2-32 μ g/mg; Be preferably 4-16 μ g/mg; 4-8 μ g/mg more preferably.
The concentration that above-mentioned antibiotic composite suppresses streptococcus growth is 0.025-32 μ g/mg; Be preferably 0.025-0.5 μ g/mg; 0.025-0.25 μ g/mg more preferably; Most preferably be 0.025-0.125 μ g/mg.
In addition, the invention provides a kind of injection antibiotics injectable powder, said injectable powder comprises above-mentioned antibiotic composite.
Preferably, in the said injectable powder, in cefoxitin weight, every injectable powder comprises component A) 0.25-2.0g, preferred 0.5-2.0g, more preferably 1.0g.
Preferably, the compatibility solution during said injectable powder clinical practice comprises one or more in glucose solution, sodium chloride solution or the water for injection; More preferably, the concentration of said glucose solution is 5-10%; And/or the concentration of said sodium chloride solution is 0.9%.
In addition, the present invention also provides the purposes of above-mentioned injectable powder in the preparation anti-bacterial drug; Preferably; Said antibacterial is selected from gram positive bacteria and gram negative bacteria, comprises escherichia coli, pneumobacillus, Serratia, the positive Bacillus proteus of indole, staphylococcus aureus, bacteroides fragilis, escherichia coli, Klebsiella Pneumoniae, hemophilus influenza, salmonella, shigella dysenteriae, Pseudomonas aeruginosa or streptococcus; More preferably, said antibacterial is a Resistant strain.
In sum, antibiotic composite provided by the invention is combined by MK-306 and beta-lactamase inhibitor sodium-tazobactam, and by the weight of cefoxitin and Tazobactam Sodium, the weight ratio of the two is 1～16: 1 in the compositions.The MK-306 of certain weight ratio is mixed under aseptic condition with sodium-tazobactam; Can reach favorable uniformity, and packing under aseptic condition, get product; Can be used for intravenous administration for every powder pin that contains cefoxitin 0.25g, 0.5g, 1.0g, different sizes such as 2.0.
The beta-lactamase inhibitor that the present invention selects for use is Tazobactam Sodium or sodium-tazobactam; It is a kind of irreversible competitive beta-lactamase inhibitor; The penicillinase that beta-lactamase such as staphylococcus aureus, gram negative bacilli etc. produced to producing clinically has stronger inhibitory action; Can significantly strengthen the activity of MK-306, suppress the generation of bacterial drug resistance.That is to say that the compound preparation of MK-306 and sodium-tazobactam combination has significant synergetic antibacterial effect, can suppress the generation of bacterial drug resistance, improves the activity of cefoxitin, solves the drug resistance problem that the MK-306 long-term clinical produces.
This shows that antibiotic composite provided by the invention has lower minimum inhibitory concentration to common pathogenic microorganism, have stability and good transfusion compatibility stability preferably simultaneously.Said composition is improving the active while of cefoxitin, can solve the problem of MK-306 in the bacterial drug resistance of long-term clinical generation.Therefore, it has purposes widely clinically.
The specific embodiment
The concrete embodiment of following reference explains the present invention.It will be appreciated by those skilled in the art that these embodiment only are used to explain the present invention, the scope that it does not limit the present invention in any way.
Following examples 1-10 is the preparation embodiment of antibiotic composite provided by the invention.
Embodiment 1
Under aseptic condition; MK-306 10 kilograms (by cefoxitins) is inserted in the double cone mixer with sodium-tazobactam 10 kilograms (by Tazobactam Sodiums); Mixed 20～30 minutes; Rotating speed is 60 rev/mins, in aseptic subpackaged machine, is distributed into 10000 on powder pin, and every contains MK-306 1.0 grams (in cefoxitin).
Embodiment 2
Under aseptic condition; MK-306 20 kilograms (by cefoxitins) is inserted in the double cone mixer with sodium-tazobactam 10 kilograms (by Tazobactam Sodiums); Mixed 20～30 minutes; Rotating speed is 60 rev/mins, in aseptic subpackaged machine, is distributed into 20000 on powder pin, and every contains MK-306 1.0 grams (in cefoxitin).
Embodiment 3
Under aseptic condition; MK-306 30 kilograms (by cefoxitins) is inserted in the double cone mixer with sodium-tazobactam 10 kilograms (by Tazobactam Sodiums); Mixed 20～30 minutes; Rotating speed is 60 rev/mins, in aseptic subpackaged machine, is distributed into 30000 on powder pin, and every contains MK-306 1.0 grams (in cefoxitin).
Embodiment 4
Under aseptic condition; MK-306 40 kilograms (by cefoxitins) is inserted in the double cone mixer with sodium-tazobactam 10 kilograms (by Tazobactam Sodiums); Mixed 20～30 minutes; Rotating speed is 60 rev/mins, in aseptic subpackaged machine, is distributed into 40000 on powder pin, and every contains MK-306 1.0 grams (in cefoxitin).
Embodiment 5
Under aseptic condition; MK-306 50 kilograms (by cefoxitins) is inserted in the double cone mixer with sodium-tazobactam 10 kilograms (by Tazobactam Sodiums); Mixed 20～30 minutes; Rotating speed is 60 rev/mins, in aseptic subpackaged machine, is distributed into 50000 on powder pin, and every contains MK-306 1.0 grams (in cefoxitin).
Embodiment 6
Under aseptic condition; MK-306 60 kilograms (by cefoxitins) is inserted in the double cone mixer with sodium-tazobactam 10 kilograms (by Tazobactam Sodiums); Mixed 20～30 minutes; Rotating speed is 60 rev/mins, in aseptic subpackaged machine, is distributed into 60000 on powder pin, and every contains MK-306 1.0 grams (in cefoxitin).
Embodiment 7
Under aseptic condition; MK-306 80 kilograms (by cefoxitins) is inserted in the double cone mixer with sodium-tazobactam 10 kilograms (by Tazobactam Sodiums); Mixed 20～30 minutes; Rotating speed is 60 rev/mins, in aseptic subpackaged machine, is distributed into 80000 on powder pin, and every contains MK-306 1.0 grams (in cefoxitin).
Embodiment 8
Under aseptic condition; MK-306 double centner (by cefoxitin) and sodium-tazobactam 10 kilograms (by Tazobactam Sodiums) are inserted in the double cone mixer; Mixed 20～30 minutes; Rotating speed is 60 rev/mins, in aseptic subpackaged machine, is distributed into 100000 on powder pin, and every contains MK-306 1.0 grams (in cefoxitin).
Embodiment 9
Under aseptic condition; MK-306 120 kilograms (by cefoxitins) is inserted in the double cone mixer with sodium-tazobactam 10 kilograms (by Tazobactam Sodiums); Mixed 20～30 minutes; Rotating speed is 60 rev/mins, in aseptic subpackaged machine, is distributed into 120000 on powder pin, and every contains MK-306 1.0 grams (in cefoxitin).
Embodiment 10
Under aseptic condition; MK-306 160 kilograms (by cefoxitins) is inserted in the double cone mixer with sodium-tazobactam 10 kilograms (by Tazobactam Sodiums); Mixed 20～30 minutes; Rotating speed is 60 rev/mins, in aseptic subpackaged machine, is distributed into 160000 on powder pin, and every contains MK-306 1.0 grams (in cefoxitin).
Embodiment 11The lowest bacteria fogging-resistant concentration determining of antibiotic composite
Present embodiment has been tested the minimum inhibitory concentration of the antibiotic composite of the Different Weight ratio for preparing.
Experimental technique: adopt full dose broth dilution method (specifically referring to Zhang Juntian chief editor, " modern pharmacology experimental technique " (volume two) P1412, combined publication society of China Concord Medical Science University of Beijing Medical University, 1998) to measure and adopt tube dilution method to measure.
Experimental strain: clinical isolating anti-enzyme strain staphylococcus aureus, Klebsiella Pneumoniae, each strain of Pseudomonas aeruginosa, each strain of escherichia coli.(provide by Hainan People's Hospital, identify) through Hainan Medical College
Each pathogen of table 1 is measured result (μ g/mg) to different proportion sample bacteriostatic MIC
Through the resistancing action of Tazobactam Sodium to beta-lactamase, the antimicrobial spectrum of cefoxitin is increased, the antibacterial of multiple product beta-lactamase is produced obvious synergism.Above experimental result shows; MK-306 compares the independent cefoperazone tazobactam sodium (8: 1) that uses MK-306 or gone on the market at present (available from Hainan Qi Li Pharmacy stock Co., Ltd with the compositions of sodium-tazobactam; Lot number: 091101) minimal inhibitory concentration is little; The antibacterial action that shows cefoxitin Tazobactam Sodium composition of sodium provided by the invention is stronger, and promptly the two synergism of MK-306 and sodium-tazobactam has strengthened antibacterial activity.
Embodiment 12The stability of antibiotic composite
Present embodiment has been investigated the preliminarily stabilised property of the prepared antibiotic composite (specification is 1.25g, wherein contains cefoxitin 1.0g, Tazobactam Sodium 0.25g) of embodiment 4.
1) investigation project
Outward appearance: sample is carried out visual examination.
Inspection: inspection items such as the character of these article, color, clarity, pH value, visible foreign matters, particulate matter, related substance, assay, all with reference to reach " two pertinent regulations inspections of Chinese pharmacopoeia (version in 2010) from the plan standard.
2) accelerated stability test
With 1 specification, the 1 lot sample article of packing, 40 ℃ ± 2 ℃ of temperature, test under relative humidity 75% ± 5% situation, placed 6 months, period sampling measuring during respectively at 0,1,2,3,6 month, and with 0 month with lot sample article data comparisons.
3) long-term stable experiment
With two specifications, the 6 lot sample article of packing, 25 ℃ ± 2 ℃ of temperature, test under relative humidity 60% ± 10% situation, placed 6 months, period sampling measuring during respectively at 0,3,6 month, and with 0 month with lot sample article data comparisons.
4) result
The accelerated stability test result sees table 2, shows that each item index is all up to specification.
Embodiment 13The stability test of antibiotic composite and transfusion compatibility
Present embodiment is according to the clinical application condition, investigated the stability of the prepared antibiotic composite of embodiment 4 and transfusion compatibility.
1) investigation project:
Comprise character, related substance, content's index, inspection method is with reference to intending the standard pertinent regulations certainly.
2) test method
When antibiotic composite provided by the invention uses clinically, can be intravenous drip or intravenous injection.Adopt the dilution of 5% glucose solution or 10% glucose solution or 0.9% sodium chloride injection during intravenous drip; Adopt the water for injection dilution during intravenous injection, therefore, tested sample respectively with the stability of the compatibility dilution of 5% glucose solution, 10% glucose solution, water for injection or 0.9% sodium chloride injection.
Test method: get the antibiotic composite sample; Be diluted to clinical application concentration with 5% glucose solution, 10% glucose solution, water for injection and 0.9% sodium chloride injection respectively; Respectively in 0,2,4,8 h observation character and measure its related substance and content, relatively the mensuration result of each time point has or not significant change according to the quality standard method.
3) result
Result of the test is seen table 3, placed 8 hours after showing antibiotic composite and transfusion compatibility, and the equal conformance with standard regulation of each item quality index, stability meets the requirements.
Table 3 antibiotic composite and transfusion compatibility stability result of the test
Claims (10)
1. an antibiotic composite is characterized in that, said antibiotic composite contains: component A) cefoxitin or its salt; And B component) Tazobactam Sodium or its salt.
2. antibiotic composite according to claim 1 is characterized in that, said antibiotic composite contains: MK-306 component A); And B component) sodium-tazobactam.
3. antibiotic composite according to claim 1 and 2 is characterized in that, in the weight of cefoxitin and Tazobactam Sodium, said component A) and B component) weight ratio be 1～16: 1; Preferably, said component A) and B component) weight ratio be 4～10: 1; More preferably, said component A) and B component) weight ratio be 4: 1.
4. each described antibiotic composite in the claim 1 to 3 is characterized in that, said antibiotic composite is the power for intravenous injection agent.
5. the method for each said antibiotic composite in the production claim 1 to 4 is characterized in that said method is included under the aseptic condition, with component A) and B component) mix homogeneously and packing.
In the claim 1 to 4 each said antibiotic composite in the purposes of preparation in the anti-bacterial drug; Preferably; Said antibacterial is selected from gram positive bacteria and gram negative bacteria, comprises escherichia coli, pneumobacillus, Serratia, the positive Bacillus proteus of indole, staphylococcus aureus, bacteroides fragilis, escherichia coli, Klebsiella Pneumoniae, hemophilus influenza, salmonella, shigella dysenteriae, Pseudomonas aeruginosa or streptococcus; More preferably, said antibacterial is a Resistant strain.
7. an injection antibiotics injectable powder is characterized in that, said injectable powder comprises each said antibiotic composite in the claim 1 to 4.
8. injectable powder according to claim 7 is characterized in that, in cefoxitin weight, every comprises component A in the said injectable powder) 0.25～2.0g, preferred 0.5～2.0g, more preferably 1.0g.
9. according to claim 7 or 8 described injectable powder, it is characterized in that the solution of compatibility comprised one or more in glucose solution, sodium chloride solution or the water for injection when said injectable powder was used; Preferably, the concentration of said glucose solution is 5～10%; And/or preferably, the concentration of said sodium chloride solution is 0.9%.
In the claim 7 to 9 each said injectable powder in the purposes of preparation in the anti-bacterial drug; Preferably; Said antibacterial is selected from gram positive bacteria and gram negative bacteria, comprises escherichia coli, pneumobacillus, Serratia, the positive Bacillus proteus of indole, staphylococcus aureus, bacteroides fragilis, escherichia coli, Klebsiella Pneumoniae, hemophilus influenza, salmonella, shigella dysenteriae, Pseudomonas aeruginosa or streptococcus; More preferably, said antibacterial is a Resistant strain.
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