CN103536564A - Cefonicid sodium composition powder for injection - Google Patents
Cefonicid sodium composition powder for injection Download PDFInfo
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- CN103536564A CN103536564A CN201310482350.1A CN201310482350A CN103536564A CN 103536564 A CN103536564 A CN 103536564A CN 201310482350 A CN201310482350 A CN 201310482350A CN 103536564 A CN103536564 A CN 103536564A
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- chitosan
- cefonicid
- injection
- cefonicid sodium
- sodium
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- 229960004489 cefonicid Drugs 0.000 title claims abstract description 49
- DYAIAHUQIPBDIP-AXAPSJFSSA-N cefonicid Chemical compound S([C@@H]1[C@@H](C(N1C=1C(O)=O)=O)NC(=O)[C@H](O)C=2C=CC=CC=2)CC=1CSC1=NN=NN1CS(O)(=O)=O DYAIAHUQIPBDIP-AXAPSJFSSA-N 0.000 title claims abstract description 47
- 239000000843 powder Substances 0.000 title claims abstract description 22
- 239000000203 mixture Substances 0.000 title claims abstract description 17
- 238000002347 injection Methods 0.000 title claims abstract description 8
- 239000007924 injection Substances 0.000 title claims abstract description 8
- 229920001661 Chitosan Polymers 0.000 claims abstract description 41
- 238000002360 preparation method Methods 0.000 claims abstract description 14
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 13
- 239000002105 nanoparticle Substances 0.000 claims abstract description 8
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims description 21
- 238000003756 stirring Methods 0.000 claims description 17
- 229910052799 carbon Inorganic materials 0.000 claims description 15
- 239000000243 solution Substances 0.000 claims description 11
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 10
- 239000002131 composite material Substances 0.000 claims description 10
- 238000001914 filtration Methods 0.000 claims description 10
- 238000010792 warming Methods 0.000 claims description 10
- 239000008215 water for injection Substances 0.000 claims description 9
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 6
- 239000007788 liquid Substances 0.000 claims description 6
- 238000012360 testing method Methods 0.000 claims description 6
- 239000000337 buffer salt Substances 0.000 claims description 5
- 238000005352 clarification Methods 0.000 claims description 5
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 claims description 5
- 229910000397 disodium phosphate Inorganic materials 0.000 claims description 5
- 235000019800 disodium phosphate Nutrition 0.000 claims description 5
- 238000001035 drying Methods 0.000 claims description 5
- 238000004108 freeze drying Methods 0.000 claims description 5
- 238000011068 loading method Methods 0.000 claims description 5
- 239000012982 microporous membrane Substances 0.000 claims description 5
- 229910000403 monosodium phosphate Inorganic materials 0.000 claims description 5
- 235000019799 monosodium phosphate Nutrition 0.000 claims description 5
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 claims description 5
- 238000000859 sublimation Methods 0.000 claims description 5
- 230000008022 sublimation Effects 0.000 claims description 5
- 235000015424 sodium Nutrition 0.000 claims description 4
- 235000019832 sodium triphosphate Nutrition 0.000 claims description 4
- 239000000463 material Substances 0.000 claims description 3
- 241000549556 Nanos Species 0.000 claims description 2
- 238000013019 agitation Methods 0.000 claims description 2
- 239000000084 colloidal system Substances 0.000 claims description 2
- 238000001816 cooling Methods 0.000 claims description 2
- 230000009881 electrostatic interaction Effects 0.000 claims description 2
- 238000000703 high-speed centrifugation Methods 0.000 claims description 2
- 239000002245 particle Substances 0.000 claims description 2
- 238000010298 pulverizing process Methods 0.000 claims description 2
- 239000013049 sediment Substances 0.000 claims description 2
- 238000005406 washing Methods 0.000 claims description 2
- 239000003643 water by type Substances 0.000 claims description 2
- NAXFZVGOZUWLEP-RFXDPDBWSA-L cefonicid sodium Chemical compound [Na+].[Na+].S([C@@H]1[C@@H](C(N1C=1C([O-])=O)=O)NC(=O)[C@H](O)C=2C=CC=CC=2)CC=1CSC1=NN=NN1CS([O-])(=O)=O NAXFZVGOZUWLEP-RFXDPDBWSA-L 0.000 claims 2
- 239000003814 drug Substances 0.000 abstract description 18
- 230000000844 anti-bacterial effect Effects 0.000 abstract description 13
- 241000588724 Escherichia coli Species 0.000 abstract description 6
- 230000000694 effects Effects 0.000 abstract description 6
- 238000005516 engineering process Methods 0.000 abstract description 6
- 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 abstract description 4
- 229930195725 Mannitol Natural products 0.000 abstract description 4
- 229940079593 drug Drugs 0.000 abstract description 4
- 239000000594 mannitol Substances 0.000 abstract description 4
- 235000010355 mannitol Nutrition 0.000 abstract description 4
- 210000001519 tissue Anatomy 0.000 abstract description 4
- 239000003795 chemical substances by application Substances 0.000 abstract description 3
- 210000001185 bone marrow Anatomy 0.000 abstract description 2
- 210000004027 cell Anatomy 0.000 abstract description 2
- 238000010253 intravenous injection Methods 0.000 abstract description 2
- 210000004185 liver Anatomy 0.000 abstract description 2
- 210000000056 organ Anatomy 0.000 abstract description 2
- 206010067484 Adverse reaction Diseases 0.000 abstract 1
- 241000192041 Micrococcus Species 0.000 abstract 1
- 238000009825 accumulation Methods 0.000 abstract 1
- 230000006838 adverse reaction Effects 0.000 abstract 1
- 239000004615 ingredient Substances 0.000 abstract 1
- 210000002540 macrophage Anatomy 0.000 abstract 1
- 239000002994 raw material Substances 0.000 abstract 1
- 238000004904 shortening Methods 0.000 abstract 1
- 241000894006 Bacteria Species 0.000 description 7
- 241001537924 Tetracoccus <angiosperm> Species 0.000 description 4
- 229940088710 antibiotic agent Drugs 0.000 description 4
- 230000002401 inhibitory effect Effects 0.000 description 4
- 206010059866 Drug resistance Diseases 0.000 description 3
- 241000192125 Firmicutes Species 0.000 description 3
- 235000013372 meat Nutrition 0.000 description 3
- 235000014347 soups Nutrition 0.000 description 3
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical group C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 2
- 125000000738 acetamido group Chemical group [H]C([H])([H])C(=O)N([H])[*] 0.000 description 2
- 230000000845 anti-microbial effect Effects 0.000 description 2
- 230000001580 bacterial effect Effects 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 230000003115 biocidal effect Effects 0.000 description 2
- 238000010790 dilution Methods 0.000 description 2
- 239000012895 dilution Substances 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 239000000825 pharmaceutical preparation Substances 0.000 description 2
- 125000002924 primary amino group Chemical group [H]N([H])* 0.000 description 2
- 229910052708 sodium Inorganic materials 0.000 description 2
- 239000011734 sodium Substances 0.000 description 2
- 239000002904 solvent Substances 0.000 description 2
- 238000001228 spectrum Methods 0.000 description 2
- 229920001817 Agar Polymers 0.000 description 1
- 208000035143 Bacterial infection Diseases 0.000 description 1
- 229930186147 Cephalosporin Natural products 0.000 description 1
- 108090000204 Dipeptidase 1 Proteins 0.000 description 1
- 241000305071 Enterobacterales Species 0.000 description 1
- 241001360526 Escherichia coli ATCC 25922 Species 0.000 description 1
- 241000588769 Proteus <enterobacteria> Species 0.000 description 1
- 241000589517 Pseudomonas aeruginosa Species 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 239000008272 agar Substances 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 238000004500 asepsis Methods 0.000 description 1
- 208000022362 bacterial infectious disease Diseases 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 102000006635 beta-lactamase Human genes 0.000 description 1
- 239000001913 cellulose Substances 0.000 description 1
- 229920002678 cellulose Polymers 0.000 description 1
- 229940124587 cephalosporin Drugs 0.000 description 1
- 150000001780 cephalosporins Chemical class 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 239000012141 concentrate Substances 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 239000003937 drug carrier Substances 0.000 description 1
- 239000000890 drug combination Substances 0.000 description 1
- 230000002708 enhancing effect Effects 0.000 description 1
- 239000001963 growth medium Substances 0.000 description 1
- 125000002887 hydroxy group Chemical group [H]O* 0.000 description 1
- 206010022000 influenza Diseases 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000005142 microbroth dilution method Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 210000002864 mononuclear phagocyte Anatomy 0.000 description 1
- 150000007524 organic acids Chemical class 0.000 description 1
- 230000036470 plasma concentration Effects 0.000 description 1
- 239000013612 plasmid Substances 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 230000002195 synergetic effect Effects 0.000 description 1
- 230000008685 targeting Effects 0.000 description 1
- 231100001274 therapeutic index Toxicity 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
Classifications
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention provides a cefonicid sodium composition powder for injection, and belongs to the field of medicine and medicine preparation technology. The cefonicid sodium composition powder comprises following raw material ingredients, by weight, 7.26 to 9.17 parts of cefonicid sodium, 5.16 to 6.50 parts of chitosan nanoparticle, and 82.38 to 88.10 parts of injection water. dvantages of the cefonicid sodium composition powder are that: 1) antibacterial effect of the cefonicid sodium composition on Gram-negative escherichia coli and Gram-positive micrococcus tetragenus is increased significantly; 2) the chitosan nanoparticle is capable of passing through tissue spaces, staying in tissues and cells for a long period of time, and releasing medicines; and after intravenous injection, the chitosan nanoparticle is mainly gathered in organs with abundant mononuclear macrophages, especially in liver and bone marrow; 3) improvement of activity is capable of shortening medication cycle of patients, and reducing occurrence likelihood of adverse reaction caused by accumulation of cefonicid sodium; and 4) the chitosan nanoparticle can be used as a freeze-dried skeleton agent of the freeze-dried powder injection instead of mannitol, so that active effects of mannitol on human bodies are avoided.
Description
Technical field:
The present invention relates to medicine and medicine manufacture technology field, relate in particular to a kind of cefonicid for inj composite freeze-dried powder.
Background technology:
Cefonicid sodium is semisynthetic third generation cephalosporin, most of gram positive bacterias and negative bacterium are had to powerful antibacterial activity, and antimicrobial spectrum comprises bacillus pyocyaneus, escherichia coli, pneumobacillus, hemophilus influenza, aerogenesis enterobacterial, Proteus, Diplococcus Ji Jin Portugal bacterium etc.
Cefonicid for inj effect is fast, clinical conventional.But safety range is little, effective plasma level scope is narrow, and therapeutic index is narrow, affects its pharmacokinetics many factors, eliminates speed individual variation larger in body, and clinical medicine dose is difficult to grasp.
The drug resistance that the abuse of medicine causes, has brought new problem to the control of bacterial infection disease.The appearance of superbacteria has been beaten alarm bell to us.How to reduce bacterial drug resistance, become the topic that people are more and more concerned about.Be conceived to the practical situation of current clinical application, drug combination is the effective ways that solve bacterial drug resistance.
Structure and the cellulose of chitosan are quite similar, and just the acetylamino on sugar ring C2 has replaced hydroxyl, and this acetylamino gives chitosan special characteristic, make it can be for pharmaceutical preparation aspect.Chitosan is easy to dissolve in weak acid solvent, it is worthy of note especially in solution after dissolving and contains amino, and these amino are by carrying out anti-bacteria in conjunction with negatron.Chitosan is alkalescence, has very strong hydrophilic, can be with hydrochloric acid and acetic acid etc. the inorganic or synthetic salt of organic acid.A lot of physiologically actives of chitosan make it at field of medicaments, have a wide range of applications.
Chitosan nano is as delivery system, can increase the dissolubility of medicine, improve the absorption of medicine and the bioavailability of raising medicine, change pharmacokinetic property, effectively reduce the toxic and side effects of dosage and reduction medicine, this nanoparticle is comparatively stable by the beta-lactamase of plasmid and Chromosome-encoded to most antibacterials, has weak antibiotic, bacteriostasis when having slow release, targeting and using separately as a kind of pharmaceutical carrier.
Summary of the invention:
Object of the present invention is exactly for containing the cefonicid sodium antibacterials of single component, to gram negative bacteria escherichia coli and gram positive bacteria tetracoccus is insensitive, curative effect is not good enough defect, problem that bioavailability is not high provide a kind of antimicrobial spectrum more extensively, cefonicid sodium antibacterial combination and the pharmaceutical preparation thereof of the stronger bioavailability of antibacterial action.
Technical problem to be solved by this invention realizes by the following technical solutions.
The invention provides cefonicid composition of sodium, the prescription of said composition consists of cefonicid sodium, chitosan nano, water for injection, it is characterized in that: chitosan nano can be used as skeleton agent, solubilizing agent, the synergist (chitosan nano itself has certain antibacterial activity, plays synergetic antibacterial effect after combining with cefonicid sodium) of cefonicid sodium.
A composite freeze-dried powder, is characterized in that, the material composition that comprises following weight portion:
7.26～9.17 parts of cefonicid sodiums
5.16～6.50 parts of chitosan nanos
82.38～88.10 parts of waters for injection
The preparation method that the invention provides a kind of cefonicid for inj composite freeze-dried powder, is characterized in that, comprises the steps:
(1) preparation of chitosan nano:
1) will after the pulverizing of chitosan powder, through 100 eye mesh screens, sieve;
2) the chitosan powder that takes 100g at room temperature (20 ℃) adds 0.1mol/l acetic acid solution 40L, and magnetic agitation, dissolves chitosan completely, obtains chitosan acetic acid solution (C=2.5g/L);
3) with 1%NaOH, regulate pH=5.0;
4) add 1% sodium tripolyphosphate 1667g to chitosan acetic acid solution under stirring, making chitosan/sodium tripolyphosphate mass ratio is 6:1, and the electrostatic interaction by zwitterion is cross-linked into nanoparticle;
5), by 4 ℃ of high speed centrifugations of above-mentioned colloid solution (18000r/min) 30min, collect lower sediment, with after pure water washing 3 times, cooling final vacuum dry (30 ℃ following) obtains chitosan nano, moisture is lower than 2%, particle diameter≤100nm, and zeta current potential is about 15mv;
(2) preparation of cefonicid for inj composite freeze-dried powder:
1) chitosan nano of recipe quantity is slowly joined in the water for injection of recipe quantity, stir while adding to dissolving;
2) add cefonicid sodium the extremely clarification of stirring and dissolving of recipe quantity;
3) with the buffer salt of sodium dihydrogen phosphate and sodium hydrogen phosphate, adjust pH to 5.1, add 0.1% active carbon to stir 30 minutes, filtering active carbon, medicinal liquid is again through 0.45 μ m and 0.22 μ m filtering with microporous membrane, detect intermediate content, by cefonicid sodium, every bottle of 80mg calculates loading amount;
4) according to testing requirement fill, after half tamponade, send in freezer dryer, be cooled to-40 ℃, be incubated 2 as a child, be slowly warming up to-5 ℃～0 ℃ sublimation drying, then be warming up to after 35 ℃, be incubated 3 hours, lyophilization finishes, outlet.
Beneficial effect of the present invention is:
The invention provides the compositions that a kind of cefonicid sodium mixes in 1:0.7 ratio with chitosan nano, and make injection freeze-dried powder as antibacterials for clinical.The inventor is by consulting a large amount of documents and materials and test of many times screening demonstration, and said composition tool has the following advantages:
1) said composition is entered antibacterial activity for gram negative bacteria escherichia coli and gram positive bacteria tetracoccus effect and is obviously improved.
2) and this nanoparticle energy penetrate tissue gap, can be in tissue and cell resident and discharge medicine for a long time, after intravenous injection, mainly concentrate in mononuclear phagocyte abundant organ, especially liver, bone marrow.
3) active enhancing is shortened patient's medication cycle, has reduced cefonicid sodium and has accumulated the probability that causes that untoward reaction occurs.
4) the alternative mannitol of chitosan nano, as the lyophilizing skeleton agent of freeze-dried powder, has been eliminated the active function of mannitol to human body.
The specific embodiment:
Following examples are used for illustrating the present invention, yet these embodiment do not limit the scope of the invention.
The preparation of embodiment mono-, cefonicid for inj composite freeze-dried powder, in 1000.
Prescription:
Cefonicid sodium 80g
Chitosan nano 56g
Water for injection 2000ml
2. preparation technology:
The chitosan nano that takes 56g slowly joins in the water for injection of 2000ml, stirs while adding to dissolving.
The cefonicid sodium the extremely clarification of stirring and dissolving that add 80g.
With the buffer salt of sodium dihydrogen phosphate and sodium hydrogen phosphate, adjust pH to 5.1, add 0.1% active carbon to stir 30 minutes, filtering active carbon, medicinal liquid is again through 0.45 μ m and 0.22 μ m filtering with microporous membrane, detect intermediate content, by cefonicid sodium, every bottle of 80mg calculates loading amount.
According to testing requirement fill, after half tamponade, send in freezer dryer, be cooled to-40 ℃, be incubated 2 as a child, be slowly warming up to-5 ℃～0 ℃ sublimation drying, then be warming up to after 35 ℃, be incubated 3 hours, lyophilization finishes, outlet.
The preparation of embodiment bis-, cefonicid for inj composite freeze-dried powder, in 1000.
1. write out a prescription:
Cefonicid sodium 80g
Chitosan nano 68g
Water for injection 2000ml
2. preparation technology:
The chitosan nano that takes 68g slowly joins in the water for injection of 2000ml, stirs while adding to dissolving.
The cefonicid sodium the extremely clarification of stirring and dissolving that add 80g.
With the buffer salt of sodium dihydrogen phosphate and sodium hydrogen phosphate, adjust pH to 5.1, add 0.1% active carbon to stir 30 minutes, filtering active carbon, medicinal liquid is again through 0.45 μ m and 0.22 μ m filtering with microporous membrane, detect intermediate content, by cefonicid sodium, every bottle of 80mg calculates loading amount.
According to testing requirement fill, after half tamponade, send in freezer dryer, be cooled to-40 ℃, be incubated 2 as a child, be slowly warming up to-5 ℃～0 ℃ sublimation drying, then be warming up to after 35 ℃, be incubated 3 hours, lyophilization finishes, outlet.
The preparation of embodiment tri-, cefonicid for inj composite freeze-dried powder, in 1000.
Prescription:
Cefonicid sodium 80g
Chitosan nano 47g
Water for injection 2000ml
2. preparation technology:
The chitosan nano that takes 47g slowly joins in the water for injection of 2000ml, stirs while adding to dissolving.
The cefonicid sodium the extremely clarification of stirring and dissolving that add 80g.
With the buffer salt of sodium dihydrogen phosphate and sodium hydrogen phosphate, adjust pH to 5.1, add 0.1% active carbon to stir 30 minutes, filtering active carbon, medicinal liquid is again through 0.45 μ m and 0.22 μ m filtering with microporous membrane, detect intermediate content, by cefonicid sodium, every bottle of 80mg calculates loading amount.
According to testing requirement fill, after half tamponade, send in freezer dryer, be cooled to-40 ℃, be incubated 2 as a child, be slowly warming up to-5 ℃～0 ℃ sublimation drying, then be warming up to after 35 ℃, be incubated 3 hours, lyophilization finishes, outlet.
Experimental data
1.1 method
1.1.1 dilute the aseptic solution that accurately takes cefonicid sodium (A department), cefonicid sodium (B department), embodiment mono-composition sample water dissolution and be diluted to 2048 μ g/mL of medicine, in one 20 ℃ of preservations.
1.1.2 the preparation of bacteria suspension, from escherichia coli, 3 bacterium colonies of tetracoccus agar culture medium flat board difference picking of incubated overnight, is inoculated in two kinds of identical MH meat soups and increases bacterium 6h.With colony counting method, carry out after count of bacteria, with MH meat soup dilution 1.5 * 105CFU/mL.
1.1.3 the mensuration of minimal inhibitory concentration (MIC) is with reference to each antibiotic minimal inhibitory concentration (MIC) of micro-broth dilution method.Cefonicid sodium (A department), cefonicid sodium (B department), 3 kinds of antibacterials of embodiment mono-composition sample are become to 23 concentration with sterilizing MH meat soup doubling dilution, be respectively 2048,1024 ... 0.0005 μ g/mL. gets respectively 100 μ L and adds successively 96 orifice plates, again 1.5 * 105CFU/mL bacterium liquid, 100 μ L are added in hand-hole, 37 ℃ of cultivations, observed result, the least concentration of asepsis growth of take is this medicine minimal inhibitory concentration MIC.
2 results and analysis
The MIC result (ug/mL) of five kinds of medicines of table 1 to escherichia coli ATCC25922
Can find out that no matter cefonicid sodium composition sample is to minimum compared with the cefonicid sodium of A, B two department's one-components to escherichia coli or tetracoccus minimal inhibitory concentration, this has illustrated that cefonicid composition of sodium has very strong antibacterial ability, and clinic is applied.
More than show and described ultimate principle of the present invention, principal character and advantage of the present invention.The technical staff of the industry should understand; the present invention is not restricted to the described embodiments; what in above-described embodiment and description, describe is only preference of the present invention; be not used for limiting the present invention; without departing from the spirit and scope of the present invention; the present invention also has various changes and modifications, and these changes and improvements all fall in the claimed scope of the invention.The claimed scope of the present invention is defined by appending claims and equivalent thereof.
Claims (2)
1. a cefonicid for inj composite freeze-dried powder, is characterized in that, the material composition that comprises following weight portion:
7.26～9.17 parts of cefonicid sodiums
5.16～6.50 parts of chitosan nanos
82.38～88.10 parts of waters for injection.
2. a preparation method for cefonicid for inj composite freeze-dried powder described in claim 1, is characterized in that, comprises the steps:
(1) preparation of chitosan nano:
1) will after the pulverizing of chitosan powder, through 100 eye mesh screens, sieve;
2) the chitosan powder that takes 100g at room temperature adds 0.1mol/l acetic acid solution 40L, and magnetic agitation, dissolves chitosan completely, obtains chitosan acetic acid solution;
3) with 1%NaOH, regulate pH=5.0;
4) add 1% sodium tripolyphosphate 1667g to chitosan acetic acid solution under stirring, making chitosan/sodium tripolyphosphate mass ratio is 6:1, and the electrostatic interaction by zwitterion is cross-linked into nanoparticle;
5) by 4 ℃ of high speed centrifugation 30min of above-mentioned colloid solution, collect lower sediment, with after pure water washing 3 times, the dry chitosan nano that obtains of cooling final vacuum, moisture is lower than 2%, particle diameter≤100nm, zeta current potential is about 15mv;
(2) preparation of cefonicid for inj composite freeze-dried powder:
1) chitosan nano of recipe quantity is slowly joined in the water for injection of recipe quantity, stir while adding to dissolving;
2) add cefonicid sodium the extremely clarification of stirring and dissolving of recipe quantity;
3) with the buffer salt of sodium dihydrogen phosphate and sodium hydrogen phosphate, adjust pH to 5.1, add 0.1% active carbon to stir 30 minutes, filtering active carbon, medicinal liquid is again through 0.45 μ m and 0.22 μ m filtering with microporous membrane, detect intermediate content, by cefonicid sodium, every bottle of 80mg calculates loading amount;
4) according to testing requirement fill, after half tamponade, send in freezer dryer, be cooled to-40 ℃, be incubated 2 as a child, be slowly warming up to-5 ℃～0 ℃ sublimation drying, then be warming up to after 35 ℃, be incubated 3 hours, lyophilization finishes, outlet.
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