CN106361704A - Ceftiofur sodium drug sustained-release colloid powder injection for injection and preparation method thereof - Google Patents
Ceftiofur sodium drug sustained-release colloid powder injection for injection and preparation method thereof Download PDFInfo
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- CN106361704A CN106361704A CN201610758400.8A CN201610758400A CN106361704A CN 106361704 A CN106361704 A CN 106361704A CN 201610758400 A CN201610758400 A CN 201610758400A CN 106361704 A CN106361704 A CN 106361704A
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- injection
- ceftiofur sodium
- slow release
- colloid
- release colloid
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- 239000003814 drug Substances 0.000 title claims abstract description 54
- 239000007924 injection Substances 0.000 title claims abstract description 52
- 238000002347 injection Methods 0.000 title claims abstract description 52
- RFLHUYUQCKHUKS-JUODUXDSSA-M Ceftiofur sodium Chemical compound [Na+].S([C@@H]1[C@@H](C(N1C=1C([O-])=O)=O)NC(=O)\C(=N/OC)C=2N=C(N)SC=2)CC=1CSC(=O)C1=CC=CO1 RFLHUYUQCKHUKS-JUODUXDSSA-M 0.000 title claims abstract description 40
- 229960004467 ceftiofur sodium Drugs 0.000 title claims abstract description 40
- 239000000843 powder Substances 0.000 title claims abstract description 38
- 239000000084 colloidal system Substances 0.000 title claims abstract description 30
- 238000002360 preparation method Methods 0.000 title claims abstract description 11
- 229940079593 drug Drugs 0.000 title abstract description 26
- 238000013268 sustained release Methods 0.000 title abstract 7
- 239000012730 sustained-release form Substances 0.000 title abstract 7
- 239000000203 mixture Substances 0.000 claims abstract description 8
- 239000003292 glue Substances 0.000 claims description 11
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical group CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 6
- 230000009969 flowable effect Effects 0.000 claims description 5
- 229920002907 Guar gum Polymers 0.000 claims description 2
- 239000004721 Polyphenylene oxide Substances 0.000 claims description 2
- 235000010489 acacia gum Nutrition 0.000 claims description 2
- 239000001785 acacia senegal l. willd gum Substances 0.000 claims description 2
- 239000003795 chemical substances by application Substances 0.000 claims description 2
- 235000010417 guar gum Nutrition 0.000 claims description 2
- 239000000665 guar gum Substances 0.000 claims description 2
- 229960002154 guar gum Drugs 0.000 claims description 2
- 229920000570 polyether Polymers 0.000 claims description 2
- 235000010493 xanthan gum Nutrition 0.000 claims description 2
- 239000000230 xanthan gum Substances 0.000 claims description 2
- 229920001285 xanthan gum Polymers 0.000 claims description 2
- 229940082509 xanthan gum Drugs 0.000 claims description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 abstract description 10
- 241001465754 Metazoa Species 0.000 abstract description 7
- 230000008901 benefit Effects 0.000 abstract description 4
- 239000000463 material Substances 0.000 abstract description 3
- 239000000243 solution Substances 0.000 abstract description 3
- 238000012360 testing method Methods 0.000 description 17
- 230000000694 effects Effects 0.000 description 11
- 238000010790 dilution Methods 0.000 description 10
- 239000012895 dilution Substances 0.000 description 10
- 241000287828 Gallus gallus Species 0.000 description 9
- 235000013330 chicken meat Nutrition 0.000 description 9
- 239000000725 suspension Substances 0.000 description 8
- 239000000047 product Substances 0.000 description 7
- 238000010171 animal model Methods 0.000 description 6
- 230000037396 body weight Effects 0.000 description 5
- 229960005229 ceftiofur Drugs 0.000 description 5
- ZBHXIWJRIFEVQY-IHMPYVIRSA-N ceftiofur Chemical compound S([C@@H]1[C@@H](C(N1C=1C(O)=O)=O)NC(=O)\C(=N/OC)C=2N=C(N)SC=2)CC=1CSC(=O)C1=CC=CO1 ZBHXIWJRIFEVQY-IHMPYVIRSA-N 0.000 description 5
- 238000010255 intramuscular injection Methods 0.000 description 5
- 239000007927 intramuscular injection Substances 0.000 description 5
- 239000000575 pesticide Substances 0.000 description 4
- 241000894006 Bacteria Species 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- 239000003960 organic solvent Substances 0.000 description 3
- 231100000614 poison Toxicity 0.000 description 3
- 230000035882 stress Effects 0.000 description 3
- 239000003440 toxic substance Substances 0.000 description 3
- 241000588724 Escherichia coli Species 0.000 description 2
- 239000002671 adjuvant Substances 0.000 description 2
- 230000000844 anti-bacterial effect Effects 0.000 description 2
- 230000003115 biocidal effect Effects 0.000 description 2
- 230000008859 change Effects 0.000 description 2
- 239000002552 dosage form Substances 0.000 description 2
- 230000000857 drug effect Effects 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- 239000012467 final product Substances 0.000 description 2
- 235000013312 flour Nutrition 0.000 description 2
- 230000036541 health Effects 0.000 description 2
- 238000007689 inspection Methods 0.000 description 2
- 231100000915 pathological change Toxicity 0.000 description 2
- 230000036285 pathological change Effects 0.000 description 2
- 210000002976 pectoralis muscle Anatomy 0.000 description 2
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- 231100000041 toxicology testing Toxicity 0.000 description 2
- 210000001835 viscera Anatomy 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- JGSARLDLIJGVTE-UHFFFAOYSA-N 3,3-dimethyl-7-oxo-6-[(2-phenylacetyl)amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid Chemical compound O=C1N2C(C(O)=O)C(C)(C)SC2C1NC(=O)CC1=CC=CC=C1 JGSARLDLIJGVTE-UHFFFAOYSA-N 0.000 description 1
- FRXSZNDVFUDTIR-UHFFFAOYSA-N 6-methoxy-1,2,3,4-tetrahydroquinoline Chemical compound N1CCCC2=CC(OC)=CC=C21 FRXSZNDVFUDTIR-UHFFFAOYSA-N 0.000 description 1
- 241000589220 Acetobacter Species 0.000 description 1
- 206010002198 Anaphylactic reaction Diseases 0.000 description 1
- 208000034657 Convalescence Diseases 0.000 description 1
- 108090000204 Dipeptidase 1 Proteins 0.000 description 1
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- 206010024264 Lethargy Diseases 0.000 description 1
- 102000018697 Membrane Proteins Human genes 0.000 description 1
- 108010052285 Membrane Proteins Proteins 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
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- 230000000843 anti-fungal effect Effects 0.000 description 1
- 229940121375 antifungal agent Drugs 0.000 description 1
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- 102000006635 beta-lactamase Human genes 0.000 description 1
- 210000000481 breast Anatomy 0.000 description 1
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- 235000005911 diet Nutrition 0.000 description 1
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- 239000006185 dispersion Substances 0.000 description 1
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- 239000003651 drinking water Substances 0.000 description 1
- 235000020188 drinking water Nutrition 0.000 description 1
- 230000007613 environmental effect Effects 0.000 description 1
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- 238000009472 formulation Methods 0.000 description 1
- 230000008014 freezing Effects 0.000 description 1
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- 239000000499 gel Substances 0.000 description 1
- 230000003862 health status Effects 0.000 description 1
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- 235000015110 jellies Nutrition 0.000 description 1
- 239000008274 jelly Substances 0.000 description 1
- 230000002147 killing effect Effects 0.000 description 1
- 238000004811 liquid chromatography Methods 0.000 description 1
- 238000009630 liquid culture Methods 0.000 description 1
- 230000003340 mental effect Effects 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 238000003199 nucleic acid amplification method Methods 0.000 description 1
- 239000003182 parenteral nutrition solution Substances 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 230000035479 physiological effects, processes and functions Effects 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 239000013641 positive control Substances 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 238000001243 protein synthesis Methods 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 230000000384 rearing effect Effects 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 238000011076 safety test Methods 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 238000005507 spraying Methods 0.000 description 1
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- 230000002522 swelling effect Effects 0.000 description 1
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- 238000010998 test method Methods 0.000 description 1
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- 230000014616 translation Effects 0.000 description 1
- 238000012795 verification Methods 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
- A61K31/542—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with heterocyclic ring systems
- A61K31/545—Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins, cefaclor, or cephalexine
- A61K31/546—Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins, cefaclor, or cephalexine containing further heterocyclic rings, e.g. cephalothin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
Landscapes
- Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Dermatology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention provides ceftiofur sodium drug sustained-release colloid powder injection for injection, belonging to the technical field of medicines. The ceftiofur sodium drug sustained-release colloid powder injection is prepared from the following components in parts by weight: 0.01-10 parts of ceftiofur sodium, 0.1-3.0 parts of sustained-release colloid, and 0.01-0.1 part of a flowing promoter. A preparation method of the ceftiofur sodium drug sustained-release colloid powder injection for injection comprises the following steps: (1) mixing the components at the corresponding ratio; and (2) carrying out aseptic subpackaging on the mixture obtained in the step (1) according to the specification. Compared with the common ceftiofur sodium for injection, the ceftiofur sodium drug sustained-release colloid powder injection has the advantage that after being diluted by normal saline, the medicine rapidly forms a sustained-release colloid solution; after injection, a drug storage is formed at the injection part, slow release is carried out, therefore, the medication times is reduced, the animal stress is reduced, and manpower resources, material resources and financial resources are saved; and meanwhile, the use is safe, the preparation method is simple, and the clinical popularization and application are facilitated.
Description
Technical field
The invention belongs to pharmaceutical technology field is and in particular to a kind of injection ceftiofur sodium medicament slow release colloid injectable powder
And preparation method thereof.
Background technology
Ceftiofur sodium is the clinical special antibiotic of cephalosporinses Chinese veterinarian, is broad spectrum antibiotic.To gram sun
Property bacterium and gram negative bacteria all have stronger killing action.Ceftiofur sodium molecular structure can be tied with Mycoderma surface membrane protein
Close, cause the change of ne ar, under the interaction with albumen for the medicine, drug particle rapidly enters in antibacterial body, short
High drug level is reached, epicyte protein synthesis is suppressed, imperfect outside moisture that exacerbates of membranous wall leads in time
Cross permeable pressure head and enter thalline, antibacterial shows swelling action, is quickly killed by suppression.This product has a broad antifungal spectrum, small toxicity, anaphylaxiss
Few, stable to acid and beta-lactamase.
At present, ceftiofur sodium product China market being available for injecting has two kinds, and one kind is Cefliofur injection, this
Planting injection is suspensoid, is the injection that can be used for direct injection that ceftiofur stock dispersion obtains in organic solvent,
This injection is easy to use, and the used time is directly pumped into syringe, intramuscular injection, also has certain medicament slow release to make simultaneously
With.But Cefliofur injection drawback is substantially, on market main flow content specification all between 2.5 ~ 10% that is to say, that except medicine
Outside thing, adjuvant more than 90% is organic solvent, causes cost excessive, and raiser's economic benefit reduces.And, organic solvent is
There is viscosity, while this viscosity drug brings slow release effect, also bring the problem of syringeability difference, in the market greatly
If partly this class product is using small size syringe, it is difficult to medicine is released.Another dosage form is that ceftiofur sodium is common
Injection powder pin, this class product is that ceftiofur raw material is directly loadable in cillin bottle, the injection powder that sterile vacuum process obtains
Pin, the used time with intramuscular injection after normal saline dilution dissolving using, compare with parenteral solution formulation, how a step dilution step, numb
Some have been tired of it, but the high organic adjuvants of non-use cost, cost advantage is obvious.But medicine is directly dissolved in water, after intramuscular injection directly
Absorb, be not in locally slow releasing function, this is also a drawback of normal injection powder pin.
For above-mentioned situation, market needs existing slow releasing function, using also convenient, lash easily, cost is not also simultaneously
High ceftiofur injection product meeting demand, to fill a hole in the market.
Content of the invention
The invention aims to providing a kind of injection ceftiofur sodium medicament slow release colloid injectable powder, provide its system
Preparation Method is the another goal of the invention of the present invention.
Based on above-mentioned purpose, this invention takes a kind of following technical scheme: injection ceftiofur sodium medicament slow release glue
Body injectable powder, is made up of each component of following weight portion: 0.01～10 part of ceftiofur sodium, 0.1～3.0 part of slow release glue, rush stream
0.01～0.1 part of dynamic agent.
Described slow release glue is guar gum, xanthan gum, arabic gum, one or two mixture in Resina persicae.Described slow
Release glue medicine is not reacted, and to organism safe, non-stimulated, do not react with medicine.
Described rush flowable is propylene glycol block polyether.This rush flowable has the effect promoting injection syringeability, prevents
After plastic, Clinical practice medicine is sticky, and the situation that small gauge needles are difficult to lash occurs, and this is also a prescription innovation of the present invention
Point；
The preparation method of described injection ceftiofur sodium medicament slow release colloid powder pin, comprises the following steps: 1) by each component
It is mixed in proportion；2) mixture of step 1) is obtained final product by specification is aseptic subpackaged.During subpackage, prop up as a example specification by 100ml/, often
Containing ceftiofur sodium 0.01～10g, slow release glue 0.1～3.0g in, promote flowable 0.01～0.1g；During use, directly will
It is with normal saline dilution to 100ml.By 5mg/kg dosage after shaking up, daily injection is once.
Compared with prior art, the beneficial effects of the present invention is:
1) instant component is simple, each group divide between synergism, substantially, a pin is completely up to common flour pin three pin for slow release effect
Effect, greatly save drug cost and Animal stress；Compared with normal injection ceftiofur sodium, after normal saline dilution
Medicine quickly forms slow release colloid solution；
2) compared with slow release suspension injection, the ceftiofur sodium slow release colloid powder pin syringeability of the present invention is more preferable, Clinical practice
More convenient, meanwhile, compared with slow release suspension injection, medicine cost reduces, safe；
3) preparation method of the present invention simple it is easy to popularization and application.
Brief description
Fig. 1 is normal injection ceftiofur sodium (left figure) and ceftiofur sodium slow release glue of the present invention before normal saline dilution
The contrast photo of body injectable powder (right figure) outward appearance；
Fig. 2 is with the ceftiofur sodium of the normal injection after normal saline dilution (left figure) and ceftiofur sodium slow release glue of the present invention
The contrast photo of body injectable powder (right figure) outward appearance；
Fig. 3 is the partial enlarged drawing of ceftiofur sodium slow release colloid injectable powder of the present invention in Fig. 2.
Specific embodiment
Hereinafter the present invention will be illustrated by embodiment, but these specific embodiments will limit this never in any form
Bright protection domain.
Embodiment 1-10
For making description succinct, provide a kind of injection ceftiofur sodium medicine described in embodiment 1-10 below in the form of a table
The weight composition of slow release colloid injectable powder, is specifically shown in Table 1.
The each group of table 1 embodiment 1-10 is grouped into
.
The preparation method of the injection ceftiofur sodium medicament slow release colloid injectable powder described in embodiment 1-10, including following
Step:
1) ceftiofur sodium, slow release glue and rush flowable are pressed the mixing of weight described in table；
2) mixture of step 1) is obtained final product by aseptic subpackaged 100 of the specification that 100ml/ props up.
The property of embodiment 11 product of the present invention and stability
The product of the present invention is white or off-white powder, appearance uniform, shown in its outward appearance material object photo as Fig. 1 right figure；Simultaneously
Fig. 2 confirms that the colloid injectable powder dissolving of the present invention is good, and compare outward appearance after dissolving with common flour pin jelly, slightly sticky, non-
Clear completely；Fig. 3 is then the colloid visual condition after confirming the molten water of colloid injectable powder of the present invention.
Separately sampled to embodiments of the invention 1-10, each sample is carried out respectively room temperature placement, 40 DEG C hot and humid put
Put, 4 DEG C of low temperature are placed and -20 DEG C of freezing placements, and separately sampled observation character, result when 0d, 15d, 30d, 90d and 180d
Show, under the conditions of above-mentioned placement, the outward appearance of the present invention is persistently off-white powder, no lumps, the unstable situation such as variable color is sent out
Raw, still be can dissolve with after normal saline dilution, outward appearance is gluey, and using high effective liquid chromatography for measuring, it about material and contains simultaneously
, all there is not significant change, this shows that the ageing stability of the present invention is good in amount.
Embodiment 12 test of pesticide effectiveness
Of the present invention medicine is expanded on further below by way of drug safety test and the test of pesticide effectiveness to the safety of animal, drug effect
And cleansing pin effect during Clinical practice.
Usage and dosage: during use, with normal saline dilution to 100ml, firmly shake up up to complete drug dissolution, outward appearance glue
Shape.
Intramuscular injection is it is recommended that dosage 5mg/kg body weight.
12.1 safety testings
Following safety is carried out for sample with a kind of injection ceftiofur sodium medicament slow release colloid injectable powder that embodiment 1 is obtained
Test.
Safety testing: by 80 40 ages in days health laying chickling be randomly divided into 4 groups, every group 20,4 groups be respectively labeled as right
According to group, low dose group, middle dose group, high dose group, and raise under same environmental condition.Wherein low dose group every is pressed
2.5mg/kg body weight, middle dose group every press 5mg/kg body weight, high dose group by 10mg/kg body weight, and chest muscle injects this medicine
Thing, once a day, once every three days, every injection 2ml normal saline of matched group.The overall condition of each group chicken group is observed after injection,
Test period is one week, the mental status of period primary part observation animal, diet, death condition and active situation etc., experiment
If there being dead chicken after end, cut open inspection on the spot within the 8h after death, if no death, after off-test, by every for each group chicken group with
Machine selects 3 execution, observes the pathological changes situation of its internal organs, and records.
Result shows: after ceftiofur sodium medicament slow release colloid injectable powder of the present invention, each group chicken group's active situation and
Health status are all normal, each internal organs also pathological changes without exception after cut open inspection, zero difference between each group, and this shows colloid powder pin liquid of the present invention
Safety is good.
12.2 tests of pesticide effectiveness
Following drug effect examination is carried out for sample with a kind of injection ceftiofur sodium medicament slow release colloid injectable powder that embodiment 1 is obtained
Test.
The test of pesticide effectiveness: 100 2 week old Ai Weiyin white meat-type chickens are randomly divided into 5 groups, every group 20, the 1st～5 group successively
Be labeled as healthy control group, positive controls, common ceftiofur sodium injection group, Cefliofur injection (suspension) group and
The colloid injectable powder group of the embodiment of the present invention 1.By the escherichia coli liquid culture amplification of o78 serotype before experiment, then use physiology
Saline is by concentration dilution to 1.0 × 109Individual/ml, by the bacterium solution after dilution in addition to healthy control group, remaining every breast of every group of chicken
Portion's intramuscular injection 1.0ml, lethargy in the chicken when 50%, and eyes are blurred, peel off and solely crouch, and drinking-water is searched for food when substantially reducing, and starts to use
Medicine.1st group of not counteracting toxic substances not medication, the 2nd group of counteracting toxic substances not medication, inject corresponding medicine respectively for the 3rd～5 group.In order to verify gel
The slow release effect of injectable powder, this test period is one week, and once, once every three days, the 4th, 5 groups only for the 3rd group of first three sky injection daily
No longer medication (Ceftiofur Suspension for injection has slow releasing function in itself, has obtained clinical verification) after injection once in first day, then right
Compare effect.Each group chicken dosage is 5.0mg/kg body weight, and usage is injected for chest muscle.
Evaluation criterion:
Dead: during finger to finger test, experimental animal appearance is dead, -1 point；
Invalid: after referring to medication, though death in experimental animal, Symptoms and sign do not have improves sign, 0 point；
Lapse to: after referring to medication, experimental animal achieves certain effect, is in convalescence, 1 point；
Recovery from illness: after referring to medication, experimental animal returns to one's perfect health, and all behaviors premorbid and sign indifference, 2 points；
Total effective rate: the experimental animal number lapsing to after referring to medication and fully recovering ratio × 100% total with this group experimental animal；
Protective rate: refer to the total effective rate that the total effective rate after medication deducts the matched group of non-medication；
Table 2 comparative efficacy test's result
.
Result of the test: do not use any medicine after counteracting toxic substances, in the case of leaning on animal self-resistance completely, have 50% chicken to deposit
Live；Attacking same serotype escherichia coli, under same rearing conditions, in the range of test error allows, the 3rd, 4,5 group of test
Result no significant difference, total effective rate all reaches more than 90%, protective rate all more than 40%, scores also no significant difference.
Result shows: using the slow release colloid injectable powder of present invention preparation, substantially, a pin fully achieves slow release effect
The effect of common injectable powder three pin, greatlys save drug cost and Animal stress.This shows the release injectable powder of the present invention
Injection has slow release effect, Clinical practice, cost-saved, minimizing times for spraying, reduces Animal stress, economic benefit improves.
12.3 syringeability is tested
This test and Selection ceftiofur sodium suspension injection (having slow releasing function) is contrasted, to verify the convenience of Clinical practice
Property.Tested using market minimum gauge pin hole 1ml syringe the thinnest.
Test method: pulled into vacuum to full scale 1ml rapidly after syringe is penetrated, record medicinal liquid is from pin hole stream
Enter the injector current full time, experimental result is shown in Table 3.
Can be obtained by table 3: by 1ml syringe needle, long run test 5 times, the average time of ceftiofur suspension injection
For 21.64 seconds, and release injectable injectable powder average time of the present invention was 10.14 seconds, and syringeability is substantially better than suspension injection
Liquid.
Conclusion: more preferably, Clinical practice is more convenient the ceftiofur sodium slow release colloid injectable powder syringeability of the present invention.
Table 3 embodiment of the present invention 1 and commercially available slow release ceftiofur sodium suspension dosage form syringeability contrast test
.
Claims (4)
1. a kind of injection ceftiofur sodium medicament slow release colloid injectable powder is it is characterised in that each component by following weight portion
Make: 0.01～10 part of ceftiofur sodium, 0.1～3.0 part of slow release glue, 0.01～0.1 part of flowable of rush.
2. injection ceftiofur sodium medicament slow release colloid injectable powder as claimed in claim 1 is it is characterised in that described slow release
Glue is guar gum, xanthan gum, arabic gum, one or two mixture in Resina persicae.
3. injection ceftiofur sodium medicament slow release colloid injectable powder as claimed in claim 1 is it is characterised in that described rush stream
Dynamic agent is propylene glycol block polyether.
4. the preparation method of the arbitrary described injection ceftiofur sodium medicament slow release colloid injectable powder of claim 1-3, it is special
Levy and be, comprise the following steps: 1) each component is mixed in proportion；2) mixture of step 1) is pressed specification aseptic subpackaged i.e.
?.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610758400.8A CN106361704B (en) | 2016-08-30 | 2016-08-30 | A kind of injection ceftiofur sodium medicament slow release colloid powder-injection and preparation method thereof |
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| CN201610758400.8A CN106361704B (en) | 2016-08-30 | 2016-08-30 | A kind of injection ceftiofur sodium medicament slow release colloid powder-injection and preparation method thereof |
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| CN106361704A true CN106361704A (en) | 2017-02-01 |
| CN106361704B CN106361704B (en) | 2019-02-12 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111467310A (en) * | 2020-04-15 | 2020-07-31 | 长江大学 | Cefquinome sustained-release colloidal powder injection for injection and preparation method thereof |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101780035A (en) * | 2010-03-22 | 2010-07-21 | 海南永田药物研究院有限公司 | Cefmenoxime hydrochloride suspended preparation and novel application thereof |
| CN101785756A (en) * | 2010-01-26 | 2010-07-28 | 海南美大制药有限公司 | Celtezole sodium suspension preparation and novel application thereof |
| CN103191057A (en) * | 2012-01-05 | 2013-07-10 | 洛阳惠中兽药有限公司 | Aqueous suspension injection of ceftiofur, and preparation method thereof |
| CN103585117A (en) * | 2013-10-15 | 2014-02-19 | 海南卫康制药(潜山)有限公司 | Cefotaxime sodium composition freeze-dried powder for injection |
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101785756A (en) * | 2010-01-26 | 2010-07-28 | 海南美大制药有限公司 | Celtezole sodium suspension preparation and novel application thereof |
| CN101780035A (en) * | 2010-03-22 | 2010-07-21 | 海南永田药物研究院有限公司 | Cefmenoxime hydrochloride suspended preparation and novel application thereof |
| CN103191057A (en) * | 2012-01-05 | 2013-07-10 | 洛阳惠中兽药有限公司 | Aqueous suspension injection of ceftiofur, and preparation method thereof |
| CN103585117A (en) * | 2013-10-15 | 2014-02-19 | 海南卫康制药(潜山)有限公司 | Cefotaxime sodium composition freeze-dried powder for injection |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111467310A (en) * | 2020-04-15 | 2020-07-31 | 长江大学 | Cefquinome sustained-release colloidal powder injection for injection and preparation method thereof |
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