CN105640881A - Cefquinome sulfate muscle injection and preparation method thereof - Google Patents
Cefquinome sulfate muscle injection and preparation method thereof Download PDFInfo
- Publication number
- CN105640881A CN105640881A CN201511028387.2A CN201511028387A CN105640881A CN 105640881 A CN105640881 A CN 105640881A CN 201511028387 A CN201511028387 A CN 201511028387A CN 105640881 A CN105640881 A CN 105640881A
- Authority
- CN
- China
- Prior art keywords
- cefquinome sulfate
- preparation
- intramuscular dose
- cefquinome
- dose
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
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
- A61K9/10—Dispersions; Emulsions
-
- 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
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
-
- 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)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Dermatology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Dispersion Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a cefquinome sulfate muscle injection and a preparation method of the cefquinome sulfate muscle injection. The cefquinome sulfate muscle injection is prepared from cefquinome sulfate, a suspending agent, a wetting agent, an antioxidant and an oily solvent. The preparation method is characterized by preparing a suspension of which the color is similar to white and is sandy beige through grinding of a high-speed shear dispersion instrument, and sterilizing the cefquinome sulfate muscle injection by adopting an irradiation sterilization technology. The cefquinome sulfate muscle injection prepared by the invention has the advantages of good physical and chemical stability, fine granularity, slow sedimentation, good redispersibility, good needling performance, stable content, simplicity and feasibility in preparation technology and capability of being beneficial for industrial large-scale production; after the cefquinome sulfate muscle injection is injected intramuscularly, the release is slow, the elimination half life is long, the effect is durable, and the bioavailability is high.
Description
Technical field
The present invention relates to a kind of Cefquinome sulfate intramuscular dose and its preparation method, belong to technical field of veterinary.
Background technology
In recent years, China's aquaculture industry constantly grows and development, for raiser brings huge economic interests. Meanwhile, various bacterial infection disease is still one of main disease of harm bird and livestock, and rapidly, lethality rate height, for raiser causes serious financial loss in its morbidity. Microbiotic is a kind of conventional bacterial-infection resisting medicine, but the abuse due to microbiotic, resistance phenomenon is increased gradually, antibacterials curative effect obviously declines, and therefore, field of veterinary urgently needs a kind of animal specific antibacterials emerging, efficient.
Cefquinome, is also called spore quinoline promise or a HOE 111, is the animal specific forth generation cephalosporins of a kind of latest find. It is compared with microbiotic used before, there is has a broad antifungal spectrum, anti-microbial activity is strong, and the advantage such as toxicity is lower, especially has good clinical efficacy to infecting disease by the microbial pigs of cause of disease such as streptococcus aureus, suis, intestinal bacteria, bovine respiratory. The relevant data display of pharmacokinetics, cefquinome oral absorption is poor, and therefore clinical its vitriol conventional makes suspension, injects for intramuscular injection or breast.
Cefquinome sulfate is registered in China, but existing Cefquinome sulfate intramuscular injection suspension viscosity height, redispersibility are poor, and cleansing pin is poor, not easily takes out note, and medicament contg is low, and body absorption is poor, can not maintain effective antibacterial concentration for a long time. Therefore, develop a kind of high quality, slow releasing, persistent Cefquinome sulfate intramuscular dose field of veterinary is significant.
Summary of the invention
For overcoming problem in background technology, the present invention provides a kind of Cefquinome sulfate intramuscular dose and its preparation method, makes that gained preparation has physics, chemical stability is good, release is slow, persistent, bioavailability advantages of higher.
For realizing described goal of the invention, the present invention adopts technical scheme as follows:
A kind of Cefquinome sulfate intramuscular dose, is characterized in that every 100ml Cefquinome sulfate intramuscular dose is composed of the following components::
Specifically, suspending agent be selected from tristearin, aluminum monostearate, beeswax and white vaseline one or more combine, it will be preferred that stearic.
Specifically, wetting agent be selected from polyoxyethylene hydrogenated castor oil, sorbester p17, tween 80 and glycerine one or more combine, it will be preferred that polyoxyethylene hydrogenated castor oil.
Specifically, oxidation inhibitor be selected from 2,4-di-tert-butyl-4-methy phenol, butyl hydroxy anisol and Tenox PG one or more combine, it will be preferred that 2,4-di-tert-butyl-4-methy phenol.
Specifically, solvent be selected from soybean oil, medium chain triglyceride, ethyl oleate and Isopropyl myristate one or more combine, it will be preferred that soybean oil and medium chain triglyceride mix by volume at 1: 3-3: 1.
A kind of Cefquinome sulfate intramuscular dose, its preparation method is realized by following step:
(1) suspending agent, wetting agent, oxidation inhibitor are successively added in oiliness solvent successively, stir be warming up to 50 DEG C make suspending agent, oxidation inhibitor melting after, be cooled to 30 DEG C;
(2) Cefquinome sulfate sterilized powder is added in (1), stirs evenly;
(3) mixture in (2) is transferred to grinding distribution in high speed shear separating apparatus, setting speed 8000rpm, time 15min;
(4) by filling for made preformulation in 50mL vial, carrying out Co 60 x ray irradiation x sterilizing, irradiation dose is 6KGY, obtains Cefquinome sulfate intramuscular dose.
Specifically, main medicine Cefquinome sulfate is sterilized powder, and particle diameter is D90=10-20 ��m.
Specifically, apparatus for grinding and dispersing is high speed shear separating apparatus, and its rotating speed 8000rpm, time 15min, makes dispersion of medicine, stable content.
Specifically, sterilization process adopts 60Coradiation sterilizing, and irradiation dose is 6KGY, makes preparation sterility assurance level��10-6��
Compared with prior art, tool of the present invention has the following advantages:
(1) adding suspending agent and wetting agent, preparation physical properties is stablized, granularity is relatively thin, sedimentation is slow, redispersibility good, cleansing pin is good;
(2) preparation is simple, formulation content is stablized, and ensures uniformity of dosage units, be conducive to industrialized production;
(3) solvent used is oiliness solvent, and after intramuscular injection said preparation, release slowly, eliminates long half time, persistent, bioavailability height.
Accompanying drawing explanation
Fig. 1For embodiment 13 is made by oneself the blood concentration-time curve of preparation and commercial preparation.
Embodiment
Below in conjunction with specific embodiment, the present invention is described in further detail, but the present invention is not only confined to given example.
Test method in following embodiment, if no special instructions, is ordinary method; Reagent and material, if no special instructions, all obtain by commercial sources.
Embodiment 1
Oiliness solvent is mixed by volume by soybean oil and medium chain triglyceride at 1: 3.
Preparation method:
(1) tristearin, polyoxyethylene hydrogenated castor oil, 2,4-di-tert-butyl-4-methy phenol are successively added in oiliness solvent successively, stir be warming up to 50 DEG C make suspending agent, oxidation inhibitor melting after, be cooled to 30 DEG C;
(2) Cefquinome sulfate sterilized powder is added in (1), stirs evenly;
(3) mixture in (2) is transferred to grinding distribution in high speed shear separating apparatus, setting speed 8000rpm, time 15min;
(4) by filling for made preformulation in 50mL vial, carrying out Co 60 x ray irradiation x sterilizing, irradiation dose is 6KGY, obtains Cefquinome sulfate intramuscular dose.
Embodiment 2
Oiliness solvent is mixed by volume by soybean oil and medium chain triglyceride at 1: 2.
Preparation method:
(1) tristearin, polyoxyethylene hydrogenated castor oil, 2,4-di-tert-butyl-4-methy phenol are successively added in oiliness solvent successively, stir be warming up to 50 DEG C make suspending agent, oxidation inhibitor melting after, be cooled to 30 DEG C;
(2) Cefquinome sulfate sterilized powder is added in (1), stirs evenly;
(3) mixture in (2) is transferred to grinding distribution in high speed shear separating apparatus, setting speed 8000rpm, time 15min;
(4) by filling for made preformulation in 50mL vial, carrying out Co 60 x ray irradiation x sterilizing, irradiation dose is 6KGY, obtains Cefquinome sulfate intramuscular dose.
Embodiment 3
Oiliness solvent is mixed by volume by soybean oil and medium chain triglyceride at 3: 1.
Preparation method:
(1) tristearin, polyoxyethylene hydrogenated castor oil, 2,4-di-tert-butyl-4-methy phenol are successively added in oiliness solvent successively, stir be warming up to 50 DEG C make suspending agent, oxidation inhibitor melting after, be cooled to 30 DEG C;
(2) Cefquinome sulfate sterilized powder is added in (1), stirs evenly;
(3) mixture in (2) is transferred to grinding distribution in high speed shear separating apparatus, setting speed 8000rpm, time 15min;
(4) by filling for made preformulation in 50mL vial, carrying out Co 60 x ray irradiation x sterilizing, irradiation dose is 6KGY, obtains Cefquinome sulfate intramuscular dose.
Embodiment 4
Oiliness solvent is mixed by volume by soybean oil and medium chain triglyceride at 1: 3.
Preparation method:
(1) aluminum monostearate, sorbester p17,2,4-di-tert-butyl-4-methy phenol are successively added in oiliness solvent successively, stir be warming up to 50 DEG C make suspending agent, oxidation inhibitor melting after, be cooled to 30 DEG C;
(2) Cefquinome sulfate sterilized powder is added in (1), stirs evenly;
(3) mixture in (2) is transferred to grinding distribution in high speed shear separating apparatus, setting speed 8000rpm, time 15min;
(4) by filling for made preformulation in 50mL vial, carrying out Co 60 x ray irradiation x sterilizing, irradiation dose is 6KGY, obtains Cefquinome sulfate intramuscular dose.
Embodiment 5
Oiliness solvent is mixed by volume by ethyl oleate and medium chain triglyceride at 3: 1.
Preparation method:
(1) beeswax, tween 80, Tenox PG are successively added in oiliness solvent successively, stir be warming up to 50 DEG C make suspending agent, oxidation inhibitor melting after, be cooled to 30 DEG C;
(2) Cefquinome sulfate sterilized powder is added in (1), stirs evenly;
(3) mixture in (2) is transferred to grinding distribution in high speed shear separating apparatus, setting speed 8000rpm, time 15min;
(4) by filling for made preformulation in 50mL vial, carrying out Co 60 x ray irradiation x sterilizing, irradiation dose is 6KGY, obtains Cefquinome sulfate intramuscular dose.
Embodiment 6
Oiliness solvent is mixed by volume by soybean oil and Isopropyl myristate at 2: 1.
Preparation method:
(1) white vaseline, glycerine, butyl hydroxy anisol are successively added in oiliness solvent successively, stir be warming up to 50 DEG C make suspending agent, oxidation inhibitor melting after, be cooled to 30 DEG C;
(2) Cefquinome sulfate sterilized powder is added in (1), stirs evenly;
(3) mixture in (2) is transferred to grinding distribution in high speed shear separating apparatus, setting speed 8000rpm, time 15min;
(4) by filling for made preformulation in 50mL vial, carrying out Co 60 x ray irradiation x sterilizing, irradiation dose is 6KGY, obtains Cefquinome sulfate intramuscular dose.
Embodiment 7
Oiliness solvent is mixed by volume by soybean oil and ethyl oleate at 2: 1.
Preparation method:
(1) tristearin, polyoxyethylene hydrogenated castor oil, butyl hydroxy anisol are successively added in oiliness solvent successively, stir be warming up to 50 DEG C make suspending agent, oxidation inhibitor melting after, be cooled to 30 DEG C;
(2) Cefquinome sulfate sterilized powder is added in (1), stirs evenly;
(3) mixture in (2) is transferred to grinding distribution in high speed shear separating apparatus, setting speed 8000rpm, time 15min;
(4) by filling for made preformulation in 50mL vial, carrying out Co 60 x ray irradiation x sterilizing, irradiation dose is 6KGY, obtains Cefquinome sulfate intramuscular dose.
Embodiment 8
The present embodiment is the granularity Detection test of Cefquinome sulfate intramuscular dose.
Trial-product is embodiment 1-7 gained preparation.
The method of granularity Detection is: gets trial-product 1 bottle and shakes even, application Malvern 2000 laser particle analyzer measure, D90=10-15 ��m be qualified.
Particle size measurement resultSuch as table 1Shown in:
Table 1Embodiment 1-7 particle size measurement result
| Embodiment | Example 1 | Example 2 | Example 3 | Example 4 | Example 5 | Example 6 | Example 7 |
| D90/��m | 11.121 | 12.423 | 12.526 | 14.238 | 13.257 | 14.253 | 13.252 |
Test-results shows, the granularity of various embodiments of the present invention preparation is all qualified.
Embodiment 9
The sedimentation volume that the present embodiment is Cefquinome sulfate intramuscular dose compares detection experiment.
Trial-product is embodiment 1-7 gained preparation.
Sedimentation volume than the method for detection is: get trial-product 1 bottle, and firmly jolting is after 1 minute, is transferred to by content in 50mL tool plug graduated cylinder, close plug, record elemental height H0, leaves standstill 3h, records final height H, sedimentation volume specific volume is than F=H/H0, F >=0.90, and it is qualified to be.
Sedimentation volume compares measurement resultSuch as table 2Shown in:
Table 2Embodiment 1-7 sedimentation volume compares measurement result
| Embodiment | Example 1 | Example 2 | Example 3 | Example 4 | Example 5 | Example 6 | Example 7 |
| Sedimentation volume ratio | 0.98 | 0.97 | 0.96 | 0.95 | 0.95 | 0.93 | 0.92 |
Test-results shows, the sedimentation volume of various embodiments of the present invention preparation is more qualified than all.
Embodiment 10
The present embodiment is the redispersibility detection experiment of Cefquinome sulfate intramuscular dose.
Trial-product is embodiment 1-7 gained preparation.
The method of redispersibility detection is: gets trial-product 1 bottle, is transferred to by content in 100mL tool plug graduated cylinder and leaves standstill after 3h, rotate with the speed of 20rpm/min, and in 2min, sediment bottom graduated cylinder evenly disperses, and it is qualified to be.
The sediment of result various embodiments of the present invention preparation all disperses in 2min.
Embodiment 11
The present embodiment is the cleansing pin detection experiment of Cefquinome sulfate intramuscular dose.
Trial-product is embodiment 1-7 gained preparation.
The method of cleansing pin detection is: gets trial-product 1 bottle and shakes even, extracts with the syringe that No. 7 syringe needles are housed, and the time is 1min, extracts content volume and is more than or equal to 5mL, and it is qualified to be.
As a result, each embodiment preparation extracts in 1min that object is long-pending is all greater than 5ml, and each embodiment cleansing pin is all qualified.
Embodiment 12
The present embodiment is content and the uniformity of dosage units detection experiment of Cefquinome sulfate intramuscular dose.
Trial-product is embodiment 1-7 gained preparation.
Content assaying method:
(1) chromatographic condition and system suitability: be weighting agent with octadecylsilane chemically bonded silica; It is moving phase with perchlorate damping fluid (getting a perchloric acid hydrate sodium 3.45g, the 860ml that adds water dissolves, and adds phosphatase 11 2ml, adds triethylamine adjust ph to 3.5 �� 0.05)-acetonitrile (86: 14); Post temperature: 25 DEG C; Flow velocity: 1ml/min; Determined wavelength: 270nm; Sample size: 20 �� l; LC stand-by time: 30min.
(2) measuring method: precision measures shakes even rear trial-product 1mL and be placed in 25ml volumetric flask, adding 1mL Bio-Rad-Laboratories (10%v/v) jolting breakdown of emulsion, moving phase is held surely, after taking off layer solution filtration, precision measures 20 �� l injection liquid chromatographies, record chromatogramFigure; Separately getting Cefquinome sulfate reference substance appropriate (in cefquinome 25.0mg), moving phase is settled to 25mL, and precision measures 20 �� l injection liquid chromatographies, record chromatogramFigure. By external standard method with calculated by peak area, to obtain final product.
Determination of Content Uniformity method: " People's Republic of China's veterinary drug allusion quotation " version in 2010 annex 118 pages.
Assay resultSuch as table 3Shown in:
Table 3Embodiment 1-7 assay result
| Embodiment | Example 1 | Example 2 | Example 3 | Example 4 | Example 5 | Example 6 | Example 7 |
| Content (%) | 98.3 | 100.2 | 97.6 | 101.5 | 99.4 | 99.8 | 103.2 |
Test-results shows, gained formulation content of the present invention is stablized, and all at 95%-105%.
Determination of Content Uniformity resultSuch as table 4Shown in:
Table 4Embodiment 1-7 Determination of Content Uniformity result
| Embodiment | Example 1 | Example 2 | Example 3 | Example 4 | Example 5 | Example 6 | Example 7 |
| A+1.80S | 5.243 | 4.268 | 5.724 | 6.735 | 7.245 | 8.244 | 8.345 |
Test-results shows, it is qualified that gained formulation content uniformity coefficient of the present invention is.
Embodiment 13
The present embodiment is the pharmacokinetics test of Cefquinome sulfate intramuscular dose in pig body
Testing program: choose health pig 12, be divided into test group and control group at random, commercially available 2.5% Cefquinome sulfate suspension injection of control group intramuscular injection, test group then intramuscular injection embodiment 1 gained preparation. Two groups of dosages are 2mg/kg, and administering mode is the disposable intramuscularly of neck.
Blood specimen collection: two groups, all in precaval vein blood sampling, gather 1 blank blood sample before administration, after administration, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h take a blood sample 5mL respectively, inject vacuum anticoagulant blood-collecting pipe, centrifugal, separated plasma ,-20 DEG C of freezen protective are to be measured.
Plasma treatment: the blood plasma of freezen protective is thawed naturally, shake the even rear 1mL that draws and it is placed in 5mL centrifuge tube, add 1mL acetonitrile, after mixing 2min on turbula shaker, use supercentrifuge centrifugal 10min under rotating speed 8000rpm, precision measures supernatant liquid 20 �� l and injects high performance liquid chromatograph, record chromatogramFigure��
Chromatographic condition: be weighting agent with octadecylsilane chemically bonded silica; It is moving phase with perchlorate damping fluid (getting a perchloric acid hydrate sodium 3.45g, the 860ml that adds water dissolves, and adds phosphatase 11 2ml, adds triethylamine adjust ph to 3.5 �� 0.05)-acetonitrile (86: 14); Post temperature: 25 DEG C; Flow velocity: 1ml/min; Determined wavelength: 270nm; Sample size: 20 �� l:LC stand-by time: 30min.
Separately getting Cefquinome sulfate reference substance appropriate (in cefquinome 25.0mg), moving phase is settled to 25mL, and precision measures 20 �� l injection liquid chromatographies, record chromatogramFigure. By external standard method with calculated by peak area, to obtain final product.
Data analysis: testing data is carried out statistical analysis by application PhoenixWinNonlin6.0 software.
Blood concentration-time curve in blood plasmaSuch as Fig. 1Shown in.
Test-results shows, the made preparation of the present invention discharges slowly compared with commercial preparation, has the longer transformation period, persistent, and relative bioavailability is 142.3%, and bioavailability significantly improves.
In addition to the implementation, the present invention can also have other enforcement modes. All employings are equal to replacement or the technical scheme of equivalent transformation formation, all drop on the protection domain of requirement of the present invention.
Claims (9)
1. a Cefquinome sulfate intramuscular dose, is characterized in that every 100ml Cefquinome sulfate intramuscular dose is composed of the following components:
2. Cefquinome sulfate intramuscular dose as claimed in claim 1 a kind of, one or more that it is characterized in that suspending agent is selected from tristearin, aluminum monostearate, beeswax and white vaseline combine, it will be preferred that stearic.
3. Cefquinome sulfate intramuscular dose as claimed in claim 1 a kind of, one or more that it is characterized in that wetting agent is selected from polyoxyethylene hydrogenated castor oil, sorbester p17, tween 80 and glycerine combine, it will be preferred that polyoxyethylene hydrogenated castor oil.
4. a kind of Cefquinome sulfate intramuscular dose as claimed in claim 1, it is characterized in that oxidation inhibitor is selected from 2, one or more in 4-di-tert-butyl-4-methy phenol, butyl hydroxy anisol and Tenox PG combine, it will be preferred that 2,4-di-tert-butyl-4-methy phenol.
5. a kind of Cefquinome sulfate intramuscular dose as claimed in claim 1, one or more that it is characterized in that solvent is selected from soybean oil, medium chain triglyceride, ethyl oleate and Isopropyl myristate combine, it will be preferred that soybean oil and medium chain triglyceride mix by volume at 1: 3-3: 1.
6. a kind of Cefquinome sulfate intramuscular dose as claimed in claim 1, is characterized in that its preparation method is realized by following step:
(1) suspending agent, wetting agent, oxidation inhibitor are successively added in oiliness solvent successively, stir be warming up to 50 DEG C make suspending agent, oxidation inhibitor melting after, be cooled to 30 DEG C;
(2) Cefquinome sulfate sterilized powder is added in (1), stirs evenly,
(3) mixture in (2) is transferred to grinding distribution in high speed shear separating apparatus, setting speed 8000rpm, time 15min;
(4) by filling for made preformulation in 50mL vial, carrying out Co 60 x ray irradiation x sterilizing, irradiation dose is 6KGY, obtains Cefquinome sulfate intramuscular dose.
7. a kind of Cefquinome sulfate intramuscular dose as described in claim 1-6 and its preparation method, is characterized in that described main medicine Cefquinome sulfate is sterilized powder, and particle diameter is D90=10-20 ��m.
8. a kind of Cefquinome sulfate intramuscular dose as described in claim 1-6 and its preparation method, is characterized in that apparatus for grinding and dispersing is high speed shear separating apparatus, and its rotating speed 8000rpm, time 15min, makes dispersion of medicine, stable content.
9. a kind of Cefquinome sulfate intramuscular dose as described in claim 1-6 and its preparation method, is characterized in that sterilization process adopts 60Coradiation sterilizing, and irradiation dose is 6KGY, makes preparation sterility assurance level��10-6��
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201511028387.2A CN105640881A (en) | 2015-12-30 | 2015-12-30 | Cefquinome sulfate muscle injection and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201511028387.2A CN105640881A (en) | 2015-12-30 | 2015-12-30 | Cefquinome sulfate muscle injection and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN105640881A true CN105640881A (en) | 2016-06-08 |
Family
ID=56490944
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201511028387.2A Pending CN105640881A (en) | 2015-12-30 | 2015-12-30 | Cefquinome sulfate muscle injection and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN105640881A (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107334730A (en) * | 2017-06-30 | 2017-11-10 | 广东温氏大华农生物科技有限公司 | A kind of cefquinome sulfate injection and its low temperature high shear preparation method |
| CN112972418A (en) * | 2021-05-18 | 2021-06-18 | 北京金城泰尔制药有限公司 | Nifuratel nysfungin vaginal soft capsule and preparation method thereof |
| CN117982413A (en) * | 2024-04-03 | 2024-05-07 | 山东恒邦中科生物工程有限公司 | Preparation method of cefquinome sulfate injection |
Citations (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20040115260A1 (en) * | 2002-12-16 | 2004-06-17 | Peter Schmid | Prolonged release pharmaceutical composition |
| CN101347407A (en) * | 2008-09-17 | 2009-01-21 | 河北远征药业有限公司 | Cefquinome sulfate injection and process for producing the same |
| CN101721366A (en) * | 2010-01-13 | 2010-06-09 | 洛阳惠中兽药有限公司 | Components and preparation method of beta-lactam injection |
| CN101987100A (en) * | 2010-11-10 | 2011-03-23 | 洛阳惠中兽药有限公司 | Method for preparing Cefquinome sulfate suspension injection |
| CN102319210A (en) * | 2011-09-29 | 2012-01-18 | 武汉回盛生物科技有限公司 | A kind of long-acting veterinary cefquinome sulfate injection and preparation method thereof |
| CN103751103A (en) * | 2014-02-21 | 2014-04-30 | 山东鲁抗立科药业有限公司 | Long-acting cefquinome sulfate injection and preparation method thereof |
| CN104127419A (en) * | 2014-08-12 | 2014-11-05 | 中国药科大学 | Stable cefquinome sulfate oil suspension injection |
| CN104473868A (en) * | 2014-12-01 | 2015-04-01 | 上海同仁药业有限公司 | Cefquinome sulfate suspension injection and preparation method thereof |
| CN104758245A (en) * | 2015-03-10 | 2015-07-08 | 河南牧翔动物药业有限公司 | A cefquinome sulfate oily suspension injection and a preparing method thereof |
| CN104873462A (en) * | 2014-11-18 | 2015-09-02 | 中国农业科学院饲料研究所 | Cefquinome-sulfate breast injection agent for dry period of dairy cows and preparation method thereof |
-
2015
- 2015-12-30 CN CN201511028387.2A patent/CN105640881A/en active Pending
Patent Citations (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20040115260A1 (en) * | 2002-12-16 | 2004-06-17 | Peter Schmid | Prolonged release pharmaceutical composition |
| CN101347407A (en) * | 2008-09-17 | 2009-01-21 | 河北远征药业有限公司 | Cefquinome sulfate injection and process for producing the same |
| CN101721366A (en) * | 2010-01-13 | 2010-06-09 | 洛阳惠中兽药有限公司 | Components and preparation method of beta-lactam injection |
| CN101987100A (en) * | 2010-11-10 | 2011-03-23 | 洛阳惠中兽药有限公司 | Method for preparing Cefquinome sulfate suspension injection |
| CN102319210A (en) * | 2011-09-29 | 2012-01-18 | 武汉回盛生物科技有限公司 | A kind of long-acting veterinary cefquinome sulfate injection and preparation method thereof |
| CN103751103A (en) * | 2014-02-21 | 2014-04-30 | 山东鲁抗立科药业有限公司 | Long-acting cefquinome sulfate injection and preparation method thereof |
| CN104127419A (en) * | 2014-08-12 | 2014-11-05 | 中国药科大学 | Stable cefquinome sulfate oil suspension injection |
| CN104873462A (en) * | 2014-11-18 | 2015-09-02 | 中国农业科学院饲料研究所 | Cefquinome-sulfate breast injection agent for dry period of dairy cows and preparation method thereof |
| CN104473868A (en) * | 2014-12-01 | 2015-04-01 | 上海同仁药业有限公司 | Cefquinome sulfate suspension injection and preparation method thereof |
| CN104758245A (en) * | 2015-03-10 | 2015-07-08 | 河南牧翔动物药业有限公司 | A cefquinome sulfate oily suspension injection and a preparing method thereof |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107334730A (en) * | 2017-06-30 | 2017-11-10 | 广东温氏大华农生物科技有限公司 | A kind of cefquinome sulfate injection and its low temperature high shear preparation method |
| CN107334730B (en) * | 2017-06-30 | 2020-05-15 | 广东温氏大华农生物科技有限公司 | Cefquinome sulfate injection and low-temperature high-shear preparation method thereof |
| CN112972418A (en) * | 2021-05-18 | 2021-06-18 | 北京金城泰尔制药有限公司 | Nifuratel nysfungin vaginal soft capsule and preparation method thereof |
| CN112972418B (en) * | 2021-05-18 | 2021-08-27 | 北京金城泰尔制药有限公司 | Nifuratel nysfungin vaginal soft capsule and preparation method thereof |
| CN117982413A (en) * | 2024-04-03 | 2024-05-07 | 山东恒邦中科生物工程有限公司 | Preparation method of cefquinome sulfate injection |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN103751103B (en) | A kind of long-acting cefquinome sulfate injection and preparation method thereof | |
| CN101721366B (en) | Components and preparation method of beta-lactam injection | |
| CN101401787B (en) | Ceftiofur long-acting injection and preparation method thereof | |
| CN105640881A (en) | Cefquinome sulfate muscle injection and preparation method thereof | |
| CN102178862A (en) | Preparation and quality detection methods of Xianglian disinfectant | |
| CN104758245A (en) | A cefquinome sulfate oily suspension injection and a preparing method thereof | |
| CN102018669B (en) | Long-acting ceftiofur hydrochloride injection and preparation method thereof | |
| CN104873462A (en) | Cefquinome-sulfate breast injection agent for dry period of dairy cows and preparation method thereof | |
| CN101982173B (en) | Danofloxacin mesylate-amoxicillin suspension injection applicable to livestock and poultry as well as preparation and application thereof | |
| CN105560177B (en) | Animal use suspensoid liquid and preparation method thereof containing Amoxicillin and baicalein | |
| CN110607344A (en) | Construction method and application of veterinary antibacterial drug cefquinome PK/PD model | |
| CN103705447B (en) | A kind of long-acting ceftiofur hydrochloride injection and preparation method thereof | |
| Tang et al. | Preparation of a newly formulated long‐acting ceftiofur hydrochloride suspension and evaluation of its pharmacokinetics in pigs | |
| CN101732632B (en) | Skin disease lotion composition and preparation method thereof | |
| CN106038482A (en) | Enrofloxacin uterus perfusion liquid as well as preparation method and application thereof | |
| CN103191058A (en) | Aqueous suspension injection of cephalosporin medicines, and preparation method thereof | |
| CN102772359A (en) | Enrofloxacin injection and preparation method thereof | |
| CN105769874B (en) | Animal use suspensoid liquid and preparation method thereof containing Ceftiofur and baicalein | |
| CN105943541B (en) | For treating the long-acting breast injection and preparation method thereof of milk cow dry breast phase mammitis | |
| Mao et al. | Cefquinome sulfate oily nanosuspension designed for improving its bioavailability in the treatment of veterinary infections | |
| CN113209014A (en) | Long-acting cefquinome sulfate suspension injection and preparation process thereof | |
| CN106309360B (en) | A kind of preparation method of long-acting ceftiofur hydrochloride injection | |
| CN105769762A (en) | Ampicillin suspension injection and preparation method thereof | |
| CN103910750B (en) | A kind of Ceftizoxime sodium compound | |
| CN104127431B (en) | A kind of ring for animals third-lincomycin long-acting injection and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| WD01 | Invention patent application deemed withdrawn after publication | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20160608 |