CN108578362A - A kind of cephalo dimension star suspension injection and preparation method thereof - Google Patents
A kind of cephalo dimension star suspension injection and preparation method thereof Download PDFInfo
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- CN108578362A CN108578362A CN201810537577.4A CN201810537577A CN108578362A CN 108578362 A CN108578362 A CN 108578362A CN 201810537577 A CN201810537577 A CN 201810537577A CN 108578362 A CN108578362 A CN 108578362A
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- 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
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- 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
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- 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
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- 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
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
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- 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
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/02—Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
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- Urology & Nephrology (AREA)
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Abstract
The invention discloses a kind of cephalos to tie up star suspension injection, and based on mass volume ratio, wherein tieing up star 0.5 2% containing cephalo, suspending agent 1 3%, antioxidant 0.1 0.3%, solvent for injection adds to 100%；The present invention also provides the preparation method that cephalo ties up star suspension injection, prepared cephalo ties up star suspension injection, and character is stable, uniform, easy to use, it is easy to preserve, long shelf-life reaches 65d, and preparation method is simple, process is easily controllable, and cephalo dimension star solute effect is good, is suitble in industrialized production.The present invention is suitable for preparing cephalo dimension star suspension injection.
Description
Technical field
The invention belongs to pharmaceutical fields, are related to a kind of preparation method of cephalo dimension star suspension injection.
Background technology
Cephalo dimension star is used exclusively for a kind of broad-spectrum cephalosporin class antibiotic that treatment cat, dog sensitive bacteria cause disease,
There is special efficacy to gram-positive bacteria, negative bacterium and conveyor screw.Caused by staphylococcus and streptococcus sensitive strain for treating dog
Skin infection（Such as secondary superficial pyoderma, abscess and wound）, the urethra sense caused by Escherichia coli and/or proteus
Dye.Treat cat skin infection caused by pasteurella multocida and staphylococcus sensitive strain（Such as wound and abscess）, by big
Urinary tract infection caused by enterobacteria.It is third generation animal specific cephalosporins that cephalo, which ties up star, because of its powerful antibacterial
The characteristics such as active, wide antimicrobial spectrum and low drug resistance and be widely used.But the specific diluted of medicine needs, using trouble,
And its unstable chemcial property, it is insoluble in water, the facile hydrolysis under acid or alkaline conditions of the beta-lactam nucleus in structure, greatly
Ground limits its clinical application.
Invention content
The technical problem to be solved in the present invention is to provide a kind of cephalo dimension star suspension injection, injection character stabilization,
Uniformly, easy to use, it is easy to preserve, the shelf-life is longer；
It is yet another object of the present invention to provide the preparation methods that above-mentioned cephalo ties up star suspension injection, and this method is simple,
Process is easily controllable, and cephalo ties up that star solute effect in water is good, and the injection of formation is uniform, character is stablized.
In order to solve the above technical problems, the technical solution used in the present invention is：
A kind of cephalo dimension star suspension injection, wherein tieing up star 0.5-2%, suspending agent 1-3% containing cephalo, resists based on mass volume ratio
Oxygen agent 0.1-0.3%, solvent for injection add to 100%.
Restriction as the present invention：
The suspending agent is glycerin monostearate；
The antioxidant is vitamin E；
The solvent for injection is soybean oil；
The present invention also provides the preparation method that a kind of cephalo ties up star suspension injection, it according to following step sequence successively into
Row：
（1）Cephalo dimension star is taken to crush, sterilizing obtains A；
（2）After taking antioxidant, suspending agent sterilized, B is obtained；
（3）It takes solvent for injection to heat, sterilizes after heat preservation, be cooled to room temperature, obtain C；
（4）A and B are sequentially added in C, suspension is completely dispersed into after stirring；
（5）Step（4）Suspension after homogeneous, finished product.
Restriction as preparation method of the present invention：
The cephalo dimension star is crushed to 90% grain diameter≤20 μm；
The solvent for injection is heated to 65-80 DEG C, keeps the temperature 20min, sterilize 10min at 120 DEG C.
The preparation method of the present invention also has a kind of restriction, step（5）In, the homogenization pressure is 6.5MPa, homogenizing time
For 5min.
Due to the adoption of the above technical solution, compared with prior art, the present invention acquired technological progress is：
The present invention provides a kind of cephalo dimension star suspension injection, and character is stable, uniform, easy to use, is easy to preserve, long shelf-life
Up to 65d；The preparation method that cephalo ties up star suspension injection is simple, and process is easily controllable, and cephalo dimension star solute effect is good, formation
Injection is uniform, character is stablized, and is suitble in industrialized production.
The present invention is suitable for preparing cephalo dimension star suspension injection.
The present invention is described in further detail below in conjunction with specific embodiment.
Specific implementation mode
Reagent as used in the following examples is commercially available reagent, preparation method is such as without special theory unless otherwise specified
Bright is existing method.
A kind of 1 cephalo of embodiment ties up star suspension injection
The present embodiment is that a kind of cephalo ties up star suspension injection, it is carried out successively according to following step sequence：
（11）Cephalo dimension star 0.8g is taken to crush, cephalo dimension star is crushed to 90% grain diameter≤20 μm, and sterilizing obtains A1；
（12）After taking antioxidant vitamins E 0.1g, suspending agent glycerin monostearate 1g sterilized, B1 is obtained；
（13）It taking solvent for injection soybean oil to add to 100mL, is heated to 65 DEG C, sterilize after heat preservation 20min at 120 DEG C 10min,
It is cooled to room temperature, obtains C1；
（14）A1 and B1 are sequentially added in C1, to be completely dispersed into suspension after the rotating speed stirring of 120r/s；
（15）Step（14）Suspension under 6.5MPa homogeneous 5min, finished product.
Cephalo prepared by the present embodiment ties up star suspension injection, and character is stable, uniform, easy to use, is easy to preserve, and protects
The matter phase is longer；Preparation method is simple, and process is easily controllable, and cephalo dimension star solute effect is good, is suitble in industrialized production.
Embodiment 2-5 cephalos tie up star suspension injection
The present embodiment is respectively a kind of cephalo dimension star dusk outstanding injection, and preparation method is similar to Example 1, and difference only exists
In：Corresponding technical parameter is different in preparation process, table specific as follows.Solvent for injection soybean oil adds to always in following embodiments
Liquor capacity reaches 100mL.
Cephalo prepared by embodiment 2-5 ties up star suspension injection, and character is stable, uniform, easy to use, is easy to preserve,
Shelf-life is longer；Preparation method is simple, and process is easily controllable, and cephalo dimension star solute effect is good, is suitble in industrialized production.
6 cephalo of embodiment ties up the temperature and soaking time pair that solvent for injection heats in star suspension injection preparation process
The influence of properties of product
In cephalo ties up star suspension injection preparation process, the temperature and soaking time of solvent for injection heating are most important
, the temperature and soaking time of soybean oil heating can ensure that soybean oil is not oxidized rotten, and in certain energy range
It is interior, so that particulate matter is dispersed in soybean oil, and particulate matter is wrapped up so that and particulate matter will not reunite or float, this
When soybean oil whether can wrap the thickness of particle and package, diameter is formed by the stability of suspension with final dispersion
And uniformity is closely bound up.In order to probe into the influence of soybean oil heating temperature and soaking time to final products performance, this implementation
Example has carried out a series of probe into, wherein cephalo dimension star suspension injection preparation process is similar to Example 1, and difference is only
It is：The temperature and soaking time of soybean oil heating are different, table specific as follows.
Embodiment 1-5 is only presently preferred embodiments of the present invention, is not the limit of other forms made for the present invention
Fixed, any person skilled in the art is changed or is modified as equivalent change possibly also with above-mentioned technology contents as enlightenment
The equivalent embodiment of change.In every case it is the technical spirit without departing from the claims in the present invention, it is simple to made by above example
Modification, equivalent variations and remodeling still fall within the range of the claims in the present invention protection.
Claims (8)
1. a kind of cephalo ties up star suspension injection, it is characterised in that：Based on mass volume ratio, wherein star 0.5-2% is tieed up containing cephalo,
Suspending agent 1-3%, antioxidant 0.1-0.3%, solvent for injection add to 100%.
2. a kind of cephalo according to claim 1 ties up star suspension injection, it is characterised in that：The suspending agent is single stearic
Acid glyceride.
3. a kind of cephalo according to claim 1 ties up star suspension injection, it is characterised in that：The antioxidant is vitamin
E。
4. a kind of cephalo according to claim 1 ties up star suspension injection, it is characterised in that：The solvent for injection is big
Soya-bean oil.
5. a kind of preparation method of cephalo dimension star suspension injection as described in any one of claim 1-4, feature exist
It is carried out successively according to following step sequence in it：
（1）Cephalo dimension star is taken to crush, sterilizing obtains A；
（2）After taking antioxidant, suspending agent sterilized, B is obtained；
（3）It is heated after taking solvent for injection, is sterilized after heat preservation, room temperature is cooled to, obtains C；
（4）A and B are sequentially added in C, suspension is completely dispersed into after stirring；
（5）Step（4）Suspension after homogeneous, finished product.
6. a kind of preparation method of cephalo dimension star suspension injection according to claim 5, it is characterised in that：The cephalo
Dimension star is crushed to 90% grain diameter≤20 μm.
7. a kind of preparation method of cephalo dimension star suspension injection according to claim 5, it is characterised in that：Step（2）
In, the solvent for injection is heated to 65-80 DEG C, keeps the temperature 20min, sterilize 10min at 120 DEG C.
8. a kind of preparation method of cephalo dimension star suspension injection according to claim 5-7 any one, feature exist
In：Step（5）In, the homogenization pressure is 6.5MPa, homogenizing time 5min.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810537577.4A CN108578362A (en) | 2018-05-30 | 2018-05-30 | A kind of cephalo dimension star suspension injection and preparation method thereof |
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| CN201810537577.4A CN108578362A (en) | 2018-05-30 | 2018-05-30 | A kind of cephalo dimension star suspension injection and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2020181024A1 (en) * | 2019-03-06 | 2020-09-10 | Zoetis Services Llc | Ready-to-use injectable formulations |
| RU2777360C1 (en) * | 2019-03-06 | 2022-08-02 | ЗОЕТИС СЕРВИСИЗ ЭлЭлСи | Ready-to-use dosage forms for injection |
Citations (3)
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| CN101401787A (en) * | 2008-11-19 | 2009-04-08 | 肖希龙 | Ceftiofur long-acting injection and preparation method thereof |
| CN103191058A (en) * | 2012-01-05 | 2013-07-10 | 洛阳惠中兽药有限公司 | Aqueous suspension injection of cephalosporin medicines, 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 |
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2018
- 2018-05-30 CN CN201810537577.4A patent/CN108578362A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101401787A (en) * | 2008-11-19 | 2009-04-08 | 肖希龙 | Ceftiofur long-acting injection and preparation method thereof |
| CN103191058A (en) * | 2012-01-05 | 2013-07-10 | 洛阳惠中兽药有限公司 | Aqueous suspension injection of cephalosporin medicines, 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 |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2020181024A1 (en) * | 2019-03-06 | 2020-09-10 | Zoetis Services Llc | Ready-to-use injectable formulations |
| KR20210120084A (en) * | 2019-03-06 | 2021-10-06 | 조에티스 서비시즈 엘엘씨 | Ready-to-use injectable formulations |
| RU2777360C1 (en) * | 2019-03-06 | 2022-08-02 | ЗОЕТИС СЕРВИСИЗ ЭлЭлСи | Ready-to-use dosage forms for injection |
| RU2777360C9 (en) * | 2019-03-06 | 2022-09-14 | ЗОЕТИС СЕРВИСИЗ ЭлЭлСи | Ready-to-use dosage forms for injection |
| KR102671650B1 (en) * | 2019-03-06 | 2024-06-04 | 조에티스 서비시즈 엘엘씨 | Ready-to-use injectable formulation |
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