CN101953889A - Compound ceftiofur suspension emulsion injection and preparation method thereof - Google Patents
Compound ceftiofur suspension emulsion injection and preparation method thereof Download PDFInfo
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- CN101953889A CN101953889A CN2010102752279A CN201010275227A CN101953889A CN 101953889 A CN101953889 A CN 101953889A CN 2010102752279 A CN2010102752279 A CN 2010102752279A CN 201010275227 A CN201010275227 A CN 201010275227A CN 101953889 A CN101953889 A CN 101953889A
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Abstract
The invention discloses a compound ceftiofur suspension emulsion injection, which comprises the following components in percentage by mass: 1.5 to 15 percent of ceftiofur hydrochloride, 1.5 to 15 percent of magnolia flower oil, 1 to 10 percent of surfactant, 3 to 30 percent of oil for injection, 0.1 to 1 percent of antioxidant, 0.01 to 0.1 percent of thickening agent, and the balance of water for injection, wherein the sum of the mass percents of the components is 100 percent. The compound ceftiofur suspension emulsion injection has simple operation for the preparation method, strong antibacterial property and lasting pharmacological effect, and avoids stresses caused by multi-time administration of conventional formulations to animals; furthermore, the preparation cost is much lower than that of an oil suspension, and the compound ceftiofur suspension emulsion injection has a very high popularization and application value.
Description
Technical field
The invention belongs to field of medicaments, relate to a kind of veterinary drug novel form, what be specifically related to is a kind of suspendible emulsion formulations and preparation method thereof of animal specific antibiotic hydrochloric acid ceftiofur and the application aspect medical.
Technical background
Ceftiofur is first third generation cephalosporin class antibiotic that is specifically designed to animal, and the most of Cefliofur injection effective drug duration on the market are short, needs injection every day once, and logotype three days causes manpower financial capacity's waste, and also producing to animal stress.The long-acting dosage form of Ceftiofur Hydrochloride injecta is succeeded in developing and is applied for a patent at present, number of patent application is respectively 200810226889.X, 200710189747.6,200710189807.4,200910114976.0,200910054708.4, the common feature of these injection is the oil suspensions that are Ceftiofur Hydrochloride, promptly use the solvent of oil for injection fully as various raw materials, its shortcoming is to increase oil viscosity, and can't cause the inconvenience when using sometimes with dilutions such as waters for injection when using; Use oil higher fully as the solvent cost; Need to use instruments such as colloid mill that each effective ingredient is ground to form fine powder in the preparation, equipment manufacturing cost is higher.The long-acting ceftiofur injection is existing based on folk prescription in addition, but the cause of disease that causes livestock and birds respiratory disease becomes mixed infection by single, mainly two or more causes by virus, antibacterial, mycoplasma etc., and the antibiotic resistance problem of thereupon bringing is also serious day by day.So at present by improving technology and prescription, develop a kind of safety and effectivity more, antibiotic property is strong, and the low ceftiofur suspension Emulsion injection of production cost, the treatment of the various respiratory tract diseases of poultry is had more practical significance.
Summary of the invention
The present invention will overcome the deficiency in the existing Ceftiofur Hydrochloride injecta technology, propose a kind of new ceftiofur suspension Emulsion injection.This suspension emulsion injection has significantly reduced the use amount of oil for injection in the preparation, can alleviate the stimulation to the injection site with sterilized water dilution to reduce the viscosity of injection in use, is guaranteeing to have saved the raw material production cost in long-acting and safe; This injection is the best proportioning by screening emulsifying agent and oil for injection, thereby the emulsification that increases emulsifying agent reduces to diameter of aspirin particle about 0.2 μ m, does not need other equipment that each raw material is ground, and has reduced equipment cost.In addition, the present invention is also composite with Ceftiofur Hydrochloride and Flos Magnoliae oil.Flos Magnoliae is a kind of Chinese medicine with antibiotic double antivirus action, and multiple pathogenic fungus is had inhibitory action, simultaneously Flos Magnoliae also have dispel the wind, sensible effect, symptoms such as the nasal obstruction due to the respiratory system infection, watery nasal discharge are had certain mitigation.In addition Chinese medicine have suppress virus replication, regulate immunologic function, improve pulmonary circulation, comprehensive effect such as antalgic and inflammation relieving, can promote the effect of the recovery of infection so Chinese medicine and western medicine is rationally united, to tend to play treating both the principal and secondary aspects of a disease, the effect of raising curative effect.
The technical scheme that realizes the foregoing invention purpose is a kind of compound ceftiofur suspension emulsion injection, comprises following component:
Ceftiofur Hydrochloride 5%～7.5%
Flos Magnoliae oil 5%～7.5%
Surfactant 3%～5%
Oil for injection 6%～8%
Antioxidant 0.3%～0.5%
Thickening agent 0.06%～0.08%
Surplus is a water for injection, and the mass percent sum of above-mentioned composition is 100%.
Described surfactant refers to one or more composite of RH-40, tween 80, Arlacel-80, EL-40, TX-10 etc.
Described oil for injection pointed injection is with one or both mixture of soybean oil, glyceryl triacetate, diacetine, IPM, liquid paraffin, ethyl acetate, Semen Ricini wet goods.
Described antioxidant refers to Ve oil, and thickening agent is sodium carboxymethyl cellulose or aluminum monostearate.
Compound ceftiofur suspension emulsion injection of the present invention, optimum ratio is:
Ceftiofur Hydrochloride 2.5%～10%
Flos Magnoliae oil 2.5%～10%
Surfactant 2%～8%
Oil for injection 5%～25%
Antioxidant 0.2%～0.8%
Thickening agent 0.03%～0.08%
Surplus is a water for injection, and the mass percent sum of above-mentioned composition is 100%.
The best proportioning of compound ceftiofur suspension emulsion injection of the present invention is:
Ceftiofur Hydrochloride 7.5%
Flos Magnoliae oil 7.5%
Surfactant 5%
Oil for injection 7%
Antioxidant 0.5%
Thickening agent 0.06%
Surplus is a water for injection, and the mass percent sum of above-mentioned composition is 100%.
Another purpose of the present invention provides a kind of preparation method of compound ceftiofur suspension emulsion injection, specifically comprises the following steps:
1) with Ceftiofur Hydrochloride and Flos Magnoliae oil, slowly join in the oil for injection, the limit edged stirs, and messenger drug and oil is mixing fully;
2) surfactant is joined in the oil for injection of step 1) gained, fully stir;
3) antioxidant and the thickening agent of adding aequum fully stir;
4) water for injection is slowly added in the oil for injection that is added with various raw materials that stirs at normal temperatures, the limit edged stirs, and promptly gets compound ceftiofur suspension emulsion injection.
Compound ceftiofur suspension emulsion injection of the present invention compared with prior art has the following advantages:
(1) develops the suspension emulsion injection type of Ceftiofur Hydrochloride, compared with oil suspension and significantly reduced the greasy use amount of injection, reduced production cost.
(2) preparation technology is simple, and is workable without any need for the instrument and equipment of complexity, is applicable to production in enormous quantities.
(3) suspension emulsion can also reduce the injection pain sense that causes because of the injection thickness with dilutions such as waters for injection, and is easy to use.
(4) injection stability is high, not stratified, does not lump, and does not have tangible wall sticking phenomenon.
(5) particle diameter of injection is less, mainly is distributed between 0.15 μ m～0.25 μ m.
(6) carry out compositely with Flos Magnoliae oil, improved therapeutic effect.
Description of drawings
Fig. 1 Ceftiofur Hydrochloride suspension emulsion particle size distribution figure.
The transmission electron microscope photo of Fig. 2 compound Ceftiofur Hydrochloride suspension emulsion.
The specific embodiment
Following examples mainly are to be used to further specify the present invention, rather than limit the scope of the invention.
The preparation temperature of embodiment 1～2 is 70 ℃, and the preparation temperature of embodiment 3～4 is 60 ℃, and the preparation temperature of embodiment 5～6 is 50 ℃, and the preparation temperature of embodiment 7～8 is at normal temperatures.
The preparation technology of embodiment 1 compound ceftiofur suspension emulsion injection is as follows:
Ceftiofur Hydrochloride 1.5g
Flos Magnoliae oil 1.5g
EL-40 10.0g
Ethyl acetate 5.0g
Ve oil 0.1g
Sodium carboxymethyl cellulose 0.1g
Water for injection 81.8g
The concrete operations step is:
1) the injection soybean oil is filtered, about autoclaving postcooling to 70 ℃, it is standby to take by weighing 5.0g;
2) take by weighing 1.5g Ceftiofur Hydrochloride and 1.5g Flos Magnoliae oil, slowly join in the good oil for injection of sterilization, the limit edged stirs, and messenger drug and oil is mixing fully;
3) take by weighing EL-4010.0g, join step 2 after stirring) in the oil for injection of gained.
4) in step 3) gained oil for injection, add 0.1gVe oil and 0.1g sodium carboxymethyl cellulose, fully stir.
5) measure 81.8g water for injection, be heated to 70 ℃, slowly add in the injection soybean oil that is added with various raw materials that stirs, the limit edged stirs, and promptly gets compound ceftiofur suspension emulsion injection.
The preparation technology of embodiment 2 compound ceftiofur suspension emulsion injection is as follows:
Ceftiofur Hydrochloride 2.5g
Flos Magnoliae oil 2.5g
Tween 80 4.2g
Arlacel-80 2.8g
Injection soybean oil 7.0g
Ve oil 0.1g
Sodium carboxymethyl cellulose 0.07g
Water for injection 80.83g
The concrete operations step is with embodiment 1.
The preparation technology of embodiment 3 compound ceftiofur suspension emulsion injection is as follows:
Ceftiofur Hydrochloride 5.0g
Flos Magnoliae oil 5.0g
Tween 80 3.0g
Arlacel-80 2.0g
Injection soybean oil 10.0g
Ve oil 0.3g
Sodium carboxymethyl cellulose 0.05g
Water for injection 74.65g
The concrete operations step is with embodiment 1.
The preparation technology of embodiment 4 compound ceftiofur suspension emulsion injection is as follows:
Ceftiofur Hydrochloride 7.5g
Flos Magnoliae oil 7.5g
TX-10 5.0g
Liquid paraffin 15.0g
Ve oil 0.5g
Sodium carboxymethyl cellulose 0.05g
Water for injection 64.45g
The concrete operations step is with embodiment 1.
The preparation technology of embodiment 5 compound ceftiofur suspension emulsion injection is as follows:
Ceftiofur Hydrochloride 10.0g
Flos Magnoliae oil 10.0g
Tween 80 1.8g
Arlacel-80 1.2g
Oleum Ricini 17.0g
Ve oil 0.5g
Aluminium stearate 0.03g
Water for injection 59.47g
The concrete operations step is with embodiment 1.
The preparation technology of embodiment 6 compound ceftiofur suspension emulsion injection is as follows:
Ceftiofur Hydrochloride 12.0g
Flos Magnoliae oil 12.0g
RH-40 3.0g
Glyceryl triacetate 20.0g
Ve oil 0.7g
Aluminium stearate 0.01g
Water for injection 52.29g
The concrete operations step is with embodiment 1.
The preparation technology of embodiment 7 compound ceftiofur suspension emulsion injection is as follows:
Ceftiofur Hydrochloride 15.0g
Flos Magnoliae oil 15.0g
RH-40 1.0g
Injection soybean oil 15.0g
Glyceryl triacetate 10.0g
Ve oil 0.9g
Aluminium stearate 0.01g
Water for injection 43.09g
The concrete operations step is with embodiment 1.
The preparation technology of embodiment 8 compound ceftiofur suspension emulsion injection is as follows:
Ceftiofur Hydrochloride 15.0g
Flos Magnoliae oil 15.0g
RH-40 1.0g
Injection soybean oil 15.0g
Diacetine 15.0g
Ve oil 1.0g
Aluminium stearate 0.01g
Water for injection 37.99g
Embodiment 9
Ceftiofur Hydrochloride 7.5%
Flos Magnoliae oil 7.5%
Surfactant 5%
Oil for injection 7%
Antioxidant 0.5%
Thickening agent 0.06%
Compound ceftiofur suspension emulsion injection of the present invention is carried out the syringeability test, and settling volume ratio and heavy dispersibility inspection and content detection are to estimate its quality.
1. syringeability test
After getting compound ceftiofur suspension emulsion injection and shaking up,, write down one minute extraction amount with 6～No. 12 syringe needle sample thiefs.Result of the test is for except that No. 6 syringe needle extracts slowly, and all the other all easily extract, and show that the injection syringeability is good.
2. settling volume ratio
Get this product 50ml and place tool plug test tube, firmly jolting is 1 minute, and record suspensoid original height before sedimentation is H
0, leave standstill the sedimentation face of observing behind the certain hour when no longer changing the precipitum height be H.Its settling volume is than being F=H/H
0, the F value is bigger, represents settled height more near the original height of suspensoid, and suspensoid is more stable.Experimental result be the settling volume of compound ceftiofur suspension emulsion injection than all between 0.95～1, show that it has good stability.
3. heavy dispersibility
Suspensoid is added in the 100ml tool plug graduated cylinder, close plug, after placement sedimentation a period of time, graduated cylinder turns (evenly shake, one anti-one is just calculating once) after being inverted, and the observed quantity tube bottom has or not precipitation.Experimental result is that the even upset of compound ceftiofur suspension emulsion injection can be uniformly dispersed heavy favorable dispersibility for 4～6 times.
4. content detection
Adopt ultraviolet spectrophotometer method to measure the medicament contg of compound ceftiofur suspension emulsion injection, the result shows that the content of Ceftiofur Hydrochloride is 97.35%～100.24% of labelled amount
Experiment 1～experiment 3 injection with the embodiment of the invention 3 gained are experiment product, be that the long-acting ceftiofur suspension injection of embodiment 2 gained is contrast 1 in 200910114976.0 the patent with application number, application number is that the ceftiofur long-acting suspension injection of embodiment 2 gained in the patent of 200810226889.X is contrast 2, application number is that the long-acting ceftiofur injection of embodiment 4 gained in 200710189807.4 the patent is contrast 3, application number is that the compound ceftiofur oil suspension injection of embodiment 3 gained in 200710189747.6 the patent is contrast 4, carries out the pharmacokinetics experiment respectively, the cost of material of injection calculates and efficacy experiment.
Experimental example 1: pharmacokinetics experiment
One experimental technique
Get 25 of the close healthy rabbits of body weight, male and female half and half, body weight is 2.5 ± 0.3kg, raises in cages, free choice feeding drinking-water after the use complete feedstuff was fed 7 days, is divided into 5 groups at random.Injection experiment product in the A group hind leg quadriceps femoris, inject contrast 1 in the B group hind leg quadriceps femoris, inject contrast 2 in the C group hind leg quadriceps femoris, inject contrast 3 in the D group hind leg quadriceps femoris, inject contrast 4 in the D group hind leg quadriceps femoris, injected dose all are 10mg/kg (pressing the ceftiofur amount calculate).After the administration, regularly carry out ear edge vein exploitating blood, interval: 0 (give and want preceding), 15min, 0.5h, 1h, 2h, 3h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, get rabbit ear edge venous blood 2mL.With the blood drug level in the HPLC mensuration blood plasma, curve during with 3P97 pharmacokinetics process simulation medicine calculates pharmacokinetic parameter.
Two experimental results
Table 1 pharmacokinetics experimental result
T
1/2 βRefer to drug eliminated half life, T
MaxRefer to peak time, F refers to bioavailability.
By experimental result as can be known, compound Ceftiofur Hydrochloride suspension emulsion injection of the present invention is compared the half-life with the durative action preparation of other ceftiofurs short, and peak time is long, and the bioavailability height has tangible long-acting.
Experimental example 2: the cost of material of injection calculates
Cost of material is pressed 1kg injection (all hydrochloric ceftiofur 50g) and is calculated, each cost of material is with reference to the market price that shows on the public network, this experiment only as the cost contrast of each Ceftiofur Hydrochloride injecta raw material, does not comprise instrument and equipment and other consumable goods, non-final real cost of production.
Table 2 injection cost statistics
Can it is evident that by last table cost of material of the present invention compares many that other each oil suspension injection will be low.
Experimental example 3: efficacy experiment
One test method
Get 300 health, 1 age in days Luo Man chick, be divided into five groups of A, B, C, D, E at random, complete feed is fed the 8 equal secondary haemophiluss of artificial challenges in week back.Morbidity back A group intramuscular injection experiment product, B group intramuscular injection contrast 1, C group intramuscular injection contrast 2, D group intramuscular injection contrast 3, E group intramuscular injection contrast 4.Injected dose is 10mg/kg (pressing the ceftiofur amount calculates), and injection was once treated 7 days every three days, observed therapeutic effect, statistics cure rate and effective percentage.
Two experimental results
Give all in various degree following symptoms of appearance of sick chicken behind the manual-induced secondary haemophilus: inappetence, feather pine are disorderly, nasal cavity has serosity or mucus secretion, with conjunctivitis and rhinitis, the inflammation of eye conjunctiva etc.After the administration sick chicken is observed, it is as shown in the table to get experimental result.
Table 3 injection for treating effect
By the result as can be known, compound ceftiofur suspension emulsion injection of the present invention is compared the raising evident in efficacy of other injection.
Experimental example 4: compound Ceftiofur Hydrochloride suspension emulsion injection muscle irritation experiment
One test method
Get 5 of the close healthy rabbits of body weight, inject the self-control compound ceftiofur suspension emulsion injection of various concentration in the rear flank limb quadriceps femoris respectively, the normal saline of injection of opposite side hind leg corresponding position and opposite side same dose in contrast.The injected dose of injection all is 10mg/kg (pressing the ceftiofur amount calculates).Behind the 48h rabbit is put to death the variation of anatomic observation injection site muscular tissue.
Two experimental results
Cuing open inspection position test group and matched group does not have obvious difference, phenomenons such as the hyperemia of local nothing, edema, degeneration or necrosis.Show that compound ceftiofur suspension emulsion injection does not have muscle irritation.
Experimental example 5: the particle diameter of compound Ceftiofur Hydrochloride suspension emulsion injection detects
With transmission electron microscope the compound Ceftiofur Hydrochloride suspension emulsion injection of being developed is carried out particle diameter and detect, the result who is drawn is following illustrated in figures 1 and 2.
Most as seen from the figure particle size distribution at 0.15 μ m between the 0.25 μ m, and be not more than 0.35 μ m, contrasting 1 diameter of aspirin particle as can be known according to the description in the patent specification is 4 μ m～10 μ m, and the diameter of aspirin particle of contrast 2 is 1 μ m～15 μ m, and the diameter of aspirin particle of contrast 3 is 5 μ m.
Claims (5)
1. compound ceftiofur suspension emulsion injection is characterized in that being made up of the raw material of following component:
Ceftiofur Hydrochloride 1.5%～15%
Flos Magnoliae oil 1.5%～15%
Surfactant 1%～10%
Oil for injection 3%～30%
Antioxidant 0.1%～1%
Thickening agent 0.01%～0.1%
Surplus is a water for injection, and the mass percent sum of above-mentioned composition is 100%;
Described surfactant is one or both composite of RH-40, tween 80, Arlacel-80, EL-40, TX-10 etc.;
Described oil for injection pointed injection is with one or both mixture of soybean oil, glyceryl triacetate, diacetine, IPM, liquid paraffin, ethyl acetate, Semen Ricini wet goods;
Described antioxidant is a Ve oil;
Described thickening agent is any in sodium carboxymethyl cellulose or the aluminum monostearate.
2. compound ceftiofur suspension emulsion injection according to claim 1 is characterized in that being made up of the raw material of following component:
Ceftiofur Hydrochloride 2.5%～10%
Flos Magnoliae oil 2.5%～10%
Surfactant 2%～8%
Oil for injection 5%～25%
Antioxidant 0.2%～0.8%
Thickening agent 0.03%～0.08%
Surplus is a water for injection, and the mass percent sum of above-mentioned composition is 100%.
3. compound ceftiofur suspension emulsion injection according to claim 1 is characterized in that being made up of the raw material of following component:
Ceftiofur Hydrochloride 7.5%
Flos Magnoliae oil 7.5%
Surfactant 5%
Oil for injection 7%
Antioxidant 0.5%
Thickening agent 0.06%
Surplus is a water for injection, and the mass percent sum of above-mentioned composition is 100%.
4. a preparation method for preparing the described compound ceftiofur suspension emulsion of claim 1 injection is characterized in that, specifically comprises the following steps:
1) with Ceftiofur Hydrochloride and Flos Magnoliae oil, slowly join in the oil for injection, the limit edged stirs, and messenger drug and oil is mixing fully;
2) surfactant is joined in the oil for injection of step 1) gained, fully stir;
3) antioxidant and the thickening agent of adding aequum fully stir;
4) water for injection is slowly added in the oil for injection that is added with various raw materials that stirs at normal temperatures, the limit edged stirs, and promptly gets compound ceftiofur suspension emulsion injection.
5. the application among the secondary haemophilus disease of the described compound ceftiofur suspension emulsion of claim 1 injection for treating domestic animals and fowls, contagious pleuropneumonia, the atrophic rhinitis.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103301147A (en) * | 2012-03-12 | 2013-09-18 | 河南省针剂兽药工程技术研究中心 | Nanometer compound ceftiofur suspension and preparation method thereof |
| CN104080456A (en) * | 2011-12-23 | 2014-10-01 | 拜耳新西兰有限公司 | Antibiotic formulations |
| CN106420612A (en) * | 2016-11-30 | 2017-02-22 | 河南牧翔动物药业有限公司 | Cefovecin microemulsion and preparation method thereof |
| CN112870159A (en) * | 2021-02-03 | 2021-06-01 | 西安乐道生物科技有限公司 | Veterinary ceftiofur hydrochloride injection for clearing heat, detoxifying and reducing fever and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101406447A (en) * | 2007-10-12 | 2009-04-15 | 河南农业大学 | Technique for preparing compound ceftiofur oil suspension injection |
-
2010
- 2010-09-07 CN CN2010102752279A patent/CN101953889B/en not_active Expired - Fee Related
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101406447A (en) * | 2007-10-12 | 2009-04-15 | 河南农业大学 | Technique for preparing compound ceftiofur oil suspension injection |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104080456A (en) * | 2011-12-23 | 2014-10-01 | 拜耳新西兰有限公司 | Antibiotic formulations |
| CN103301147A (en) * | 2012-03-12 | 2013-09-18 | 河南省针剂兽药工程技术研究中心 | Nanometer compound ceftiofur suspension and preparation method thereof |
| CN106420612A (en) * | 2016-11-30 | 2017-02-22 | 河南牧翔动物药业有限公司 | Cefovecin microemulsion and preparation method thereof |
| CN106420612B (en) * | 2016-11-30 | 2019-07-26 | 河南牧翔动物药业有限公司 | A kind of cephalo dimension star micro emulsion and preparation method thereof |
| CN112870159A (en) * | 2021-02-03 | 2021-06-01 | 西安乐道生物科技有限公司 | Veterinary ceftiofur hydrochloride injection for clearing heat, detoxifying and reducing fever and preparation method thereof |
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