CN103230365B - Novel slow-release breast perfusion agent for preventing cow subclinical mastitis in milk shortage stage - Google Patents
Novel slow-release breast perfusion agent for preventing cow subclinical mastitis in milk shortage stage Download PDFInfo
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- CN103230365B CN103230365B CN201310087067.9A CN201310087067A CN103230365B CN 103230365 B CN103230365 B CN 103230365B CN 201310087067 A CN201310087067 A CN 201310087067A CN 103230365 B CN103230365 B CN 103230365B
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Abstract
The invention provides a novel slow-release breast perfusion agent for preventing cow subclinical mastitis in a milk shortage stage. 100g of the novel slow-release breast perfusion agent comprises 7-11g of cefalonium, 0.5 to 8g of polyethylene glycol-400, Tween materials or propylene glycol, 0.5 to 8g of fatty alcohol polyoxyethylene ether, cyclomethylene glyceryl ether, triacetin or poloxamer, 0.5 to 8g of aluminum stearate or silica, 0.02 to 0.05g of vitamin E, 0.05 to 0.1g of benzyl alcohol, and the balance liquid paraffin, soybean oil for injection or median chain triglyceride. The invention also provides a preparation method of the novel slow-release breast perfusion agent. The novel slow-release breast perfusion agent is suspension colloid, can be slowly released, can effectively reduce administration frequency, can effectively prevent and treat cow subclinical mastitis by being used in a milk shortage stage, and does not produce residues. Compared with the like foreign products, the suspension colloid has better stability.
Description
Technical field
The present invention relates to veterinary drug preparation field, specifically, relate to a kind of slow release breast perfusion preparation that prevents milk cow recessive mastitis and preparation method thereof.
Background technology
Bovine mastitis is one of common disease of harm milk cattle cultivating industry, and the whole world approximately has 50% milch cow to suffer from various types of bovine mastitis, and milk cattle cultivating industry is caused to huge economic loss.The main cause that causes bovine mastitis is cause pathogeny imcrobe infection, wherein especially common with these 5 kinds of cause of disease types of staphylococcus aureus, streptococcus agalactiae, streptococcus dysgalactiae, streptococcus uberis and various gram negative bacteria.Milk cow recessive mastitis do not have obvious clinical symptoms, show as milk somatic cell number and raise, and milk yield declines, and the composition of milk changes, thereby affects the quality of milk.As treatment or malpractice not in time can develop into clinical mastitis, even cause blind teat, when serious, cause milch cow to be eliminated.Due to problems such as sickness rate height and milk antibiotic remainss, general tree subclinical mastitis is treated.
Slow releasing preparation refers to by delaying the rate of release of medicine from this dosage form, reduces medicine and enters the absorption rate of body, thereby play better therapeutic effect.
Summary of the invention
The object of this invention is to provide a kind of novel in the dry milk phase for preventing the slow release breast perfusion preparation of milk cow recessive mastitis.
The present invention also provides the preparation method of described filling agent.
In order to realize the object of the invention, in a kind of every 100g filling agent of slow release breast that prevents milk cow recessive mastitis of the present invention, contain cefalonium 7-11g, PEG-4000 (PEG-400), Tweens material or propylene glycol 0.5-8g, fatty alcohol-polyoxyethylene ether (AEO-7) glycerol formal, glyceryl triacetate or poloxamer 0.5-8g, aluminium stearate or silicon dioxide 0.5-8g, vitamin E 0.02-0.05g, benzyl alcohol 0.05-0.1g, surplus is liquid paraffin, injection soybean oil or median chain triglyceride oil.
Preferably, described filling agent consists of the following composition: in every 100g filling agent, contain cefalonium 9g, and PEG-4000 1g, fatty alcohol-polyoxyethylene ether 1g, aluminium stearate 2g, vitamin 0.04g, benzyl alcohol 0.06g, surplus is liquid paraffin.
The present invention also provides the preparation method of described filling agent, comprises the following steps:
(1) cefalonium crude drug is crushed to 90% above particle diameter and reaches 3-5 μ m, sterilizing reaches aseptic requirement, is material A;
(2) by liquid paraffin sterilizing (with aseptic membrane filtration degerming), add PEG-4000 (PEG-400), fatty alcohol-polyoxyethylene ether (AEO-7) and aluminium stearate, stirring and evenly mixing, continuous heating 4-6 hour, is down to room temperature, obtains liquid B;
(3) material A, liquid B, vitamin E and benzyl alcohol are dosed in high pressure homogenizer, utilize the high pressure homogenizer homogeneous 5-10min that circulates, pressure is controlled at 50-150MPa, quantitatively to prescribed dose, and subpackage, sealing, packing.
Of the present invention in the dry milk phase for preventing the slow release breast perfusion preparation of milk cow recessive mastitis to use as eye ointment or uterine perfusion agent.
Of the present invention is suspendible colloid in the dry milk phase for preventing the slow release breast perfusion preparation of milk cow recessive mastitis, can slowly discharge, effectively reduce administration number of times, use this filling agent in the administration of dry milk phase, can effectively prevent the generation of milk cow recessive mastitis, the feature with noresidue in milk lactation period, compares with same kind of products at abroad, and the suspendible colloid of this dosage form has better stability.
Accompanying drawing explanation
Fig. 1 is the vitro release curve curve of the cefalonium filling agent of preparation in the embodiment of the present invention 1.
The specific embodiment
Following examples are used for illustrating the present invention, but are not used for limiting the scope of the invention.If do not specialize, the conventional means that in embodiment, technological means used is well known to those skilled in the art, the raw materials used commercial goods that is.
Embodiment 1 is used for preventing slow release breast perfusion preparation and the preparation thereof of milk cow recessive mastitis in the dry milk phase
The composition of every 100g filling agent is composed as follows:
Cefalonium crude drug is crushed to 90% above particle diameter and reaches 3-5 μ m, sterilizing reaches aseptic requirement, is material A; By liquid paraffin sterilizing (with aseptic membrane filtration degerming), add PEG-4000 (PEG-400), fatty alcohol-polyoxyethylene ether (AEO-7) and aluminium stearate, stirring and evenly mixing, continuous heating 5 hours, is down to room temperature, is liquid B; Material A, liquid B, vitamin E, benzyl alcohol are dosed to high pressure homogenizer, utilize the high pressure homogenizer homogeneous 7min that circulates, pressure is controlled at 50MPa, quantitatively to 100g, and subpackage, sealing, packing.
Embodiment 2 is used for preventing slow release breast perfusion preparation and the preparation thereof of milk cow recessive mastitis in the dry milk phase
The composition of every 100g filling agent is composed as follows:
Cefalonium crude drug is crushed to 95% above particle diameter and reaches 3-5 μ m, sterilizing reaches aseptic requirement, is material A; By liquid paraffin sterilizing (with aseptic membrane filtration degerming), add PEG-4000 (PEG-400), fatty alcohol-polyoxyethylene ether (AEO-7) and aluminium stearate, stirring and evenly mixing, continuous heating 4 hours, is down to room temperature, is liquid B; Material A, liquid B, vitamin E, benzyl alcohol are dosed to high pressure homogenizer, utilize the high pressure homogenizer homogeneous 5min that circulates, pressure is controlled at 150MPa, quantitatively to 100g, and subpackage, sealing, packing.
Embodiment 3 is used for preventing slow release breast perfusion preparation and the preparation thereof of milk cow recessive mastitis in the dry milk phase
The composition of every 100g filling agent is composed as follows:
Cefalonium crude drug is crushed to 90% above particle diameter and reaches 3-5 μ m, sterilizing reaches aseptic requirement, is material A; By the sterilizing of injection soybean oil (with aseptic membrane filtration degerming), add tween 80, glycerol formal and aluminium stearate, stirring and evenly mixing, continuous heating 5 hours, is down to room temperature, is liquid B; Material A, liquid B, vitamin E, benzyl alcohol are dosed to high pressure homogenizer, utilize the high pressure homogenizer homogeneous 9min that circulates, pressure is controlled at 120MPa, quantitatively to 100g, and subpackage, sealing, packing.
Embodiment 4 is used for preventing slow release breast perfusion preparation and the preparation thereof of milk cow recessive mastitis in the dry milk phase
The composition of every 100g filling agent is composed as follows:
Cefalonium crude drug is crushed to 95% above particle diameter and reaches 3-5 μ m, sterilizing reaches aseptic requirement, is material A; By median chain triglyceride oil sterilizing (with aseptic membrane filtration degerming), add Tween-60, glyceryl triacetate and silicon dioxide, stirring and evenly mixing, continuous heating 6 hours, is down to room temperature, is liquid B; Material A, liquid B, vitamin E, benzyl alcohol are dosed to high pressure homogenizer, utilize the high pressure homogenizer homogeneous 10min that circulates, pressure is controlled at 120MPa, quantitatively to 100g, and subpackage, sealing, packing.
Embodiment 5 is used for preventing slow release breast perfusion preparation and the preparation thereof of milk cow recessive mastitis in the dry milk phase
The composition of every 100g filling agent is composed as follows:
Cefalonium crude drug is crushed to 90% above particle diameter and reaches 3-5 μ m, sterilizing reaches aseptic requirement, is material A; By the sterilizing of injection soybean oil (with aseptic membrane filtration degerming), add propylene glycol, poloxamer and silicon dioxide, stirring and evenly mixing, continuous heating 4.5 hours, is down to room temperature, is liquid B; Material A, liquid B, vitamin E, benzyl alcohol are dosed to high pressure homogenizer, utilize the high pressure homogenizer homogeneous 6min that circulates, pressure is controlled at 100MPa, quantitatively to 100g, and subpackage, sealing, packing.
Embodiment 6 in the dry milk phase for preventing the application of slow release breast perfusion preparation of milk cow recessive mastitis
Use in embodiment 1-5, prepare in the dry milk phase for preventing the slow release breast perfusion preparation of milk cow recessive mastitis, certain farm is chosen to 134 2 years old milch cows at random and carry out the treatment of dry milk phase, after just finishing lactation period, treat immediately, in the whole dry milk phase, its treatment can not be interrupted.Each nipple perfusion administration 3g of every cow head.In order to assess the effect of whole control procedure, before begin treatment, after begin treatment 2.5 months, 5 months, 7.5 months and within 10 months, differentiate respectively the incidence rate of milk cow recessive mastitis.Preventive effect is assessed with the reduction rate of milk cow recessive mastitis.
The reduction rate of milk cow recessive mastitis=(A-B)/A * 100%
A: the incidence rate of the milk cow recessive mastitis before treatment starts; B: the incidence rate of milk cow recessive mastitis when treatment finishes.
Result is as shown in table 1.
The reduction rate of milk cow recessive mastitis before and after the treatment of table 1 dry milk phase
For there is the milk ox head number of subclinical mastitis in note: I, II is the incidence rate of milk cow recessive mastitis
As can be seen from Table 1, in embodiment 1-5, prepare in the dry milk phase for preventing the slow release breast perfusion preparation of milk cow recessive mastitis to there is good prophylactic treatment effect to bovine mastitis.
The vitro release curve of embodiment 7 filling agents of the present invention
With syringe, accurately extract the cefalonium filling agent 10ml of the embodiment 1 mixing, putting into diameter is 1cm, be about in the bag filter of 20cm, remove a bag interior air, tighten with cotton rope at two, coiling is fixed on digestion instrument stirring paddle, the phosphate buffer 900ml of pH value 7.8 of take is dissolution medium, add a small amount of surfactant, keep temperature (37 ± 0.5) ℃, rotating speed is 100rpm, respectively at 0.5h, 1h, 2h, 4h, 8h, 12h, 16h, 20h, 24h and 48h sampling 5ml, and supplement in time dissolution medium 5ml, utilize the release amount of medicine of high-performance liquid chromatogram determination day part, vitro release curve as shown in Figure 1, illustrate that this dosage form has good release in vitro effect.
Embodiment 8 drug residues detect (TTC method)
Drug residue detects and carries out according to TTC method operation sequence.TTC ratio juris is: if while having antibiotic to exist in milk, inoculated after streptococcus thermophilus (Streptococcus thermophilus), the growth of antibacterial is suppressed, and milk can not molding; If antibiotic-free exists in milk, bacterial multiplication, makes milk molding.Gather the treatment milk sample of latter 49 days, drawing 10ml is put in sterilized test tube, then test tube is placed on to heating in water bath on electric furnace, when reaching 80 ℃, after maintaining 5min, take out test tube, be placed in cold water and be cooled to 37 ℃, in each test tube, add streptococcus thermophilus strain 2.5ml, after mixing, be placed in the incubator of 37 ℃ and cultivate 2.5 hours, observed result.
Drug residue free in the milk sample detecting after 49 days in drug withdrawal, can continue to use milk.The dry milk phase of milch cow was generally about 60 days, so can not cause and produce drug residue in lactation period in the treatment of dry milk phase.
In the present embodiment, adopt the dry milk phase Therapeutic Method identical with embodiment 6.The slow release breast perfusion preparation that the medicine using is the prevention milk cow recessive mastitis prepared in embodiment 1-5.
Embodiment 9 investigates the stability of filling agent of the present invention
Cefalonium filling agent and the same kind of products at abroad of preparation in embodiment 1 are placed in respectively to the close plug of 100ml tool plug graduated cylinder, jolting is 1 minute separately, record respectively settling volume that two kinds of dosage forms place 3 days, 7 days, 14 days, 21 days, 28 days and 35 days than (table 2), computing formula:
Settling volume compares F=H
u/ H
0
Wherein, H
0for the elemental height of suspension, H
ufor precipitum height.
Table 2 settling volume compares experimental result
| ? | Cefalonium filling agent | Same kind of products at abroad |
| 3 days | 0.99 | 0.98 |
| 7 days | 0.98 | 0.95 |
| 14 days | 0.97 | 0.68 |
| 21 days | 0.95 | 0.49 |
| 28 days | 0.92 | 0.33 |
| 35 days | 0.87 | 0.18 |
Cefalonium filling agent and the same kind of products at abroad of preparation in embodiment 1 are rotated to 5min respectively under 2000rpm rotating speed, make its precipitation, then tool plug graduated cylinder is inverted to upset (anti-just for once), is recorded precipitum at the bottom of cylinder is disperseed to required upset number of times (table 3) again.
Table 3 is dispersion experiment result again
| ? | Cefalonium filling agent | Same kind of products at abroad |
| Be inverted upset number of times | 2 | 5 |
Settling volume than and again dispersion experiment result effectively proved and utilize the stability of cefalonium filling agent form formula prepared by high pressure homogenizer to be obviously better than same kind of products at abroad, good stability is conducive to preservation and the transportation of preparation.
Although above the present invention is described in detail with a general description of the specific embodiments, on basis of the present invention, can make some modifications or improvements it, this will be apparent to those skilled in the art.Therefore, these modifications or improvements, all belong to the scope of protection of present invention without departing from theon the basis of the spirit of the present invention.
Claims (2)
- One kind in the dry milk phase for preventing the slow release breast perfusion preparation of milk cow recessive mastitis, it is characterized in that, consist of the following composition: in every 100g filling agent, contain cefalonium 7-11g, PEG-4000, Tweens material or propylene glycol 0.5-8g, fatty alcohol-polyoxyethylene ether, glycerol formal, glyceryl triacetate or poloxamer 0.5-8g, aluminium stearate or silicon dioxide 0.5-8g, vitamin E 0.02-0.05g, benzyl alcohol 0.05-0.1g, surplus is liquid paraffin, injection soybean oil or median chain triglyceride oil;The preparation method of described filling agent, comprises the following steps:1) particle diameter cefalonium crude drug being crushed to more than 90% reaches 3-5 μ m, and sterilizing, is material A;2) in liquid paraffin, add PEG-4000, fatty alcohol-polyoxyethylene ether and aluminium stearate, stirring and evenly mixing, continuous heating 4-6 hour, is down to room temperature, obtains liquid B;3) material A, liquid B, vitamin E and benzyl alcohol are dosed in high pressure homogenizer, pressure is 50-150Mpa, homogeneous 5-10min.
- 2. filling agent according to claim 1, is characterized in that, in every 100g filling agent, contains cefalonium 9g, PEG-4000 1g, and fatty alcohol-polyoxyethylene ether 1g, aluminium stearate 2g, vitamin 0.04g, benzyl alcohol 0.06g, surplus is liquid paraffin.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103479574A (en) * | 2013-09-12 | 2014-01-01 | 华南农业大学 | Breast injectant used for preventing and treating dry-milk-period dairy cow mastitis and preparation method thereof |
| CN104288136B (en) * | 2014-04-30 | 2017-06-23 | 郑州百瑞动物药业有限公司 | A kind of milk cow chlorhexidine acetate uterus injectant and preparation method thereof |
| CN105726461B (en) * | 2014-12-10 | 2021-02-09 | 瑞普（天津）生物药业有限公司 | Ceftiofur hydrochloride breast injection in dry period |
| CN106074384A (en) * | 2016-08-08 | 2016-11-09 | 甘肃新天马制药股份有限公司 | A kind of pirlimycin micellar preparation and preparation method thereof |
| CN114404365B (en) * | 2022-01-18 | 2023-03-14 | 山东鲁抗舍里乐药业有限公司 | Cefalonium breast injection and preparation method and application thereof |
| CN115138444B (en) * | 2022-05-31 | 2023-04-28 | 青岛农业大学 | Preparation method and application of cefalotin cream for dairy cows |
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| CN101107015A (en) * | 2005-01-19 | 2008-01-16 | 日本全药工业株式会社 | Injection for mastitis |
| CN101579347A (en) * | 2009-06-25 | 2009-11-18 | 中国农业大学 | Breast perfusion preparation for treating mammitis of milk cow in lactation period and preparation method thereof |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101107015A (en) * | 2005-01-19 | 2008-01-16 | 日本全药工业株式会社 | Injection for mastitis |
| CN101579347A (en) * | 2009-06-25 | 2009-11-18 | 中国农业大学 | Breast perfusion preparation for treating mammitis of milk cow in lactation period and preparation method thereof |
Non-Patent Citations (2)
| Title |
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| 吴文学等.头孢菌素类抗生素的研究与应用.《中国兽药杂志》.2003,第37卷(第9期),第32-36页. * |
| 头孢菌素类抗生素的研究与应用;吴文学等;《中国兽药杂志》;20031231;第37卷(第9期);第32-36页 * |
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