CN104586777B - Ceftiofur Hydrochloride powder-injection and preparation method and application - Google Patents
Ceftiofur Hydrochloride powder-injection and preparation method and application Download PDFInfo
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- CN104586777B CN104586777B CN201410811497.5A CN201410811497A CN104586777B CN 104586777 B CN104586777 B CN 104586777B CN 201410811497 A CN201410811497 A CN 201410811497A CN 104586777 B CN104586777 B CN 104586777B
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Abstract
The invention belongs to veterinary drug technical field, more particularly to a kind of Ceftiofur Hydrochloride powder-injection and preparation method and application.The Ceftiofur Hydrochloride powder-injection is made up of Ceftiofur Hydrochloride with cosolvent, and its active ingredient Ceftiofur is 48~52 by weight with cosolvent：28~34.The present invention substitutes ceftiofur sodium using Ceftiofur Hydrochloride, by Ceftiofur Hydrochloride with active ingredient and cosolvent by weight 48~52：28~34 weigh material, well mixed, packing, that is, Ceftiofur Hydrochloride powder-injection for animals is made, can ordinary temperature production, room temperature storage.The present invention solves that existing veterinary ceftiofur sodium freeze-drying powder must be produced with desivac, raw material and preparation are intended in 4~10 DEG C of cryopreservations, normal temperature or high temperature season standing time are long, cause the problems such as medication effect is poor because of degraded.The powder-injection prepared has the antibacterial effect equal with Ceftiofur sodium for injection pin, and its cost is low, has a extensive future.
Description
Technical field
The invention belongs to veterinary drug technical field, more particularly to a kind of Ceftiofur Hydrochloride powder-injection for animals and preparation method thereof
With application.
Background technology
Ceftiofur system animal doctor special sterilizing broad-spectrum antibiotic, is the cephalo-type antibiosis in beta-lactam antibiotic
Element, can kill a variety of Gram-positives and gramnegative bacterium, be clinically one of widely used antibiotic.Animal doctor
On, typically make freeze-dried powder with ceftiofur sodium, oiliness suspension injection etc. is made with Ceftiofur Hydrochloride, for families such as pigs
Raise the infection of Escherichia coli, the salmonellas of poultry such as bacterial respiratory tract infection, and chicken etc..
At present, Ceftiofur application effect on animal doctor is good, consumption greatly be Ceftiofur sodium for injection pin, hydrochloric acid cephalo
Thiophene furan oiliness suspension injection is because of complex manufacturing, and consumption is relatively much smaller.But, ceftiofur sodium draws moist strong, easily by
Tide degraded, rotten smelly, decreased solubility.
For ceftiofur sodium because drawing the drawbacks, existing veterinary ceftiofur sodium powder such as moist strong, moisture-sensitive degraded is rotten
Pin must make freeze-dried powder, raw material and its preparation and be intended to these problems in presence such as 4~10 DEG C of cryopreservations, it would be highly desirable to develop one
Kind of raw material and its preparation can room temperature storage Ceftiofur Hydrochloride powder pin for animals.Also, at present, not yet see both at home and abroad for animals
Ceftiofur Hydrochloride powder pin listing application report.
The content of the invention
The primary and foremost purpose of the present invention is to overcome shortcoming and deficiency present in prior art, and there is provided a kind of hydrochloric acid cephalo thiophene
Furan powder-injection.
Another object of the present invention is to provide the preparation method of described Ceftiofur Hydrochloride powder-injection.
It is still another object of the present invention to provide the application of described Ceftiofur Hydrochloride powder-injection.
The purpose of the present invention is achieved through the following technical solutions：A kind of Ceftiofur Hydrochloride powder-injection, by hydrochloric acid cephalo thiophene
Furan is constituted with cosolvent；
Described Ceftiofur Hydrochloride is sterile powder for injection, active ingredient Ceftiofur (C19H17N5O7S3) content not
Less than 85%；
Described Ceftiofur Hydrochloride powder-injection, in terms of active ingredient Ceftiofur, the weight with cosolvent is than 48~52：
28~34.
The granularity of described Ceftiofur Hydrochloride is preferably 60~100 mesh, is easy to well mixed and quick dissolving.
Described cosolvent is preferably sodium carbonate or sodium acid carbonate；
Described sodium carbonate or sodium acid carbonate are sterile powder for injection, with the content of active ingredient sodium carbonate or sodium acid carbonate
Meter, must not be less than 99%.
Described sodium carbonate or the granularity of sodium acid carbonate are preferably 60~100 mesh, are easy to well mixed and quick dissolving.
The preparation method of described Ceftiofur Hydrochloride powder-injection, comprises the following steps：Will be with active ingredient Ceftiofur
With cosolvent by weight 48~52：28~34 materials weighed are well mixed, packing, obtain Ceftiofur Hydrochloride powder-injection.
The granularity of described Ceftiofur Hydrochloride is preferably 60~100 mesh.
The granularity of described cosolvent is preferably 60~100 mesh.
Described packing is carried out preferably on racking machine.
Aforesaid operations are carried out in powder pin cleaning shop, and the purity requirements in all these step operation posies are 100
Level.
Described Ceftiofur Hydrochloride powder-injection be applied to the treatment respiratory system of animal, urogenital system, skin and
The infection of the systems such as soft tissue, liver and gall or ear nose larynx.
Described infection is by the sensitive S. aureus L-forms of benzyl penicillin, streptococcus, pneumococcus, Escherichia coli, Pasteur's bar
Respiratory system, genito-urinary system caused by bacterium, haemophilus, salmonella, Bacillus influenzae, shigella dysenteriae or proteus etc.
The infection of system, skin and soft tissue, liver and gall, ear nose larynx etc..
The present invention has the following advantages and effect relative to prior art：
(1) present invention substitutes ceftiofur sodium using without hygroscopic Ceftiofur Hydrochloride, by Ceftiofur Hydrochloride with helping
Solvent is by weight 48~52 (active ingredient Ceftiofurs)：28~34, material is weighed, is well mixed, beast just can be made in packing
Use Ceftiofur Hydrochloride powder-injection, can ordinary temperature production (needn't desivac production), raw material and its preparation can room temperature storages.Supporting
Grow the field substantial amounts of clinical test of progress and show that this powder-injection has the antibacterial effect equal with Ceftiofur sodium for injection pin.This
Outside, sodium benemid, anti inflammation and heat resolution antalgesic and local anesthetic of injection stage etc. can be also added, is made in extension effective blood drug concentration
With the time, anti-inflammatory analgesic, it is antipyretic bring down a fever, reduce and effect stress greatly strengthen in terms of pain, also increase feeding.
(2) present invention solves existing veterinary ceftiofur sodium freeze-drying powder, because Ceftiofur sodium raw materials draw moist strong, easy
The reason such as degraded of making moist is rotten, its powder-injection must be produced with desivac, raw material and preparation are intended in 4~10 DEG C of cryopreservations, often
Temperature or summer high-temperature standing time in season are long, cause the problems such as medication effect is poor because of degraded.Also, the raw material of this powder-injection
Ceftiofur Hydrochloride price is much lower, reduces production and use cost, and wide market, social benefit is big.The present invention is carried
The Ceftiofur Hydrochloride powder-injection scientific formula of confession is reasonable, no incompatibility；The Ceftiofur Hydrochloride powder for animals that the present invention is provided
The preparation method of injection, technological process is easy rationally.
Embodiment
With reference to embodiment, the present invention is described in further detail, but the implementation of the present invention is not limited to this.
Embodiment 1
A kind of preparation method of Ceftiofur Hydrochloride powder-injection, comprises the following steps：By Ceftiofur Hydrochloride and sodium carbonate
By weight 48 (in terms of active ingredient Ceftiofurs)：28 weigh material, put into SYH-100 three-dimensional motion mixers, mix
After closing 15 minutes, it is transferred on KGL-120 type antibiotic glass bottle screw type sub packaging machines, is dispensed, obtain Ceftiofur Hydrochloride
Powder-injection.It is 0.1g, 0.2g, 0.5g or 1.0g (in terms of active ingredient Ceftiofur) per bottled amount, wherein, 0.1g and 0.2g
Specification is dispensed with 5~7mL cillin bottles, and 0.5g specifications are dispensed with 10~15mL cillin bottles, 1.0g specifications 20~25mL cillin bottles
Packing.
The granularity of Ceftiofur Hydrochloride is 60~100 mesh.
The granularity of sodium carbonate is 60~100 mesh.
Aforesaid operations are carried out in powder pin cleaning shop, and the purity requirements in all these step operation posies are 100
Level.
Embodiment 2
A kind of preparation method of Ceftiofur Hydrochloride powder-injection, comprises the following steps：By Ceftiofur Hydrochloride and sodium carbonate
By weight 50 (in terms of active ingredient Ceftiofurs)：31 weigh material, put into SYH-100 three-dimensional motion mixers, mix
After closing 15 minutes, it is transferred on KGL-120 type antibiotic glass bottle screw type sub packaging machines, is dispensed, obtain Ceftiofur Hydrochloride
Powder-injection.It is 0.1g, 0.2g, 0.5g or 1.0g (in terms of active ingredient Ceftiofur) per bottled amount, wherein, 0.1g and 0.2g
Specification is dispensed with 5~7mL cillin bottles, and 0.5g specifications are dispensed with 10~15mL cillin bottles, 1.0g specifications 20~25mL cillin bottles
Packing.
The granularity of Ceftiofur Hydrochloride is 60~100 mesh.
The granularity of sodium carbonate is 60~100 mesh.
Aforesaid operations are carried out in powder pin cleaning shop, and the purity requirements in all these step operation posies are 100
Level.
Embodiment 3
A kind of preparation method of Ceftiofur Hydrochloride powder-injection, comprises the following steps：By Ceftiofur Hydrochloride and sodium carbonate
By weight 52 (in terms of active ingredient Ceftiofurs)：34 weigh material, put into SYH-100 three-dimensional motion mixers, mix
After closing 15 minutes, it is transferred on KGL-120 type antibiotic glass bottle screw type sub packaging machines, is dispensed, obtain Ceftiofur Hydrochloride
Powder-injection.It is 0.1g, 0.2g, 0.5g or 1.0g (in terms of active ingredient Ceftiofur) per bottled amount, wherein, 0.1g and 0.2g
Specification is dispensed with 5~7mL cillin bottles, and 0.5g specifications are dispensed with 10~15mL cillin bottles, 1.0g specifications 20~25mL cillin bottles
Packing.
The granularity of Ceftiofur Hydrochloride is 60~100 mesh.
The granularity of sodium carbonate is 60~100 mesh.
Aforesaid operations are carried out in powder pin cleaning shop, and the purity requirements in all these step operation posies are 100
Level.
Embodiment 4
A kind of preparation method of Ceftiofur Hydrochloride powder-injection, comprises the following steps：By Ceftiofur Hydrochloride and bicarbonate
Sodium is by weight 48 (in terms of active ingredient Ceftiofurs)：28 weigh material, put into SYH-100 three-dimensional motion mixers,
After mixing 15 minutes, it is transferred on KGL-120 type antibiotic glass bottle screw type sub packaging machines, is dispensed, obtain hydrochloric acid cephalo thiophene
Furan powder-injection.Per bottled amount be 0.1g, 0.2g, 0.5g or 1.0g (in terms of active ingredient Ceftiofur), wherein, 0.1g with
0.2g specifications are dispensed with 5~7mL cillin bottles, and 0.5g specifications are dispensed with 10~15mL cillin bottles, 1.0g specifications 20~25mL west
Woods bottle packing.
The granularity of Ceftiofur Hydrochloride is 60~100 mesh.
The granularity of sodium carbonate is 60~100 mesh.
Aforesaid operations are carried out in powder pin cleaning shop, and the purity requirements in all these step operation posies are 100
Level.
Embodiment 5
A kind of preparation method of Ceftiofur Hydrochloride powder-injection, comprises the following steps：By Ceftiofur Hydrochloride and bicarbonate
Sodium is by weight 50 (in terms of active ingredient Ceftiofurs)：31 weigh material, put into SYH-100 three-dimensional motion mixers,
After mixing 15 minutes, it is transferred on KGL-120 type antibiotic glass bottle screw type sub packaging machines, is dispensed, obtain hydrochloric acid cephalo thiophene
Furan powder-injection.Per bottled amount be 0.1g, 0.2g, 0.5g or 1.0g (in terms of active ingredient Ceftiofur), wherein, 0.1g with
0.2g specifications are dispensed with 5~7mL cillin bottles, and 0.5g specifications are dispensed with 10~15mL cillin bottles, 1.0g specifications 20~25mL west
Woods bottle packing.
The granularity of Ceftiofur Hydrochloride is 60~100 mesh.
The granularity of sodium carbonate is 60~100 mesh.
Aforesaid operations are carried out in powder pin cleaning shop, and the purity requirements in all these step operation posies are 100
Level.
Embodiment 6
A kind of preparation method of Ceftiofur Hydrochloride powder-injection, comprises the following steps：By Ceftiofur Hydrochloride and bicarbonate
Sodium is by weight 52 (in terms of active ingredient Ceftiofurs)：34 weigh material, put into SYH-100 three-dimensional motion mixers,
After mixing 15 minutes, it is transferred on KGL-120 type antibiotic glass bottle screw type sub packaging machines, is dispensed, obtain hydrochloric acid cephalo thiophene
Furan powder-injection.Per bottled amount be 0.1g, 0.2g, 0.5g or 1.0g (in terms of active ingredient Ceftiofur), wherein, 0.1g with
0.2g specifications are dispensed with 5~7mL cillin bottles, and 0.5g specifications are dispensed with 10~15mL cillin bottles, 1.0g specifications 20~25mL west
Woods bottle packing.
The granularity of Ceftiofur Hydrochloride is 60~100 mesh.
The granularity of sodium carbonate is 60~100 mesh.
Aforesaid operations are carried out in powder pin cleaning shop, and the purity requirements in all these step operation posies are 100
Level.
Embodiment 7
The sample prepared to above-described embodiment, under the conditions of 40 DEG C of high temperature, humidity 75% ± 5%, carries out accelerating examination in 6 months
Investigation is tested, it the results are shown in Table 1.
6 months accelerated tests investigate experiment and show that every bottle of active ingredient of sample average from embodiment 1 to embodiment 6 is equal
For more than the 90% of labelled amount, in acceptability limit, the Ceftiofur Hydrochloride powder-injection stabilization that explanation is prepared with the inventive method
Property is good.
The accelerated test of the Ceftiofur Hydrochloride powder-injection for animals of table 1
Note：Relevant detection data reference in table 1《Republic of China Veterinary Pharmacopoeia》(the Chinese veterinary pharmacopoeia committee
Compile, Chinese agriculture publishing house publishes), (in a 2010 version) P65：The clarity check item and assay of solution.
Effect example 1
The effect test of Ceftiofur Hydrochloride powder-injection
(1) medicine：One group is the Ceftiofur Hydrochloride powder pin (test group) prepared by embodiment 2,0.5g/ bottles of loading amount；Separately
One group is injection Ceftiofur sodium powder pin (control group), and loading amount is also 0.5g/ bottles, and loading amount is with active ingredient Ceftiofur
(C19H17N5O7S3) meter.
(2) to the respiratory tract infection caused by Pasteurella of certain pig farm, symptom, body weight are declined with cough and asthma, fever, feeding
Treated in 15~20kg 80 piglets, be divided into two groups, every group 40.One group with Ceftiofur Hydrochloride powder pin, separately
One group with Ceftiofur sodium powder pin.
(3) process of injection powder injection：0.5g/ bottles of injection 10mL waters for injection, shaking dissolving, dilution is configured to injection
Liquid；Respectively to above-mentioned two groups ill piglets in neck intramuscular injection, by 5mg Ceftiofurs (C19H17N5O7S3The dosage note of)/kg body weight
Penetrate, 1 times a day, be used in conjunction 3, the result after observed and recorded injection, every group of data are averaged.Result of the test is shown in Table 2.
The Ceftiofur Hydrochloride powder of table 2 is directed to the effect test of piglet bacillary respiratory tract infection
Note：1st, the normal body temperature of pig is between 37.8~40.0 DEG C, and 40.0 DEG C of ＞ is generally viewed as fever；2nd, test group,
Control group has part, goes back medication 1 time within the 4th day.
The result of the test of table 2 shows that test group and control group total cure rate are also slightly higher more than 80%, illustrates this
Ceftiofur Hydrochloride powder-injection prepared by inventive method, to the therapeutic effect of piglet bacillary respiratory tract infection, with Ceftiofur
Sodium powder pin is quite, also slightly strong.
Effect example 2
The effect test of Ceftiofur Hydrochloride powder-injection
(1) medicine：One group is the Ceftiofur Hydrochloride powder pin (test group) prepared by embodiment 5,0.1g/ bottles of loading amount；Separately
One group is injection Ceftiofur sodium powder pin (control group), and loading amount is also 0.1g/ bottles, and loading amount is with active ingredient Ceftiofur
(C19H17N5O7S3) meter.
(2) certain chicken house is had loose bowels caused by Escherichia coli, salmonella infection, dysentery characterized by white mucous stool, with paste anus, feeding decline disease
Shape, 500 chicks of 3 ages in days are treated, and are divided into two groups, every group 250.One group with Ceftiofur Hydrochloride powder pin, separately
One group with Ceftiofur sodium powder pin.
(3) process of injection powder injection：0.1g/ bottles of injection injection 10mL waters for injection, shaking dissolving, then use water for injection
Dilution is configured to 0.50mg/ml parenteral solution；Above-mentioned two groups ill chickens are noted in neck skin respectively, by 0.25mg Ceftiofurs
(C19H17N5O7S3The dose subcutaneous injection an of)/chick, 1 times a day, is used in conjunction 3, the result after observed and recorded skin note, every group of number
According to averaging.Result of the test is shown in Table 3.
The Ceftiofur Hydrochloride powder of table 3 is directed to chick Escherichia coli, the effect test of salmonella infection
The result of the test of table 3 shows that test group is with control group cure rate more than 80%, and gap is little, and slightly higher,
Illustrate Ceftiofur Hydrochloride powder-injection prepared by the inventive method, chick is drawn caused by Escherichia coli, salmonella infection
Dilute, dysentery characterized by white mucous stool therapeutic effect, it is suitable with Ceftiofur sodium powder pin, it is also slightly better.
Above-described embodiment is preferably embodiment, but embodiments of the present invention are not by above-described embodiment of the invention
Limitation, other any Spirit Essences without departing from the present invention and the change made under principle, modification, replacement, combine, simplification,
Equivalent substitute mode is should be, is included within protection scope of the present invention.
Claims (4)
1. a kind of Ceftiofur Hydrochloride powder-injection, it is characterised in that be made up of Ceftiofur Hydrochloride with cosolvent；
Described Ceftiofur Hydrochloride is sterile powder for injection, and the content of active ingredient Ceftiofur is not less than 85%；
Described Ceftiofur Hydrochloride powder-injection, in terms of active ingredient Ceftiofur, the weight ratio with cosolvent is 48~52：28
~34；Described cosolvent is sodium carbonate or sodium acid carbonate.
2. Ceftiofur Hydrochloride powder-injection according to claim 1, it is characterised in that described sodium carbonate or sodium acid carbonate
For sterile powder for injection, with active ingredient sodium carbonate or the content meter of sodium acid carbonate, 99% must not be less than.
3. Ceftiofur Hydrochloride powder-injection according to claim 1, it is characterised in that the grain of described Ceftiofur Hydrochloride
Spend for 60~100 mesh.
4. Ceftiofur Hydrochloride powder-injection according to claim 1, it is characterised in that described sodium carbonate or sodium acid carbonate
Granularity be 60~100 mesh.
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| CN201410811497.5A CN104586777B (en) | 2014-12-22 | 2014-12-22 | Ceftiofur Hydrochloride powder-injection and preparation method and application |
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| CN201410811497.5A CN104586777B (en) | 2014-12-22 | 2014-12-22 | Ceftiofur Hydrochloride powder-injection and preparation method and application |
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Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104983695B (en) * | 2015-07-17 | 2018-01-09 | 江西博莱大药厂有限公司 | A kind of Ceftiofur Hydrochloride liposome freeze-drying agent and preparation method thereof |
| CN106860857A (en) * | 2017-01-16 | 2017-06-20 | 安徽天安生物科技股份有限公司 | A kind of chinese-western medicine preparation for treating the yellowish-white dysentery of pig |
| CN112645965B (en) * | 2020-12-22 | 2022-03-25 | 浙江华尔成生物药业股份有限公司 | Preparation process of ceftiofur sodium for vacuum freeze-drying injection |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1813760A (en) * | 2005-12-12 | 2006-08-09 | 浙江升华拜克生物股份有限公司 | Ceftiofur-containing powder injection for beast |
| CN102106857A (en) * | 2009-12-29 | 2011-06-29 | 齐鲁动物保健品有限公司 | Compound ceftiofur sodium freeze-dried power injection used for injection |
-
2014
- 2014-12-22 CN CN201410811497.5A patent/CN104586777B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1813760A (en) * | 2005-12-12 | 2006-08-09 | 浙江升华拜克生物股份有限公司 | Ceftiofur-containing powder injection for beast |
| CN102106857A (en) * | 2009-12-29 | 2011-06-29 | 齐鲁动物保健品有限公司 | Compound ceftiofur sodium freeze-dried power injection used for injection |
Non-Patent Citations (3)
| Title |
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| 复方盐酸头孢噻呋混悬剂的药代动力学研究;党晓林等;《中国兽药杂志》;20121231;第46卷(第2期);第10-15页 * |
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