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Long-acting ceftiofur hydrochloride injection and preparation method thereof

A technology of ceftiofur hydrochloride and injection, which is applied in the field of long-acting ceftiofur hydrochloride suspension injection and its preparation, can solve the problems of short action time and achieve the effects of improving fluidity, good fluidity, and eliminating half-life

Active Publication Date: 2012-06-20
武汉回盛生物科技股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The dosage forms of ceftiofur currently studied both at home and abroad include dosage forms such as ceftiofur sodium powder for injection and ceftiofur sodium liposome. ~5 days, in order to reduce the waste of manpower and financial resources of the farm caused by frequent injections of ceftiofur, and to avoid animal stress reactions caused by multiple administrations, the present invention provides a convenient administration method for the breeding industry in my country. The long-acting ceftiofur preparation provides convenience for clinical drug use

Method used

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  • Long-acting ceftiofur hydrochloride injection and preparation method thereof
  • Long-acting ceftiofur hydrochloride injection and preparation method thereof
  • Long-acting ceftiofur hydrochloride injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] (1) Add 7.5g of ceftiofur hydrochloride to 40ml of glycerol triacetate, stir magnetically, and mix well;

[0028] (2) Add 0.3g of compound suspending agent (hydrogenated castor oil: lecithin 1:2 (g / g) mixture) into glycerol triacetate at 90°C to dissolve;

[0029] (3) Cool the solution in step (2) to room temperature and add it to the stirring suspension in step (1), and stir evenly;

[0030] (4) Add 0.5g bacteriostatic agent chlorobutanol to the suspension in step (3), adjust to 100ml with the remaining triacetin, and stir thoroughly;

[0031] (5) Stir and mix for 30 minutes, pass through a high-speed shear disperser for 30 minutes at a speed of 1200r / min, pass through a colloid mill for 4 hours, and finally sterilize the sample by irradiating 60Co-γ rays at 3KGY to obtain a milky white or light yellow suspension .

[0032] The properties of the suspension are milky white or light yellow, the particle size distribution is uniform, the average particle size is 8.38 μm...

Embodiment 2

[0034] (1) Add 7.5g of ceftiofur hydrochloride to 40ml of composite solvent (36ml of glycerol triacetate and 4ml of polyethylene glycol 200), stir magnetically, and mix well;

[0035] (2) Add 0.3g of compound suspending agent (hydrogenated castor oil: lecithin 1:2 (g / g) mixture) into glycerol triacetate at 90°C to dissolve;

[0036] (3) Cool the solution in step (2) to room temperature and add it to the stirring suspension in step (1), and stir evenly;

[0037] (4) Add 0.2g of bacteriostatic agent benzyl alcohol to the suspension in step (3), adjust to 100ml with the remaining triacetin, and stir thoroughly;

[0038] (5) Stir and mix for 30 minutes, pass through a high-speed shear disperser for 30 minutes at a speed of 1200r / min, pass through a colloid mill for 4 hours, and finally sterilize the sample by irradiating 60Co-γ rays at 3KGY to obtain a milky white or light yellow suspension .

[0039] The properties of the suspension are milky white or light yellow, the particle...

Embodiment 3

[0041] (1) Add 7.5g of ceftiofur hydrochloride to 40ml of compound solvent (36ml of glycerol triacetate and 4ml of polyethylene glycol 200: Span 80 at a ratio of 2:1 (v / v) mixture), stir magnetically, and mix well ;

[0042](2) Add 0.3g of compound suspending agent (hydrogenated castor oil: lecithin 1:2 (g / g) mixture) into glycerol triacetate at 90°C to dissolve;

[0043] (3) Cool the solution in step (2) to room temperature and add it to the stirring suspension in step (1), and stir evenly;

[0044] (4) Add 0.5g of bacteriostatic agent benzyl alcohol to the suspension in step (3), adjust to 100ml with the remaining triacetin, and stir thoroughly;

[0045] (5) Stir and mix for 30 minutes, pass through a high-speed shear disperser for 30 minutes at a speed of 1200r / min, pass through a colloid mill for 4 hours, and finally sterilize the sample by irradiating 60Co-γ rays at 3KGY to obtain a milky white or light yellow suspension .

[0046] The properties of the suspension are ...

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Abstract

The invention relates to a long-acting ceftiofur hydrochloride injection which is prepared by the following method: adding ceftiofur hydrochloride as a bulk pharmaceutical chemical into a compound solvent to be stirred; fully and evenly mixing to obtain a mixed suspension; adding a suspending agent into an injection solvent, and dissolving at the temperature of 80-90 DEG C to obtain a solution liquid; after cooling the solution liquid to room temperature, adding the solution liquid into the mixed suspension, and evenly stirring to obtain a mixed liquid; adding a bacteriostatic agent into the mixed liquid, adding residual injection-grade solvent to reach total amount, and evenly mixing; respectively processing by a high-speed shearing dispersion machine and a colloid mill; and sterilizing to obtain the long-acting ceftiofur hydrochloride injection. The preparation method of the long-acting ceftiofur hydrochloride injection is simple in operation, and the obtained mixed suspension injection is even and has the advantages of good redispersibility, good liquidity and slow settlement. The long-acting ceftiofur hydrochloride injection has the advantages of good solubility and stability,is long in half life of elimination after porcine muscle is injected, can prolong the effective in-vivo acting time of the injection, and reduces usage times.

Description

technical field [0001] The invention belongs to the field of animal medicines, and in particular relates to a long-acting ceftiofur hydrochloride suspension injection and a preparation method thereof. Background technique [0002] Ceftiofur has the characteristics of long-lasting drug effect. It can be reversibly combined with protein in animals to form a bactericidal inventory. It has a wide antibacterial spectrum and is effective against various Gram-negative bacteria (such as E. ) and Gram-positive bacteria (such as Staphylococcus, Streptococcus) have significant efficacy. Ceftiofur has a stable molecular structure and is not destroyed by β-lactamase, so it is not easy to produce drug resistance or cross-resistance, and is widely used in the field of veterinary medicine. [0003] The dosage forms of ceftiofur currently studied at home and abroad include dosage forms such as ceftiofur sodium powder for injection and ceftiofur sodium liposome. ~5 days, in order to reduce t...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/10A61K31/546A61P31/04
Inventor 张卫元操继跃陈翠兰张永丹张翠平
Owner 武汉回盛生物科技股份有限公司
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